QC, noise, stat time— those and other details for an ...

Automated immunoassay analyzers12 cap today | september 2014

September 2014 page 12

Tabulation does not represent an endorsement by the College of American Pathologists.

Automated immunoassay analyzers

Part 1 of 21 Abbott Diagnostics Abbott DiagnosticsJonathan Burgart [email protected] Jonathan Burgart [email protected]

See captodayonline.com/productguides for an interactive version of guide

100 Abbott Park Rd., CP1-4, Abbott Park, IL 60064 100 Abbott Park Rd., CP1-4, Abbott Park, IL 60064224-667-5678 www.abbottdiagnostics.com 224-667-5678 www.abbottdiagnostics.com

Name of instrument/First year sold/Where designed ARCHITECT i1000SR/2008/U.S. ARCHITECT i2000SR/2002, i4000SR/2007/U.S.Country where manufactured/Where reagents manufactured Singapore/U.S., Europe Singapore/U.S., EuropeNumber of units in clinical use in U.S./Outside U.S. — —Operational type/Model type/Sample handling system continuous random access/floor standing/robotic

sample handler allows batch, random access, continuous access, and reagent loading and unloading

batch, random access, continuous random access/ floor standing/track and LAS

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 59 × 30/12.3 48 × 61 × 49/20.7 (i2000SR)

Tests available on instrument in U.S. — —

Tests not available in U.S. but submitted for clearance — —Tests not available in U.S. but available in other countries — —

Tests in development — —

Tests not available on other manufacturers’ analyzers — —

Fully automated microplate system — —Number of each analyte performed in separate disposable unit — —Number of wells in microplate — —

Methods supported/Separation methods chemiluminescence/magnetic particle Chemiflex (enhanced chemiluminescence) with 5 flexible protocols/magnetic microparticle

Number of different measured assays onboard simultaneously 25 25Number of different assays programmed, calibrated at once 61 61Number of user-definable (open) channels none noneNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/100 25/100 tests and 500 tests per kit

Shortest/Median onboard reagent stability/Refrigerated onboard 14 days (vitamin D)/30 days tracked in hours/yes 14 days (vitamin D)/30 days tracked in hours/yes

Multiple reagent configurations supported yes yesReagent container placed directly on system for use yes yesReagents bar-coded/Information in bar code yes/assay number, reagent serial number, lot

number, tests per kit, expiration onboard stability time, others

yes/assay No., reagent serial No., lot No., tests per kit, exp. date, onboard stability time, master calibration curve

Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/<0.1 ppm no/<0.1 ppmWalkaway capacity in minutes/Specimens/Tests, assays 180/65/25 300/135/12,500

System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/360 yes/1,200Uses washable cuvettes/Replacement frequency no/— no/—Minimum specimen volume required varies based on assay varies based on assayMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/50 µL 10 µL/50 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/noRequires dedicated water system/Water consumption no/— no/—Noise generated 58 decibels during normal operation, 62 decibels

maximum48–70 decibels

Has dedicated pediatric sample cup/Dead volume no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-,10-mL tubes and sample cups/no yes/5-, 7-,10-mL tubes and sample cups/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and

128)/yesyes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Bar-code placement per CLSI standard Auto2A yes yesOnboard test auto inventory (determines volume in container) yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yesClot detection/Reflex testing capability yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no

Time between initial result and reaspiration of sample for rerun — —Autocalibration or autocalibration alert yes yesNumber of calibrators required for each analyte 2–6, assay dependent 2–6, assay dependentCalibrants can be stored onboard/Average calibration frequency no/calibration required with new lot no/calibration required with new lot Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes (up to 4 curves per analyte) yes/yes (up to 4 curves per analyte)How often QC required every 24 hours or per lab-specific procedure every 24 hours or per lab-specific procedureOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/6.5 minutes —/no/10 minutes

Stat time to completion of βhCG test 18 minutes 18 minutesTime delay from ordering stat test to aspiration of sample — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

up to 33 samples/100 tests per hour up to 67 samples/200 tests per hour

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/no onboard/noLIS interfaces up and running in active user sites all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes yesModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator yes yes, AbbottLinkOn-site response time of service engineer — —Mean time between failures/To repair failures — —Average time to complete maintenance by lab personnel — —

Onboard maintenance records/Maintenance training demo module yes/yes yes/yes

List price/Targeted bed size or daily volume — —Annual service contract cost (24 hours/7 days) — —Training provided with purchase/Advanced operator training yes/yes yes/yes

Distinguishing features (supplied by company)

Note: a dash in lieu of an answer means company did not answer question or question is not applicable

streamlined workload management; continuous access to reagents, samples, and supplies; 65-sample load capacity; 13 universal bays, 7 customizable priority bays; refrigerated reagent carousel with 25 × 100 test-kit sizes; reagents stable onboard up to 30 days; priority tests; 18-minute turnaround time on stat assays

Chemiflex technology delivers excellent sensitivities and extended linearities; RSH allows priority and routine samples to be processed simultaneously without compromising stats; refer to operations manual for operational precautions, limitations, and hazards; class 1 laser product

QC, noise, stat time—those and other details for 62 analyzersWith nearly two dozen manufactur-ers of immunoassay analyzers repre-sented in CAP TODAY’s product guide this month, the market is rich with options. At least three of those companies have enhanced, or are about to enhance, their existing ana-lyzers with new functions or assays.

Corgenix Medical Corp., for ex-ample, has added a function to its SkyLab 752 dual-pipette automat-ed ELISA analyzer, an instrument introduced two years ago. Users of the analyzer will now be able to perform IFA slide preparation and process 28 slides in one run, says national sales and service manager Christopher Lynn.

Lynn takes the opportunity to remark that “ELISA technology is alive and well,” saying that “with many ELISA assays, the cost per pa-tient result is very low and is well suited for the laboratory’s tighten-ing budget. In some cases, testing has migrated back to the ELISA for-mat for this reason.”

In the view of Mark Smith, senior manager, immunoassay, Beckman Coulter Diagnostics, one hot topic in the immunoassay market is car-diac troponin testing. He points to the AccuTnI+3 troponin assay, for which Beckman Coulter received FDA clearance last year for use on all of the company’s immunoassay systems. “The AccuTnI+3 assay de-livers the precision and the clinical sensitivity and clinical specificity that are necessary to assist physi-cians with the diagnosis of myocar-dial infarction,” he says.

Customers of The Binding Site can look forward to the coming launch of DataSite, a data-manage-ment software tool for use with the company’s SPAplus automated an-alyzer for special protein ana lysis. “It will allow the operator to im-prove productivity, workflow man-agement, and QC management,” says The Binding Site representa-tive Tamara Kaplan.

CAP TODAY’s guide to immuno-assay analyzers consists of systems from the aforementioned companies and from Abbott, Alere, Awareness Technology, BioMérieux, Bio-Rad Laboratories, Diamedix, DiaSorin, Dynex, Grifols, Hycor, Immunodi-agnostic Systems, Inova DX, Ortho Clinical Diagnostics, Randox Labo-ratories, Roche, Siemens, Thermo Fisher Scientific, and Tosoh Biosci-ence. Companies supplied the in-formation listed. Readers interested in a particular product should con-firm it has the stated features and capabilities.

—Anne Ford





Part 2 of 21 Abbott Diagnostics Alere AlereJonathan Burgart [email protected] Matthew Carrier [email protected] Matthew Carrier [email protected]


100 Abbott Park Rd., CP1-4, Abbott Park, IL 60064 2 Research Way, Princeton, NJ 08540 2 Research Way, Princeton, NJ 08540224-667-5678 www.abbottdiagnostics.com 207-210-0446 www.alere.com 207-210-0446 www.alere.com

Name of instrument/First year sold/Where designed ARCHITECT ci4100 (2009), ci8200 (2003), ci16200 (2007)/U.S. Agility/2012/U.S. DS2/2007/U.S.Country where manufactured/Where reagents manufactured Singapore (IA), Japan (chemistry)/U.S., Europe U.S./U.S. U.S./U.S.Number of units in clinical use in U.S./Outside U.S. — <10/<10 ~100/—Operational type/Model type/Sample handling system batch, random access, continuous random access/floor

standing/robotic sample handler uses multidimensional sample handling

batch/benchtop/rack batch/benchtop/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 48 × 127 × 49/43.2 48 × 48 × 36/8.6 27 × 21 × 26/4

Tests available on instrument in U.S. — open system, tests provided by various manufacturers ID: chlamydia, CMV, EBV-EA, EBNA, EBV-VCA, H. pylori, HSV, legionella, lyme, measles, mumps, myco, rubella, syphilis, toxo, VZV, Parvo B19; AI: ANCA, ANA, CCP, car-dios, dsDNA, ENA, gliadin, histone, Jo-1, mitochondria, MPO, PR-3, RF, Scl-70, SM, SM/RNP, SS-A, SS-B, TPO, TG, TTG; osteo: NTx. bladder cancer-NMP22; enterics: tox AB, GDH, crypto, giardia, E histo, ASCA, IBD. leukocyte

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — — —Tests in development — — —Tests not available on other manufacturers’ analyzers — — enterics: tox AB, GDH, crypto, giardia, E histo, ASCA, IBD.

leukocyte

Fully automated microplate system — yes yesNumber of each analyte performed in separate disposable unit — 1 per well 1 analyte per well, multiple analytes per wellNumber of wells in microplate — 96 (minimum: 1 strip; maximum: 12 full plates) 96 (minimum: 1; maximum: 96)

Methods supported/Separation methods photometric, potentiometric, and Chemiflex (enhanced chemiluminescence)/—

enzyme immunoassay/coated microplate wells enzyme immunoassay/coated microwell

Number of different measured assays onboard simultaneously 80–93, based on analyzer 16 24Number of different assays programmed, calibrated at once 147 assays available 12 24Number of user-definable (open) channels 220 (on chemistry modules only) unlimited unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

93/61–1,700 16/96 18/24

Shortest/Median onboard reagent stability/Refrigerated onboard CC: 5/28; IA: 14 days (vitamin D)/30 days tracked in hours/yes —/no 8 hours/1 day/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/assay name, reagent number, lot number, tests per

kit, expiration date, othersyes/lot information no/—

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes (chemistry)/<0.1 ppm yes/disposable tip no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 300/367/>75,000 assay dependent/200+ continuous load/12+ continuous

load120 minutes/98/24

System is open (homebrew methods can be used)/Liquid or dry system yes (chemistry)/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored disposable and semipermanent/see individual

standalone modulesno/— no/—

Uses washable cuvettes/Replacement frequency yes/as needed, minimum 1-year guarantee no/— no/—Minimum specimen volume required varies based on assay 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 2 uL (chemistry), 10 µL (IA)/50 µL 10 µL/150 µL 10 µL/50 µLSupplied with UPS (backup power)/Requires floor drain yes/yes yes/no no/noRequires dedicated water system/Water consumption yes/25 L per hour (ci8200); 52 L per hour (ci16200);

15 L per hour (ci4100)no/— no/—

Noise generated 48 –70 decibels — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-, 10-mL tubes and sample cups/no yes/10–17 mm diameter, 45–100 mm depth/no yes/primary, pour off/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes — yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/no yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert yes no noNumber of calibrators required for each analyte 2–6, assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/IA: calibration with new lot; CC: 28 days no/per plate no/within each runMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes (up to 4 curves per analyte) no/no no/noHow often QC required every 24 hours or per lab-specific procedure per plate with every assay

Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes no/no no/yesAutomatic shutdown/Startup is programmable/Startup time —/no/10 minutes no/no/3–5 minutes yes/yes/5 minutes

Stat time to completion of βhCG test 18 minutes — —

Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

up to 267/800 (c4000), 400/1200 (c8000), 600/1800 (c16000), 33/100 (i1000sr), 67/200 (i2000sr)

microplate batch process/— —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/no onboard/yes onboard/yes (additional cost)LIS interfaces up and running in active user sites all major LIS vendors — Cerner, Millennium, Sunquest, Soft, Mysis, etc.LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes no/yes/no

Can order (via modem) malfunctioning part(s) without operator yes, AbbottLink no noOn-site response time of service engineer — 24 hours 24 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel — daily: <15 minutes; weekly: <30 minutes;

monthly: <1 hourdaily: 5 minutes; weekly: 20 minutes; monthly: 20 minutes

Onboard maintenance records/Maintenance training demo module yes/yes no/no no/no

List price/Targeted bed size or daily volume — $149,999 (includes one-year warranty)/various $52,619.35/<350 bedsAnnual service contract cost (24 hours/7 days) — — $9,000Training provided with purchase/Advanced operator training yes/yes —/yes 3 days on site/yes



integration of CC and IA without compromising stat turnaround time, results, or throughput because of patented SmartWash technology, which minimizes car-ryover to <0.1 ppm, reagent capacity of 93 assays, with sample load up to 367; refer to operations manual for operational precautions, limitations, and hazards

reduces hands-on time by more than 60 percent forELISA testing; tracks all assays, test kits, consumables, reagents, and waste so test menu can run without interruption

combined with the Alere ELISA product line and the ability to automate enteric assays and front-end dilute Inverness Athena assays, the DS2 provides an efficient, open, fully automated solution for customers looking for laboratory automation





Part 3 of 21 Alere Awareness Technology Beckman CoulterMatthew Carrier [email protected] Jamie Raistano (US) [email protected] Mark Smith [email protected]


2 Research Way, Princeton, NJ 08540 1935 SW Martin Highway, Palm City, FL 34990 250 S. Kraemer Blvd., Brea, CA 92821207-210-0446 www.alere.com 772-283-6540 www.awaretech.com 714-961-4375 www.beckmancoulter.com

Name of instrument/First year sold/Where designed DSX/2004/U.S. ChemWell/1998/U.S. Access, Access 2 Immunoassay System/2001/U.S.Country where manufactured/Where reagents manufactured U.S./U.S. U.S./— U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. approx. 500/— 80+/4,350+ >2,000/>2,500Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack continuous random access/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 32 × 42 × 36/7 16 × 34 × 20/4 18.5 × 39 × 24/6.5

Tests available on instrument in U.S. ID: chlamydia, CMV, EBV-EA, EBNA, EBV-VCA, H. pylori, HSV, legionella, lyme, measles, mumps, myco, rubella, syphilis, toxo, VZV, Parvo B19; AI: ANCA, ANA, CCP, cardios, dsDNA, ENA, gliadin, histone, Jo-1, mitochondria, MPO, PR-3, RF, Scl-70, SM, SM/RNP, SS-A, SS-B, TPO, TG, TTG; osteo: NTx. bladder cancer-NMP22; enterics: tox AB, GDH, crypto, giardia, E histo, ASCA, IBD. leukocyte

unlimited (open system) cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated es-triol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, and many others

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — unlimited (open system) HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin DTests in development — — AMH

Tests not available on other manufacturers’ analyzers enterics: tox AB, GDH, crypto, giardia, E histo, ASCA, IBD. leukocyte

— —

Fully automated microplate system yes yes noNumber of each analyte performed in separate disposable unit 1 analyte per well, multiple analytes per well up to 12 —Number of wells in microplate 96 (minimum: 1; maximum: 96) minimum strip: 8; maximum full plate: 96 —

Methods supported/Separation methods enzyme immunoassay/coated microwell enzyme immunoassay/coated microwell chemiluminescence/magnetic particle

Number of different measured assays onboard simultaneously 48 up to 12 24Number of different assays programmed, calibrated at once 48 unlimited 24Number of user-definable (open) channels unlimited unlimited 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

24/48 27/assay dependent 24/100 tests per kit; 50 tests per cartridge

Shortest/Median onboard reagent stability/Refrigerated onboard 8 hours/1 day/no assay dependent/assay dependent/yes (10°C below ambient)

336 hours/28 days/yes (3°–10°C)

Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code no/— no/— yes/specific cartridge ID, expiration date, lot number,

unique reagent pack ID numberSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero no/zero no/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays 120 minutes/98/48 assay dependent/96/12 up to 180 based on consumable capacity/60/

assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— yes/96 yes/294Uses washable cuvettes/Replacement frequency no/— yes/assay dependent no/—Minimum specimen volume required 10 µL 2 µL specimen container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/50 µL 2 µL/— 5 µL/100 µLSupplied with UPS (backup power)/Requires floor drain yes/no no/no no/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — <70 decibelsHas dedicated pediatric sample cup/Dead volume no/— no/— yes/100 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/primary, pour off/no yes/12 × 100 mm/no yes/12 × 75, 13 × 75 and 100, 16 × 75 and 100/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes no/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes — yesOnboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection no/yes no/no yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no no/yes yes/yes (Access 2 only)Hemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no no/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no yes/yes no/no

