Analytical performance evaluation and the 99th percentile reference limit study of a rapid whole blood high-sensitivity cardiac troponin T assay

Key Points

• The study aims to evaluate the analytical performance of a rapid whole blood high-sensitivity cardiac troponin T assay and establish its 99th percentile reference limit.
• Evaluated analytical performance metrics for the cardiac troponin T assay.
• Determined the 99th percentile reference limit using a diverse population sample.
• Conducted validation through comparison with established methods.
• Achieved a high analytical sensitivity with a limit of detection at 0.001 ng/mL.
• Established a 99th percentile reference limit of 0.014 ng/mL with a confidence interval of 0.012 to 0.016 ng/mL.
• Demonstrated improved diagnostic accuracy for acute myocardial infarction using the assay.