Objective: To evaluate the performance of a rapid assay for cardiac troponin T (cTn-T) in patients with chest pain in the prehospital setting.
Methods: A prospective, observational clinical trial in a rural county served by a single emergency medical services system and two emergency departments. Patients fulfilling prehospital criteria to identify acute coronary ischemia (ACI) had a blood sample applied to the cTn-T rapid-assay device. Quantitative analysis of cTn-T was also performed on each sample at a later time. Medical records were reviewed to determine ultimate diagnoses. Non-admitted patients were followed by telephone at one week. Main outcome measures included the sensitivity, specificity, positive predictive value, and negative predictive value of the rapid cTn-T assay for detecting ACI defined as acute myocardial infarction (AMI) or unstable angina (UA) within one week of presentation.
Results: Of 87 patients enrolled, 29 were identified with ACI. This included 15 patients diagnosed as having AMI and 14 patients diagnosed as having UA. The cTn-T rapid-assay device was positive for five of 87 patients (5.7%); three were associated with AMI and two with UA. Measurement of a single cTn-T to detect ACI had a sensitivity of 17.2% (0.058, 0.358), specificity of 100% (0.950, 1), positive predictive value of 100% (0.549, 1), and negative predictive value of 70.7% (0.609, 0.806).
Conclusion: The cTn-T rapid-assay device may be useful in the prehospital setting to identify a small number of patients with ACI. The authors caution, however, that a negative test in the prehospital setting cannot be used to rule out significant disease.