A practical approach for the validation and clinical implementation of a high-sensitivity cardiac troponin I assay across a North American city

OBJECTIVES: Despite several publications on the analytical performance of high-sensitivity cardiac troponin (hs-cTn) assays, there has been little information on how laboratories should validate and implement these assays into clinical service. Our study provides a practical approach for the validation and implementation of a hs-cTn assay across a large North American City. DESIGN AND METHODS: Validation for the Abbott ARCHITECT hs-cTnI assay …