CYSTATIN C

Superior GFR marker for the diagnosis and therapeutic control of renal function and Chronic Kidney Disease (CKD)

Cystatin C Immunoassay – Test Kit

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 standardised) is an open channel turbidimetric test for quantitative determination of cystatin C in human serum and plasma.

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

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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 mass2-5. Equations that include cystatin C predict GFR more accurately than serum creatinine in children6, adults7, and older adults8. Clinical use of cystatin C is recommended in guidelines published by KDIGO2 and NICE3.

 

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 creatinine2-8.


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 cost9.

Request validation kit for cystatin C

Technical details

 
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
Standardisation 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

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.

Compatible with:

 

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

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.

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

 
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

 

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
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1-2

Turbidimetric test

17

Faster throughput

2-3

Open channel

5

10 minutes to result

Design uten navn (6)

Cost efficient

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Gentian's cystatin C immunoassay is applied to turbidimetry-based clinical chemistry platforms. It is an open channel assay, meaning it can be added to all clinical chemistry analysers.

  • FDA510(k) cleared and CE-marked
  • IVDR registration in progress
  • Developed and manufactured by Gentian
  • Manufactured according to ISO 13485:2016

Explore cystatin C in your laboratory - fill out the form or send an email to marketing@gentian.com for more information about the product and prices.

Frequently asked questions

Why can cystatin C provide an estimate of Glomerular Filtration Rate (GFR)?

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 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 the Gentian Cystatin C Immunoassay 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 the Gentian Cystatin C Immunoassay 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 the Gentian Cystatin C Immunoassay FDA510(k)-cleared?

Yes, the Gentian Cystatin C Immunoassay is FDA510(k) cleared and CE-marked.

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