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

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus

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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Figure 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.

Mentions: Table 3 shows the statistical performance of all three assays, and Fig. 1 shows the Bland Altman plots, and Fig. 2, the Passing-Bablok Regression, comparing each of the assays. Table 3 presents the sensitivity and specificity for the three devices at the enrollment time point. In the first comparison of Table 3, the cohort sizes vary because only those samples with detectable troponin levels were included, resulting in the following results; Triage vs PathFast (n=130), Triage vs Singulex (n=74), and PathFast vs Singulex (n=65). The C-statistic (95% confidence interval [CI]) for distinguishing MI from no-MI by using the enrollment draw was 0.90 (0.86, 0.93) for the Alere, 0.96 (0.93, 0.99) for the Singulex, and 0.88 (0.84, 0.92) for the PathFast assays. The P values are 0.177 for Triage vs PathFast, 0.0002 for Triage vs Singulex, and <0.0001 for Pathfast vs Singulex. Enrollment draws with detectable troponin levels exhibited high-to-very-high correlation among the three assay platforms. Pearson (RP) and Spearman (RS) correlations, respectively, 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.


Can a Point-of-Care Troponin I Assay be as Good as a Central Laboratory Assay? A MIDAS Investigation
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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4940482&req=5

Figure 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.
Mentions: Table 3 shows the statistical performance of all three assays, and Fig. 1 shows the Bland Altman plots, and Fig. 2, the Passing-Bablok Regression, comparing each of the assays. Table 3 presents the sensitivity and specificity for the three devices at the enrollment time point. In the first comparison of Table 3, the cohort sizes vary because only those samples with detectable troponin levels were included, resulting in the following results; Triage vs PathFast (n=130), Triage vs Singulex (n=74), and PathFast vs Singulex (n=65). The C-statistic (95% confidence interval [CI]) for distinguishing MI from no-MI by using the enrollment draw was 0.90 (0.86, 0.93) for the Alere, 0.96 (0.93, 0.99) for the Singulex, and 0.88 (0.84, 0.92) for the PathFast assays. The P values are 0.177 for Triage vs PathFast, 0.0002 for Triage vs Singulex, and <0.0001 for Pathfast vs Singulex. Enrollment draws with detectable troponin levels exhibited high-to-very-high correlation among the three assay platforms. Pearson (RP) and Spearman (RS) correlations, respectively, 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.

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus