Analytical and Workflow Performance of a High‐Throughput Chemiluminescent Immunoassay System in a Clinical Laboratory

Background Increasing test volumes and shorter turnaround time (TAT) requirements, particularly in acute‐care settings, challenge clinical laboratories to maintain accurate immunoassay testing. High‐throughput chemiluminescent immunoassay systems must therefore provide robust analytical performance and efficient workflow integration. This study evaluated the analytical performance and selected workflow characteristics of one such system under routine clinical laboratory conditions in Taiwan. Methods Thirty‐six analytes were evaluated at a tertiary‐care medical center. Analytical performance assessments included precision, accuracy, limit of blank (LoB), method comparison, carryover, and reference interval verification, conducted in accordance with relevant Clinical and Laboratory Standards Institute (CLSI) guidelines. Selected workflow characteristics, including pipettor consistency, low‐volume precision, and time‐to‐first‐result (TTFR) for high‐sensitivity troponin I (hsTnI), beta‐human chorionic gonadotropin (β‐hCG), and procalcitonin (PCT)—were also assessed to evaluate operational suitability for STAT testing. Results All analytes demonstrated stable performance, with within‐run coefficients of variation (CV) generally below 4% and within‐laboratory CV predominantly below 5%. Accuracy verification met peer‐group or external quality assessment acceptance criteria for all assays. LoB values met or exceeded manufacturer specifications. Method comparison showed excellent agreement with established platforms (coefficients of determination [ R 2 ] > 0.95; bias within 0.8 × total allowable error [TEa]). Carryover was negligible, reference interval verification met acceptance criteria, and TTFR for STAT assays was reduced by at least 5 min compared with the predecessor platform. Conclusion This evaluation demonstrated that the assessed high‐throughput chemiluminescent immunoassay system provided reliable analytical performance across a broad test menu and improved STAT turnaround time, supporting its routine use in hospital laboratories.