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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 [R2] > 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.
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Analytical and Workflow Performance of a High-Throughput Chemiluminescent Immunoassay System in a Clinical Laboratory
ABSTRACT
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.
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 [R2] > 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.
這篇論文評估了 DxI 9000 Access 免疫分析系統在大型醫療機構中的臨床應用表現，重點考察其分析可靠性與工作流程效率。團隊針對 36 種不同的分析物進行測試，證實該設備在精密度、準確度及方法比對上皆符合國際臨床實驗室標準。數據顯示，該系統能有效縮短急診關鍵指標（如心肌酶等…）的報告產出時間，顯著提升自動化作業效率。此外，研究也確認了該平台在低樣本量精確度與抗污染能力方面的優異表現。整體而言，DxI 9000 Access該系統在現代高運量實驗室環境下的穩定性與營運優勢提供了實證數據支持。
全文連結 : https://onlinelibrary.wiley.com/doi/10.1002/jcla.70270
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