Ann Lab Med.  2016 Sep;36(5):405-412. 10.3343/alm.2016.36.5.405.

Can a Point-of-Care Troponin I Assay be as Good as a Central Laboratory Assay? A MIDAS Investigation

• Peacock WF
• Diercks D
• Birkhahn R
• Singer AJ
• Hollander
• Nowak R
• Safdar B
• Miller CD
• Peberdy M
• Counselman F
• Chandra A
• Kosowsky J
• Neuenschwander J
• Schrock J
• Lee-Lewandrowski E
• Arnold W
• Nagurney J

• KMID: 2373569
• DOI: http://doi.org/10.3343/alm.2016.36.5.405

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 (R(P)) and Spearman (R(S)) correlations and were R(P)=0.94 and R(S)=0.94 for Triage vs Singulex, R(P)=0.93 and R(S)=0.85 for Triage vs PathFast, and R(P)=0.89 and R(S)=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

MeSH Terms

Acute Coronary Syndrome/*diagnosis
Biomarkers/analysis
Emergency Service, Hospital
Humans
Laboratories/standards
Myocardial Infarction/diagnosis
*Point-of-Care Systems
Prospective Studies
Reagent Kits, Diagnostic
Sensitivity and Specificity
Troponin I/*analysis
Biomarkers
Reagent Kits, Diagnostic
Troponin I

Figure

• 

  Fig. 1 Bland Altman plots of Triage TnI vs Singulex TnI (A), Triage TnI vs PathFast TnI (B), and PathFast TnI vs Singulex TnI (C). Samples above or below the measurable range for either assay were excluded.

• 

  Fig. 2 Passing-Bablok regression plots of Triage TnI vs Singulex TnI (A), Triage TnI vs PathFast TnI (B), and PathFast TnI vs Singulex TnI (C). Samples above or below the measurable range for either assay were excluded.Abbreviation: CI, confidence interval.

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