Cystatin C Immunoassay – Test Kit
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.
Compatible with:
- ADVIA®, Siemens Healthcare
- ARCHITECT®, Abbott Laboratories
- AU®, Beckman Coulter
- VITROS®, Ortho Clinical Diagnostics
- BS®, Mindray
- Cobas®, Roche
Background – Gentian Cystatin C
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].
Webinar: Gentian Cystatin C Immunoassay
Want to know more about Gentian’s CystatinC immunoassay? Watch this 10 minutes long webinar with Product Manager for Cystatin C, Gaute Tangen, and get more insight about the assay’s advantages.
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.
Cystatin C: Products Available
| Product no. | Product | Content |
|---|---|---|
| 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 |
Contact us for more information and ordering
For more details on Gentian Cystatin C Immunoassay products and prices please contact us at marketing@gentian.com or fill out the form below:
Technical Specifications
| 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 | 0.28 mg/L |
| Security zone1 | 29 mg/L |
| Standardization | Calibrated against the reference material ERM-DA471/IFCC |
| 1Instrument specific, validation results for Roche Cobas c501 | |
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 marketing@gentian.com
References:
- Abrahamson M et al: Biochem J 1990;268:287-94.
- Laterza OF et al: Clin Chem 2002;48:63-99.
- Grubb AO. Adv Clin Chem 2000;35:63-99.
- Filler G et al: Clin Biochem 2005;38:1-8.
- Grubb A et al. Clin Chem Lab Med. 2010;48:1619-21
- Eckfeldt JH, et al. 2014 CYS Survey. Arch Pathol Lab Med 2015;139:888-93.
- Bargnoux AS, et al. Arch Pathol Lab Med. 2016;140:117-8.
- Bargnoux AS, et al. Clin Chem. 2017;63:833-841.
*not pediatric use in US
FAQ: Cystatin C
Cystatin C is a superior Glomerular Filtration Rate (GFR) marker for the diagnosis and therapeutic control of renal function for patients of all ages. The low molecular weight protein is 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 it is then reabsorbed and almost entirely catabolised in the proximal tubules. Hence, the cystatin C concentration in human blood is closely related to GFR [2].
Why can Cystatin C provide an estimate of Glomerular Filtration Rate (GFR)?
Cystatin C is a potent cysteine proteinase inhibitor produced at a constant rate by all nucleated cells. Cystatin C is filtered effectively by the glomerulus, and then fully reabsorbed and broken down by the renal tubules for recycling. A raised level of serum cystatin C correlates closely with GFR and is therefore a good indicator of reduced kidney function.
What is the advantage of using Cystatin C for GFR estimation compared to creatinine?
Creatinine values are dependent on variables including age and body mass and you must correct for this in calculating GFR. Cystatin C GFR gives a direct and accurate measurement of GFR independent of age and muscle mass.
What is the “creatinine-blind area”?
Serum creatinine values are not a direct measure of GFR. GFR can be reduced by as much as 50% while the serum creatinine value is still within the normal range – this is the “creatinine-blind area”.
Does Cystatin C GFR have a blind area?
Cystatin C does not have a blind area and gives an immediate and true measurement of GFR.
How does Cystatin GFR compare to gold standards for precise determination of GFR?
Gold standard methods include the use of intravenous injections of radio labelled substances such as Cr-51-EDTA and Tc-99m-DTPA, or iodinated agents such as iohexol. GFR determined as cystatin C GFR shows a direct relationship between the reciprocal of cystatin C concentration in serum/plasma and GFR. Correlation is very good and is not hampered by collection errors or errors introduced by multiple measurements of blood or urine samples.
What is the advantage of using cystatin C to estimate GFR compared to gold standard methods for determination of GFR?
The Gentian Cystatin C analysis can be carried out on one routine blood samples, which can conveniently be done together with other standard tests in clinical analysers. Patients do not have to be invaded specifically for the Gentian Cystatin C test. More importantly, Gentian Cystatin C can replace a range of unpleasant tests, including urine collection or radioactive measurements with repeated blood sampling. Especially for paediatricians, Cystatin GFR is the preferred test method.
How can we get access to the Gentian Cystatin C GFR test?
Please contact marketing@gentian.com for information on how to access the Gentian Cystatin C GFR test in your country.
Is Gentian Cystatin C assay available on all clinical chemistry analysers?
The Gentian Cystatin C assay is available on most major clinical analyser. Please contact marketing@gentian.com for more information on availability on the clinical analyser in your laboratory.
Is Gentian Cystatin C assay standardised?
The Gentian Cystatin C assay is standardised to the international reference material ERM-DA471/IFCC, and has been repeatedly proven to be aligned with the world standards for cystatin C measurement.
Is Gentian Cystatin C assay FDA510(k)-cleared?
Yes, the Gentian Cystatin C Immunoassay is FDA510(k) cleared and CE-marked.
References:
- Abrahamson M et al: Biochem J 1990;268:287-94.
- Laterza OF et al: Clin Chem 2002;48:63-99.
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 in your own language we have package inserts in a selection of languages.