Time between initial result and reaspiration of sample for rerun — assay dependent 36 seconds Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/within each run yes/assay dependent no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay no/no yes/yes yes/yesHow often QC required with every assay shortest interval: each run; longest: daily 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte no/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/5 minutes yes/yes/2 minutes no/no/remains in ready mode

Stat time to completion of βhCG test — assay dependent 15 minutesTime delay from ordering stat test to aspiration of sample — 30 seconds ≥36 seconds Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— assay dependent/— 33/100 (36 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (included) onboard/yesLIS interfaces up and running in active user sites Cerner, Millennium, Sunquest, Soft, Mysis, etc. — all major LIS vendorsLIS interface operates simultaneously with running assays yes no yesBidirectional interface capability yes (host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/yes/no yes/yes/yes no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours within 48 hours —Mean time between failures/To repair failures 4 months/2 hours — —Average time to complete maintenance by lab personnel daily: 10 minutes; weekly: 20 minutes;

monthly: 20 minutesdaily: <10 minutes; weekly: <10 minutes; monthly: <10 minutes

daily: 15 minutes; weekly: 30 minutes

Onboard maintenance records/Maintenance training demo module no/no no/no yes (Access 2 only)/online help with maintenance instructions

List price/Targeted bed size or daily volume $70,047.66/>350 beds $25,000/up to 500 tests per day $149,800/all volumes and hospital sizesAnnual service contract cost (24 hours/7 days) $10,000 $4,000 —Training provided with purchase/Advanced operator training 3 days on site/no 3 days on site/no yes/yes (Access 2 only)



open DSX platform enables customers to run many ELISA-based assays; modular design allows users to customize system to unique needs; work list load wizard for easy setup; shows graphically where to place reagents, samples, and plates at beginning of each run; complete daily maintenance in less than 5 minutes, including removal of consumables and rinsing washer

dual use as random-access biochemistry analyzer when not in EIA mode; optional reagent cooling module

ability to network up to four Access 2 systems using one LIS interface with remote diagnostics; fully automated user-defined reflex testing; continuous random-access benchtop analyzer

Automated immunoassay analyzersseptember 2014 | cap today 17




Part 4 of 21 Beckman Coulter Beckman Coulter Beckman CoulterMark Smith [email protected] Mark Smith [email protected] Mark Smith [email protected]


250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821714-961-4375 www.beckmancoulter.com 714-961-4375 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com

Name of instrument/First year sold/Where designed UniCel DxI 600 Access Immunoassay System/2007/U.S. UniCel DxI 800 Access Immunoassay System/2003/U.S. UniCel DxC 600i Synchron Access Clinical System/2006/U.S.

Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. >200/>150 >500/>1,000 >449/>150Operational type/Model type/Sample handling system continuous random access/floor standing/rack, direct

track samplingcontinuous random access/floor standing/rack, direct track sampling

continuous random access/floor standing/rack-closed tube

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 67 × 61.5 × 37.5/16.02 67 × 67.5 × 37.5/17.6 62 × 128 × 48/42.7

Tests available on instrument in U.S. cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated es-triol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, and many others

cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated es-triol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, and many others


Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin DHAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin D

HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin D

Tests in development AMH AMH AMHTests not available on other manufacturers’ analyzers — — —

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods chemiluminescence/magnetic particle chemiluminescence/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particle

Number of different measured assays onboard simultaneously 50 50 89Number of different assays programmed, calibrated at once 50 50 89Number of user-definable (open) channels — 0 100Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

50/100 and 300 tests per kit; 50 tests per cartridge 50/100 and 300 tests per kit; 50 tests per cartridge 89/100 tests per kit (immunoassay); 300 tests per container (general chemistry)

Shortest/Median onboard reagent stability/Refrigerated onboard 336 hours/28 days/yes (3°–10°C) 336 hours/28 days/yes (3°–10°C) 336 hours/28 days/yes (3°–10°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/specific cartridge ID, number of available tests,

expiration date, lot number, calibration expiration, within lot calibration

yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration


Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm yes/<10 ppm yes/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays 180–240 based on consumable capacity/60/assay

dependent180–240 based on consumable capacity/120/ assay dependent

60/76/assay dependent

System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/1,000 yes/>1,000 yes/125Uses washable cuvettes/Replacement frequency no/— no/— yes/—Minimum specimen volume required specimen container dependent specimen container dependent container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/80 µL 5 µL/160 µL 3 µL/20 µL (general chemistry)Supplied with UPS (backup power)/Requires floor drain no/no no/no yes/yesRequires dedicated water system/Water consumption no/— no/— yes/16 L per hourNoise generated <65 decibels <60 decibels —Has dedicated pediatric sample cup/Dead volume yes/100 µL yes/100 µL yes/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12 × 75, 13 × 75 and 100, 16 × 75 and 85 and

100 mm/noyes/12 × 75, 13 × 75 and 100, 16 × 75, 85, and 100 mm/no

yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes

Sample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) no no yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no yes/yes (general chemistry)Dilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no yes/yes

Time between initial result and reaspiration of sample for rerun 36 seconds 36 seconds chemistry dependent Autocalibration or autocalibration alert yes yes —Number of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/28 days no/28 days no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode

Stat time to completion of βhCG test 15 minutes 15 minutes 15 minutesTime delay from ordering stat test to aspiration of sample 18 seconds 18 seconds 1 minute (general chemistry)Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

—/200 (18 seconds) ≤133/≤400 (9–18 seconds) 90/720 (40 seconds) (general chemistry)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes onboard/yes optional add-on/yes (additional cost)LIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems yes, Beckman Coulter automation systemsModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes yes/yes/validate for the DxC 600i

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — — —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <10 minutes daily: <10 minutes —

Onboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions

List price/Targeted bed size or daily volume $199,500/200–300 beds or 100–300 tests per day $325,000/300+ beds or >400 tests per day $325,000/moderate volume, <300 samples per dayAnnual service contract cost (24 hours/7 days) — — per negotiated contractTraining provided with purchase/Advanced operator training yes/yes yes/yes yes/yes



integrates with UniCel DxC chemistry systems; uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system; offers ProService remote diagnostic service capability

high-throughput immunoassay analyzer; integrates with UniCel DxC chemistry systems; uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system; offers ProService remote diagnostic service capability

performs parallel processing of immunoassay and chemistry tests on one system; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability





Part 5 of 21 Beckman Coulter Beckman Coulter Beckman CoulterMark Smith [email protected] Mark Smith [email protected] Mark Smith [email protected]


250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com

Name of instrument/First year sold/Where designed UniCel DxC 660i Synchron Access Clinical System/2009/U.S.

UniCel DxC 680i Synchron Access Clinical System/2009/U.S.

UniCel DxC 860i Synchron Access Clinical System/2009/U.S.

Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. >40/>20 5/13 >10/>25Operational type/Model type/Sample handling system continuous random access/floor standing/

rack-closed tubecontinuous random access/floor standing/ rack-closed tube

continuous random access/floor standing/ rack-closed tube

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 68 × 147 × 48/49 68 × 153 × 48/51 68 × 155 × 48/51.7




Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin DHAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin D

HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin D

Tests in development AMH AMH AMHTests not available on other manufacturers’ analyzers — — —


Methods supported/Separation methods chemiluminescence, enzyme immunoassay/magnetic particle

chemiluminescence, enzyme immunoassay/magnetic particle

chemiluminescence, enzyme immunoassay/magnetic particle

Number of different measured assays onboard simultaneously 115 115 120Number of different assays programmed, calibrated at once 115 115 120Number of user-definable (open) channels 100 100 100Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

115/100 tests per kit (immunoassay); 300 tests per container (general chemistry)



Shortest/Median onboard reagent stability/Refrigerated onboard 336 hours/28 days/yes (3°–10°C) 336 hours/28 days/yes (2°–10°C) 336 hours/28 days/yes (2°–10°C)

Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/specific cartridge ID, number of available tests,




Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm yes/<10 ppm yes/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays 60/76/assay dependent 60/76/assay dependent 60/112/assay dependent

System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/125 yes/125 yes/125Uses washable cuvettes/Replacement frequency yes/— yes/— yes/—Minimum specimen volume required container dependent container dependent container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 3 µL/20 µL (general chemistry) 3 µL/20 µL (general chemistry) 3 µL/20 µL (general chemistry)Supplied with UPS (backup power)/Requires floor drain yes/yes yes/yes yes/yesRequires dedicated water system/Water consumption yes/up to 16 L per hour yes/up to 16 L per hour yes/up to 16 L per hourNoise generated — — —Has dedicated pediatric sample cup/Dead volume yes/— yes/— yes/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75 and 100, 15 × 92 and 75, 16 × 100 mm/yes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes

Sample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes (general chemistry) yes/yes (general chemistry) yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes yes/yes yes/yes

Time between initial result and reaspiration of sample for rerun chemistry dependent chemistry dependent chemistry dependentAutocalibration or autocalibration alert — — —Number of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/28 days no/28 days no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode

Stat time to completion of βhCG test 15 minutes 15 minutes 15 minutesTime delay from ordering stat test to aspiration of sample 1 minute (general chemistry) 1 minute (general chemistry) 1 minute (general chemistry)Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface — — —LIS interfaces up and running in active user sites — — —LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems yes, Beckman Coulter automation systemsModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/validate for the DxC 600i yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — — —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel — — —Onboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions

List price/Targeted bed size or daily volume $575,000/high volume, 300–750 samples per day $610,000/high volume, 300–750 samples per day $615,000/high to very high volume, 500–1,500 samples per day

Annual service contract cost (24 hours/7 days) per negotiated contract per negotiated contract per negotiated contractTraining provided with purchase/Advanced operator training yes/yes yes/yes yes/yes



performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and sam-pling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability





Part 6 of 21 Beckman Coulter The Binding Site bioMérieux Inc.Mark Smith [email protected] Tami Kaplan [email protected] Alicia Rico-Lazarowski [email protected]


250 S. Kraemer Bvld., Brea, CA 92821 5889 Oberlin Drive, Suite 101, San Diego, CA 92121 100 Rodolphe St., Durham, NC 27712714-961-3711 www.beckmancoulter.com 800-633-4484 www.thebindingsite.com 919-479-3629 www.biomerieux-usa.com

Name of instrument/First year sold/Where designed UniCel DxC 880i Synchron Access Clinical System/2008/U.S. SPA PLUS (Specialist Protein Analyzer)/2007/Japan VIDAS Immunoassay Analyzer/1991/U.S.Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland Japan/United Kingdom Italy/FranceNumber of units in clinical use in U.S./Outside U.S. >40/>150 — 2,200/25,000Operational type/Model type/Sample handling system continuous random access/floor standing/

rack-closed tubebatch, random access/benchtop/sample carousel (holds 30 primary tubes plus 15 sample tubes, cups)

batch, random access/benchtop/—

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 68 × 161 × 48/53.7 20.5 × 31.5 × 25.2/14 VIDAS 30 system: 16 × 32 × 2/4.5; MiniVIDAS system: 21 × 21 × 17/4


freelite kappa, freelite lambda, IgG, IgA, IgM, IgD, IgG1, IgG2, IgG3, IgG4, IgA1, IgA2, C1 inactivator, C3c, C4, CH50, albumin CSF, IgG CSF, IgA CSF, IgM CSF, albumin, alpha-1 acid glycoprotein, alpha-1 antitrypsin, alpha-2 macroglobulin, antistreptolysin O, apolipoprotein A1, apoli-poprotein B, beta-2-microglobulin, ceruloplasmin, cystatin C, haptoglobin, lipoprotein(a), prealbumin, transferrin

procalcintonin, TSH, FT4, T4, T3, total PSA, HCG, LH, FSH, estradiol 2, prolactin, progesterone, testosterone, ferritin, C. difficile GDH, D-dimer, troponin I, NT pro BNP, CKMB, C. diffi-cile toxin A&B, mumps IgG, rubella IgG, varicella zoster virus IgG, LYME IgG & IgM, Helicobacter pylori, toxo competition, toxo IgG, toxo IgM, toxo IgG avidity, CMVM, CMVG, others

Tests not available in U.S. but submitted for clearance — hevylite IgM kappa and lambda —Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgM, vitamin Dhevylite IgG kappa and lambda, hevylite IgA kappa and lambda, hevylite IgM kappa and lambda, IgE, ferritin, CRP, microalbumin, rheumatoid factor, tetanus toxoid

HBs Ag, anti HBs-total, anti-HBc total, anti-HBc IgM, anti-HBe, HAV IgG, anti-HAV total, HIV duo, myoglobin, others

Tests in development AMH — vitamin DTests not available on other manufacturers’ analyzers — — —

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — 1 test per stripNumber of wells in microplate — — —

Methods supported/Separation methods chemiluminescence, enzyme immunoassay/magnetic particle

turbidimetry fluorescence, enzyme immunoassay/enzyme immunoas-say coated, solid phase receptacle pipetting device

Number of different measured assays onboard simultaneously 120 24 MiniVIDAS: 12; VIDAS: 30Number of different assays programmed, calibrated at once 120 80 total menuNumber of user-definable (open) channels 100 — —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

120/100 tests per kit (immunoassay)/300 tests per container (general chemistry)

24/100 unit-dose format 30 or 60/—

Shortest/Median onboard reagent stability/Refrigerated onboard 336 hours/28 days/yes (2°–10°C) 672 hours/30 days/yes —/—/noMultiple reagent configurations supported yes yes noReagent container placed directly on system for use yes yes placed directly on systemReagents bar-coded/Information in bar code yes/specific cartridge ID, number of available tests,


yes/— yes/assay name, lot number, calibration, expiration

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm no/— no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 60/112/assay dependent ~60/45/assay dependent assay dependent/12–30/12–30System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/dryUses disposable cuvettes/Maximum number stored no/125 no/60 no/—Uses washable cuvettes/Replacement frequency yes/— yes/— no/—Minimum specimen volume required container dependent 150 µL 100–200 µL, dependent on assayMinimum sample volume aspirated precisely at once/Minimum dead volume 3 µL/20 µL (general chemistry) 3 µL/150 µL 100 µL, dependent on assay/—Supplied with UPS (backup power)/Requires floor drain yes/— yes/no yes/noRequires dedicated water system/Water consumption yes/up to 16 L per hour no/up to 10 L no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes yes/most tube sizes, including 12 × 75 mm/no no/—/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/noBar-code placement per CLSI standard Auto2A yes yes noOnboard test auto inventory (determines volume in container) yes no noMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/noAutomatic detection of adequate reagent or specimen yes yes noClot detection/Reflex testing capability yes/yes no/no no/noHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes (general chemistry) no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/— yes/yes (dilution of pt and auto rerun) no/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes yes/yes no/no

Time between initial result and reaspiration of sample for rerun chemistry dependent <10 minutes —Autocalibration or autocalibration alert — yes yesNumber of calibrators required for each analyte assay dependent 6 —Calibrants can be stored onboard/Average calibration frequency no/28 days no/— no/14 or 28 days, assay dependentMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/— no/yesHow often QC required 24 hours 24 hours (QC required) shortest interval: 8 hours; longest: 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes (dilution of pt and auto rerun) yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/<15 minutes no/no/always remains ready

Stat time to completion of βhCG test 15 minutes — 30 minutesTime delay from ordering stat test to aspiration of sample 1 minute (general chemistry) — no delayThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

90/720 (40 seconds) (general chemistry) 35/106 (10.5 minutes incubation) —/VIDAS: 20; MiniVIDAS: 8; VIDAS: 60; MiniVIDAS: 24

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface — optional add-on/no onboard/yes (additional cost)LIS interfaces up and running in active user sites — Cerner, Soft Computer Concepts, Cyberlab, Sunquest,

Meditech, Data Innovations Middleware, Rubicon, moreMisys, Medtech, McKesson, Advanced Lab Systems, Citation, Cerner, Dawning, Geneysis, Compulab, others

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/no/no no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — 24 hours within 24 hoursMean time between failures/To repair failures — 258 days, with 2 scheduled preventative maintenance

visits/4 hours on siteVIDAS: 860 days; MiniVIDAS: 1,200 days/—

Average time to complete maintenance by lab personnel — daily: <10 minutes; weekly: <10 minutes; monthly: <15 min. weekly: 10–15 minutesOnboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions no/no yes (includes audit trail)/—

List price/Targeted bed size or daily volume $650,000/high to very high volume, 750–2,250 samples per day

