P2675Validation of a 0/1h diagnostic algorithm using a point of care high-sensitivity troponin I assay

Abstract

Abstract Background The numbers of patients presenting to emergency departments with suspected acute myocardial infarction (AMI) are increasing worldwide. The use of point of care (POC) troponin assays with an increased sensitivity – equal to laboratory-based high-sensitivity immunoassays – might enable faster decision making in this high-risk population. Objective To validate a rapid diagnostic algorithm using a novel point of care (POC) high-sensitivity troponin I (hs-TnI) assay in comparison to a laboratory-based hs-TnI assay. Methods A diagnostic 0/1h algorithm for the POC hs-TnI assay (PATHFAST hs-cTnI, LSI Medience) was derived in a dataset of 669 patients with suspected AMI, aiming for a negative predictive value (NPV) ≥99.5% for rule-out and a positive predictive value (PPV) ≥75% for rule-in of non-ST-elevation myocardial infarction (NSTEMI). The performance of the developed algorithm was tested in a validation cohort of 610 patients. Diagnostic accuracy of the POC hs-TnI assay was compared to an established hs-TnI assay (Abbott ARCHITECT) using an ESC guideline-recommended 0/1h diagnostic algorithm. Results The derived 0/1h algorithm consisted of an admission POC hs-TnI <4 ng/L and a delta from 0h to 1h <3 ng/L for rule-out and an admission POC hs-TnI ≥90 ng/L or a delta from 0h to 1h ≥20 ng/L for rule-in of NSTEMI. Application of the algorithm in the validation cohort showed a NPV of 99.7% (Confidence Interval (CI) 98.1%-100.0%) and 48.0% of patients ruled out, while 14.6% were ruled in with a PPV of 86.5% (CI 77.6%-92.8%). The diagnostic performance of the POC hs-TnI assay was comparable to guideline-recommended use of a laboratory-based hs-TnI assay (Figure 1). Conclusion The clinical application of a 0/1h diagnostic algorithm based on a novel POC hs-TnI assay showed good diagnostic performance and was comparable to a laboratory-based hs-TnI assay. Acknowledgement/Funding German Center of Cardiovascular Research, Abbott Diagnostics, DIAneering GmbH, German Heart Foundation/ German Foundation of Heart Research