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  • Title: Stratus CS cardiac troponin I method: performance characteristics including imprecision at low concentrations.
    Author: Christenson RH, Cervelli DR, Bauer RS, Gordon M.
    Journal: Clin Biochem; 2004 Aug; 37(8):679-83. PubMed ID: 15302610.
    Abstract:
    OBJECTIVES: Define performance characteristics of the Stratus CS cardiac troponin I (cTnI) assay in routine practice. METHODS: Imprecision at low cTnI values was assessed according to NCCLS EP5-A. Linearity was assessed by regression analysis; the reference interval was determined in 345 healthy individuals. Minimum detectable concentration (MDC) was assessed with 20 replicates of zero calibrator, and method correlation and bias (n = 77) were by Passing-Bablok regression and Bland-Altman plot. RESULTS: cTnI of 0.06 microg/l corresponded to the 10% CV; the 99th percentile of the reference population was 0.07 microg/l. Linearity extended from 0 to 50.0 microg/l and the MDC was 0.010 microg/l. The method comparison equation was Stratus CS = 1.00 (Dimension RxL)-0.02 microg/l with no bias. CONCLUSIONS: The Stratus CS cTnI assay in routine practice has performance characteristics appropriate for clinical use, including good correlation to a central laboratory cTnI method and imprecision of a high sensitivity troponin method with a CV of <10% at the 99th percentile of the reference population.
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