Post on 13-Oct-2020
Multitasker-LC Walk AwayUHPLC Analyzer For LC-MS/MS
ZIVAK TECHNOLOGIES
Clinical Diagnostic Market
Immunoassay, ELISA, RIA,FIA
Gold Standart Methods
Roche, Siemens,MidrayAbbott, Beckman
Sciex, Agilent, ThermoShimadzu, Waters..
WHY ?
CurrrentClinical
DiagnosticMarket
Clinical Diagnosiswith
LC-MS/MS andHPLC
2. False positive samples, when the results of the reference assay (LC-MS/MS-total-D) were less than 40 nmol/L but one or more of the immunoassays gave greater than or equal to 40 nmol/L.
State-of-the-Art Vitamin D Assays:A Comparison of Automated Immunoassays with Liquid Chromatography–Tandem Mass Spectrometry MethodsChristopher-John L. Farrell,1,2 Steven Martin,1 Brett McWhinney,3 Isabella Straub,4 Paul Williams,5 and Markus Herrmann1,4*Clinical Chemistry 58:3531–542 (2012)
NIST USA Traceability Report for Different Technicsfor Vit D2-D3 (Zivak 243A and 243B)
Limitations of HPLC and LC-MS/MS For RoutineClinical Use
Immunoassay, ELISA, RIA,FIA%95-97
Gold Standart Methods%3-5
Roche, Siemens,MidrayAbbott, Beckman
Sciex, Agilent, ThermoShimadzu, Waters..
FUTUREReady to UseAnalysis Kits
Automation and BarcodeReading
Walk-away HPLC and LC-MS/MS Analysers
CurrrentClinical
DiagnosticMarket
Clinical Diagnosiswith
LC-MS/MS andHPLC
LC-MS/MS vs ImmunoassayAdvantages Disadvantages
MS/MS methods
High SpecificityHigh SensitivityLower Kit Costs
Multiplexing MeasurementsHigh Throughput
Non-AutomatedQualified staff required
The need of rigorous kit validationAutomated Barcode Reading
Direct injection from Vacu tubeHigher maintenance cost (20 K USD / year)
Higher owner capital cost (200 K USD / device)
Immunoassay
AutomatedNo need for qualified staff
Validated kitsAffordable prices
Better traceability (barcode readers,Online LIS connection)
Low SpecificityLow SensitivityHigher Kit Costs
High Potential for interference
LC-MS/MS vs ImmunoassayAdvantages Disadvantages
Zivak MultitaskerAutomated LC-MS/MS
System
High SpecificityHigh SensitivityLower Kit Costs
Multiplexing MeasurementsHigh Throughput
Non-AutomatedQualified staff required
The need of rigorous kit validationAutomated Barcode Reading
Direct injection from VacutubeOnline LIS connection
Higher maintenance cost (20 K USD / year)Higher owner capital cost (200 K USD / device)
Immunoassay
AutomatedNo need for qualified staff
Validated kitsAffordable prices
Better traceability (barcode readers,
Online LIS connection)
Low SpecificityLow SensitivityHigher Kit Costs
High Potential for interference
Turn Your LC-MS/MS Instrument into WalkAway Clinical Analyzer
Immunoassay, ELISA, RIA,FIA
Gold Standart Methods
Roche, Siemens, MidrayAbbott, Beckman
Sciex, Agilent, ThermoShimadzu, Waters..
CurrrentClinical
DiagnosticMarket
Clinical Diagnosiswith
LC-MS/MS andHPLC
OUR VISION – Each LC-MS/MS will need an automatedsample prep LC
Zivak Multitasker Full Automated Sample Preparationand Injection System
Zivak Multitasker-LC
Multitasker - LC with TandemGold MS Turkey
Multitasker - LC with Shimadzu 8040 MS India
Multitasker – LC with Sciex 4500 MS Italy
Multitasker - LC with Thermo TSQ MS South Korea
The New HBA1c Analyser
1,5 min analysis time for HbA1c and HbF6,0 min analysis time for A1c, F, A0, A2, S, C, D, E VariantsReal walk-away system with unique modules
HB-100 New Design – 2017
Zivak NEW VD-200 D2-D3 Analyser UHPLC SystemWorld’s only Walk-Away 25-OH Vitamin D2-D3 UHPLC-UV System – April-2016
HPLC and LC/MS/MS Kits
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Kit Test Times (sample prep. + run time)Psychoactive Drugs Urine LC-MS/MS Analysis Kit 7 minAmino Acid Biological Fluids LC-MS/MS Analysis Kit 20 minPKU Serum LC-MS/MS Analysis Kit 2 minPKU Dried Blood Spots LC-MS/MS Analysis Kit 2 minOrganic Acid Urine LC-MS/MS Analysis Kit 20 minNeonatal Screening Dried Blood Spots LC-MS/MS Analysis Kit 1.5 minImmunosuppressant Whole Blood LC-MS/MS Analysis Kit 2 minVMA HVA 5-HIAA Urine LC-MS/MS Analysis Kit 15 minCatecholamines Urine LC-MS/MS Analysis Kit 16 minMetanephrine Urine LC-MS/MS Analysis Kit 13 minNeurotransmitters in Urine LC-MS/MS Analysis Kit 13 min25-Hydroxyvitamin D2-D3 Serum LC-MS/MS APCIAnalysis Kit 2 minTotal Homocysteine Serum LC-MS/-MS Analysis Kit 2.5 minHemoglobin A1c Whole Blood HPLC Analysis Kit 1.5 minHemoglobin Variant Whole Blood HPLC Analysis Kit 6.5 minPKU Serum HPLC Analysis Kit 2 minPKU Dried Blood Spots HPLC Analysis Kit 2 min25-Hydroxyvitamin D2-D3 Serum HPLC Analysis Kit 6 minVitamin A-E Serum HPLC Analysis Kit 8 min25-Hydroxyvitamin D2-D3 Serum VD-200 UHPLC Analysis Kit 3 min
Matrix /IS Labeled Standarts,Controls and Calibrators
.
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• HbA1C in Whole Blood • Hb Variant and ß-Thalassemia• 25-OH Vitamin D2/D3 in Serum
• Phe, Tyr and Trp in Serum & Plasma and DBS
Clinical HPLC Analysis Kits