Gentian Diagnostics has been a leading manufacturer of turbidimetric cystatin C immunoassays since 2006. The Gentian Cystatin C Immunoassay is an IVD test for quantitative determination of cystatin C in human plasma and serum, supporting an early detection of reduced kidney function.
The assay has been FDA 510(k) cleared since 2007 and is and CE-marked and IVDR certified.
Cystatin C on instruments already in your lab
Our assay is compatible with a wide range of clinical chemistry analyzers and ensures high inter-instrument accuracy for both serum and plasma samples.
- Abbott Laboratories (CLIA for Alinity c)
- Beckman Coulter (CLIA for AU480, AU 5800, AU 680, Immage 800, DxC 500AU, DxC 700AU)
- Mindray
- Roche
- Siemens Healthineers
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.
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 zone |
31.13 mg/L |
| Standardisation |
Calibrated against the reference material
ERM-DA471/IFCC |
Kidney health advocates and organizations embrace increased use of cystatin C
Recommended by the KDIGO guidelines (2024), the National Kidney Foundation (NKF) and American Society of Nephrology (ASN) Task Force (2021), and the European Kidney Function Consortium (EKFC) (2023), cystatin C in combination with creatinine provides the most accurate assessment of glomerular filtration rate (GFR) and kidney function compared to creatinine alone. Increased use of cystatin C, alongside creatinine, is advised to offer a more reliable estimation of eGFR.
Is cystatin C really that expensive? Cost-Effectiveness of scaling cystatin C testing
The relationship between test volumes and reagent costs is tied to the operational dynamics of automated clinical chemistry analysers. The standard assay is composed of three components:
- Test reagents
- Quality control reagents
- Calibration reagents
Notably, it’s only the test reagent volume that changes depending on the number of patient samples being tested. Running more samples allows the cost of the control and calibration reagents to be spread across a larger number of tests, bringing down the overall cost of the test. For instance, a health system conducting a 10 000 cystatin C tests annually will reduce their cost per test by up to 80% compared to a hospital performing around 1000 cystatin C tests. This is due to the economies of scale achieved through increased testing volume.
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About Gentian Diagnostics – Gentian USA Inc.
Gentian Diagnostics, a Norwegian company, develops and manufactures open channel turbidimetric assays for clinical chemistry analyzers. We manufacture reagents for both laboratories and industry partners. Our headquarters in Norway handle R&D, production, marketing, and distribution. Global operations are supported by subsidiaries in Sweden and the US, and a representative office in China.
Gentian USA, Inc., a wholly owned subsidiary established in 2012, serves the US market. For our US customers, our assays are shipped domestically from within the United States.
1Instrument specific, validation results for Roche Cobas c501
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