Analytical and clinical evaluation of an automated high-sensitivity cardiac troponin I assay for whole blood
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J Yu, K Cui, Y Li, F Yang, F Xu, Z Zhou…
Clinical Chemistry and …, 2025
degruyterbrill.com
Objectives To evaluate the performance of the iStar high-sensitivity cardiac troponin I (hs-cTnI) assay, focusing on its sensitivity, precision, linearity, and consistency with plasma samples, and to establish sex-specific 99th percentile upper reference limits. Methods The iStar hs-cTnI assay was assessed using the Drawray iStar 500 analyzer. Key performance metrics such as the limits of blank (LoB), detection (LoD) and quantitation (LoQ), precision, linearity, and agreement between sample types were evaluated according to Clinical and …
