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Clin Biochem. 2004 Aug;37(8):679-83.

Stratus CS cardiac troponin I method: performance characteristics including imprecision at low concentrations.

Author information

1
Department of Pathology, University of Maryland School of Medicine, Baltimore, MD 21201, USA. rchristenson@umm.edu

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.

[Indexed for MEDLINE]

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