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Cystatin C Immunoassay – Test Kit

Cystatin C Immunoassay – Test Kit

Ordering Information

Cat. No. Mfr. No. Type Certificates Specification Price Quantity
MD01090440-01 1101 Gentian Cystatin C Immunoassay Reagent Kit FDA510(k) cleared; CE-marked 58 mL + 10 mL Inquiry
MD01090440-02 1019 Gentian Cystatin C Control Kit 2 x 1 mL Inquiry
MD01090440-03 1026 Gentian Cystatin C Control Kit 2 x 5 mL Inquiry
MD01090440-04 1029 (USA only) Gentian Cystatin C Single Use Control Low 100 x 150µL Inquiry
MD01090440-05 1030 (USA only) Gentian Cystatin C Single Use Control High 100 x 150µL Inquiry
MD01090440-06 1051 Gentian Cystatin C Calibrator Kit 6 x 1 mL Inquiry
MD01090440-07 1012 Gentian Cystatin C Calibrator 1 mL Inquiry

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    • Introduction

      • Introduction

        Cystatin C is a superior GFR marker for the diagnosis and therapeutic control of renal function1 for patients of all ages. The Gentian Cystatin C Immunoassay (ERM-DA471/IFCC standardized) is an open channel turbidimetric test for quantitative determination of cystatin C in human serum and plasma.

    • Certificates

      • The Gentian Cystatin C Immunoassay is FDA510(k) cleared since 2008 and CE-marked.

    • Cystatin C in estimating GFR

      • Cystatin C is an established marker for estimating glomerular filtration rate (GFR). GFR calculations performed using cystatin C are independent of protein intake, ethnicity, and muscle mass. Equations that include cystatin C predict GFR more accurately than serum creatinine in children, adults, and older adults. Clinical use of cystatin C is recommended in guidelines published by KDIGO and NICE.

    • Cystatin C in clinical settings

      • While the clinical use of cystatin C can have far-reaching benefits across all patient groups, certain vulnerable patient populations may experience a greater benefit. Specifically, children, amputees and the elderly would receive more accurate eGFRs with cystatin C because its concentrations are independent of muscle mass and show less age and gender-related variation relative to creatinine.

        Precise eGFR determination is also important in patients who are prescribed medications that are renally excreted. Drugs with a narrow therapeutic index or toxic range can be more accurately dosed when cystatin C is included in the evaluation of the patients’ kidney function. Cystatin C based dosing of pharmaceuticals such as Digoxin, Carboplatin and Vancomycin can lead to better patient outcomes, decreased length of stay and lower treatment cost.

    • Technical Specification
      • Assay Performance
        Sample type Serum, plasma
        Assay type PETIA
        Format Two reagents, ready to use
        Measuring range ~ 0.4 - 8.0 mg/L
        Precision1 Total CV < 4 %
        Limit of quantification1 0.43 mg/L
        Security zone1 31.13 mg/L
        Standardization Calibrated against the reference material ERM-DA471/IFCC

        1 Instrument specific, validation results for Roche Cobas c501

        Assay Principle

        The Gentian Cystatin C Immunoassay is a Particle-Enhanced Turbidimetric Immunoassay (PETIA) for in vitro diagnostic testing of cystatin C in human plasma and serum samples.

        The Gentian Cystatin C Immunoassay is rapidly performed in only 10 minutes and can be applied on a wide range of clinical chemical analyzers with documented high inter instrument accuracy.

        Compatible with:

        ADVIA®, Siemens Healthcare

        ARCHITECT®, Abbott Laboratories

        AU®, Beckman Coulter

        VITROS®, Ortho Clinical Diagnostics

        BS®, Mindray

        Cobas®, Roche

        Calibrator Standardization

        The calibrator for the Gentian Cystatin C Immunoassay is available in two versions, one-level calibrator for auto-dilution or a 6-point pre-diluted calibrator kit.

        Both types of calibrators are standardized against the international calibrator standard ERM-DA471/IFCC.

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