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

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Author

  • Lars-Olof Hansson
  • Anders Grubb
  • Anders Liden
  • Mats Flodin
  • Annacarin Berggren
  • Joris Delanghe
  • Veronique Stove
  • Hilmar Luthe
  • Karl-Heinz Rhode
  • Claus Beck
  • Ingrid Domke
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Summary, in English

Objective. The goal with this study was to evaluate the analytical performance of a new cystatin C immunoassay (Tina-quant (R) 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 (R) a Cystatin C is a latex particle-enhanced immunoturbidimetric assay. Roche cobas (R) 6000, MODULAR ANALYTICS SWA and COBAS INTEGRA (R) 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 (R) 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 (R) 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 (R) 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.

Publishing year

2010

Language

English

Pages

347-353

Publication/Series

Scandinavian Journal of Clinical & Laboratory Investigation

Volume

70

Issue

5

Document type

Journal article

Publisher

Informa Healthcare

Topic

  • Medicinal Chemistry
  • Pharmacology and Toxicology

Keywords

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

Status

Published

ISBN/ISSN/Other

  • ISSN: 1502-7686