Multicenter Clinical and Analytical Evaluation of the AxSYM Troponin-I Immunoassay to Assist in the Diagnosis of Myocardial Infarction

We evaluated the AxSYM troponin I (cTnI) immunoassay for assisting in the detection of acute myocardial infarction (AMI). At four sites, the total imprecision (CV) over 20 days was 6.3-10.2%. The minimum detectable concentration was 0.14 +/- 0.05 microgram/L. Comparison of cTnI measurements between...

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Bibliographic Details
Published in:Clinical chemistry (Baltimore, Md.) Md.), 1999-02, Vol.45 (2), p.206-212
Main Authors: Apple, Fred S, Maturen, Andrew J, Mullins, Richard E, Painter, Pennell C, Pessin-Minsley, Melissa S, Webster, Robert A, Spray Flores, Jennifer, DeCresce, Robert, Fink, Daniel J, Buckley, Patrice M, Marsh, Julie, Ricchiuti, Vincent, Christenson, Robert H
Format: Article
Language:English
Subjects:
Biological and medical sciences
Cardiology. Vascular system
Coronary heart disease
Evaluation Studies as Topic
Heart
Humans
Immunoenzyme Techniques - methods
Immunoenzyme Techniques - standards
Medical sciences
Myocardial Infarction - blood
Myocardial Infarction - diagnosis
Reproducibility of Results
ROC Curve
Sensitivity and Specificity
Troponin I - blood
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Summary:We evaluated the AxSYM troponin I (cTnI) immunoassay for assisting in the detection of acute myocardial infarction (AMI). At four sites, the total imprecision (CV) over 20 days was 6.3-10.2%. The minimum detectable concentration was 0.14 +/- 0.05 microgram/L. Comparison of cTnI measurements between the AxSYM and Stratus (n = 406) over the dynamic range of the AxSYM assay demonstrated good correlation, r = 0.881, with a proportional bias: AxSYM cTnI = 3.50(Stratus cTnI) - 1. 10. The confidence intervals (95%) for the slope and intercept were 3.39-3.64 and -1.32 to -0.95, respectively. The expected cTnI concentration in healthy individuals was /=96%, in skeletal muscle injury, chronic renal disease, and same-day noncardiac surgery patients.
ISSN:0009-9147
1530-8561
DOI:10.1093/clinchem/45.2.206