Abstract / Summary
Abstract Objectives We validated the analytical performance and clinical diagnostic efficacy of the eCL8000i point-of-care testing (POCT) system for high-sensitivity cardiac troponin T (hs-cTnT), following the standardized verification protocol for hs-cTnT POCT assays. Methods A two-phase evaluation was conducted: Phase I (564 samples) assessed precision, lower limit of quantitation (LoQ), method comparison, calibrator interchangeability, reference intervals and turnaround time (TAT) per CLSI guidelines; Phase II (721 emergency chest pain patients) used coronary angiography as the gold standard to evaluate AMI diagnostic performance vs. Roche Cobas e801 via receiver operating characteristic (ROC) analysis. Results Phase I showed total CVs of 5.22 % (low) and 1.69 % (high), qualified LoQ, strong correlation with Cobas e801 (r=0.998), acceptable calibrator interchangeability, sex-specific 99th percentile reference values, and TAT shortened to 17 min. Phase II revealed eCL8000i AUC 0.860 (95 % CI 0.833–0.885) vs. Cobas 0.891 (95 % CI 0.865–0.912); sensitivities/specificities were 74.8/85.1% and 82.0/84.3 %, with high negative predictive values (94.9 vs. 96.3 %). Conclusions The eCL8000i hs-cTnT POCT system meets international analytical standards and has reliable clinical performance for rapid AMI exclusion, complementing central laboratory testing for efficient chest pain center triage. Although the sample size for establishing sex-specific 99th percentile URLs (280 males, 284 females) did not fully meet the IFCC-recommended target of ≥400 per sex, our preliminary reference intervals provide a useful starting point for the Chinese population and require further validation in a larger cohort.