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

16

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

.

18

• 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