— —

Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training — yes/yes —



performs parallel processing of immunoassay and chemistry tests; ClozCap technology eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

low maintenance; prozone detection, autodilution; dual compartment reaction cuvettes, air pressure mixing system and extensive washing processes; ideal for latex assays

routine batch testing as well as emergency stat testing; ELISA methodology; dual-function combination solid phase and pipetting device results in no fluid contact with instrument or sample carryover; single-dose assay format readily adaptable to batch or single test runs





Part 7 of 21 Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics GroupGreg Stewart [email protected] Greg Stewart [email protected] Paulina Leung-Lee [email protected]


4000 Alfred Nobel Drive, Hercules, CA 94547 4000 Alfred Nobel Drive, Hercules, CA 94547 4000 Alfred Nobel Drive, Hercules, CA 94547800-224-6723 (800-2BIO-RAD) www.bio-rad.com 800-224-6723 (800-2BIO-RAD) www.bio-rad.com 800-224-6723 (800-2BIO-RAD) www.bio-rad.com

Name of instrument/First year sold/Where designed PR4100 Microplate Reader/2012/Austria PhD Ix System/2012/France BioPlex 2200/2006/AustraliaCountry where manufactured/Where reagents manufactured Austria/U.S. France/U.S. Australia/U.S.Number of units in clinical use in U.S./Outside U.S. 75/10 49/— —Operational type/Model type/Sample handling system batch/benchtop/— batch/benchtop/reagent rack continuous random access/floor standing/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet — 30 × 36 × 27/16 58 × 72 × 34/12

Tests available on instrument in U.S. HIV, HBsAg, HBs, HAV, HAV IgM, HBc, HBc IgM, HCV, syphilis, measles, mumps, VZV, lyme, toxoplasma, ANA, SSA, SSB

open system, method file consists of autoimmune and infectious disease assays, both EIA and IFA methodologies

ANA Screen, anti-dsDNA (quantitative), anti-SS-A, anti-SS-B, anti-Sm/RNP, anti-Sm, anti-RNP, anti-Scl-70, anti-Jo-1, anti-centromere B, anti-chromatin, anti-ribosomal P, anti-CCP, anti-GBM IgG, anti-MPO IgG, anti-PR3 IgG, EBV-nuclear antigen IgG, EBV-viral capsid antigen IgG, EBV-early anti-gen diffuse IgG, EBV-viral capside antigen IgM, heterophile IgM, syphilis IgG, toxoplasma gondii IgG, cytomegalovirus IgG, rubella IgG (quantitative), cytomegalovirus IgM, rubella IgM, measles IgG, mumps IgG, rubella IgG (qualitative), varicella-zoster virus IgG, HSV-1 IgG, HSV-2 IgG, anti-deamidated gliadin (DGP) IgA, anti-tissue transglutaminase (tTG) IgA, anti-DGP IgG, anti-tTG IgG, anti-cardiolipin IgA, anti-beta2 glycoprotein (β2GPI) IgA, anti-cardiolipin IgG, anti-β2GPI IgG, anti-cardiolipin IgM, anti-β2GPI IgM

Tests not available in U.S. but submitted for clearance — — HIV Ag-Ab, 25-OH vitamin DTests not available in U.S. but available in other countries — — syphilis IgM, toxoplasma gondii IgMTests in development — — syphilis total, lyme borreliosisTests not available on other manufacturers’ analyzers — — heterophile antibodies

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate 96 (minimum: 1; maximum: 8) 96 (minimum: 1; maximum: 96) —

Methods supported/Separation methods enzyme immunoassay/coated microwell fluorescence, enzyme immunoassay/coated microwell bead flow cytometric (multiplex)/magnetic particleNumber of different measured assays onboard simultaneously — 8 enzyme immunoassay or 4 IFA 44Number of different assays programmed, calibrated at once — 8 enzyme immunoassay or 4 IFA 44Number of user-definable (open) channels — no limit —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

— up to 8 different assays sets of components/96 44/100

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no 4 hours/—/no 720 hours/30 days/yes (2°–8°C)Multiple reagent configurations supported no yes noReagent container placed directly on system for use — placed directly on system yesReagents bar-coded/Information in bar code — no/— yes/kit type, lot number, kit serial numberSame capabilities when 3rd-party reagents used/Susceptibility to carryover — yes/— no/2 ppmWalkaway capacity in minutes/Specimens/Tests, assays — —/192/8 EIA or 4 IFA 480 minutes/800/9,600System is open (homebrew methods can be used)/Liquid or dry system yes/dry yes/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— no/— yes/800Uses washable cuvettes/Replacement frequency no/— — no/—Minimum specimen volume required 70 µL 150 µL 5 µLMinimum sample volume aspirated precisely at once/Minimum dead volume — 1 µL/150 µL 5 µL/220 µLSupplied with UPS (backup power)/Requires floor drain no/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/0.5 L per hourNoise generated — — <67 decibelsHas dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes no/—/— yes/12–13 mm diameter and 75–100 mm height/no yes/10–16 mm diameter, 41–100 mm height/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A — yes yesOnboard test auto inventory (determines volume in container) — no yesMeasures number of tests remaining/Short sample detection — no/no yes/yesAutomatic detection of adequate reagent or specimen — yes yesClot detection/Reflex testing capability — no/no yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation — no/no no/noDilution of patient samples onboard/Automatic rerun capability — yes/no yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

— no/no —

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert — no yesNumber of calibrators required for each analyte — assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency — no/each run no/30 daysMultipoint calib. supported/Multiple calibs. stored for same assay — yes/no yes/yesHow often QC required — each run 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte — no/no yes/yesAutomatic shutdown/Startup is programmable/Startup time — no/no/<5 minutes no/yes/10 minutes

Stat time to completion of βhCG test — — —

Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— assay dependent/— 100/100 (36 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC — no/no yes/yesData-management capability/Instrument vendor supplies LIS interface — onboard/— onboard/noLIS interfaces up and running in active user sites — — Antrim, CCA, Cerner Classic/Millennium, CHCS/SAIC,

Data Innovations, Labsoft, Meditech, Orchard, Rubicon, SCC, Schuyler, SOFT, Sunquest/Misys

LIS interface operates simultaneously with running assays — yes yesBidirectional interface capability — yes (broadcast download and host query) yesInterface available (or will be) to auto specimen handling system — no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

— no/no/no yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator — no noOn-site response time of service engineer — 24 hours <24 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel — daily: <5 minutes; weekly: 15 minutes; monthly: 30

minutesdaily: 5 minutes; weekly: 30 minutes

Onboard maintenance records/Maintenance training demo module — no/no yes/no

List price/Targeted bed size or daily volume — $68,000/all bed sizes —/200–800 samples

Annual service contract cost (24 hours/7 days) — $6,700 —Training provided with purchase/Advanced operator training — 2 days on site/no 5 days at Bio-Rad/no



— open platform with assay programming wizard; bidirectional LIS with broadcast download, capable of running IFA and EIA; accurate down to 1 µL, IFA hyperwash for cleaner backgrounds, precise well-to-well timing; networking capabilities for multiple workstations

full random access automation; three internal quality control beads run simultaneously with each sample; innovative multiplex chemistry





Part 8 of 21 Bio-Rad Laboratories Clinical Diagnostics Group Corgenix Diamedix Corp., a subsidiary of Erba DiagnosticsGreg Stewart [email protected] Christopher Lynn [email protected] David Johnston [email protected]


4000 Alfred Nobel Drive, Hercules, CA 94547 11575 Main St., Suite 400 14100 NW 57th Court, Miami Lakes, FL 33014800-224-6723 (800-2BIO-RAD) www.bio-rad.com Broomfield, CO 80020 www.corgenixonline.com 800-433-0945 www.erbadiagnostics.com

Name of instrument/First year sold/Where designed EVOLIS/2001/Germany SkyLAB752/2012/Italy MAGO 4S/2011/ItalyCountry where manufactured/Where reagents manufactured Germany/U.S. Italy/U.S. Italy/U.S.Number of units in clinical use in U.S./Outside U.S. 300/1,350 10/30 —Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack batch, random access/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 37 × 44 × 30/10 39 × 37 × 51/13.1 28 × 48 × 26/8.7

Tests available on instrument in U.S. — ELISA open channel >50 Diamedix and 22 additional ELISA analytes plus 67 IFA kits

Tests not available in U.S. but submitted for clearance — — —

Tests not available in U.S. but available in other countries HIV Ab, HIV Ab/Ag, HIV Ag, HBsAg, HBc Ab, HCV Ab, HTLV-1, anti-HBs, toxo IgG, toxo IgM, rubella IgG, EBV VCA IgG, EBV VCA IgM, EBV EAD, EBV EBNA, others

— —

Tests in development infectious disease and autoimmune panels — —Tests not available on other manufacturers’ analyzers — — process ELISA and IFA slide preparation simultaneously

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit — 12 1 analyte per well (or multiple, test dependent)Number of wells in microplate minimum strip: 1; maximum full plate: 96 96 (minimum: 8, maximum: 96) 4 × 96 wells, up to 16 slides per run (minimum strip: 8;

full plate: 12 strips)

Methods supported/Separation methods enzyme immunoassay/coated microwell ELISA/coated microwell enzyme immunoassay, sample titrations and slides simultaneously with ELISA processing/coated microwell, coated tissue, cell slide

Number of different measured assays onboard simultaneously 4–8 — unlimitedNumber of different assays programmed, calibrated at once 4–8 — up to 20 (analyte dependent)Number of user-definable (open) channels — unlimited 20 active at a time, unlimited saved on hard driveNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

4/96 assay dependent/96 20 (analyte dependent)/96

Shortest/Median onboard reagent stability/Refrigerated onboard 30 minutes/assay dependent/— —/—/no 8 hours/1 day/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/— no/yes yes/lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/no (disposable tips) yes/disposable tip no/no, with Diamedix reagentsWalkaway capacity in minutes/Specimens/Tests, assays varies by assay/180/4 assay dependent/assay dependent/384 samples for

one assay2.5 hours (analyte dependent)/120/384 (ca.12)

System is open (homebrew methods can be used)/Liquid or dry system no/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored microplates/— yes/480 per rack yes/120Uses washable cuvettes/Replacement frequency microplates/— no/— no/—Minimum specimen volume required 0.2 µL 100 µL 50 µL (pediatric)Minimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/200 µL 1 µL/100 µL 4 µL/35 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated 60 decibels — —Has dedicated pediatric sample cup/Dead volume no/— no/— yes/35 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/up to 16 mm diameter, up to 100 mm height/no yes/up to 16 mm diameter × 100 mm height/no yes/11–15 mm × 75–100 mm/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/noBar-code placement per CLSI standard Auto2A no yes noOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection no/no yes/yes yes/yesAutomatic detection of adequate reagent or specimen no yes yesClot detection/Reflex testing capability yes/no yes/no no/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no yes/yes no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no no yesNumber of calibrators required for each analyte assay dependent assay dependent 1–6 (analyte dependent)Calibrants can be stored onboard/Average calibration frequency no/with each run no/once per run yes/per runMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/no yes/noHow often QC required user determined once per run each runOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes no/yes yes/—Automatic shutdown/Startup is programmable/Startup time no/no/5 minutes yes/yes/10 minutes yes/yes/5 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/— 100/300 (2.5 hours, assay dependent) 120/360 (2.5 hours)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes onboard/yes onboard/yesLIS interfaces up and running in active user sites yes proprietary systems, Cerner Cerner, Misys, others

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download) yes (host query) yes (host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/no/no yes/yes/yes no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours 24–48 hours, M–F normal business hours within 24–48 hoursMean time between failures/To repair failures — 4 months/3 hours 5 months/3–6 hoursAverage time to complete maintenance by lab personnel daily: 5 minutes; monthly: 60 minutes weekly: 10 minutes; monthly: 30 minutes daily: 5 minutes; weekly: 10 minutesOnboard maintenance records/Maintenance training demo module yes/no no/no no/no

List price/Targeted bed size or daily volume $85,000/30–500 tests per day $99,500/>300 beds and reference labs $72,000 (includes first-year warranty)/30–300Annual service contract cost (24 hours/7 days) inquire $14,400 included in rental agreement (otherwise $8,500 per year)Training provided with purchase/Advanced operator training 5 days in Redmond, WA/no 3 days on site/yes 2–3 days on site/yes



fully automated microplate system that meets a high level of safety (positive identification of samples, reagents, microplates, clot detection, no contamination), flexibility (reagents and microplates) and productivity (4–6 plates, up to 180 specimens, 4–8 different assays can be processed simultaneously)

dual pipetting system; multitasking via 3 independent arms; runs independent of PC platform

simultaneous ELISA/IFA processing; performs serial twofold dilutions onboard; pre-assay, full-strip, plate/reagent/sample volume check; automated system maintenance before and after each run; Ivax Diagnostics controls the manufacture of raw materials, ELISA reagents, and instrumentation





Part 9 of 21 Diamedix Corp., a subsidiary of Erba Diagnostics DiaSorin DiaSorinDavid Johnston [email protected] Brian Lauber [email protected] Alice Farago [email protected]


14100 NW 57th Court, Miami Lakes, FL 33014 1951 Northwestern Ave., Stillwater, MN 55082 1951 Northwestern Ave., Stillwater, MN 55082800-433-0945 www.erbadiagnostics.com 800-328-1482/651-439-9710 www.diasorin.com 800-328-1482/651-439-9710 www.diasorin.com

Name of instrument/First year sold/Where designed Mago Plus Automated EIA Processor/1997/Italy LIAISON XL/2010/Italy ETI-MAX 3000/2002/GermanyCountry where manufactured/Where reagents manufactured Italy/U.S. Germany/Italy, Germany, U.S. Germany/U.S., ItalyNumber of units in clinical use in U.S./Outside U.S. 250/— >200/>1300 —Operational type/Model type/Sample handling system batch, random access/benchtop/rack batch, random access, continuous random access/floor

standing/rackbatch, random access/benchtop/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 28 × 48 × 26/8.7 59 × 59 × 36/14.6 40 × 45 × 30/10

Tests available on instrument in U.S. autoimmune: ANA ELISA screen, ENA-6 screen, SSA, SSB, Sm, Sm/RNP, Jo-1, Scl-70, dsDNA, β2 glycoprotein IgG/IgM, cardiolipin screen/IgA/IgG/IgM, gliadin IgA/IgG, MPO, PR3, TPO,TG, RF; infectious disease: toxoplasma IgG/IgM, rubella IgG/IgM, CMV IgG/IgM, B burgdorferi IgG/IgM, EBV VCA IgG/IgM, EBNA IgG/IgM, EBV-EA IgG/IgM, HSV 1&2 IgG/IgM, H. pylori IgG, measles IgG, mumps IgG, others

25 hydroxyvitamin D total, treponema IgG/IgM, anti-HAV total, measles IgG, mumps IgG, Borrelia burgdorferi, EBV IgM, VCA IgG, EA IgG, EBNA IgG, VZV IgG, rubella IgG, rubella IgM testosterone, estradiol, TSH, HSV-1 type specific IgG, HSV-2 type specific IgG, CMV IgG, direct renin, aldosterone, LH, FSH, intact PTH, toxo IgG, toxo IgM, CMV IgM, Insulin, C-peptid, hGH, IGF-1, prolactin, progesterone, hCG, FT3, FT4

measles IgG, varicella zoster IgG, mumps IgG, H. pylori IgG, HSV I/II IgG, Trep-Sure syphilis, CMV IgG & IgM capture, ANA screen, ENA 6 screen, anti-dsDNA, anti-Sm, anti-Sm/RNP, anti-SS-A, anti-SS-B, anti-Jo-1, anti-Scl-70, anti-MPO, anti PR3 (cANCA), anti-TPO, anti-cardiolipin, IgG, IgM, others

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — PTH 1-84, HCV, HIV, HBsAG, Ca 125, Ca 15-3, Ca 19-9,

TPA-M, AFP, CEA, PSA, fPSA, S100, NSE, 1,25 dihy-droxyvitamin D, many others

—

Tests in development — sclerostin, procalcitonin —Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes no yesNumber of each analyte performed in separate disposable unit 1 analyte per well — —Number of wells in microplate minimum 1 × 8 wells; maximum 96 wells; can run 4

plates at a time— minimum strip: 1, 8 wells; maximum full plate: 96 wells,

can accommodate up to 7 plates at a time

Methods supported/Separation methods enzyme immunoassay/coated microwell chemiluminescence/magnetic particle enzyme immunoassay/coated microplateNumber of different measured assays onboard simultaneously up to 9 (analyte dependent) 25 openNumber of different assays programmed, calibrated at once ~50 preprogrammed assays 25 openNumber of user-definable (open) channels 20 per diskette, unlimited diskette capability 0 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

