Possible Misdiagnosis of Myocardial Infarction Using Regulatory-Approved and Close-to-Bioequivalent Upper Limits of Normal for Cardiac Troponin.

ABSTRACT:

Background

Possible misdiagnosis of acute myocardial infarction (AMI) may occur due to inappropriate upper limit of normal (ULN) for cardiac troponin and has the potential to harm patients. In this observational international multicenter study, we aimed to assess to what extent the novel hs-cTn-assays are affected.

Methods

A total of 6646 patients presenting with suspected AMI to the emergency department were enrolled. All level pairs (n=18 732) of 4 widely used high-sensitivity cardiac troponin T/I (hs-cTnT/I) assays using (1) the regulatory-approved uniform and sex-specific clinical ULN and (2) mathematically derived close-to-bioequivalent ULNs were assessed. The primary outcome was the quantification of the incidence of inconsistencies in the diagnosis of AMI. Inconsisten

SUBMITTER: Wildi K 

PROVIDER: S-EPMC12184563 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature