Data Sheet - Diazyme Laboratories

TURN ON YOUR LYTES...WITHOUT THE ELECTRICITYSODIUMPOTASSIUMLITHIUMCARBON DIOXIDEINTRODUCING AN ALTERNATIVE TO HIGH PRICED ISE ASSAYS• Accurate and Precise• Low Cost per test• Extensive range of instrument parameters• Packaging options for labs of all sizesDIAZYMEINNOVATIONS IN CLINICAL DIAGNOSTICS

DIAZYME ENZYMATIC ELECTROLYTESSodium Potassium Lithium CO 2MethodEnzymatic - A sodiumdependent β-galactosidasecleaves ONPG substrate.The product O-nitrophenyl isread at 405 nm and isproportional to the sodiumconcentrationEnzymatic – A potassiumdependent pyruvate kinasecatalyzes the conversion ofNADH analog to NAD analogwhich is measured at 380 nmand is proportional to thepotassium concentrationEnzymatic - A lithiumsensitive phosphatasecatalyzes the conversion ofadenosine biphosphate (PAP)to hypoxanthine and hydrogenperoxide which is thenquantified by a Trinder reactionThe assay is based on acoupled reagent withphosphoenolpyruvatecarboxylase (PEPC) and malatedehydrogenase (MDH).The decrease in absorbanceat 405 or 415 nm is directlyproportional to CO 2concentration in the sampleTraceabilitySodium calibrator and controlare traceable to NIST standardand an ISE methodPotassium calibrator and controlare traceable to NIST standardand an ISE methodLithium calibrator and controlare traceable to NIST standardand an ISE methodCO 2 calibrator and controlare traceable to NIST standardand an ISE methodMethodCorrelationto PredicateR 2 = 0.9801regressiony = 1.0516x - 2.2343R 2 = 0.98regressiony = 1.07x - 0.30R 2 = 0.99regressiony = 1.03x - 0.04R 2 = 0.99regressiony = 1.0447x - 0.9742PrecisionThe Within-Run CVs1.2% at 137 mmol/L1.1% at 160 mmol/LThe total CVs1.56% at 137 mmol/L1.65% at 160 mmol/LThe Within-Run CVs1.12% at 4.46 mmol/L1.20% at 6.86 mmol/LThe total CVs1.77% at 4.46 mmol/L1.77% at 6.86 mmol/LThe Within-Run CVs4.3% at 1.0 mmol/L1.2% at 2.5 mmol/LThe total CVs4.8% at 1.0 mmol/L1.3% at 2.5 mmol/LThe Within-Run CVs2.3% at 25 mmol/L2.3% at 40 mmol/LThe total CVs2.8% at 25 mmol/L3.3% at 40 mmol/LOn-BoardStability*4 weeks 2 weeks 8 weeks 4 weeksCalibratorLiquid stable calibrator set,no serial dilutions are requiredLiquid stable calibrator set,no serial dilutions are requiredLiquid stable calibrator set,no serial dilutions are requiredLiquid stable calibrator set,no serial dilutions are requiredSample Type Serum Serum SerumSerum,Heparinized PlasmaSampleVolume8 uL 5 uL 5 uL 3 uLAssay RangeLinear range of80 - 180 mmol/LLinear range of2 - 8 mmol/L0.19 - 3.0 mmol/L 1.12 - 50 mmol/LInstrumentSpecificPackagingUniversal kit packagingUniversal kit packagingUniversal kit packagingBeckman• SynchronRoche• HitachiUniversal kit packagingBeckman• Synchron• AURegulatoryStatus• 510 (k) Cleared• CE• 510 (k) Cleared• CE• 510 (k) Cleared• CE• Health Canada• 510 (k) Cleared• CE*Analyzer DependentDIAZYME LABORATORIES12889 Gregg Court, Poway, CA 92064PO Box 85608, San Diego, CA 92186Tel: 858-455-4768 888-DIAZYMEwww.diazyme.com sales@diazyme.comDIAZYME EUROPE GMBHZum Windkanal 21, 01109 Dresden, DeutschlandTel. +49 (0) 351 886 3300 Fax +49 (0) 351 886 3366sales@diazyme.deD048 (6/2014)MK040 Rev. E