Cystatin C Immunoassay | GFR Marker | Glomerular Filtration | Gentian
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Cystatin C

Cystatin C

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 a Particle-Enhanced Turbidomentric Immunoassay (PETIA) for use on a wide range of clinical chemistry analysers. The Gentian Cystatin C Immunoassay is FDA510(k) cleared and CE-marked.


Cystatin C is a low molecular weight protein produced at a constant rate in nearly every nucleated cell in the human body [1]. 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) [2]. 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 [5]. 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].



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 analysers with documented high inter instrument accuracy [6].



Calibrator Standardisation

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.

Products available

Product no.ProductContent
1101Gentian Cystatin C Immunoassay Reagent Kit58 mL + 10 mL
1019Gentian Cystatin C Control Kit2 x 1 mL
1026Gentian Cystatin C Control Kit2 x 5 mL
1029Gentian Cystatin C Single Use Control Low100 x 150µL
1030Gentian Cystatin C Single Use Control High100 x 150µL
1051Gentian Cystatin C Calibrator Kit6 x 1 mL
1012Gentian Cystatin C Calibrator1 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

Technical Specifications

Assay Performance 
Sample typeSerum, plasma
Assay typePETIA
FormatTwo reagents, ready to use
Measuring range~ 0.4 - 8.0 mg/L
Precision1Total CV < 4%
Limit of quantification10.28 mg/L
Security zone129 mg/L
StandardizationCalibrated against the reference material ERM-DA471/IFCC
1Instrument specific, validation results for Roche Cobas c501

For further technical specifications please contact

Beckman Coulter Customers

For customer service and technical support regarding Gentian products purchased via Beckman Coulter, please contact your local Beckman Coulter representative.If you are looking for package insert we have package inserts in all available languages here.


  1. Abrahamson M et al: Biochem J 1990;268:287-94.
  2. Laterza OF et al: Clin Chem 2002;48:63-99.
  3. Grubb AO. Adv Clin Chem 2000;35:63-99.
  4. Filler G et al: Clin Biochem 2005;38:1-8.
  5. Grubb A et al. Clin Chem Lab Med. 2010;48:1619-21
  6. Eckfeldt JH, et al. 2014 CYS Survey. Arch Pathol Lab Med 2015;139:888-93.
  7. Bargnoux AS, et al. Arch Pathol Lab Med. 2016;140:117-8.
  8. Bargnoux AS, et al. Clin Chem. 2017;63:833-841.
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