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KMID : 1100720160360050405
Annals of Laboratory Medicine
2016 Volume.36 No. 5 p.405 ~ p.412
Can a Point-of-Care Troponin I Assay be as Good as a Central Laboratory Assay? A MIDAS Investigation
Frank Peacock W.

Diercks Deborah B.
Birkhahn Robert
Singer Adam J.
Hollander Judd E.
Nowak Richard
Safdar Basmah
Miller Chadwick D.
Peberdy Mary
Counselman Francis
Chandra Abhinav
Kosowsky Joshua
Neuenschwander James F.
Schrock Jon
Lee Lewandrowski Elizabeth
Arnold William
Nagurney John
Abstract
Background: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA).

Methods: Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI). The MIDAS dataset, described elsewhere, is a prospective multicenter dataset of emergency department (ED) patients with suspected acute coronary syndrome (ACS) and a planned objective myocardial perfusion evaluation. Myocardial infarction (MI) was diagnosed by central adjudication.

Results: The C-statistic with 95% confidence intervals (CI) for diagnosing MI by using a common population (n=241) was 0.95 (0.91-0.99), 0.95 (0.91-0.99), and 0.93 (0.89-0.97) for the Triage, Singulex, and PathFast assays, respectively. Of samples with detectable troponin, the absolute values had high Pearson (RP) and Spearman (RS) correlations and were RP =0.94 and RS=0.94 for Triage vs Singulex, RP =0.93 and RS=0.85 for Triage vs PathFast, and RP =0.89 and RS=0.73 for PathFast vs Singulex.

Conclusions: In a single comparative population of ED patients with suspected ACS, the Triage Cardio3 TnI, PathFast, and Singulex TnI assays provided similar diagnostic performance for MI.
KEYWORD
Troponin, Point-of-care, Emergency medicine, Diagnostic accuracy
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