Development of the Cardiac Troponin T Immunoassay

Abstract

Featured Article: Katus HA, Looser S, Hallermayer K, Remppis A, Scheffold T, Borgya A, et al. Development and in vitro characterization of a new immunoassay of cardiac troponin T. Clin Chem 1992;38:386–93.1 This paper was the first report on the development and analytical characterization of an immunoassay for cardiac troponin T (cTnT)2 that was useful for large-scale clinical chemistry testing. Preceding methods we had generated for measurement of cTnT using a pilot immunoassay yielded promising clinical data in patients with chest pain, indicating a higher diagnostic sensitivity and specificity than measurement of cardiac enzymes for detection of myocardial injury. Whereas the pilot assay used polyclonal antisera, the novel sandwich assay employed 2 preselected monoclonal antibodies with high cardiospecificity, thereby decreasing cross-reactivity with skeletal muscle troponin T to <0.5%. This cTnT assay allowed measurement of cTnT in only 90 min with a between-run precision below 5%. The assay was manufactured by Boehringer Mannheim (Enzymun-Test System) and provided sufficient analytical sensitivity and precision to be employed in large multicenter trials, which ultimately led to the redefinition of acute myocardial infarction (AMI). This report …