Abbott Diagnostics Beckman Coulter Beckman Coulter · Siemens Healthcare Diagnostics Siemens...

20 February 2013 | clpmag.com

Abbott Diagnostics Beckman Coulter Beckman Coulter

Abbott Park, Ill(847) 937-6100www.abbottdiagnositcs.com

Brea, Calif(800) 526-3821www.beckmancoulter.com


Name of productAbbott ARCHITECT immunochemistry analyzers

AU480 AU680

1) What does this product detect?

ARCHITECT performs approximately 150 different clinical chemistry and immunoassay tests: general chemistry, toxicology, metabolic and cardiac markers, specific proteins, therapeutic drugs, and infectious diseases

General chemistry, special proteins, therapeutic drugs, drugs of abuse, serology, cardiac


2) This product is used in:

hospital or other large lab a physician’s office at the points of care other



3) Please briefly explain “other”: N/A N/A Reference lab, toxicology

4) Intended volume use: high volume medium volume low volume

high volume medium volume low volume


5) What is the throughput under ideal conditions?

Throughput is up to 1,800 clinical chemistry and 200 immunoassay tests per hour.

800 tests/hour 1,200 tests/hour

6) Are there any automation options?

ARCHITECT analyzers offer labor-saving automation with the ACCELERATOR p540 automated sample handling system and the ACCELERATOR Automated Processing System (APS). Labs can streamline operations, improve efficiency, reduce errors, and improve turnaround times.

NoYes, connection to Beckman Power Processor

7) How long does it take to train a tech on the instrument?

The automated system requires minimal technician training time

2 days 4 days

8) What is the product’s price range? Contact Abbott representative for pricing information.

$140,000 $213,000

9) For controls, which analyzers can this product be used with?

The Abbott ARCHITECT analyzerAll general chemistry, specialty, TDM, or DAT control material

All general chemistry, specialty, TDM, or DAT control material

10) Briefly describe what sets this product apart from others in the market

Abbott ARCHITECT analyzers are fully automated and help labs manage increasing testing volumes by eliminating several manual steps, consolidating workloads, and expediting results reporting. ARCHITECT satisfies the need for an automated, reliable, and cost-effective clinical chemistry system. Further, Abbott verifies ARCHITECT quality with Six Sigma metrics and offers a full suite of safeguards to prevent errors and identify potential problems before the result leaves the lab.

Small footprint, extensive menu (125 assays), STAT interrupt capability, high performance ISE, lowest mean time between failure (MTBF)

Extensive menu (125 assays), STAT interrupt capability, high-performance ISE, low MTBF, integration options with automation and immunoassay

www.clpmag.com

Chemistry Analyzers

guide[ tech ]

clpmag.com | February 2013 21

Beckman Coulter Beckman Coulter Carolina Liquid Chemistries Corp



Winston-Salem, NC(877) 722-8912www.carolinachemistries.com

AU5800 DxC800 CLC720



More than 80 general chemistry tests, including urine drug tests and adulterant tests: 6-AM, ACET, AMPH, BARB, BENZ, BUP, CARI*, COCM, EDDP, EtG, ETOH, FENT*, MEP*, METD, OP, OXY, PCP, PROX, SAL, TAP*, TCA, THC, TRAM*, UCREA, XTSY, ZOL*, Aldehyde, BUN, chromate reagent, halogen, nitrite, oxidant, pH reagent, specific gravity, and more (* for forensic use).




Toxicology, dialysis N/A

Pain management labsOncology labsFamily practice labRheumatology lab




3,800 to 9,800 tests/hour 1440 tests/hourCLC720 is capable of performing up to 640 tests/hour without Li.

Yes, connection to Beckman Power Processor, Power Express

Yes, connection to Beckman Power Processor N/A

1 week 4 days 3 days

$266,000 to $890,000 $340,000 For pricing information please contact Carolina Liquid Chemistries



N/A

Fastest throughput (up to 9,800 tests/hour), extensive menu (125 assays), STAT interrupt capability, high-performance ISE, low MTBF, integration options with automation and immunoassay

Closed-tube sampling, STAT turnaround time (less than 1 minute for 14 assays), PROService Internet-based remote diagnostics, integration options with automation and immunoassay

One of the largest test menus.Excellent calibration curve for urine drug tests.Produces same-day results in ng/mL.Designed in this century.Takes up less space.Makes less noise.Generates less heat.


Carolina Liquid Chemistries Corp

Carolina Liquid Chemistries Corp

Nova Biomedical



Waltham, Mass(781) 894-0800www.novabiomedical.com

Name of product CLC480 BS200 Stat Profile pHOx Ultra

1) What does this product detect?

More than 80 general chemistry tests, including urine drug tests and adulterant tests: 6-AM, ACET, AMPH, BARB, BENZ, BUP, CARI*, COCM, EDDP, EtG, ETOH, FENT*, MEP*, METD, OP, OXY, PCP, PROX, SAL, TAP*, TCA, THC, TRAM*, UCREA, XTSY, ZOL*, Aldehyde, BUN, chromate reagent, halogen, nitrite, oxidant, pH reagent, specific gravity, and more (* for forensic use).

More than 80 general chemistry tests, including urine drug tests and adulterant tests: 6-AM, ACET, AMPH, BARB, BENZ, BUP, CARI*, COCM, EDDP, EtG, ETOH, FENT*, MEP*, METD, OP, OXY, PCP, PROX, SAL, TAP*, TCA, THC, TRAM*, UCREA, XTSY, ZOL*, aldehyde, BUN, chromate reagent, halogen, nitrite, oxidant, pH reagent, specific gravity, and more (* for forensic use).

Individual tests include pH, PCO2, PO

2,

SO2%, hematocrit, hemoglobin, sodium, potassium, chloride, ionized calcium, ionized magnesium, glucose, BUN, creatinine, lactate, and bilirubin

2) This product is used in:




3) Please briefly explain “other”:



N/A

4) Intended volume use: high volume medium volume low volume



5) What is the throughput under ideal conditions?

CLC480 is capable of performing up to 400 tests/hour

BS200 distributed by CLC is capable of performing up to 225 tests/hour

38 samples/hour

6) Are there any automation options? N/A N/AYes. Automatic onboard QC; auto-monitoring of QC and reagent pack; automated maintenance

7) How long does it take to train a tech on the instrument?

3 days 3 days

All Nova analyzers receive a Primary Operator Training (POT). The POT typically last 4 to 5 hours. These sessions cover all aspects of operation, including operation, maintenance, troubleshooting, and setup. For ongoing training, each Stat Profile pHOx Ultra analyzer has onboard help to instruct users in operation and maintenance.

8) What is the product’s price range? For pricing information please contact Carolina Liquid Chemistries

For pricing information please contact Carolina Liquid Chemistries

Varies. See account representative

9)For controls, which analyzers can this product be used with?

N/A N/A N/A

10) Briefly describe what sets this product apart from others in the market

Smallest benchtop footprint with the largest test menu.Produces same-day results in ng/mL.Reusable reaction cuvettes.

It is an economical, ideal choice for low-volume labs.

Nova Stat Profile pHOx Ultra blood gas/critical care analyzers offer the broadest test menu of any blood gas/critical care analyzers, at low cost. With up to 20 tests on board, fast, economical critical care results, and the industry’s best overall user satisfaction, Nova’s products are the best value in critical care testing.

www.clpmag.com

Chemistry Analyzers

guide[ tech ]


Randox Laboratories-US Ltd Randox Laboratories-US Ltd Randox Laboratories-US Ltd

Kearneysville, WVa(304) 728-2890; TOLL FREE (866) 4-RANDOXwww.randox.com



RX monza RX daytona RX imola

A range of different analytes present in serum, plasma, urine, and CSF.

A range of different analytes present in serum, plasma, urine, CSF, and supernatents.

A range of different analytes present in serum, plasma, urine, CSF, and supernatents.




Clinical chemistry labs, educational and research establishments

Clinical chemistry labs, educational and research establishments, and forensic toxicology

Clinical chemistry labs, educational and research establishments, and forensic toxicology




The RX monza is a semiautomated system so throughput is dependent upon the operator, methods used, and analytes to be tested.

The RX daytona can perform 180 photometric tests per hour and 270 ISE tests per hour for a combined throughput of 450 tests per hour.

The RX imola can perform 400 photometric tests per hour or 240 ISE tests per hour for a combined throughput of 560 tests per hour.

No System is fully automated. System is fully automated.

1 to 2 days (Training period depends on the tech’s competence level.)

3 days (Training period depends on the tech’s competence level.)

3 days (Training period depends on the tech’s competence level.)

Price available on request. Price available on request. Price available on request.

N/A N/A N/A

The RX monza is a low-maintenance, compact, semiautomated clinical chemistry with impressive functionality and an extensive test menu consisting of routine chemistry and coagulation testing profiles.

The RX daytona is an easy-to-use, compact benchtop chemistry analyzer providing rapid, cost-effective testing. The RX Series test menu is the most extensive on the market, with profiles covering clinical, specific proteins, and research testing.

The RX imola is an easy-to-use, fully automated benchtop chemistry analyzer with random access, providing rapid and comprehensive testing. The RX Series test menu is the most extensive on the market, with profiles covering clinical, specific proteins, and research testing.