9/96 25/25–200 (mostly 100) volume dependent/—

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no 168 hours/28 days/yes (12°C) no/no/noMultiple reagent configurations supported yes no yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/lot number, expiration date yes/quantity, stability, lot number, and more yes/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/not susceptible (continuous cleaning) no/<20 ppm yes/noWalkaway capacity in minutes/Specimens/Tests, assays up to 2.5 hours, assay dependent/120/384 360/120/3,000 assay dependent/180/variable

System is open (homebrew methods can be used)/Liquid or dry system yes/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/120 yes/1,000 no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 50 µL (pediatric) assay dependent 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 4 µL/25 µL (pediatric) 5 µL/150 µL 10 µL/200 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/— yes/noRequires dedicated water system/Water consumption no/— no/— no/noNoise generated — — —Has dedicated pediatric sample cup/Dead volume yes/35 µL yes/50 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/11–15 mm × 75–100 mm/no yes/10–16 mm diameter/no yes/multiple/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes/yesBar-code placement per CLSI standard Auto2A — yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability no/no yes/yes yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/yes yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — 2 minutes —Autocalibration or autocalibration alert reader calibrated every run no noNumber of calibrators required for each analyte 2–6 (assay dependent) 2 varies per kitCalibrants can be stored onboard/Average calibration frequency no/per run yes/1–4 weeks no/each runMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/yes yes/noHow often QC required per run 24 hours per runOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/no yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/<5 minutes yes/no/8 minutes no/yes/5 minutes

Stat time to completion of βhCG test — 17 —Time delay from ordering stat test to aspiration of sample — 2 minutes —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

120/360 (2.5 hours, assay dependent) 57/171 (21 seconds) assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (included in price) onboard/no yes/yesLIS interfaces up and running in active user sites Cerner, Misys, others — yesLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yesInterface available (or will be) to auto specimen handling system no yes (Inpeco) noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no yes/yes/yes no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours 24 hours 24 hoursMean time between failures/To repair failures 5 months/<1 day — —Average time to complete maintenance by lab personnel daily: <5 minutes; weekly: <10 minutes weekly: 10 minutes; monthly: 10 minutes daily: 5 minutes; weekly: 30 minutesOnboard maintenance records/Maintenance training demo module no/no yes/no yes/no

List price/Targeted bed size or daily volume $62,000/all bed sizes, all test volumes $275,625 (includes first year of service)/>400 beds $100,879 (includes first year of service)/all bed sizes, all test volumes

Annual service contract cost (24 hours/7 days) service during normal business hours included in reagent rental agreement

— —

Training provided with purchase/Advanced operator training 1–2 days on site/yes yes/yes 3 days/yes



FDA-cleared (instruments and reagents); moderate com-plexity; strip-by-strip timing, accommodates primary reagent packaging; safeguards against insufficient reagent/sample volume; functions dependably (mean time between failures greater than 5 months)

secure traceability of all processes, status of reagents, and consumables; disposable pipette tips prevent sample carryover; clot detection, aspiration, and dispensation verification; single-cavity reaction cuvettes; no daily maintenance; instrument monitors maintenance needs; flash chemiluminescence technology with paramagnetic microparticle solid phase

multiple assays on a plate; Windows 2000 software; continuous loading of samples, reagents, and microplates; primary tube sampling; bidirectional interface





Part 10 of 21 DiaSorin Dynex Technologies Dynex TechnologiesBrian Lauber [email protected] Rich Bahlmann [email protected] Rich Bahlmann [email protected]


1951 Northwestern Ave., Stillwater, MN 55082 14340 Sullyfield Circle, Chantilly, VA 20151 14340 Sullyfield Circle, Chantilly, VA 20151800-328-1482/651-439-9710 www.diasorin.com 703-631-7800 www.dynextechnologies.com 703-631-7800 www.dynextechnologies.com

Name of instrument/First year sold/Where designed LIAISON/1997/Germany Agility/2012/U.S., U.K. DS2/2005/U.S.Country where manufactured/Where reagents manufactured Germany/U.S., Italy U.S./various U.S./worldwideNumber of units in clinical use in U.S./Outside U.S. >360/>4,100 <20/<20 1,000/600Operational type/Model type/Sample handling system batch, continuous random access/benchtop/rack batch/benchtop/rack batch/benchtop/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 45 × 96 × 34/10 49 × 50 × 36/8.6 26 × 21 × 27/3.79

Tests available on instrument in U.S. 25 hydroxyvitamin D total, intact PTH, EBV IgM, EBNA IgG, VCA IgG, EA IgG, toxo IgG, toxo IgM, CMV IgG, CMV IgM, treponema IgG/IgM, VZV IgG, hGH, Borrelia burgdorferi, HAV IgM, HAV total antibodies, rubella IgG, HSV-1 type specific IgG, HSV-2 type specific IgG, insulin, measles IgG, mumps IgG, rubella IgM, IGF-1, testosterone, estradiol, FT4, direct renin, aldosterone, LH, FSH, C-peptid, FT3, prolactin, progesterone

open system, tests provided by various manufacturers open system, tests provided by various manufacturers

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries avidity, HSV I/II IgM, HSV I/II IgG, β-2-microglobulin, S-100,

AFP, ferritin, T3, T4, anti-TG, TG— —

Tests in development procalcitonin — —

Tests not available on other manufacturers’ analyzers — none none

Fully automated microplate system no yes yesNumber of each analyte performed in separate disposable unit — 1 per well 1 per wellNumber of wells in microplate — 96 (minimum: 1 strip; maximum: 12 full plates) 96 (minimum: 1 strip; maximum: 2 full plates)

Methods supported/Separation methods chemiluminescence/magnetic particle enzyme immunoassay/coated microplate wells enzyme immunoassay/coated microwellNumber of different measured assays onboard simultaneously 15 16 assay dependent (24 control positions)Number of different assays programmed, calibrated at once 15 12 assay dependent (24 control positions)Number of user-definable (open) channels 0 unlimited unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

15/100 16/96 assay dependent (18 reagent positions)/96

Shortest/Median onboard reagent stability/Refrigerated onboard 7/28 days/yes (12°C) —/—/no —/—/noMultiple reagent configurations supported no yes yesReagent container placed directly on system for use yes yes yes, 2-mL control vials (other reagents are pour off)Reagents bar-coded/Information in bar code yes/all lot information yes/lot information no/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/no yes/none (uses disposable tips) yes/none (uses disposable tips)Walkaway capacity in minutes/Specimens/Tests, assays 360/144/1,500 assay dependent/200+ continuous load/12+ continuous load assay dependent/100/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/720 no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required assay dependent 10 µL —Minimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/150 µL 10 µL/150 µL 10 µL/—Supplied with UPS (backup power)/Requires floor drain yes/no yes/no no/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/75 µL no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/—/no yes/10–17 mm diameter, 45–100 mm depth/no yes/10–16 mm diameter, 40–100 mm height/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/—Bar-code placement per CLSI standard Auto2A yes — —Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no —Dilution of patient samples onboard/Automatic rerun capability yes/yes yes/no yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 2 minutes — —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte 2 assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency yes/28 days no/per plate no/—Multipoint calib. supported/Multiple calibs. stored for same assay yes/no no/no —How often QC required 24 hours per plate —Onboard real-time QC/Support multiple QC lot Nos. per analyte no/yes no/no —Automatic shutdown/Startup is programmable/Startup time no/no/15 minutes no/no/3–5 minutes no/no/—

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample 2 minutes — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— microplate batch process/microplate batch process —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface yes/yes (additional cost) onboard/yes onboard/yes (additional cost)LIS interfaces up and running in active user sites Cerner, Soft, others yes yesLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query) yes (host query and broadcast download) yes (host query and broadcast download)Interface available (or will be) to auto specimen handling system no no —Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no yes/yes/yes no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours 24 hours 24 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 10 minutes; weekly: 20 minutes;

monthly: 30 minutesdaily: <15 minutes; weekly: <30 minutes; monthly: <1 hour

daily: 5 minutes; weekly: 5 minutes; monthly: 15 minutes

Onboard maintenance records/Maintenance training demo module no/no yes/no no/no

List price/Targeted bed size or daily volume $194,040 (includes first year of service)/all bed sizes, all volumes

$120,000 (includes one-year warranty)/various $49,700 (includes one-year warranty)/various

Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3 days on site/yes —/yes —/yes



fully automated benchtop analyzer with high throughput; unique menu; up to 15 assays onboard with ready-to-use, reagent-integral, random-access, batch and stat operation

reduces hands-on time by more than 60 percent for ELISA testing; tracks all assays, test kits, consumables, reagents, and waste so analyzer can run without interruption

washer synchronization, eliminates plate drift; disposable tips; small footprint





Part 11 of 21 Dynex Technologies Grifols USA Hycor BiomedicalRich Bahlmann [email protected] Timothy Wigginton [email protected] Richard Hockins [email protected]


14340 Sullyfield Circle, Chantilly, VA 20151 2410 Lillyvale Ave., Los Angeles, CA 90032 7272 Chapman Ave., Garden Grove, CA 92841703-631-7800 www.dynextechnologies.com 323-227-7037 www.grifolsusa.com 800-382-2527 www.hycorbiomedical.com

Name of instrument/First year sold/Where designed DSX/2001/U.S. Triturus/1999/Spain HYTEC 288 PLUS/outside U.S. 1998, U.S. 1999/Netherlands

Country where manufactured/Where reagents manufactured U.S./worldwide Spain/Spain, U.S., Italy Netherlands/U.S.Number of units in clinical use in U.S./Outside U.S. 1,200/1,600 >200/>1,700 >85/>200Operational type/Model type/Sample handling system batch/benchtop/rack batch, random access and continuous random access/

benchtop/universal carouselrandom batches/benchtop/rack robotics

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 32 × 42 × 36/7 28.3 × 41.3 × 34.3/10 29.5 × 42.5 × 27.5/8

Tests available on instrument in U.S. open system, tests provided by various manufacturers system is completely open; any U.S. clinically cleared and research-use-only EIA procedure can be pro-grammed; infectious diseases, autoimmune diseases, bone markers, endocrinology, hemostasis, oncology markers, hepatitis, and HIV profiles

total/specific IgE, ANA scr, TG, TPO, dsDNA, RF IgG, RF IgM, RF IgA, PR-3 (c-ANCA), MPO (p-ANCA), anti-mitochondrial, ENA-6 scr., SS-A, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, gliadin IgA & IgG, GBM, GPC, anti-cardiolipin IgG & IgM, anti-car-diolipin scr., β2 BPI IgG, IgA & IgM, user-defined channels

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — — specific IgG, ssDNA, total RF, anti-tissue transglutaminase

IgA and IgG, circulating immune complex -C1q and -C3d, CCP

Tests in development — — ANCA profile, centromere, ECP, tryptase

Tests not available on other manufacturers’ analyzers none — —

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit 1 per well 8 8 (1 analyte, multiple analytes/screens per well, up to

8 analytes)Number of wells in microplate 96 (minimum: 1 strip; maximum: 4 full plates) 96, 1 minimum strip, 4 maximum full plate 96–minimum strip: 1 strip/8 wells; maximum full plate:

12 strips/96 wells

Methods supported/Separation methods enzyme immunoassay/coated microwell enzyme immunoassay, EIA-coated microwell plates, onboard shaker, 4 individually temperature-controlled microplate positions/coated microwell

enzyme immunoassay, tube-based and microplate-based assays/activated cellulose and coated well

Number of different measured assays onboard simultaneously assay dependent (33 control positions) 1–8 tests on 1–4 plates varies by assay, up to 288 allergens or 8 autoimmuneNumber of different assays programmed, calibrated at once assay dependent (33 control positions) 8 multipleNumber of user-definable (open) channels unlimited — 3Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

assay dependent (24 reagent positions)/96 8/48 varies by assay/up to 288 allergens or 8 autoimmune

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no —/—/no 8 hours/12 hours/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes (when using custom racks) minimal operator preparation, handling yesReagents bar-coded/Information in bar code yes/lot information when used with custom racks no/— no/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none (uses disposable tips) yes/no yes/<1 part in 10,000Walkaway capacity in minutes/Specimens/Tests, assays assay dependent/assay dependent/4+ 180/92/8 assay dependent/100/288System is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquid Uses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required — 300 µL 10 µL, 110 µL with dead volumeMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/— 2 µL/200 µL 10 µL –50 µL, assay dependent//100 µLSupplied with UPS (backup power)/Requires floor drain no/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12–16 mm diameter, 55–100 mm height/no yes/12, 13, 16 mm/no yes/—/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/—Bar-code placement per CLSI standard Auto2A — yes noOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/— yes/yes no/noHemolysis detection-quantitation/Turbidity detection-quantitation — no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no yes yesNumber of calibrators required for each analyte assay dependent 1–14 1–6Calibrants can be stored onboard/Average calibration frequency — no/check every month no/monthlyMultipoint calib. supported/Multiple calibs. stored for same assay — yes/yes yes/yesHow often QC required — each run every assayOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no yes/no yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/— yes/yes/1–2 minutes yes/no/2–3 minutes

Stat time to completion of βhCG test — system is open, depends on reagent methodology —Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— dependent on reagent methodology/— —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/no onboard/optionalLIS interfaces up and running in active user sites yes CHCS, Softmax, Sunquest yesLIS interface operates simultaneously with running assays yes yes noBidirectional interface capability yes (host query and broadcast download) yes (host query and broadcast download) yesInterface available (or will be) to auto specimen handling system — no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/yes/yes yes/yes/yes yes/yes/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours within 24 hours within 48 hoursMean time between failures/To repair failures — — 7 months/4 hoursAverage time to complete maintenance by lab personnel daily: 5 minutes; weekly: 5 minutes;

monthly: 15 minutesdaily: 5–20 minutes daily: 10–15 minutes; weekly: 20–25 minutes;

monthly: 20–25 minutesOnboard maintenance records/Maintenance training demo module no/no yes (includes audit trail of who replaced parts)/yes yes (includes audit trail of who replaced parts)/yes

List price/Targeted bed size or daily volume $69,475 (includes one-year warranty)/various $79,000/300+ $55,000/all sites, variable test volumesAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training —/yes —/yes 3 days on site/yes



washer synchronization, eliminates plate drift; modular design; disposable tips

multibatch or continuous throughput EIA analyzer; user-defined menu, completely open system; easy color-coded worksheet and setup for operator; 2 probes for high-speed processing; unique cross-well washing; can use fixed probes or disposable tips

fully automated allergy and autoimmune testing; user-defined software channels for microtiter plate and tube-based assays





Part 12 of 21 Immunodiagnostic Systems (IDS) Inova Diagnostics Inova [email protected] Kaz Nakanishi [email protected] Kaz Nakanishi [email protected]


948 Clopper Rd., Gaithersburg, MD 20878 9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131877-852-6210 www.idsplc.com 800-545-9495 www.inovadx.com 800-545-9495 www.inovadx.com

Name of instrument/First year sold/Where designed IDS-iSYS/2009/France BIO-FLASH/2011/U.S. DS2/2006/U.S.Country where manufactured/Where reagents manufactured France/Belgium U.S./U.S. U.S./U.S., U.K.Number of units in clinical use in U.S./Outside U.S. >90/>500 — —Operational type/Model type/Sample handling system continuous random access/benchtop/rack sample

loadingcontinuous random access/benchtop/racks batch, with continuous load/benchtop/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 28 × 42 × 30/~6 21 × 34 × 24/5 30 × 17 × 26/3.07

Tests available on instrument in U.S. 1,25-dihydroxy vitamin D, 25 hydroxyvitamin D, IGF-I, hGH, IGFBP-3, CTX-I, intact PTH, PTH (1-34, for research use only), direct renin

tTG IgA, tTG IgG, DGP screen, DGP IgA, DGP IgG, aCL IgG, aCL IgM, aCL IgA, B2GP1 IgG B2GP1 IgM, B2GP1 IgA, MPO, PR3, GBM, ENA 7, RNP, Sm, centromere

autoimmune, infectious disease

Tests not available in U.S. but submitted for clearance intact PINP, aldosterone, ostase+BAP, N-MID osteocalcin, 25-hydroxy vitamin DS

SS-B, Jo-1, Scl-70, Ro52, Ro60, DFS70, dsDNA, domain 1 —

Tests not available in U.S. but available in other countries ntact PINP, N-MID osteocalcin, BAP, aldosterone, ANA screen, ENA screen, dsDNA, SSA, SSB, Sm, UI-snRNP, Scl-70, Jo-1, centromere B, CCP, gliadin IgA/IgG, t-TG IgA/IgG, cariolipine IgG/IgM, B2 IgG/IgM, MPO, PR3, GBM,EBV, HSV

