Analytical performance of 4 automated assays for measurement of cystatin C

Jinong Li, Willard Dunn, Autumn Breaud, Debra Elliott, Lori J Sokoll, William Clarke

Research output: Contribution to journalArticle

Abstract

BACKGROUND: We evaluated the analytical performance of 4 cystatin C assays (Siemens N Latex on BNII, Roche Tina-quant on Cobas c501, Genzyme on Cobas c501, and Tosoh ST AIA-PACK on Tosoh AIA-600II) according to guidelines published by the Clinical and Laboratory Standards Institute. METHODS: We evaluated total imprecision, limit of detection, and limit of quantification for each assay using patient serum pools and linearity/recovery using serial dilutions of a patient serum pool with cystatin C-free serum. We compared patients (n = 102) using the Siemens assay as a comparison method. RESULTS: All assays had limits of detection and quantification y|x = 0.246 for Genzyme; y = 0.937x + 0.231, S y|x = 0.231 for Roche; and y = 1.010x + 0.216, Sy|x = 0.115 for Tosoh. The Genzyme assay appeared to report higher results than the Siemens assay, which is consistent with a higher reference interval specified by the manufacturer. CONCLUSIONS: Although all assays were acceptable for clinical use, their diagnostic performances were not optimal. Limitations include imprecision greater than claimed, overrecovery for the Roche assay on low concentration samples, and differences in results for patient samples. The latter situation requires assayspecific cystatin C-based glomerular filtration rate prediction equations at least until calibration is standardized using the international cystatin C calibrator now being developed.

Original languageEnglish (US)
Pages (from-to)1336-1339
Number of pages4
JournalClinical Chemistry
Volume56
Issue number8
DOIs
StatePublished - Aug 2010

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Cystatin C
Assays
Limit of Detection
Serum
Latex
Glomerular Filtration Rate
Calibration
Guidelines
Dilution
Recovery

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Analytical performance of 4 automated assays for measurement of cystatin C. / Li, Jinong; Dunn, Willard; Breaud, Autumn; Elliott, Debra; Sokoll, Lori J; Clarke, William.

In: Clinical Chemistry, Vol. 56, No. 8, 08.2010, p. 1336-1339.

Research output: Contribution to journalArticle

Li, Jinong ; Dunn, Willard ; Breaud, Autumn ; Elliott, Debra ; Sokoll, Lori J ; Clarke, William. / Analytical performance of 4 automated assays for measurement of cystatin C. In: Clinical Chemistry. 2010 ; Vol. 56, No. 8. pp. 1336-1339.
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