Siemens Healthcare Diagnostics




Tarrytown, NY(847) 236-7404www.healthcare.siemens.com




Dimension Vista 1500 Intelligent Lab System

Dimension EXL with LM Integrated Chemistry System

ADVIA 2400 Clinical Chemistry System ADVIA 1800 Clinical Chemistry System

General Chemistries, Enzymes, metabolites, TDMs/DAUs/Tox, proteins, Immunochemistries on Serum, Urine, whole blood and CSF samples

General Chemistries, Enzymes, metabolites, TDMs/DAUs/Tox, proteins, Immunochemistries on Serum, Urine, whole blood and CSF samples

chemistry, special chemistry, TDMs, DAUs toxicology, special proteins

chemistry, special chemistry, TDMs, DAUs toxicology, special proteins





N/A N/A N/A N/A





1,500 photometric and 500 ISE tests per hour

624 test per hour 2,400 tests per hour 1,800 tests per hour

Yes – Twinning Package, Aptio Automation, StreamLAB Automation Solutions, and ADVIA Automation Solutions (Labcell, Workcell)

Yes - Versacell System, Aptio Automation, StreamLAB Automation Solutions, ADVIA LabCell

Yes – Aptio Automation, StreamLAB Automation Solutions, and ADVIA Automation Solutions (LabCell, WorkCell)

Yes – Aptio Automation, StreamLAB Automation Solutions, and ADVIA Automation Solutions (LabCell, WorkCell)

5-day operator training is offered, on-site training, and online Personalized Education Plan (PEP) offered

4-day operator training is offered, on-site training, and online Personalized Education Plan (PEP) offered

3 ½-day operator training is offered, on-site training, and online Personalized Education Plan (PEP) offered

3 ½-day operator training is offered, on-site training, and online Personalized Education Plan (PEP) offered

Contact company Contact company Contact company Contact company

Bio-Rad, Thermo Fisher, others Bio-Rad, Thermo Fisher, others Bio-Rad, Thermo Fisher, others Bio-Rad, Thermo Fisher, others

LOCI Immunoassay technology, broad menu with fast STAT TAT, automated calibration and QC.

Clot Check capability.Trusted, proven, built-in technologies with LOCI technology inside for reliable results. Easy-to-use Dimension platform provides the confidence that every trained operator can run any test, any time. Chemistry and immunoassay integration allows simultaneous processing to maximize workflow.

Comprehensive menu; >100 assays, including chemistry, special chemistry, TDMs, DAUs, special proteins; long-life ISEs; 90,000 tests; unlimited open channels; third-party applications available; 3-second cycle time; 2,400 tests per hour; automation-ready; concentrated reagents available for high-volume chemistries, walkaway capability; clot detect; liquid level sense; auto reruns, dilutions, and repeats.

Comprehensive menu; >100 assays, including chemistry, special chemistry, TDMs, DAUs, special proteins; long-life ISEs; 90,000 tests; unlimited open channels; third-party applications available; 3-second cycle time; 1,800 tests per hour; automation-ready; concentrated reagents available for high-volume chemistries, walkaway capability; clot detect; liquid level sense; auto reruns, dilutions, and repeats.

www.clpmag.comguide[ tech ]


Plastics/Liquid Handling/Consumables/Pipettes

spotlight [ product ]

Wipes and LinersMaterials trap, isolate fluidsBio-Hazard wipes and liners from Current Technologies Inc, Crawfordsville, Ind, come with a white absorbent side and bright-orange plastic backing to prevent leakage of blood, fluids, and chemicals to hands, gloves, and other surfaces. The absorbent side traps blood, patho-gens, and chemicals while the plastic prevents leakage. The wipes prevent the subsequent transmission of microbes or chemicals from gloves to phones, pens, equipment, and other high-touch surfaces. The orange polyethylene backing is imper-meable to strong solvents (eg, xylene, acetone, ketones, alcohols, formalin), blood, and urine. The wipes and liners are available in three absorbencies: standard, heavy, and super; and in multiple sizes.

Current Technologies Inc(765) 364-0490; www.currtechinc.com

Pipette and Filter TipsFor precise and comfortable pipettingGreiner Bio-One, Monroe, NC, offers Sapphire Pipette Tips, a new range of pipette and filter tips. The Sapphire product family comprises standard pipette tips, standard filter tips, low-retention pipette tips, and low-retention filter tips, which are all designed for precise and comfortable pipetting with maximum recovery. All tips are transparent; graduated; free of detectable DNase, RNase, and human DNA; and nonpyrogenic.

