Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay.

Abstract:

BACKGROUND:Increasing numbers of patients are presenting worldwide to emergency departments with suspected myocardial infarction. The use of point-of-care troponin assays might enable faster decision-making in this high-risk population and reduce the burden on emergency facilities. Here, we evaluate the diagnostic performance of a point-of-care high-sensitivity troponin I assay. METHODS:We conducted a prospective cohort study including patients presenting to the emergency department with suspected myocardial infarction from July 2013 to July 2016. A diagnostic algorithm for a high-sensitivity troponin I point-of-care assay was developed in a derivation data set with 669 patients and validated in an additional 610 patients. RESULTS:The derived 0/1 h algorithm for the point-of-care assay consisted of an admission troponin I <4 ng/L and a δ from 0 h to 1 h <3 ng/L for rule out and an admission troponin I ≥90 ng/L or a δ from 0 h to 1 h ≥20 ng/L for rule in of non-ST-elevation myocardial infarction. Application to the validation cohort showed a negative predictive value of 99.7% (95% CI, 98.1%-100.0%) and 48.0% of patients ruled out, whereas 14.6% were ruled in with a positive predictive value of 86.5% (95% CI, 77.6%-92.8%). The diagnostic performance of the point-of-care high-sensitivity assay was highly comparable to guideline-recommended use of a laboratory-based high-sensitivity troponin assay. CONCLUSIONS:The clinical application of a 0/1 h diagnostic algorithm based on a high-sensitivity troponin I point-of-care assay is safe, and diagnostic performance is comparable to a laboratory-based high-sensitivity troponin I assay.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Sörensen NA,Neumann JT,Ojeda F,Giannitsis E,Spanuth E,Blankenberg S,Westermann D,Zeller T

doi

10.1373/clinchem.2019.307405

subject

Has Abstract

pub_date

2019-12-01 00:00:00

pages

1592-1601

issue

12

eissn

0009-9147

issn

1530-8561

pii

clinchem.2019.307405

journal_volume

65

pub_type

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