Comparable analysis of six immunoassays for carcinoembryonic antigen detection

作者：Wenxuan Fu, Yuhong Yue, Yichuan Song, Shunli Zhang, Jie Shi, Rui Zhao, Qingtao Wang, Rui Zhang · 发表于：Heliyon · 年份：2024 · DOI：10.1016/j.heliyon.2024.e25158 · 被引用次数：13 · 研究领域：Radiopharmaceutical Chemistry and Applications、Monoclonal and Polyclonal Antibodies Research、Advanced Biosensing Techniques and Applications

Objective: This study aimed to assess the current status of carcinoembryonic antigen (CEA) detection. We evaluated the correlation, consistency, and comparability of CEA results among six automated immunoassays, and combined with the results of CEA trueness verification of the Beijing Center for Clinical Laboratories (BCCL) for further analysis. Methods: Abbott Architect i2000, Beckman DxI800, Roche Cobas E601, Diasorin Liaison XL, Maccura IS1200, and Autolumo A2000 were used to detect 40 individual serum CEA samples. Taking the optimal analytical quality specifications calculated from data on biological variation as the evaluation criterion. Passing-Bablok regression and Bland-Altman analysis were performed between each assay and all-assays median values to evaluate the correlation and relative difference. The concordance correlation coefficient (CCC) was used for consistency analysis. Additionally, the trueness verification program used samples at three concentration levels to assess the bias, coefficient of variation (CV), and total error (TE) between the average measured values and the target value. Results: ) was ≥0.996 and the CCC ranged between 0.9448 and 0.9990 for each assay vs. all-assays median. Considering the all-assays median value of each sample as a reference, there were proportional and systematic differences according to the Passing-bablok regression analysis. The relative difference of the four assays (Abbott Architect i2000, Autolumo A2000, Diasorin Liaiso...