Cystatin C is a superior GFR marker for the diagnosis and therapeutic control of renal function for patients of all ages. The Gentian Cystatin C Immunoassay (ERM-DA471/IFCC standardised) is an in vitro diagnostic test for quantitative determination of cystatin C in human serum and plasma. The Gentian Cystatin C Immunoassay is FDA510(k) cleared and CE-marked.
The Gentian Cystatin C Immunoassay is a Particle-Enhanced Turbidomentric Immunoassay (PETIA) for use on a wide range of clinical chemistry analysers, including:
Cystatin C is a low molecular weight protein produced at a constant rate in nearly every nucleated cell in the human body . It is freely filtered through a normal Glomerular membrane, and is then reabsorbed and almost entirely catabolised in the proximal tubules. Hence, the cystatin C concentration in human blood is closely related to glomerular filtration rate (GFR) . A reduction in the GFR causes a rise in the concentration of cystatin C. The cystatin C concentration has not been shown to be significantly influenced by other factors such as muscular mass, inflammatory diseases, sex, age or diet [2, 3, 4].
In 2010 the International Federation of Clinical Chemistry (IFCC) formed a working group to produce an international reference material (ERM-DA471/IFCC). The Gentian Cystatin C Immunoassay was one of the methods selected to evaluate the commutability of this world standard . You can be at ease when using this assay knowing that it is has been repeatedly proven to be aligned with the world standards for cystatin C measurement [6, 7, 8].
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 analysers with documented high inter instrument accuracy .
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 standardised against the international calibrator standard ERM-DA471/IFCC.
Diagnosis of chronic kidney disease
|1101||Gentian Cystatin C Immunoassay Reagent Kit||58 mL + 10 mL|
|1019||Gentian Cystatin C Control Kit||2 x 1 mL|
|1026||Gentian Cystatin C Control Kit||2 x 5 mL|
|1029||Gentian Cystatin C Single Use Control Low||100 x 150µL|
|1030||Gentian Cystatin C Single Use Control High||100 x 150µL|
|1051||Gentian Cystatin C Calibrator Kit||6 x 1 mL|
|1012||Gentian Cystatin C Calibrator||1 mL|
The Gentian Cystatin C Immunoassay is FDA510(k) cleared and CE-marked. For more details on Gentian Cystatin C Immunoassay products and prices please contact us at email@example.com.
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|Sample type||Serum, plasma|
|Format||Two reagents, ready to use|
|Measuring range||~ 0.4 - 8.0 mg/L|
|Precision1||Total CV < 4%|
|Limit of quantification1||0.28 mg/L|
|Security zone1||29 mg/L|
|Standardization||Calibrated against the reference material ERM-DA471/IFCC|
|1Instrument specific, validation results for Roche Cobas c501|
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