A-009 Analytical Concordance of High-Sensitivity Cardiac Troponin I and T Assays in Patients From the CONTRAST Trial Presenting to an Emergency Department
Abstract Background There are limited data on the analytical concordance of high-sensitivity cardiac troponin (hs-cTn) T and hs-cTnI assays. The goal of this study was to evaluate the concordance of one hs-cTnT and one hs-cTnI assay relative to each assay’s limit of quantitation (LoQ) and 99th perce...
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Veröffentlicht in: | Clinical chemistry (Baltimore, Md.) Md.), 2023-09, Vol.69 (Supplement_1) |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | Abstract
Background
There are limited data on the analytical concordance of high-sensitivity cardiac troponin (hs-cTn) T and hs-cTnI assays. The goal of this study was to evaluate the concordance of one hs-cTnT and one hs-cTnI assay relative to each assay’s limit of quantitation (LoQ) and 99th percentile upper reference limit (URL).
Methods
The Comparison of Troponin I and T Assays Trial (CONTRAST) NCT03214029 is an observational study that evaluated the concordance of two FDA-cleared hs-cTn assay concentrations measured at presentation (0 h) and 2 h by the Abbott ARCHITETCT i2000 hs-cTnI (clinically used assay) and Roche cobas 601 Gen 5 hs-cTnT (measured for investigational purposes) from consecutively enrolled patients presenting to an urban US medical center with symptoms suggestive of ischemia. Concordance at presentation (0 h) was assessed relative to each assay’s FDA-cleared reporting concentration (LoQ), and FDA-cleared sex-specific 99th percentile URLs. The incidence of myocardial injury, defined as at least one concentration above the 99th percentile URL over serial sampling, was also evaluated.
Results
At presentation hs-cTn concentrations |
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ISSN: | 0009-9147 1530-8561 |
DOI: | 10.1093/clinchem/hvad097.008 |