Performance evaluation of a turbidimetric cystatin C assay on different high-throughput platforms

Abstract

Objective. The goal with this study was to evaluate the analytical performance of a new cystatin C immunoassay (Tina-quant® a Cystatin C, Roche Diagnostics GmbH). The evaluation was carried out at four centers according to a standardized protocol. Material and methods. The Tina-quant® a Cystatin C is a latex particle-enhanced immunoturbidimetric assay. Roche cobas® 6000, MODULAR ANALYTICS SWA and COBAS INTEGRA® instruments were included in the study. Method comparison studies were carried out against two turbidimetric methods (Dako Cystatin C, Gentian Cystatin C), and one nephelometric method (Siemens N-Latex Cystatin C). Results. Linearity was proven throughout the measuring range from 0.4 to 8 mg/L. Within-run CVs ranged from 0.7–2.8%, and total CVs from 1.4–4.7 % (concentration range 0.6–3.9 mg/L). Comparable results were obtained with paired serum and Li-heparinate plasma samples. Good agreement was achieved in the comparisons between the Tina-quant® a Cystatin C assay and the other commercially available cystatin C assays, two different turbidimetric methods (slope range 0.88–1.04, intercept < 0.17 mg/L, r ≥ 0.993) and one nephelometric assay (slope range 0.90–1.05, intercept < 0.21 mg/L, r ≥ 0.986). Conclusions. The Tina-quant® a Cystatin C assay was shown to be precise and accurate with proven linearity over the measuring range. Good comparability was obtained with other commercially available assays for the determination of cystatin C. The Tina-quant® a Cystatin C assay is very well suited for clinical use on routine clinical chemistry analysers to detect renal dysfunction with a 24 h availability.

Key Words::

• Cystatin C
• estimated GFR
• glomerular filtration rate
• kidney
• renal function
• performance evaluation

Acknowledgements

The authors thank Mrs Heike Sauter (Roche Diagnostics GmbH) for her skillful technical assistance.

Note

COBAS, COBAS INTEGRA, MODULAR and TINA-QUANT are trademarks of Roche.

Declaration of interest: C. Beck and I. Domke are employed by Roche Diagnostics GmbH, Germany. The authors alone are responsible for the content and writing of the paper.