Greiner Bio-One(704) 261-7800; us.gbo.com

Multichannel Verification SystemDetermines performance on a tip-by-tip or well-by-well basisThe MVS Multichannel Verification System from Artel, Westbrook, Me, is a universal system that provides the ability to measure the accuracy and precision of volumes dispensed into 96- or 384-well microplates. The system provides objective data that is traceable to the international system of units, enabling liquid-handling operations to be standardized between methods, instruments, and locations under the conditions at which they are run. The system quickly determines liquid-handler performance on a tip-by-tip or well-by-well basis, and can also be used to assess the effectiveness of mixers and plate washers.

Artel(888) 406-3463; www.artel-usa.com

Transport SystemsAccommodates automation and traditional processingThe Puritan Liquid Amies Transport System from Puritan Medical Products Company LLC, Guilford, Me, is a self-contained, ready-to-use multipurpose collection and transport system for aerobes, anaerobes, and fas-tidious bacteria up to 48 hours at room temperature. The sys-tem is designed to accommodate both automation and traditional liquid specimen processing in clinical labs, including culturing and Gram staining.

Puritan Medical Products Company LLC(800) 321-2313; www.puritandiagnostics.com

Pipette Calibration SystemProvides instant feedbackThe Artel PCS pipette calibration system from Artel, Westbrook, Me, provides a fast and convenient method for measuring the accuracy and precision of dispensed volumes. The system can be used to efficiently ensure pipette and operator performance throughout the laboratory year—not just at predetermined calibration cycle times. It has also been used as a training tool, instantly providing the user with feedback on accuracy and precision performance. The system minimizes calibration turnaround time, allows the pipettes to remain in the lab, and provides increased confidence in calibration results. It is fully compliant with ISO 8655, CAP, and CLIA guidelines, and produces measurements that are traceable to the International System of Units.

Artel(888) 406-3463; www.artel-usa.com


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Syringe FiltersISO9000-certified manufacturingSyringe filters from PerkinElmer, Waltham, Mass, are a high-quality,

packaged filter priced economically. Available in packs of 100 or 200, the line is available in the most pop-

ular membrane materials, including nylon, PTFE, and PVDF. The filters are supplied in 4-mm, 13-mm, 17-mm, 25-mm, and 30-mm formats in virgin color-coded polypropylene housings. The ISO9000-certified manufacturing is carried out

in certified clean-room conditions, using the latest manufacturing technology to ensure high-quality,

consistent products. All syringe filters are HPLC certified.

PerkinElmer(781) 663-6900; www.perkinelmer.com

IVF ICSI DishEasy-grip designThe Thermo Scientific Nunc® IVF ICSI Dish from Thermo Fisher Scientific, Waltham, Mass, maintains an optimal temperature with true flat bottom, as well as increased safety with the easy-grip design. The low profile pro-vides optimal angles during the ICSI process, while the super-polished optical center allows clear viewing of the sample. Thermo Scientific Nunc in vitro fertilization products provide security, safety, and reproducibility for your valuable samples, and are certified based on a 1-cell stage mouse embryo toxicity test. Stringent lot-level manufacturing controls ensure viability, reliability, and reproducibility. Dishes are produced under ISO 13485, MEA tested, CE-marked class II medical device and FDA cleared for use in IVF. Lid is present.

Thermo Fisher Scientific(781) 622-1000; www.thermoscientific.com/ivf; www.thermoscientific.com


Atmosphere ChambersFlexible system offers variety of features

The Whitley A95 Workstation from Don Whitley Scientific, UK, is the largest model in the company’s range of modified atmosphere chambers, with a capacity of up to 1,400 petri dishes. The chamber uses full-color, touchscreen technology. The integral 30-liter airlock with automatic internal door can transfer 90 plates in 5 minutes. Dual gas operation contributes to low running costs. Remote monitoring allows access from any computer or mobile device with a secure Internet connection. The A95 features four oval, manual, sleeved ports that enable two people to operate simultaneously within the same worksta-tion. These ports also act as mini airlocks for 10 plates each, so for smaller quantities of samples, users do not have to use the airlock.

Don Whitley Scientific(800) 396-4276; www.dwscientific.co.uk

Automated Osmometer

Easy-to-operate, intuitive software

The A2O, an automated osmometer with intelligent liquid-handling technology from Advanced Instruments, Norwood, Mass, is a fully automated, multisample osmometer that incorporates 50 years of applied technology experience in the field of freezing-point osmometry. It combines a functional design, analytical performance, and an intuitive software control package that is user-friendly.

Advanced Instruments(800) 225-4034; www.aicompanies.com

Biopsy System Gains FDA Approval

Organizes tissue samples

Mammotome revolve, a dual vacuum-assist-ed biopsy system from Devicor Medical Products Inc, Cincinnati, has received FDA approval. The system features a specimen management system capable of collecting and organizing individual tissue samples in numbered, specimen radiograph, and pathology-ready chambers that preserve tissue integrity. It also features DualVac vacuum technology, which gives clinicians the ability to secure larger contiguous tis-sue samples. These features, in combination with a physician-controlled variable aperture, allow clinicians to confirm or adjust sample acquisition in response to procedural situa-tions to confidently access and acquire chal-lenging lesions.

Devicor(513) 864-9000; www.devicormedical.com

LIS Product Gets UpdateOffers new customization, display features

NeTLIMS NJ LLC, Teaneck, NJ, has released AutoLims Version 3.3.1, a new ver-sion of its AutoLims product suite. The new version offers improvements for users including on-the-fly user customization of menus, display of table columns and

medical data, and a docking tool for easy access to screens and favorites. It also includes the company’s new AutoAccess module, a physician and service center remote access tool that uses a patient-oriented design. The advanced architecture and design of AutoLims includes multitier technology, multiple platforms support (all variants of Windows clients, UNIX/Windows Servers), multiple database support

(Oracle, MSSQL, Informix, Cache), multiple order-entry method support (screen, bar code, OMR, ASCII files), multiuser technology, browser access to lab results, and flexible color XML/XSL reporting.

NeTLIMS(201) 894-5300; www.netlims.com

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Guided Pipetting SystemSoftware creates, saves, executes

applications

Hamilton Co, Reno, Nev, introduces the Microlab 300 series pipettor, a guided pipetting system. The lightweight, handheld device enables labs to achieve quality assurance through reproducible and traceable methods and to reduce sample-preparation time by eliminating inefficient steps. Users can dispense between 0.5 to 1,000 μL without needing to exchange pipettes. The pipet-tor achieves this range using one probe and two tip sizes. It meets GLP/GMP, RoHS, 21 CFR Part 11, and ISO-8655 regulations. The device also comes with user-friendly, proprietary software that allows technicians to create, save, and exe-cute pipetting applications from start to finish.

Hamilton Co(800) 648-5950; www.hamiltoncompany.com/microlab300

Mid-Volume Chemistry AnalyzerSize does not sacrifice features

Randox, UK, introduces RX daytona plus, a new solution for mid-volume clinical chemistry testing. RX daytona plus features familiar performance in a compact space. The benchtop, fully automated, random access clinical chemistry analyzer consolidates routine and special-

ized testing onto one platform. It offers a sample clot detection sensor and includes many of the features typically found on larger automated analyzers. The analyzer is capable of running 270 photometric

tests per hour, or 450 tests per hour includ-ing ISE’s, via the optional ISE unit. Water consumption of 5 liters per hour keeps costs to a minimum, and a loading hatch allows emergency samples to be analyzed quickly at any time. Remote access diag-nostics allows for immediate access to the system, ensuring reduced downtime. FDA clearance is pending.

Randox(304) 728-2890, toll free: (866) 4-RANDOX; www.Randox.com

Data Management Program

Automatically analyzes all QC data

Randox, UK, introduces Acusera 24.7 Live Online, a new Web-based interlaboratory data-manage-ment program. It is designed to complement Acusera third-party quality controls, and aims to improve the effectiveness of quality control processes within the clinical laboratory while also helping to interpret QC results. Users have the ability to monitor analytical performance and access peer group reports online. Access to com-prehensive charts, reports, and statistically rel-evant peer group data generated from thousands of labs worldwide enable users to identify any trends, system errors, and reagent issues. Acusera 24.7 automatically analyzes all QC data and applies user-defined QC multi-rules that highlight any rejected results. The audit trail report records all events leading to the creation, modification, and deletion of an electronic record.


Automated Pipetting Systems

DNA purification made easy

Two new additions to the range of auto-mated pipetting systems from Eppendorf, Hauppauge, NY, are tailored for PCR setup and nucleic acid purification. The epMotion M5073 fully automates the process of DNA purification, providing reproducibility with high yield and purity. Elution volumes as low as 25 μL for high concentrations can be used. The company’s MagSep reagent kits are specifically designed for use with the epMotion M5073. Per run, one to 24 samples can be extracted for nucleic acid from a variety of sources, such as blood, tissue, cells, bacteria, or viruses. The epMotion P5073 helps streamline and automate the whole PCR setup workflow in 96- or 384-well formats. Four different, step-by-step guided PCR assistants are available to facilitate working with normalization, dilution, setup reactions, and composing mastermixes. Both the epMotion P5073 and epMotion M5073 have six SBS positions and are installed with a large, color touchscreen.

