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

Fred S. Apple | Zendy; Andrew Maturen | Zendy; Richard E. Mullins | Zendy; Pennell C. Painter | Zendy; Melissa S. Pessin | Zendy; Robert A. Webster | Zendy; Jennifer Spray Flores | Zendy; Robert DeCresce | Zendy; Daniel Fink | Zendy; Patrice M Buckley | Zendy; Julie Marsh | Zendy; Vincent Ricchiuti | Zendy; Robert H. Christenson | Zendy

Open Access

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

Author(s) -

Fred S. Apple,

Andrew Maturen,

Richard E. Mullins,

Pennell C. Painter,

Melissa S. Pessin,

Robert A. Webster,

Jennifer Spray Flores,

Robert DeCresce,

Daniel Fink,

Patrice M Buckley,

Julie Marsh,

Vincent Ricchiuti,

Robert H. Christenson

Publication year - 1999

Publication title -

clinical chemistry

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.705

H-Index - 218

eISSN - 1530-8561

pISSN - 0009-9147

DOI - 10.1093/clinchem/45.2.206

Subject(s) - troponin i , medicine , myocardial infarction , immunoassay , cardiology , receiver operating characteristic , confidence interval , immunology , antibody

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.

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