Observational studyClinical chemistry2025
Analytical Error of Cardiac Troponin and Impact on the Performance of Accelerated Diagnostic Protocols in Patients with Acute Chest Pain.
Observational study in Clinical chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02620202 (Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR Study)
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Authors and funding
18 authors.
Funding
Abstract
backgroundThis study simulates how assay-specific bias influences the diagnostic performance of 0/1-h accelerated diagnostic protocols (ADPs) for 3 different high-sensitivity cardiac troponin (hs-cTn) assays.
methodsWe included 1493 patients presenting with chest pain. hs-cTnT (Roche Diagnostics), hs-cTnI from Abbott Diagnostics (hs-cTnI-A), and Siemens Healthineers (hs-cTnI-S) were measured at admission. The absolute total error observed in a state-of-the-art EQA study were added to the admission concentrations, producing 6 new variables being adjusted for maximum possible bias (if analytical variation is 0) (+biasmean, +biasmax95%CI, +biasmin95%CI, -biasmean, -biasmax95%CI, -biasmin95%CI). The influence of this "worst-case scenario" bias was compared after calculating sensitivity, specificity, negative and positive predictive values, and rule-out proportion for 30-day myocardial infarction or death for the observed and bias-adjusted hs-cTn concentrations.
resultsFor 0-h rule-out, hs-cTnI-S and hs-cTnT had a sensitivity of >99.0%, compared to 97.7% for hs-cTnI-A. After adding the bias, sensitivity was unchanged for hs-cTnI-S (99.5%), but lower for hs-cTnT (95.5%), and hs-cTnI-A (96.2%). For the 0-/1-h algorithm, adding bias reduced sensitivity to 95.5% for hs-cTnT, while both hs-cTnI algorithms were unchanged (100.0%). Rule-out proportions for 0 h ranged from 0% to 60.0% for hs-cTnT, 28.2%-62.7% for hs-cTnI-A, and 3.5%-35.5% for hs-cTnI-S. For the 0-/1-h algorithm, ranges were 57.7%-75.8% (hs-cTnT), 52.8%-67.5% (hs-cTnI-A), and 45.7%-61.2% (hs-cTnI-S).
conclusionAnalytical bias of hs-cTn assays affects the clinical rule-out rate of the 0/1-h ADPs more than the diagnostic sensitivity. Bias may have a greater influence on the proportion of patients requiring hospital admission and may contribute to the heterogeneity of the reported rule-out rates of current ADPs. ClinicalTrials.gov Registration Number: NCT02620202.
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