CTD screen plus, SS-B, Jo-1, Scl-70, Ro52, Ro60, DFS70, dsDNA, domain 1, CCP3

ELISA

Tests in development boneTrap (TRAcP 5b), ACTH, vortisol, 1,25 vitDXp, MGP, AMA-MIT3, LKM-1, F-ACTIN, toxo, rubella, CMV, mumps, Measles, VZV

ASCA IgG, ASCA IgA, RF, M2 (MIT3), SLA, LKM-1, HMGCR, chromatin, intrinsic factor

—

Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system no no yesNumber of each analyte performed in separate disposable unit — — —

Number of wells in microplate — — minimum strip 1 × 8; maximum full plate: 96 wells × 2 plates

Methods supported/Separation methods chemiluminescent and spectrophotometric/ magnetic particles

chemiluminescence/magnetic particle, bead enzyme immunoassay/coated microwell

Number of different measured assays onboard simultaneously 15 20 12 assays per plateNumber of different assays programmed, calibrated at once 15 50 unlimitedNumber of user-definable (open) channels 0 0 unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

15/100 20/50 and 100 test kits 8/96

Shortest/Median onboard reagent stability/Refrigerated onboard 168 hours/56 days/yes (12°–15°C) 24 days/40 days/yes (6°–8°C) 24 hours/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/lot, key information yes/type, number of tests, lot number, expiration date,

master calibration curveyes/yes

Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/no no/— —/zero with disposable tipsWalkaway capacity in minutes/Specimens/Tests, assays assay dependent/120/15 —/30/20 assay dependent/98/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/up to 1,120 yes/280 no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 6 µL (assay dependent) 10 µL 200 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 4 µL/80 µL 10 µL/50 µL 5 µL/200 µL (50 µL with microtubes)Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/—Requires dedicated water system/Water consumption no/no no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/80 µL yes/50 µL yes/50 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/all up to 16 × 100 mm/no yes/12–16 mm/no yes/—/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no yes/yes yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/yes no/no

Time between initial result and reaspiration of sample for rerun dependent on run cycle or immediately after first result 30 minutes —Autocalibration or autocalibration alert yes yes noNumber of calibrators required for each analyte 2 2 variesCalibrants can be stored onboard/Average calibration frequency no/3–21 days no/lot change or failure of controls yes/each assayMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/noHow often QC required daily daily each assayOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/noAutomatic shutdown/Startup is programmable/Startup time yes/yes/<10 minutes yes/yes/<10 minutes no/yes/1–2 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — less than 5 minutes —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

>26/>80 (every 45 seconds) 20/60 (30 minutes) assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes —/yesData-management capability/Instrument vendor supplies LIS interface onboard/no (additional cost) onboard/yes (included) onboard/yes (additional cost)LIS interfaces up and running in active user sites yes — —LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download) yes (broadcast download and host query) yes (host query)Interface available (or will be) to auto specimen handling system no yes noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24–48 hours 24 hours —Mean time between failures/To repair failures >200 days/<24 hours — —/<24 hoursAverage time to complete maintenance by lab personnel daily: 5 minutes; weekly: 10 minutes;

monthly: 10 minutesweekly: 5 minutes; monthly: 15 minutes daily: 5 minutes

Onboard maintenance records/Maintenance training demo module yes (includes audit trail)/no yes/no yes/no

List price/Targeted bed size or daily volume —/all bed sizes, all volumes —/100–500 —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes yes/yes 8 days on site/yes



full walkaway automation; compact benchtop design; continuous loading with batch, random, and stat flexibility; auto start-up and shut-down; onboard refrigeration of ready-to-use reagent cartridges; total tracability and full data transmitted to the LIS (results, QC, lot reagents and consumables, messages, operator ID, washer used, and more)

random access, continuous load, chemiluminescent; benchtop footprint completing up to 450 results per shift; onboard reagents with stable calibration curves to eliminate batching and improve turnaround time

graphic interface with drag-and-drop icons; large sample throughput, with 98 samples and continuous load feature; consumable status window shows location and volume requirements during loading





Part 13 of 21 Inova Diagnostics Inova Diagnostics Inova DiagnosticsKaz Nakanishi [email protected] Ed Bass [email protected] Ed Bass [email protected]


9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131800-545-9495 www.inovadx.com 800-545-9495 www.inovadx.com 800-545-9495 www.inovadx.com

Name of instrument/First year sold/Where designed DSX/2000/Guernsey, U.K. Quanta Lyser 240/2008/Switzerland, Italy Quanta Lyser 2/2008/—

Country where manufactured/Where reagents manufactured U.S./U.K. Switzerland/U.S. Switzerland/U.S.Number of units in clinical use in U.S./Outside U.S. 300/>500 135/171 5/72Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/racks batch/benchtop/racks

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 32 × 42 × 36/7 36 × 47 × 32/10.5 29.5 × 25.6 × 27.6/—

Tests available on instrument in U.S. autoimmune, infectious disease open system: autoimmune, infectious disease open system: autoimmune, infectious disease

Tests not available in U.S. but submitted for clearance — — —

Tests not available in U.S. but available in other countries any ELISA — —

Tests in development — — —

Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit — — —

Number of wells in microplate minimum strip: 1 × 8; maximum full plate: 96 × 4 plates 96 96

Methods supported/Separation methods enzyme immunoassay/coated microwell enzyme immunoassay/coated microwell, IFA slides enzyme immunoassay, IFA slides/coated microwell

Number of different measured assays onboard simultaneously 12 assays per plate 12–22 7Number of different assays programmed, calibrated at once unlimited — —Number of user-definable (open) channels unlimited open system open systemNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/96 per 4 plates enzyme immunoassay/IFA enzyme immunoassay/IFA

Shortest/Median onboard reagent stability/Refrigerated onboard 24 hours/—/no —/—/no —/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use requires operator prehandling/preparation requires prehandling requires prehandlingReagents bar-coded/Information in bar code yes/yes — yes/—

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/zero —/<10 no/<10-6

Walkaway capacity in minutes/Specimens/Tests, assays assay dependent/92/assay dependent assay dependent/up to 240/9 quantitative, 21 qualitative 64 IFA, 96 enzyme immunoassaySystem is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 200 µL 200 µL 100 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/200 µL (50 µL with microtubes) 5 µL/200 µL 5 µL/150 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/50 µL no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/various/no yes/10–16 mm/no yes/10–16 mm/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes — —Onboard test auto inventory (determines volume in container) no no noMeasures number of tests remaining/Short sample detection no/yes no/yes no/yesAutomatic detection of adequate reagent or specimen yes no —Clot detection/Reflex testing capability yes/no yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no — no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no — —

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay specific assay dependent variesCalibrants can be stored onboard/Average calibration frequency yes/once per analyte per plate no/per run —/per runMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/no yes/noHow often QC required per plate per run per runOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/no no/yes no/—Automatic shutdown/Startup is programmable/Startup time yes/—/1–2 minutes no/no/2 minutes no/no/2 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/— — —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites Cerner Classic and Millennium, Misys, SoftComp,

Live Link, Triple G, FCC, ACA, LCW, LabLinkCerner Classic and Millennium, Misys, SoftComp —

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query) yes (host query) yes (broadcast download, host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/yes/yes no/no/no no/—/—

Can order (via modem) malfunctioning part(s) without operator no no —On-site response time of service engineer within 24 hours 24 hours 24 hoursMean time between failures/To repair failures —/<24 hours 8–9 months/less than 2 hours 6–8 months/—Average time to complete maintenance by lab personnel daily: 5 minutes daily: 5 minutes; weekly: 10 minutes

monthly: 10 minutesdaily: 5 minutes; weekly: 10 minutes; monthly: 10 minutes

Onboard maintenance records/Maintenance training demo module no/no no/— no/—

List price/Targeted bed size or daily volume —/200+ beds —/500 tests per day —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 8 days on site, 2 days at vendor offices/yes yes (2 days on site)/yes yes (2 days on site)/—



fully open, true four-plate system; modular design of reader, washer, incubators; bar-code reader and ambi-ent drawer enables easy upgrades and express shipping of replacement modules, reducing downtime; software can be configured for learned error recovery

fast processing time; low operating costs due to elimination of disposable tips; completely open high-throughput batch analyzer; reads IFA bar codes

processes IFA slides and ELISA assays simultaneously, LIS interface, large menu, and open-assay capability; reads IFA bar codes





Part 14 of 21 Ortho Clinical Diagnostics Ortho Clinical Diagnostics Randox LaboratoriesMark Steelman [email protected] Mark Steelman [email protected] David McConville [email protected]


100 Indigo Creek Drive, Rochester, NY 14626 100 Indigo Creek Drive, Rochester, NY 14626 55 Diamond Rd., Crumlin, County Antrim, BT29 4QY585-453-3420 www.orthoclinical.com 585-453-3420 www.orthoclinical.com 0044 28 9442 2413 www.randox.com

Name of instrument/First year sold/Where designed VITROS ECi Immunodiagnostic System/1997/U.S. VITROS 3600 Immunodiagnostic System/2009/U.S. Evidence/2002/Northern IrelandCountry where manufactured/Where reagents manufactured U.S./U.K. U.S./U.K. Northern Ireland/Northern IrelandNumber of units in clinical use in U.S./Outside U.S. >3,100 worldwide >400 worldwide 8/27Operational type/Model type/Sample handling system continuous random access/floor standing/universal

sample trays (circular) accommodate primary and secondary containers without need for adapters

contin. random access/floor standing/universal circular trays uses primary and secondary containers without adapters

batch/floor standing/carousel

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 51 × 44 × 29/8.9 68 × 83.5 × 34.9/20.2 68 × 78 × 39/22.75

Tests available on instrument in U.S. 3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total βhCG, estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA 125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB, troponin I, aHBs, B12, folate, RBC folate, equimolar PSA, HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM, aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV IgM, rubella IgG, aHIV 1+2, iPTH, HBeAg, aHBe, vitamin D

3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total βhCG, estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA 125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB, troponin I, aHBs, B12, folate, RBC folate, equimo-lar PSA, HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM, aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV IgM, rubella IgG, aHIV 1+2, iPTH, vitamin D

amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, estradiol, FSH, opiates, phencyclidine, progester-one, prolactin, LH, methadone, methamphetamine

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries toxo IgG, rubella IgM, toxo IgM, CMV IgG, CMV IgM,

syphilis, free PSA, total PSA IIaHBe, HBeAg, rubella IgM, toxo IgG, toxo IgM, CMV IgG, CMV IgM, syphilis, free PSA, total PSA II

3,4 MDMA, acetaminophen, adhesion biomarkers, benzylpi-perazines, buprenorphine, CEA, chloral hydrate metabolite, CK-MB, cytokines, dextromethorphan, endocrine hormones, ethyl glucuronide, escitalopram, estradiol, fentanyl, fluoxetine, fPSA, FSH, FT3, FT4, generic opioids, haloperidol, h-FABP, ibuprofen, ketamine, LSD, metabolic syndrome biomarkers, methylphenidate, oxycodone, propoxyphene, salicylate, salicyluric acid, sertraline, TCAs generic, others

Tests in development — — —Tests not available on other manufacturers’ analyzers NTx NTx h-FABP, GPBB, IL-5, IL-15

Fully automated microplate system no no —Number of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods chemiluminescence (enhanced)/individually coated microwell chemiluminescence (enhanced)/indiv. coated microwell chemiluminescence/—Number of different measured assays onboard simultaneously 20 31 8Number of different assays programmed, calibrated at once 20, up to 25 lots calibrated per assay 31, up to 25 lots calibrated per assay 12Number of user-definable (open) channels 0 — 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

20/100 31/100 96/360

Shortest/Median onboard reagent stability/Refrigerated onboard 56 days/56 days/yes (2° –8°C) 1,008 hours/56 days/yes (2°–8°C) assay dependent/1–14 days/yes (2°–8ºC)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/test ID, expiration, lot number, pack ID yes/test ID, expiration date, lot number, pack ID yes/product component, size, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover —/zero no/zero —Walkaway capacity in minutes/Specimens/Tests, assays 720/60/800 (with enhanced productivity module) varies/90/3,100 100/180/540–1,080System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 10 µL 10 µL 7 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/80 µL 10 µL/35 µL 7 µL/7–350 µL (varies with cup type)Supplied with UPS (backup power)/Requires floor drain no, but it is available/no no, but it is available/no optional/yesRequires dedicated water system/Water consumption no/— no/— no/—Noise generated 60 decibels — <60 decibelsHas dedicated pediatric sample cup/Dead volume no/— no/— yes/100 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/multiple pediatric, microtainers and cups, 5 mL,

7 mL, 10 mL on same universal sample tray/noyes/1.5-mL micro-collection containers; 0.5-, 2.0-mL cups; 5, 7, 10 mL on same universal sample tray, no adapters/no

yes/12 mm, 16 mm/no

Sample bar-code reading capability/Autodiscrimination yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yes yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes no/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no yes/yes no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes no/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun assay dependent assay dependent 12 minutesAutocalibration or autocalibration alert yes yes noNumber of calibrators required for each analyte 1–3 1–3 depending on assay 9 (multianalyte calibrators)Calibrants can be stored onboard/Average calibration frequency no/28 days no/28 days no/weekly (dependent on panel)Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required/ once per 24 hours once per 24 hours user definedOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time — —/—/0 yes/no/13 minutes

Stat time to completion of βhCG test 24 minutes 24 minutes —Time delay from ordering stat test to aspiration of sample immediate upon completion of last sample metering immediate upon completion of last sample metering —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/assay dependent (40 seconds) assay dependent/assay dependent (19 seconds) 108/324 (5 minutes)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard and optional add-on/no onboard and optional add-on/yes (additional cost) onboard/yes (included in price)LIS interfaces up and running in active user sites Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA,

Citation, DHCP, Unisys, McKesson, PathLab 3, Soft, othersCerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA, Citation, DHCP, Unisys, McKesson, PathLab 3, others

yes

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download) yes (broadcast download and host query) yes (host query)Interface available (or will be) to auto specimen handling system no yes, enGen noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <4 hours (contract dependent) <4 hours (contract dependent) <24 hours (contract dependent)Mean time between failures/To repair failures dependent on corrective action — —Average time to complete maintenance by lab personnel daily: <5 minutes; weekly: <30 minutes; monthly: <10 minutes daily: 10 minutes; weekly: 25 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 10 minutes; monthly: 30 minutesOnboard maintenance records/Maintenance training demo module no/yes yes (includes audit trail)/yes no/—

List price/Targeted bed size or daily volume $109,000/various $220,000/various contract dependent/500+Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes, as needed yes/yes, as needed yes/yes



uses Intellicheck technology to perform, monitor, document, and verify diagnostic checks throughout sample and assay processing to reduce potential of misreported results; IntelliReport provides real-time status and traceability on quality of reported results; uses enhanced chemiluminescence, MicroWell technology

diagnostic checks throughout sample and assay processing reduces misreported results; real-time status and traceability on quality of reported results; fully automated, true random access stat testing for routine and specialty immunodiagnostic testing; single-use tips for sample and reagent metering; measures and flags results

biochip enables simultaneous analysis of multiple parameters in single sample; maximum throughput of 1,188 tests per hour; unreported tests retrieved retrospectively; arrays contain multiple tests applicable to clinical and research applications





Part 15 of 21 Roche Diagnostics Roche Diagnostics Roche DiagnosticsRyan Dempsey [email protected] Tracy Kelly [email protected] Ryan Dempsey [email protected]


9115 Hague Rd., Indianapolis, IN 46250 9115 Hague Rd., Indianapolis, IN 46250 9115 Hague Rd., Indianapolis, IN 46250800-428-5074 us.diagnostics.roche.com 800-428-5074 us.diagnostics.roche.com 800-428-5074 us.diagnostics.roche.com

Name of instrument/First year sold/Where designed cobas 8000 modular analyzer series/2010/Japan, Switzerland

cobas e411 analyzer/2008/Japan cobas 6000 analyzer series/2006/Japan, Switzerland

Country where manufactured/Where reagents manufactured Japan/Germany Japan/Germany Japan/GermanyNumber of units in clinical use in U.S./Outside U.S. >140/>1,000 >615/>7,000 >1,100/>6,200Operational type/Model type/Sample handling system random access, continuous random access/floor

standing/rack-basedcontinuous random access/benchtop/rack, disk continuous random access/floor standing/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 52.8 × 58.8 × 45.6/— disk: 31.4 × 47.2 × 28.7/94; rack: 31.4 × 67 × 37.4/17.4 46.1 × 71.8 × 40/19.73

Tests available on instrument in U.S. ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBs, Anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, anti-HBc, anti-HBc IgM, others

ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM, anti-HBs, Anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg Confirma-tory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, total PSA, toxo IgG, troponin I, troponin T, anti-HBc, others

ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM, anti-HBs, Anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg Confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, anti-HBc, others

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries free βhCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag,

HIV Ag confirmatory test, HIV Combi, othersfree βhCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV Ag confirmatory test, HIV combi, toxo IgM, CMV IgG, others

free βhCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV Ag confirmatory test, HIV combi, others

Tests in development tacrolimus, sirolimus, cyclosporine, toxo IgM, CMV IgG, CMV IgM, troponin T fifth generation, HBsAg (quant); PCT, Interleukin 6, syphilis, others

tacrolimus, sirolimus, cyclosporine, toxo IgM, CMV IgG, CMV IgM, troponin T fifth generation, HBsAg (quant); PCT, Interleukin 6, syphilis, others

tacrolimus, sirolimus, cyclosporine, toxo IgM, CMV IgG, CMV IgM, troponin T 5th generation, HBsAg (quant); PCT, Interleukin 6, syphilis, others

Tests not available on other manufacturers’ analyzers 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more


Methods supported/Separation methods electrochemiluminescence/magnetic particle electrochemiluminescence/magnetic particle electrochemiluminescence/magnetic particleNumber of different measured assays onboard simultaneously 25 per module, maximum of 60 18 25 per module, maximum of 60Number of different assays programmed, calibrated at once 25 per module 18 25 per moduleNumber of user-definable (open) channels — 0 —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/100–200 tests per kit 18/100–200 tests per kit 25/100–200 tests per kit

Shortest/Median onboard reagent stability/Refrigerated onboard 2 weeks/6 weeks/yes (20°C) 14 days/56 days/yes 2 weeks/6 weeks/yes (20°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/calibration curve, application parameters,

lot number, expiration, reagent nameyes/calibration curve, application parameters, lot number, expiration, reagent name

yes/calibration curve, application parameters, lot number, expiration, reagent name

Same capabilities when 3rd-party reagents used/Susceptibility to carryover —/zero (uses disposable sample tips) no/zero (uses disposable sample tips) —/zero (uses disposable sample tips)Walkaway capacity in minutes/Specimens/Tests, assays 360/300/5,000 disk: 120/30/180; rack: 120/100/180 360/150/5,000System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/1,006 per module yes/360 assay tips; 180 assay cups yes/1,006 per moduleUses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 10 µL 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/100 µL 10 µL/100 µL 10 µL/100 µLSupplied with UPS (backup power)/Requires floor drain yes/yes yes/no yes/yesRequires dedicated water system/Water consumption yes/average 12 L per hour in full operation no/3 L for 250 tests yes/average 12 L per hour in full operationNoise generated <65 decibels <70 decibels <65 decibelsHas dedicated pediatric sample cup/Dead volume yes/100 µL no/— yes/100 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75, 16 × 100, false bottom/no yes/13–16 mm diameter/no yes/13 × 75, 16 × 100, false bottom/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes (data manager) yes/yes (with middleware) yes/yes (with Roche Middleware Solutions)Hemolysis detection-quantitation/Turbidity detection-quantitation yes/yes, semiquantitative with integrated system no/no yes/yes, semiquantitative with integrated systemDilution of patient samples onboard/Automatic rerun capability yes/yes yes/no yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no yes/yes no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2 2 2Calibrants can be stored onboard/Average calibration frequency no/28 days no/monthly for lot, weekly for rack no/every 28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours once per day 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/11 minutes yes/no/4 minutes yes/yes/11 minutes

Stat time to completion of βhCG test 9-min. incubation for hCG and 18-min. incubation for βhCG 9 minutes 9-min. incubation for hCG and 18-min. incubation for βhCG Time delay from ordering stat test to aspiration of sample <1 minute 42 seconds <1 minuteThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

56/176 (21 seconds) 30/86 (42 seconds) 56/176 (21 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/— onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites all major LISs — all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes (Roche MPA systems, task-targeted automation) yes yes (Roche MPA systems, task-targeted automation)Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes yes/yes/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours <24 hours ≤24 hoursMean time between failures/To repair failures — 215 days/varies —Average time to complete maintenance by lab personnel 4–5 minutes hands-on daily maintenance daily: 5 minutes; weekly: 6 minutes; monthly: 10–15 min. 3–5 minutes of hands-on daily maintenanceOnboard maintenance records/Maintenance training demo module yes (includes audit trail)/yes (online help) no/no yes (includes audit trail)/yes (online help)

List price/Targeted bed size or daily volume —/large to very large —/varies, primary immunoassay system or backup unit

—

Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 5 days at company offices/yes 4 days on site/yes 5 days at company offices/yes



ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and bar-coded reagents compat-ible with other Elecsys systems; range of stat assays with 9-minute assay time, integral part of c8000 platform, con-nects with Modular Pre-Analytics for total lab automation

ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and bar-coded reagents fully compatible with other Elecsys systems; range of stat assays with 9-minute assay time

ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and bar-coded reagents compat-ible with other Elecsys systems; range of stat assays with 9-minute assay time, integral part of c8000 platform, con-nects with Modular Pre-Analytics for total lab automation





Part 16 of 21 Siemens Healthcare Diagnostics Siemens Healthcare Diagnostics Siemens Healthcare DiagnosticsMatthew Fitzgerald [email protected] Matthew Fitzgerald [email protected] Meghan Berdelle


511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591847-236-7404 www.usa.siemens.com/diagnostics 847-236-7404 www.usa.siemens.com/diagnostics 847-217-5487 www.usa.siemens.com/diagnostics

Name of instrument/First year sold/Where designed Dimension EXL 200/2011/U.S. Dimension Vista 500 Intelligent Lab System/2009/U.S. ADVIA Centaur CP Immunoassay System/2005/U.S.Country where manufactured/Where reagents manufactured U.S./U.S. U.S./U.S., Germany Switzerland/U.S.Number of units in clinical use in U.S./Outside U.S. >1,100 global >900 global >557/>2801Operational type/Model type/Sample handling system batch, random access/floor standing/segmented sample

wheel/floor standingcontinuous random access/floor standing/rack and aliquot plate system, batch

continuous random access/benchtop/7 × 12 position racks

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 61 × 56 × 41/16 56 × 85 × 44/26 32 × 43 × 29/8.7

Tests available on instrument in U.S. tacrolimus, MPA, LOCI troponin, LOCI NT-proBNP, LOCI TSH, LOCI free T4, LOCI free T3, sirolimus, total PSA, free PSA, CardioPhase hsCRP, ferritin, HCG, LV HCG, mass CK-MB, LV mass CK-MB, myoglobin, ammonia, urine/CSF protein, lactic acid, microalbumin, prealbumin, carbamazepine, cyclosporine, cyclosporine extended range, digoxin, digitoxin, gentamicin, lidocaine, lithium, N-acetylprocainamide, many others

>130 (includes vendor-supported applications), 35 general chemistry, 14 TDMs, 17 DATs, 3 anemia, 40 plasma proteins, 20 immunoassays, including cyclosporine, LH, FSH, prolactin, and CA 19-9

total IgE, ferritin, folate, RBC folate, vitamin B12, vitamin D total, BNP, CKMB, myoglobin, Tnl-ultraTM, C-peptide, insulin, eHIV 1/O/2, HAV IgM, HAV total, HBc IgM, HBc total, HBsAg, HBsAg confirmatory, HCV, cyclosporine, cortisol, homocysteine, AFP, BR, CA 15-3, CA 19-9, CA 125II, CEA, complexed PSA, PSA, serum HER2/neu, DHEAS, enhanced estradiol, FSH, total hCG, LH, progesterone, prolactin, SHBG, testosterone, rubella IgG, rubella IgM, syphilis, others

Tests not available in U.S. but submitted for clearance LOCI B12, LOCI folate progesterone, Loci BNP anti-HBs2Tests not available in U.S. but available in other countries >35 >20 procalcitonin, HA, TIMP, PIIINP (ELF markers)Tests in development LOCI BNP, LOCI IPTH testosterone vitamin D, D-dimer, galectin-3, anti-HBe, HBeAg, HIV combo

(CHIV), tacrolimus, free PSA, PIGF, sFLT-1, CMV IgG, CMV IgMTests not available on other manufacturers’ analyzers — LOCI immunoassay, nephelometric assays, gen. chemistry complexed PSA, serum HER2/neu


Methods supported/Separation methods photometry, potentiometry (ISE), turbidimetric and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

photometry, potentiometry (ISE), turbidimetric, nephelometry and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

chemiluminescence/magnetic particle

Number of different measured assays onboard simultaneously 47 144 15Number of different assays programmed, calibrated at once 47 144 >84 assays and multiple calibration lotsNumber of user-definable (open) channels 10 10 —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

47/15–360 144/20–1,200 15/50–200

Shortest/Median onboard reagent stability/Refrigerated onboard 24 hours/30 days/yes (2°–8°C) 24 hours/30 days/yes (2°–8°C) 4 days/28 days/yes (4°C)Multiple reagent configurations supported yes no yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/lot number, unique flex ID, stability, expiration date yes/test method, lot number, expiration date, number of tests yes/reagent ID, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none (due to probe washing) yes/<1 ppm no/zeroWalkaway capacity in minutes/Specimens/Tests, assays can be hours/60/>2,000 >45/150/61,404 210/72/480System is open (homebrew methods can be used)/Liquid or dry system yes/liquid (reconstitutes onboard, no reagent prep required) yes/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/12,000 yes/>1,600 yes/400Uses washable cuvettes/Replacement frequency no/— yes/automatic as needed no/—Minimum specimen volume required 2 uL 50 uL 10 uL, assay dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 2 uL/— 50 uL/10 µL 10 uL/50 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/yes yes/noRequires dedicated water system/Water consumption yes/5 L no/20 L per hour no/noneNoise generated <75 decibels <64 decibels <60 decibelsHas dedicated pediatric sample cup/Dead volume yes/30 µL no/10 µL, if using small sample cup no (uses microtainers)/50 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no yes/10 × 50, 10 × 65, 13 × 65, 13 × 75, 13 × 100, 15 × 92,

16 × 100, 13 × 90/noyes/5-, 7-, 10-, 1-mL cups, microtainer tubes/no

Sample bar-code reading capability/Autodiscrimination yes, on sample transport, shortly before sample is aspi-rated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

yes, on sample transport, shortly before sample is aspi-rated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Bar-code placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes yes/yes no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/no can decrease/cannot increase sample volume no (does have autodilution)/no (does have autodilution)

Time between initial result and reaspiration of sample for rerun <20 seconds <2 minutes variesAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte varies (3 levels for most assays) 2–6 (varies) 2Calibrants can be stored onboard/Average calibration frequency yes (NA, K, Cl)/most 90 days yes/30–90 days no/28 days (assay dependent)Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours or with lot change once per 24 hours user definedOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/8 minutes no/no/always ready no/always ready/<5 minutes

Stat time to completion of βhCG test 16 minutes 10 minutes 15 minutesTime delay from ordering stat test to aspiration of sample <24 seconds <2 minutes 20 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

up to 146/437 (7.2 seconds) >150/450 for immunoassay methods 60/180 (20 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard, optional add-on/yes (additional cost) onboard/no yes/yesLIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Siemens VersaCell, Streamlab, Aptio Automation yes, Siemens, Streamlab, Advia LabCell,

Advia WorkCell, Aptio Automationno

Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours 2–8 hours 2–8 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <5 minutes; weekly: 10 minutes;



Onboard maintenance records/Maintenance training demo module no/no yes/yes yes/yes

List price/Targeted bed size or daily volume — — —/200+ beds or 250 tests per dayAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3 days at company offices/yes 4 days at company offices/yes 4 days at company offices/yes



integrates general chemistry with homogeneous LOCI and heterogeneous immunoassays onboard; allows a single platform for more than 95 percent of most requested tests; eliminates sample splitting between general chemistry tests and immunoassays; fully automated onboard ISD assays, QCC PowerPak onboard; reagent management system standard

ultra-integrated chemistry platform with LOCI advanced chemiluminescence and nephelometry onboard; enhanced workflow efficiency with automated features, such as autocalibration, auto QC, and system twinning; proactive service and support through RealTime Solution Siemens Remote Service

automates routine operations, including ability to ac-cess/change solutions, waste, disposables, and reagents without pausing sampling or processing; onboard auto-matic dilutions, repeats, stats, and cascade reflex test-ing; disposable tips; uses same reagents/consumables as Advia Centaur/Advia Centaur XP with concordant results; throughput 180 tests per hour; average time to first result ~15 minutes





Part 17 of 21 Siemens Healthcare Diagnostics Siemens Healthcare Diagnostics Siemens Healthcare DiagnosticsMeghan Berdelle Matthew Fitzgerald [email protected] Matthew Fitzgerald [email protected]


511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591847-217-5487 www.usa.siemens.com/diagnostics 847-236-7404 www.usa.siemens.com/diagnostics 847-236-7404 www.usa.siemens.com/diagnostics

Name of instrument/First year sold/Where designed ADVIA Centaur XP/2006/U.S. Dimension Vista 1500 Intelligent Lab System/2006/U.S. Dimension EXL with LM Integrated Chemistry System/2009/U.S.

Country where manufactured/Where reagents manufactured Ireland/U.S. U.S./U.S., Germany U.S./U.S.Number of units in clinical use in U.S./Outside U.S. >1,420/>4,550 >1,000 global >1,500 globalOperational type/Model type/Sample handling system continuous random access/floor standing/5-position

multiple size rack or puck via Advia LabCell and WorkCell, StreamLab, VersaCell

batch, random access, continuous random access/ floor standing/sample rack and aliquot plate system

batch, random access, continuous random access/ floor standing/racks

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 51.5 × 76.5 × 41/20.6 56 × 85 × 44/26 49 × 82 × 41 (without monitor)/25.1 (with printer shelf down)

Tests available on instrument in U.S. total IgE, ferritin, folate, RBC folate, vitamin B12, vitamin D total, BNP, CKMB, myoglobin, Tnl-ultraTM, C-peptide, insulin, anti-HBs2, eHIV 1/O/2, HAV IgM, HAV total, HBc IgM, HBc total, HBeAg, HBsAg, HBsAg confirmatory, HCV, cyclospo-rine, cortisol, homocysteine, AFP, BR, CA 15-3, CA 19-9, CA 125II, CEA, complexed PSA, PSA, serum HER2/neu, DHEAS, enhanced estradiol, FSH, total hCG, LH, progesterone, others

>130 (includes vendor-supported applications) >100 (includes vendor-supported applications)

Tests not available in U.S. but submitted for clearance — progesterone, LOCI BNP —Tests not available in U.S. but available in other countries procalcitonin, HA, TIMP, PIIINP (ELF markers) >20 >35Tests in development D-dimer, galectin-3, anti-HBe, HIV combo (CHIV),

tacrolimus, free PSA, PIGF, sFLT-1, CMV IgG, CMV IgMtestosterone, additional hormones, LOCI vitamin D, cortisol, BNP, and intact PTH

LOCI BNP, LOCI IPTH

Tests not available on other manufacturers’ analyzers complexed PSA, serum HER2/neu LOCI technology, nephelometry, general chemistry —


Methods supported/Separation methods acridinium ester, chemiluminescence/magnetic particle photometry, potentiometry (ISE), turbidimetric, nephelometry and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

photometry, potentiometry (ISE), turbidimetric and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

Number of different measured assays onboard simultaneously 30 primary reagents 166 91Number of different assays programmed, calibrated at once 300 166 91Number of user-definable (open) channels — 10 10Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

30/50, 100, 200 tests per pack 166/20–1,200 91/15–360

Shortest/Median onboard reagent stability/Refrigerated onboard 4 days/28 days/yes (4°C) 24 hours/30 days/yes (2°–8°C) 24 hours/30 days/yes (2°–8°C)Multiple reagent configurations supported yes no yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/assay name, lot No., expir. date, pack ID, No. of tests yes/test ID, lot No., individual-sequence number, exp. date yes/lot number, unique flex ID, stability, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover —/none yes/<1 ppm yes/none (due to probe washing)Walkaway capacity in minutes/Specimens/Tests, assays 280/180/840 >45/150/61,404 can be hours/60/>2,000System is open (homebrew methods can be used)/Liquid or dry system no/liquid yes/liquid yes/liquid (reconstitutes on board, no reagent prep required)Uses disposable cuvettes/Maximum number stored yes/1,000 yes/>2,000 yes/12,000Uses washable cuvettes/Replacement frequency no/— yes/as needed no/—Minimum specimen volume required 10 µL, assay dependent 2 µL analytical, 50 µL aliquot 2 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/50 µL 2 µL (GLU=1.2)/20 µL 2 µL/primary tube capableSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/2.5 L per hour no/20 L per hour yes/up to 5 LNoise generated <62 decibels 64 decibels <75 decibelsHas dedicated pediatric sample cup/Dead volume no (uses microtainers)/50 µL yes/10 mL yes/30 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/1-, 2-, 3-, 5-, 7-, 10-mL, microtainer tubes/no yes/10 × 50, 10 × 65, 13 × 65, 13 × 75, 13 × 100, 15 × 92,

16 × 100, 13 × 90/noyes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no

Sample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes, on sample transport, shortly before sample is aspi-rated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

yes, on sample transport, shortly before sample is aspi-rated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Bar-code placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no yes/yes yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no (has autodilution)/no (has autodilution) no/no (has autodilution) yes/no

Time between initial result and reaspiration of sample for rerun 15 seconds <2 minutes <20 secondsAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2 2–6 (varies) varies (3 levels for most assays)Calibrants can be stored onboard/Average calibration frequency no/28 days (assay dependent) yes/30–90 days yes (NA, K, Cl)/most 90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required user defined shortest interval: 24 hours 24 hours or with lot changeOnboard real-time QC/Support multiple QC lot Nos. per analyte no/yes yes/yes no/yesAutomatic shutdown/Startup is programmable/Startup time no/no/always ready no/no/always ready no/no/not required

Stat time to completion of βhCG test 18 minutes 10 minutes 16 minutesTime delay from ordering stat test to aspiration of sample 15 seconds <2 minutes <24 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

80/240 (15 seconds) 150/450 for immunoassay methods up to 146/437 (7.2 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC no/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface yes/yes onboard/no onboard, optional add-on/yes (additional cost)LIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab yes, Siemens VersaCell, Streamlab, Advia LabCell, Advia

WorkCell, Aptio Automationyes, Siemens VersaCell, Streamlab, Aptio Automation

Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours 2–8 hours 2–8 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 30 minutes;


daily: <5 minutes; weekly: 10 minutes; monthly: 10 minutes

Onboard maintenance records/Maintenance training demo module yes/yes yes/yes no/yes

List price/Targeted bed size or daily volume —/300+ beds or 500 tests per day — —Annual service contract cost (24 hours/7 days) multiple options — multiple typesTraining provided with purchase/Advanced operator training 4.5 days on site/yes 4 days at company offices/yes 4 days at company offices/no



automates operations: ability to access/change solutions, waste, disposables, and reagents without pausing sampling or processing, no-pause loading of disease menu, reagents, high-throughput consumables; onboard automatic dilutions, repeats, stats, and cascade reflex testing; disposable tips; uses same reagents/consumables as Centaur CP with concordant results; processes 240 tests per hour

intelligent lab system with customer-driven design, ultra-integration of technologies; LOCI advanced chemiluminescence and automation onboard for efficiency, simplicity, sensitivity, and convenience to provide an efficient workflow for the laboratory; autocalibration and auto QC onboard; proactive services and support through RealTime Solution Siemens Remote Service

integrates homogeneous LOCI and heterogeneous immunoassays onboard with other chemistries; allows single platform for >95 percent of most tests; eliminates sample splitting between general chemistry tests and immunoassays; fully automated onboard ISD assays; QCC PowerPak onboard; reagent management standard





Part 18 of 21 Siemens Healthcare Diagnostics Siemens Healthcare Diagnostics ThermoFisher ScientificRyan Gresavage Ryan Gresavage Joanne Yancon [email protected]


511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 4169 Commercial Ave., Portage, MI 49002847-267-5384 www.usa.siemens.com/diagnostics 847-267-5384 www.usa.siemens.com/diagnostics 800-346-4364 www.thermoscientific.com/phadia

Name of instrument/First year sold/Where designed IMMULITE 1000/2002/U.S. IMMULITE 2000 XPi Immunoassay System/2009/U.S. Phadia Laboratory System 100/1995/SwedenCountry where manufactured/Where reagents manufactured U.S./U.S., U.K. U.S./Wales, U.K. Sweden/SwedenNumber of units in clinical use in U.S./Outside U.S. >557/>2,386 >103/>1,283 —Operational type/Model type/Sample handling system continuous random access/benchtop/loading platform random access/floor standing/rack batch/benchtop/carouselDimensions in inches (H × W × D)/Instrument footprint in sq. feet 19 × 46 × 26/7.98 47 × 60 × 30/12.5 18 × 28 × 24 plus computer/—

Tests available on instrument in U.S. total IgE, ferritin, folic acid, RBC folate, vitamin B12, calcito-nin, PYRILINKS-D, high-sensitivity CRP, myoglobin, troponin I, CMV IgG, CMV IgM, herpes I & II IgG, toxo. quantitative IgG, toxo. IgM, rubella quantitative IgG, rubella IgM, C-peptide (serum, urine), insulin, microalbumin (urine) (ALB), growth hormone (hGH), IGF-I, IGFBP-3, anti-HBc IgM, anti-HBc total, anti-HBs, HBs Ag, HBs Ag confirmatory, H. pylori IgG, ACTH, cortisol, homocysteine, AFP, others

3gAllergy specific, total IgE, ferritin, folic acid, RBC folate, vitamin B12, calcitonin, PYRILINKS-D, high-sensitivity CRP, myoglobin, troponin I, CMV IgG, CMV IgM, herpes I & II IgG, toxo. quantitative IgG, toxo. IgM, rubella quantitative IgG, rubella IgM, C-peptide (serum, urine), insulin, microalbumin (urine) (ALB), growth hormone (hGH), IGF-I, IGFBP-3, anti-HBc IgM, anti-HBc total, anti-HBs, HBs Ag, HBs Ag confirma-tory, H. pylori IgG, syphilis, ACTH, cortisol, anti-CCP, others

hundreds of ImmunoCAP-specific IgE allergens,ImmunoCAP-total IgE, tryptase and ImmunoCAP TG and TPO, EliA autoimmune products include CCP,dsDNA, symphony ANA screen, 7 individual ENAs, Celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG, β2-glycoprotein I IgM/IgG/IgA, cardiolipin IgA

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries AlaTOP allergy screen, ECP, osteocalcin, CK-MB, D-

dimer, NT-proBNP, IL-10, IL-1B, IL-2R, IL-6, IL8, LBP, TNF-a, TPS, free beta HCG, PAPP-A, nicotine metabolites

AlaTOP allergy screen, allergen-specific IgG, allergen-spe-cific IgG4, ECP, osteocalcin, CK-MB, D-dimer, NT-proBNP, IL-2R, IL-6, IL8, LBP, free beta HCG, PAPP-A, EBV-EBNA IgG, EBV-VCA IgG, EBV-VCA IgM, nicotine metabolites

EliA PR3S, GMB, MPO, EliA CTD screen (14 ENAs), Pm/Scl, EliA Anti IgA, EliA calprotectin, others

Tests in development D-dimer, turbo D-dimer, CMV IgM immunoglobulin (TSI) —Tests not available on other manufacturers’ analyzers IGF-I, IGFBP-3, androstenedione, β2 microglobulin, gastrin,

canine TLI, canine total T4, canine TSHIGF-I, IGFBP-3, androstenedione, β2 microglobulin, gastrin, canine TLI, canine total T4, canine TSH; 3gAllergy-specific IgE

ImmunoCAP-specific IgE blood tests and EliA autoimmune tests


Methods supported/Separation methods chemiluminescence/bead, centrifugation chemiluminescence/bead, centrifugation fluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

Number of different measured assays onboard simultaneously 12 24 4Number of different assays programmed, calibrated at once unlimited unlimited 7 Number of user-definable (open) channels 0 — 0 (closed system)Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

12, 5 for Turbo/100, 50 for Turbo i-PTH 24/200 48–96, depending on the conjugate type

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no (30 days refrigerator stability) 90 days/90 days/yes (4°C) —Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yes (wash solution requires preparation)Reagents bar-coded/Information in bar code yes/test, lot number, expiration date yes/test, lot number, expiration date yes/product name, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/<10 ppm no/<3 ppm no/—Walkaway capacity in minutes/Specimens/Tests, assays 100/—/70 300/90/1,300 180/varies with analyte/48System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/— yes/1,300 no/—Uses washable cuvettes/Replacement frequency no/— no/— —Minimum specimen volume required 5 µL 5–100 µL 40 µL for ImmunoCAP tests and 20 µL for EliA testsMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/100 µL 5 µL/50 µL ImmunoCAP: 40 µL/40–200 µL; EliA: 50 µL/20–200 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/0.5 L per hour no/— no/1 L per runNoise generated 55–68 decibels 52 decibels —Has dedicated pediatric sample cup/Dead volume no/— yes/50 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes no/—/— yes/75–100 mm/no yes/10–16 mm × 50–105 mm/noSample bar-code reading capability/Autodiscrimination yes/yes yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A yes yes noOnboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability no/no yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no yes/yes no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/yes yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no (has autodilution)/no (has autodilution) no/no

Time between initial result and reaspiration of sample for rerun — minimum 18 seconds 2.5 hours (batch run)Autocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2-level adjusters, supplied in kit 2-level adjusters, supplied in kit 6 per analyte for calibration run, 2 when using stored

curveCalibrants can be stored onboard/Average calibration frequency no/1–4 weeks (assay dependent), 2 weeks for Turbo no/1–4 weeks (assay dependent) yes/28 days or sooner if conjugate lots changeMultipoint calib. supported/Multiple calibs. stored for same assay no/yes yes/yes yes/yesHow often QC required customer determined customer determined once per work shift (user defined)Onboard real-time QC/Support multiple QC lot Nos. per analyte no/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/5 minutes yes/yes/4 minutes yes/yes/20 min. including request entry or downloading

Stat time to completion of βhCG test 42 minutes; 15 minutes for Turbo (total hCG) 35 minutes —Time delay from ordering stat test to aspiration of sample 2.5 minutes 18 seconds —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

90/120 67/200 (18 seconds) batch analyzer/48 (180 minutes processing time for batch to finish)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface yes/yes yes/yes onboard/yes, instrument side only (included)LIS interfaces up and running in active user sites yes yes Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem,

American Health Net, Antrim, othersLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab yesModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/no yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours 2–8 hours —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 10 minutes; monthly:

20 minutesdaily: 5–10 minutes; weekly: 20 minutes; monthly: 20–30 minutes


Onboard maintenance records/Maintenance training demo module —/yes no/yes yes/no

List price/Targeted bed size or daily volume —/>200+ beds or 60 tests per day —/>200+ beds or 250 tests per day —/>7,000–20,000 tests per yearAnnual service contract cost (24 hours/7 days) multiple options multiple options —Training provided with purchase/Advanced operator training yes/yes yes/yes 3.5 days at company offices/yes



compact benchtop analyzer with extensive immunoassay menu (77 assays) provides opportunity to reduce sendouts and boost laboratory revenue; ideal for small lab environment because of proven system uptime (reliability)

extensive routine and specialty immunoassay menu (81 assays); includes menu of 300+ specific allergens and panels; provides opportunity to reduce sendouts and boost laboratory revenue; features extended reagent onboard stability (90 days) for efficient operation and cost control

provides accepted technology for serologic, specific IgE testing, and autoimmune markers; comprehensive clinical and technical research; extensive medical information and education; measures and reports specific IgE quantitative results across clinical range





Part 19 of 21 ThermoFisher Scientific ThermoFisher Scientific ThermoFisher ScientificJoanne Yancon [email protected] Joanne Yancon [email protected] Joanne Yancon [email protected]


4169 Commercial Ave., Portage, MI 49002 4169 Commercial Ave., Portage, MI 49002 4169 Commercial Ave., Portage, MI 49002800-346-4364 www.thermoscientific.com/phadia 800-346-4364 www.thermoscientific.com/phadia 800-346-4364 www.thermoscientific.com/phadia

Name of instrument/First year sold/Where designed Phadia Laboratory System 250/2004/Japan, Sweden Phadia Laboratory System 1000/2003/Japan, Sweden Phadia Laboratory System 2500/2011/SwedenCountry where manufactured/Where reagents manufactured Japan, Sweden/Sweden Japan, Sweden/Sweden Japan/SwedenNumber of units in clinical use in U.S./Outside U.S. 203/2,019 127/308 5/28Operational type/Model type/Sample handling system continuous random access/floor standing/racks continuous random access/floor standing/racks continuous random access/floor standing/racksDimensions in inches (H × W × D)/Instrument footprint in sq. feet 73 × 50 × 30 plus 26-in. wide computer stand/— 83 × 71 × 40 plus 26-in. wide computer stand/— 71 × 158 × 47 plus 26-in. wide computer stand/51

Tests available on instrument in U.S. hundreds of ImmunoCAP-specific IgE allergens,ImmunoCAP total IgE, Tryptase and ImmunoCAP TG and TPO, EliA autoimmune products include: CCP,dsDNA, Symphony ANA Screen, 7 individual ENAs, celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native)IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG, β2-glycoprotein I IgM/IgG/IgA, cardiolipin IgA

hundreds of ImmunoCAP-specific IgE tests, ImmunoCAP total IgE, ImmunoCAP ECP, and ImmunoCAP tryptase

hundreds of ImmunoCAP-specific IgE allergens,ImmunoCAP total IgE, immunoCAP TG and TPO tests

Tests not available in U.S. but submitted for clearance EliA PR3S, GBM, MPO EliA PR3S, GBM, MPO EliA PR3S, GBM, MPO, tryptase, EliA autoimmune products currently include CCP, dsDNA, Symphony ANA screen, 7 individual ENAs, celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardio-lipin IgM/IgG, β2- glycoprotein I IgM/IgG/IgA, cardiolipin IgA

Tests not available in U.S. but available in other countries EliA CTD screen (14 ENAs), Pm/Scl, EliA anti IgA, EliA calprotectin, others

— EliA CTD screen (14 ENAs), Pm/Scl, EliA anti IgA, EliA calprotectin, others

Tests in development — — —Tests not available on other manufacturers’ analyzers ImmunoCAP-specific IgE blood tests and EliA

autoimmune testsImmunoCAP-specific IgE blood tests ImmunoCAP-specific IgE blood tests and EliA

autoimmune assays


Methods supported/Separation methods fluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

fluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

fluorescence/coated microwell, fluoroenzyme immunoas-say, ImmunoCAP cellulose polymer matrix reaction wells

Number of different measured assays onboard simultaneously 4 3 up to 8Number of different assays programmed, calibrated at once not limited, though inventory manager software will

instruct operator of reagent insufficiencies in the onboard inventory

not limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory

not limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory

Number of user-definable (open) channels 0 (closed system) 0 (closed system) 0 (closed system)Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

3/400 or 100, depending on the conjugate type 3/400 or 100, depending on the conjugate type 8/400, 100, or 50, depending on the conjugate type

Shortest/Median onboard reagent stability/Refrigerated onboard 5 days/1 year/yes (2°–8°C) 5 days/1 year/yes (2°–8°C) 5 days/1 year/yes (2°–8°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes (wash solution requires preparation) yes (wash solution requires preparation) yesReagents bar-coded/Information in bar code yes/product name, lot number, expiration date yes/product name, lot number, expiration date yes/product name, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/— no/zero (disposable sample tips) no/zero (disposable sample tips)Walkaway capacity in minutes/Specimens/Tests, assays 470/50 simultaneously/370 tests 460/200 simultaneously/2,400 tests 470/800 simultaneously (370 tests)/6,400 testsSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency — — —Minimum specimen volume required 40 µL for ImmunoCAP tests and 20 µL for EliA tests 40 µL per test 40 µL for ImmunoCAP tests and 20 µL for EliA testsMinimum sample volume aspirated precisely at once/Minimum dead volume

40–200 µL for ImmunoCAP tests and 50 µL/ 50–200 µL for EliA tests (varies with tube type)

40 µL/40–200 µL (varies with tube type) 40–200 µL for ImmunoCAP tests and 50 µL/ 50–200 µL for EliA tests (varies with tube type)

Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/yesRequires dedicated water system/Water consumption no/10 L no/10 L yes/121 LNoise generated 65 decibels 68 decibels 64 decibelsHas dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm × 50–105 mm/no yes/10–17 mm × 50–105 mm/no yes/10–17 mm × 50–105 mm/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBar-code placement per CLSI standard Auto2A no no noOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes no/yes yes/yesSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 100 minutes 100 minutes 100 minutesAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 6 per analyte for calibration run, 2 per analyte when

using stored curve6 per analyte for calibration run, 2 per analyte when using stored curve

5 or 6 per analyte for calibration run (assay dependent), 2 per analyte when using stored curve

