PRECLINICAL EVALUATION OF A RAPID ASSAY F OR THE QUALITATIVE DETECTION OF CARDIAC TROPONIN-T IN EMS PATIENTS WITH ACUTE MYOCARDIAL-ISCHEMIA

Objective: To evaluate the practical performance and the: diagnostic p ower of a rapid, qualitative assay for the detection of cardiac Tropon in T (indicated cut-off level: 0.3 ng/ml) in EMS patients presenting w ith acute myocardial ischemia. Patients: 145 consecutive patients with non-traumatic chest pain treated by the Mobile Intensive Care Unit te am. During phase 1 (73 patients), blood drawn at the emergency site wa s used lo perform a Troponin T rapid assay under defined conditions at the hospital. During phase 2 (72 patients), the rapid assay was alrea dy performed at the emergency site. Results: In phase I all tests were performed correctly, whereas 5.6 % of the test results had to be decl ared unvalid in phase 2. 17 (11.7 %) of the 145 patients showed a posi tive test result. Analytic sensitivity was 100 %, specificity 96.3 %. 37 of the 145 patients (median duration of symptoms: 150 minutes) show ed a myocardial infarction (MI). Related to the diagnosis of MI diagno stic sensitivity, specificity positive and negative predictive values were 35.1, 96.3, 76.5, and 81.3 %. Mortality in patients with a positi ve rapid assay was 35.3 %, compared to 6.3 % in patients with a negati ve test result (p < 0.001). Conclusions: The rapid assay allows the de tection of Troponin T in concentrations above the cut-off level. Metic ulous observance of the manufacturer's rules is imperative. A. single preclinical rapid assay does not allow to exclude a MI. However, the t est enables EMS personnel to identify patients who are at increased ri sk of dying from an acute coronary syndrome in the immediate future.