Eppendorf(800) 645-3050; www.eppendorfna.com

Tube and Vial FeederAutomated process saves time

Computype Inc, St Paul, Minn, in partnership with Nautilus Systems, Phoenix, introduces the Flexible Tube and Vial Feeder, a system for auto-matic downstream feeding of tubes and vials. The system separates tubes and vials from a bulk hopper and feeds them into an automated labeling device, ensuring each piece exiting the system is feed-ing in the correct orientation. With a changeover of one mechanical component and a few settings, the system adjusts to accommodate tubes and vials from 6 mm to 14 mm in diam-eter, and up to 96 mm long. The system can elimi-nate the need for manual operation with its high feed rate (up to 40 parts per minute) and use of a bulk storage hopper. It also includes technology requiring no vibratory element and creating virtually no noise.

Computype Inc(800) 328-0852; www.computype.com

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Instructional DVDs, Drawing

Blood SamplesShow techniques and common errors

The Center for Phlebotomy Education, Corydon, Ind, offers videos for teaching health care pro-fessionals what they must know about drawing quality blood samples safely and properly. This series of five DVDs reflects current Clinical and Laboratory Standards Institute (CLSI) standards and OSHA guidelines. Three-dimensional ani-mations illustrate nerve injury, arterial nicks, platelet clumping, hematoma formation, and hemoconcentration. Detailed demonstrations cover the critical aspects of venipuncture, skin puncture, and arterial blood gas collections. Errors that collectors can introduce during sample collection, transport, and storage that alter test results, along with the types of injuries patients suffer from poorly performed venipunctures that can lead to litigation, are discussed.

The Center for Phlebotomy Education(866) 657-9857; www.phlebotomy.com

High-Volume Coagulation Analyzer Automated preanalytical sample management

Siemens Healthcare Diagnostics, Tarrytown, NY, introduces the Sysmex CS-5100 system, a random access high-volume coagulation analyzer, in multiple markets around the world, including Europe, Africa, Canada, Latin America, Australia, and New Zealand. The sys-tem automates and standardizes sample manage-ment. This addi-tion to the Siemens Sysmex CS port-folio is equipped with simultane-ous, multiwave-length Preanalytical Sample Integrity (PSI) technology, enabling high-vol-ume laboratories to achieve first-run accuracy by identi-fying and manag-ing unsuitable test specimens prior to analysis. This technology enhances results reliability while improving efficiency by minimizing the need for manual sample inspections. The system also features third-generation cap-piercing technology, which contributes to reduced sample processing time and maintains the analyzer’s high-throughput capability. With onboard capacity of up to 3,000 tests and up to 40 reagents, the system delivers extended walkway time to streamline workflow.

Siemens Healthcare Diagnostics(888) 588-3916; www.healthcare.siemens.com

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Comprehensive Diabetes Testing from RandoxThe accurate diagnosis and monitoring of diabetes is of extreme importance as the number of people suffering from this condition continues to rise. Randox offer a range of assays for diabetes assessment and monitoring. Randox reagents are internationally recognised as being of the highest quality, benefit from extensive measuring ranges and have a variety of instrument specific applications available.Diagnosis:

Randox Laboratories

Email: [email protected] number: +1 304 728 2890

Toll Free: 8664 Randox http://www.randox.com/diabetesdiagnostics.php

Complications monitoring: Put The “Mart” In SmartFor more information on premium placement of your products here in the CLP Product Mart section, or to upgrade your CLP online Market Guide listings, please contact Carla Lira.

Carla Lira(303) 404-2038 • [email protected]

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Test for Gastrointestinal IllnessTests common bacterial pathogens in hours instead of days

The Prodesse ProGastro SSCS assay from Gen-Probe, Bedford, Mass, part of Hologic Inc, is a real-time multiplex polymerase chain reaction (PCR) IVD test for the qualitative detec-tion of the most common bacterial pathogens associated with gastroenteritis. The assay is intended for the detection and differentiation of salmonella, shigella, and Campylobacter (C. jejuni and C. coli only, undifferentiated) nucleic acids and Shiga toxin 1 (stx1) and Shiga

toxin 2 (stx2) genes. With the new assay, diagnostic labs will no longer need to wait 48 hours or more for culture results, which might be ambiguous. This solution is also scalable and fits the mid- to high-throughput setting. The assay runs on a common benchtop platform that exists in many labs. It has been optimized to use the same samples that physi-cians are collecting and labs are already accustomed to processing for stool culture, streamlining the tran-sition to a molecular Shiga toxin 1 detection method.

Gen-Probe(800) 523-5001; www.gen-probe.com

MRD AssaySimplified data reporting

Adaptive Biotechnologies, Seattle, intro-duces clonoSEQ, a clinical assay that measures minimal residual disease (MRD) in a range of blood-based cancers. It will be available for widespread clinical use by mid 2013. MRD is the name given to small numbers of leukemic cells that remain in the patient during treatment, or after treatment when the patient is in remission. The number of these residual cells may be, in some cases, correlated with the risk of relapse. The company has simplified data reporting to make comprehension easier and quicker for hematologists. Enhancements include

developing a proprietary set of immune receptor templates to eliminate PCR amplification bias, instituting a system-atic chain of custody to handle customer samples, and building a bioinformatics platform to enable the measurement of MRD as a ratio of the malignant clone to the total number of nucleated cells in a blood sample as well as to the lineage-related cells.

Adaptive Biotechnologies(206) 659-0067; www.adaptivebiotech.com

Parasite and Worm Assays

Made for labs of all sizes

Gold Standard Diagnostics, Davis, Calif, offers a comprehensive line of assays for parasites and worms. Its portfolio of parasite tests provides labs with a reli-able, single-source procurement option and access to a wide range of highly con-sistent and cost-effective sero-logical and stool assays. The tests are d e s i g n e d for labs of all sizes. The com-pany partners with manufacturers from around the globe to offer a broad menu of parasitology products, includ-ing Acanthocheilonema viteae, Ascaris lumbricoides IgG, Echinococcus IgG, Entamoeba histolytica IgG, Leishmania IgG, Schistosoma mansoni IgG, and more.

Gold Standard Diagnostics(530) 759-8000; www.dsdx.us

Nicotine Metabolites and Nitrosamines Products

Used in a lab’s matrix of choice

Cerilliant, Round Rock, Tex, intro-duces its new Certified Spiking Solutions of nicotine metabolites norcotinine and trans-3-hydroxy-cotinine as well as nicotine nitro-samines NNN, NNK, and NAB at concentrations of 1.0 mg/mL in methanol for each solution stan-dard. These certified reference solutions can be used as Snap-N-Spike starting materials in the lab’s matrix of choice for preparation of calibrators and controls in nicotine testing and other clinical or diagnostic applications by LC/MS or GC/MS. Nicotine biomarkers are commonly monitored in patients who smoke cigarettes, use other nicotine products such as nicotine gum and electronic cigarettes, or are exposed to environmental tobacco smoke. Accurate patient results in clinical and diagnostic testing of nicotine use depend on accurate and consistent certified reference materials for the numerous nicotine metabolites.

Cerilliant(800) 848-7837; www.cerilliant.com

Tumor Marker Control Independently assesses performance

The new Acusera multianalyte Liquid Tumor Marker Control from Randox, UK, covers a total of 12 commonly tested and esoteric cancer antigens and tumor markers. It includes AFP, beta-2- microglobulin, CA15-3, CA19-9, CA27-29, CA125, CEA, ferritin, hCG, PSA free, PSA total, and thyroglobulin. The liquid ready-to-use format requires no preparation. Open vials have a

stability of 30 days for all analytes listed, which helps minimize waste. The serum is 100% human in origin, providing a matrix similar to the patient sample, but also reducing antibody cross reactivity and the possibility of control values shifting when reagent batch is changed. Three distinct levels of control are available with all analytes, including PSA present at desirable levels. Labs can use the Acusera liquid tumor marker control to indepen-dently assess analytical performance.


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Testosterone Assay Second-generation test

Abbott, Abbott Park, Ill, has received FDA clearance for its new testosterone test. The ARCHITECT 2nd Generation Testosterone Assay is a chemiluminescent microparticle immunoassay for the quantitative determination of testosterone in human serum and plasma. It is more sensitive, accurate, and precise than previous versions. The new assay runs on the company’s fully automated ARCHITECT family of analyzers (pictured) and is available in the United States. Measurements of testosterone are used in the diag-nosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, and impotence in males; and in females, hirsutism (excessive hair) and virilization (masculization) due to tumors, polycystic ovaries, and androgenital syndromes.

Abbott(800) 323-9100; www.abbottdiagnostics.com

Assay EvaluatorEvaluates for interference from five interfering

substances

The Assurance Interference test kit and Dextran sulfate sodium salt are the latest products from Sun Diagnostics, New Gloucester, Me. The Assurance kit evaluates assays for interference from five common interfering substances. It is made with human-sourced, triglyceride-rich lipoproteins to evaluate lipemia interfer-ence; human hemolysate to evaluate hemo-lysis interfer-ence; human albumin and gamma-globu-lins to evaluate protein inter-ference; and conjugated and unconjugated bilirubin to evaluate icterus interference. The company also offers Dextran sulfate sodium salt for lab use. It has a variety of lab applications, including use in preparing a precipitating reagent for the determination of HDL cholesterol.

Sun Diagnostics(877) 786-3424; www.sundiagnostics.us

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ICD-9 code sets are set to be supplanted by ICD-

10 code sets. Although the new code’s name

sounds about as incremental as an update can

get, ICD-10 codes actually have a completely

different structure than ICD-9 codes. ICD-9 codes

are mostly numeric and have three to five digits.

ICD-10 codes are alphanumeric and contain three

to seven characters. ICD-10 codes are able to cap-

ture more valuable information, such as “one-to-

many” matches. The transition will go into effect

in October 2014.

CLP sat down with three industry leaders to get

their take on what the switch means and how labs

can prepare.

With more than 30 years of laboratory experi-

ence encompassing clinical laboratory manage-

ment, research and development, and product

management, Sandy Laughlin brings valuable

experience to CompuGroup Medical - Lab Division,

LabDAQ, Boston, as its product manager.

Julie Pekarek, VP of solutions management,

Merge Healthcare, Chicago, oversees Merge’s

efforts for Meaningful Use in radiology, orthope-

dics, eye care, and ob-gyn. She has spent 20 years

in the health care industry, both on the provider

side as a part of a health care system and on the

vendor side.

Lâle White, CEO, XIFIN Inc, San Diego, is an

expert in the field of health care financial manage-

ment and regulatory compliance, with more than

25 years of experience in information systems

development and medical billing.

CLP: How are clinical laboratories uniquely challenged by the transition to ICD-10 as indi-rect service providers?

Pekarek: As indirect service providers, clinical

labs are dependent on the order received. If this

order is done correctly and has sufficient detail,

they are able to code and bill for the test more eas-

ily. In the move to ICD-10, the ordering clinician

will be changing the condition/reason for the test

[ roundtable ]

Adopting ICD-10 Code Sets

to comply with ICD-10 codes. Labs will be depen-

dent on these providers re-coding correctly and in

sufficient detail. If this does not happen, they will

need to spend time completing or correcting in

order to get paid.

Laughlin: If the lab is currently checking for

medical necessity, the laboratory staff will be

responsible for training order entry personnel to

ensure that the appropriate diagnosis codes are

used for the procedures requested. Laboratories

will also be impacted if they are exporting data

electronically from the laboratory information sys-

tem to a billing or practice-management system.

The exports must include ICD-10 codes for prop-

er claim submissions to insurance carriers after

October 1, 2014. If history is any indication, major

changes in the charge export format to insurance

carriers and clearinghouses will cause an increase

in claim rejections and delayed payments, which

will impact cash flow.

White: As indirect providers, clinical laborato-

ries are completely dependent on ordering physi-

cians to provide accurate ICD-10 codes required

by payors to obtain reimbursement. Labs cannot

code their own claims or fill in the blanks without

consulting the ordering physician, which could

result in cash flow interruptions. This will be the

single greatest challenge labs face in transitioning

to ICD-10.

CLP: What can labs do to ensure compliance with ICD-10 technology changes required of their IT vendors and third-party payors?

Laughlin: Labs should be contacting their labo-

ratory vendors to determine if software or hard-

ware updates are required and when the update

will be installed. They should also determine a

time line for updating the product and whether

the software update will support both ICD-9 and

ICD-10 to accommodate transactions for services

performed prior to October 1, 2014 that are submit-

ted after October 1, 2014. Labs should implement

By Kurt Woock

Sandy Laughlin Julie Pekarek Lâle White

the software version that supports ICD-10 months

in advance of the October 2014 deadline and allow

for sufficient time to train and test all involved

systems.

White: By now, labs should have contacted

their billing and lab information system vendors

to determine their plan, time lines, and costs

for upgrading their systems to support ICD-10.

Similarly, labs need to determine payor readiness

and establish a testing schedule to ensure ICD-10

compliance. Labs must be persistent and proactive

to ensure vendors and payors are able to process

ICD-10 claims by the compliance date.

Pekarek: Labs will need to have the ability to

search and apply the ICD-10 codes to tests. They

will also need to be able to select ICD-9 or ICD-10,

since not every payor is going to move at the same

time. Both code sets will need to exist and be select-

ed as needed. They will need a crosswalk between

code sets that allows them to search in ICD-9

and find the related ICD-10 code(s). Laboratories

should be contacting their vendors to determine

their ICD-10 readiness and vendor contingency

plans that accommodate both compliant and non-

compliant payors. Not all payors will be ICD-10

compliant at the same time.

Kurt Woock is the associate editor for CLP.

IS YOUR LAB READY?

This is an abridged version of the interview. To read the entire interview go to http://tinyurl.com/b5fs4aa

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INTERACTIVE EDITION clp.alliedmedia360.com


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