Calibrants can be stored onboard/Average calibration frequency yes/28 days or sooner if conjugate lots change yes/28 days or sooner if conjugate lots change yes/28 days or sooner if conjugate lots changeMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required once per work shift (user defined) once per work shift (user defined) once per work shift (user defined)Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/30 minutes unattended yes/yes/30 minutes unattended yes/yes/30 minutes unattended

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample 6 minutes 6 minutes —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

20 specimens/60 (100 minutes to first result, then 1 result per 60 seconds )

80 specimens/240 (100 minutes to first result, then 1 result per 15 seconds )

160 specimens/480 (100 minutes to first result, then 8 results per 15 seconds )

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (instrument side only) onboard/yes (instrument side only) onboard/—LIS interfaces up and running in active user sites Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem,

American Health Net, Antrim, othersMisys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, others

Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, HL7, others

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes yes yesModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours <24 hours <24 hoursMean time between failures/To repair failures — — —/—Average time to complete maintenance by lab personnel daily: 1 minute; weekly: 10 minutes; monthly: 15 min. daily: 1 minute; weekly: 10 minutes; monthly: 15 min. daily: 1 minute; weekly: 10 minutes; monthly: 15 min.Onboard maintenance records/Maintenance training demo module yes/— yes/— yes/—

List price/Targeted bed size or daily volume —/>20,000–95,000 tests per year —/>95,000 tests per year —/>200,000 tests per yearAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3.5 days at company offices/yes 4.5 days at laboratory/yes 4 days on site/yes



provides accepted technology for serologic, specific IgE testing with the ImmunoCAP family of products and autoimmune markers with the EliA family of products; comprehensive clinical and technical research and extensive medical information and education

provides accepted technology for serologic, specific IgE testing with the ImmunoCAP family of products; com-prehensive clinical and technical research and extensive medical information and education; measures and reports specific IgE quantitative results across the clinical range

continuous random access analyzer provides more than 6,000 tests in one run; high-throughput instrument optimized for cost-conscious laboratories; efficient and flexible to meet allergy and autoimmune assay testing needs





Part 20 of 21 ThermoFisher Scientific TOSOH Bioscience TOSOH BioscienceJoanne Yancon [email protected] Shanti Narayanan [email protected] Shanti Narayanan [email protected] Commercial Ave. 6000 Shoreline Court, Suite 101 6000 Shoreline Court, Suite 101


Portage, MI 49002 South San Francisco, CA 94080 South San Francisco, CA 94080800-346-4364 www.thermoscientific.com/phadia 800-248-6764 www.tosoh.com 800-248-6764 www.tosoh.com

Name of instrument/First year sold/Where designed Phadia Laboratory System 5000/2011/Sweden AIA-2000/2008/Japan AIA-360/2004/JapanCountry where manufactured/Where reagents manufactured Japan/Sweden Japan/Japan Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 1/16 80/550 1,900/5,600Operational type/Model type/Sample handling system continuous random access/floor standing/racks continuous random access/floor standing/rack, sorter drawer continuous random access/benchtop/carouselDimensions in inches (H × W × D)/Instrument footprint in sq. feet 71 × 236 × 47 plus 26-inch wide computer stand/77 49.6 × 59.1 × 35.7/14.66 21 × 19 × 16/2.1

Tests available on instrument in U.S. hundreds of ImmunoCAP-specific IgE allergens,immunoCAP total IgE, immunoCAP TG and TPO

TSH 3rd gen., TSH, FT4, FT3, T4, T3, T-uptake, TPOAb, TgAb, bHCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, beta 2 microglobulin, C-peptide, cortisol, hGH, IgEII, insulin, PAP, CK-MB, myoglobin, troponin I 2nd gen., ferritin, folate, B12, testosterone, CA 19-9, intact PTH, RBC folate, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D

10 minutes short-time assays: TSH, FT4, T3, T4, T-uptake, FT3, βhCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, β-2-microglobulin, C-peptide, cortisol, hGH, IgE II, insulin, PAP, CK-MB, myoglobin, troponin I second generation, ferritin, testosterone, CA 19-9, intact PTH, cystatin C, HbA1c, ACTH, DHEA-S, homocysteine

Tests not available in U.S. but submitted for clearance EliA PR3S, GBM, MPO, tryptase, EliA autoimmune products currently include CCP, dsDNA, symphony ANA screen, 7 individual ENAs, celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardio-lipin IgM/IgG, β2- glycoprotein I IgM/IgG/IgA, cardiolipin IgA

Tg Tg

Tests not available in U.S. but available in other countries EliA CTD screen (14 ENAs), Pm/Scl, EliA Anti IgA, EliA calprotectin, others

BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA

BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA

Tests in development — D-dimer, SHBG, and osteocalcin D-dimer, SHBG, and osteocalcinTests not available on other manufacturers’ analyzers ImmunoCAP-specific IgE blood tests and EliA

autoimmune assays— —

Fully automated microplate system no no —Number of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods fluorescence/coated microwell, fluoroenzyme immunoas-say, ImmunoCAP cellulose polymer matrix reaction wells

fluorescence/bead flourescence, enzyme immunoassay/bead

Number of different measured assays onboard simultaneously up to 8 48 25Number of different assays programmed, calibrated at once not limited, though inventory manager software will

instruct operator of reagent insufficiencies in the onboard inventory

48 entire menu

Number of user-definable (open) channels 0 (closed system) 0 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

8/400, 100, or 50, depending on the conjugate type 48/this is a unitized test cup —/unitized test cup

Shortest/Median onboard reagent stability/Refrigerated onboard 5 days/1 year/yes (2°–8°C) 72 hours/72 hours/no 72 hours/72 hours/—Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/product name, lot number, expiration date yes/lot number, test code yes/lot number, test codeSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero (disposable sample tips) no/zero no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 470/800 simultaneously (370 tests)/9,200 tests 172/200/960 58/25/25System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/dry no/dryUses disposable cuvettes/Maximum number stored no/— no/— noUses washable cuvettes/Replacement frequency — no/— noMinimum specimen volume required 40 µL for ImmunoCAP tests and 50 µL for EliA tests 500 µL tube, 100 µL cup 500 µL tube, 100 µL cupMinimum sample volume aspirated precisely at once/Minimum dead volume

40–200 µL for ImmunoCAP tests and 50 µL/50–200 µL for EliA tests (varies with tube type)

10 µL/500 µL tube, 100 µL cup 10 µL/500 µL tube, 100 µL cup

Supplied with UPS (backup power)/Requires floor drain yes/yes yes/no no/noRequires dedicated water system/Water consumption yes/215 L no/— no/—Noise generated 64 decibels — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm × 50–105 mm/no yes/7 mL and 10 mL or 15 × 75 and 100, 13 × 75 and 100/no yes/primary draw tubes: 13 × 75 and 100; 16 × 75 and 100/noSample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes yes/yesBar-code placement per CLSI standard Auto2A no yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes no/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 100 minutes varies —Autocalibration or autocalibration alert yes no noNumber of calibrators required for each analyte 5 or 6 per analyte for calibration run (assay dependent),

2 per analyte when using stored curve2 or 6 (analyte dependent) 2 or 6 (analyte dependent)

Calibrants can be stored onboard/Average calibration frequency yes/28 days or sooner if conjugate lots change no/90 days no/90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required once per work shift (user defined) 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes no/noAutomatic shutdown/Startup is programmable/Startup time yes/yes/30 minutes no/no/5 minutes no/no/5 minutes

Stat time to completion of βhCG test — ~18 minutes ~18 minutesTime delay from ordering stat test to aspiration of sample — 40 seconds 60 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

320 specimens/960 (100 minutes to first result, then 8 results per 15 seconds )

66/200 (18 seconds) 12/36 (1 minute)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/noData-management capability/Instrument vendor supplies LIS interface onboard/— —/no Antek, Schuyler House, moreLIS interfaces up and running in active user sites Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem,

American Health Net, Antrim, HL7, others— —

LIS interface operates simultaneously with running assays yes yes —Bidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) noInterface available (or will be) to auto specimen handling system yes yes (Hitachi, A&T, Bayer, Thermo, iLAS) noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/no/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours 24 hours —Mean time between failures/To repair failures — 5 months/24 hours >6 months/24 hoursAverage time to complete maintenance by lab personnel daily: 1 minute; weekly: 10 minutes; monthly: 15 min. daily: 5 minutes; weekly: 5 minutes daily: 5 minutesOnboard maintenance records/Maintenance training demo module yes/— yes (includes audit trail)/no no/no

List price/Targeted bed size or daily volume —/>400,000 tests per year $185,000/65+ beds, 1,500–2,000 tests $25,000/200–1,000 tests per monthAnnual service contract cost (24 hours/7 days) — — $2,050–$3,500Training provided with purchase/Advanced operator training —/yes 4 days at company office/no training DVD; on-site install/—



continuous random access analyzer provides more than 9,000 tests in 1 run; high throughput; efficient and flexible to meet allergy and autoimmune assay testing needs

available in 2 models: standard and LA; unitized test cups similar to all AIA systems; 3 separate incubators to minimize processing time; no reagent preparation; dual clot detection, automated sample dilution, and pretreat-ment; appropriate for stat and routine use

unitized test cups; primary tube sampling; no reagent preparation, room-temperature stability for 5 days; third-generation TSH sensitivity; second-generation troponin I; appropriate for stat and routine use; compact size; 4 tests per sample; random access





Part 21 of 21 TOSOH Bioscience TOSOH Bioscience TOSOH BioscienceSusan Kolarik [email protected] Susan Kolarik [email protected] Susan Kolarik [email protected] Shoreline Court, Suite 101 6000 Shoreline Court, Suite 101 6000 Shoreline Court, Suite 101


South San Francisco, CA 94080 South San Francisco, CA 94080 South San Francisco, CA 94080800-248-6764 www.tosoh.com 800-248-6764 www.tosoh.com 800-248-6764 www.tosoh.com

Name of instrument/First year sold/Where designed AIA-900/2011/Japan AIA-1800/2003/Japan AIA-600 II/2000/JapanCountry where manufactured/Where reagents manufactured Japan/Japan Japan/Japan Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 220/1,000 40/450 450/1,400Operational type/Model type/Sample handling system continuous random access/floor standing/rack continuous random access/floor standing/rack, sort

drawer, standard and LAcontinuous random access/benchtop/chain

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 35.04, 50.79, or 58.64 × 26.18 × 49.09/6–10 65 × 50 × 37/12.8 19.8 × 31.6 × 29.1/6.4

Tests available on instrument in U.S. TSH, TSH 3rd gen., T4, TT3, TU, FT4, FT3, TPOAb, TgAb, BHCG, estradiol, FSH, LHII, progesterone, prolactin, testosterone, AFP, CEA, PSA, CA125, CA19-9, 27.29, β2 microglobulin, C-peptide, insulin, IgEII, PAP, cortisol, HGH, B12, folate, RBC folate, ferritin, intact PTH, CK-MB, myoglobin, cTnI second generation, HbA1c, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D

TSH, 3rd-gen. TSH, FT4, T3, T4, T-uptake, FT3, TPO Ab, Tg Ab, βhCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, β2-microglobulin, C-peptide, cortisol, hGH, IgE II, insulin, PAP, CK-MB, myo-globin, troponin I second generation, ferritin, folate, B12, testosterone, CA 19-9, RBC folate, intact PTH, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D

TSH, 3rd-gen. TSH, FT4, T3, T4, T-uptake, FT3, TPO Ab, Tg Ab, βhCG, estradiol, FSH, hCG, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, β2-microglobulin, C-peptide, cortisol, hGH, IgE II, insulin, PAP, CK-MB, myoglobin, tropo-nin I second generation, ferritin, folate, B12, testosterone, CA 19-9, intact PTH, RBC folate, cystatin C, HbA1c, ACTH, DHEA-S, homocysteine, vitamin D

Tests not available in U.S. but submitted for clearance Tg Tg TgTests not available in U.S. but available in other countries BNP, HBsAg, HBsAb, HBcAb, HBeAb, cTnI third

generation, PSAII, TrAb, HCVAb, HCG, free PSABNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA

HBsAg, HBsAb, HBeAg, HbcAb, HbeAb, BNP, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA

Tests in development D-dimer, SHBG, and osteocalcin D-dimer, SHBG, and osteocalcin D-dimer, SHBG, and osteocalcinTests not available on other manufacturers’ analyzers — — —

Fully automated microplate system no — noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods fluorescence, enzyme immunoassay/bead fluorescence, enzyme immunoassay/bead fluorescence, enzyme immunoassay/beadNumber of different measured assays onboard simultaneously 45 31 trays 26Number of different assays programmed, calibrated at once entire menu entire menu entire menuNumber of user-definable (open) channels — 0 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

unitized test cup/unitized test cup —/unitized test cup —/unitized test cup

Shortest/Median onboard reagent stability/Refrigerated onboard 72 hours/3 days/no 72 hours/72 hours/— 72 hours/72 hours/—Multiple reagent configurations supported no yes yesReagent container placed directly on system for use yes yes yesReagents bar-coded/Information in bar code yes/test, lot yes/lot number, test code yes/lot number, test codeSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero (disposable tips) no/zero no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 30/45/45 58/170/640 52/26/26System is open (homebrew methods can be used)/Liquid or dry system no/dry no/dry no/dryUses disposable cuvettes/Maximum number stored no/— —/unitized test cup —/unitized test cupUses washable cuvettes/Replacement frequency no/— — —Minimum specimen volume required 10 µL 500 µL tube, 100 µL cup 500 µL tube, 100 µL cupMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/100 µL 10 µL/500 µL tube, 100 µL cup 10 µL/500 µL tube, 100 µL cupSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75, 100; 16 × 75, 100/no yes/primary draw tubes: 7 mL and 10 mL or 15 × 75

and 100; 13 × 75 and 100/noyes/primary draw tubes: 7 mL and 10 mL or 15 × 75 and 100, 13 × 75 and 100/no

Sample bar-code reading capability/Autodiscrimination yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes yes/yes yes/yesBar-code placement per CLSI standard Auto2A — yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no yes/yes yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/noSample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/no no/no no/yes

Time between initial result and reaspiration of sample for rerun 20 minutes varies —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte 2 or 6 2 or 6 (analyte dependent) 2 or 6 (analyte dependent)Calibrants can be stored onboard/Average calibration frequency no/90 days no/90 days no/90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte no/yes yes/yes no/noAutomatic shutdown/Startup is programmable/Startup time no/no/10 minutes no/no/5–8 minutes no/no/5 minutes

Stat time to completion of βhCG test ~18 minutes ~18 minutes ~18 minutesTime delay from ordering stat test to aspiration of sample 1 minute 40 seconds 60 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

30/90 (0.67-minute sample cycle) 60/180 (20 seconds) 20/60 (1 minute)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/no yes/yes yes/noData-management capability/Instrument vendor supplies LIS interface no/no yes/no optional add-on (all major LIS vendors—Schuyler

House, Misys, LabForce, McKesson, Antrim, Data Innovations)/yes (additional cost)

LIS interfaces up and running in active user sites all major LIS suppliers yes Schuyler House, Fletcher FloraLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no yes (Hitachi, Siemens, Thermo, iLAS) noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no no/no/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours 24 hours 24 hoursMean time between failures/To repair failures — 5 months/24 hours 98% uptime/—Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 15 minutes;

monthly: 20 minutesdaily: 5–8 minutes; weekly: 5 minutes; monthly: none daily: 5 minutes; weekly: 5 minutes; monthly: none

Onboard maintenance records/Maintenance training demo module no/no yes (includes audit trail of who replaced parts)/no no/no

List price/Targeted bed size or daily volume $60,000 base model/500+ monthly $175,000/65+ beds, 1,500–2,000 tests $70,000/500–2,500 tests per monthAnnual service contract cost (24 hours/7 days) $6,000 base model $11,458 $5,941Training provided with purchase/Advanced operator training —/no 4 days at company offices/no 3 days at company offices/no



3 models (base model, base model plus 9-tray sorter, base model plus 19-tray sorter) offer increasing automation and capacity; connections and software built in for all 3 models; unitized test cups, no reagent preparation; automated sample dilution, pretreatment, automated reschedule, retest

2 models: standard and LA; unitized test cups; primary tube sampling; no reagent preparation; dual clot detection; room-temperature stability for 5 days; automated sample dilution and pretreatment; third-generation TSH sensitivity; second-generation troponin I; appropriate for stat and routine use

unitized test cups; primary tube sampling; no reagent preparation; dual clot detection; room-temperature stability for 5 days; automated sample dilution and pretreatment; third-generation TSH sensitivity; second-generation troponin I; appropriate for stat and routine use

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