Zhongguo shuxue zazhi (Apr 2023)
Correlation between electrochemiluminescence immunoassay and western blot confirmation for human T-lymphotropic virus screening in blood donors
Abstract
Objective To study the application effect of electrochemiluminescence immunoassay (ECLIA) in the screening of human T-lymphotropic virus (HTLV) in blood donors, explore the correlation between COI and confirmed result by western blot (WB), so as to provide scientific evidence for blood banks to select optimal screening strategy and optimize process flows. Methods A total of 1 070 HTLV reactive blood samples by ELISA in preliminary screening in our province from 2016 to 2022 were included in this study. All samples were detected by ECLIA and WB (gold standard), and the receiver operating characteristic curve (ROC) was drawn to find optimal diagnostic critical value of ECLIA. Results Among 1 070 samples, 285 were positive by ECLIA, with a positive rate of 26.64% (285/1 070), with average COI value at 81.92 and the median at 4.98. A total of 70 ECLIA positive samples were confirmed by WB, with a positive rate of 6.54% (70/1 070). According to the results of WB, the median of WB-positive group and WB-negative group was 312.45 vs 2.76, respectively(P<0.01). ROC analysis showed that optimal diagnostic critical value was 72.10 (P<0.01), with concordance rate of the two detection methods at 99.35%. Conclusion ECLIA, with high sensitivity and specificity is suitable for the detection with large sample size. When the diagnostic threshold is properly set, ECLIA results are in good agreement with those of WB, and it has good application prospect in HTLV screening in blood donors.
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