In this segment we will answer questions our Product Manager for cystatin C and Product Specialist in the US get about cystatin C at exhibitions, conferences and client meetings. Today’s question is “What type of assay is the Gentian Cystatin C immunoassay?”
What type of assay is the Gentian Cystatin C Immunoassay?
Gentian’s cystatin C assay (ERM-DA471/IFCC standardised, FDA510(k) cleared and CE-marked) is a Particle-Enhanced Turbidimetric Immunoassay (PETIA) for quantification of cystatin C in human plasma and serum.
The assay can be performed on a wide range of clinical chemistry analysers and has verified high inter-instrument accuracy. The random-access workflow capability available on most automated platforms also means that samples can be measured successively as they arrive at the testing facility, with lead times as low as 10 minutes.
The history
Since all major chemistry analysers on the market can perform immunoturbidimetric analysis, a strategic decision was made at Gentian’s inception to focus on PETIAs.
The decision coincided with the identification of a gap in the IVD market for a high quality turbidimetric cystatin C assay. In 2006, the company used its proprietary antibody and nanoparticle-based technology to launch the Gentian Cystatin C Immunoassay, which was immediately adopted by several healthcare systems in Sweden. Gentian’s foray into the US market was made possible when the assay received FDA-510(k) clearance in 2008.
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 |
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1Instrument specific, validation results for Roche Cobas c501
Gentian Cystatin CGentian’s cystatin C immunoassay was launched in 2006. It is a Particle-Enhanced Turbidimetric Immunoassay (PETIA) for in vitro testing of cystatin C in human plasma and serum samples. The test has documented high inter-instrument accuracy on a wide range of clinical chemistry analysers and can be performed in as little as 10 minutes. FAQ about cystatin CWhat type of antibodies are used in Gentian’s Cystatin C Immunoassay? Which US public health concerns cystatin C testing help alleviate? What are the advantages of measuring cystatin C in addition to creatinine? Which patient populations would benefit from cystatin C testing?
Contact usDo you want to know more about Gentian's cystatin C immunoassay or cystatin C in general? Send an email to marketing@gentian.com or fill out the form below and our Product Manager for cystatin C will contact you:
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