Investigating outlier rates of cardiac troponin I and troponin T assays: A systematic review

Objectives: This review aimed to harmoniously summarize and compare outlier rates for various cardiac troponin (cTn) assays, including high-sensitivity-cTn (hs-cTn) assays and contemporary cTn (generation of assays prior to hs-cTn ones) assays, from the published studies. Methods: The PRISMA guidelines were utilized to perform this systematic review. Five databases, including PubMed, Scopus, Embase, Cochrane Library, and Web of Science, were searched using specific keywords up to June 30th, 2023. Studies reporting specifically calculated outlier rates for cTn assays when conducting in-vitro diagnosis in human samples were included. Selected studies were then further assessed using the GRADE tool. Results: Thirteen studies were included. The data from the studies were summarized statistically in this review. The results showed substantial evidence of improved analytical robustness or reduced respective mean rates of outliers, critical outliers, and analytical outliers for hs-cTn assays (0.14 %, 0.18 %, and 0.18 %) compared to contemporary cTn assays (0.63 %, 0.71 %, and 0.50 %). Conclusion: The findings offer promisingly provide a comprehensive reference for laboratory scientists and clinical staff in choosing the most suitable cTn assay for patient care regrading outlier rates. Besides, this review reveals the advancements of hs-cTn assays with lower outlier rates than contemporary cTn assays. The emerging challenges for continuously improving analytical robustness of cTn assays are also elaborated.