Evaluation of CLIA plus NAT for detecting HBsAg single-ELISA-reactive samples of blood donors
Journal Title: Chinese Journal of Blood Transfusion - Year 2022, Vol 35, Issue 10
Abstract
Objective To study the detection performance of HBsAg single-ELISA-reactive samples of blood donors. Methods Two kinds of ELISA reagents from different manufacturers (named as reagents A and B) were used for HBsAg screening. A total of 276 samples, from January 2017 to May 2021, with HBsAg single-ELISA-reactive results were collected for further nucleic acid detection technology (NAT) and chemiluminescence immunoassay (CLIA) testing, to undergo HBV-DNA and five hepatitis B tests, respectively. The relationship between HBsAg single-ELISA-reactivity, NAT and CLIA was statistically analyzed. Results Among the 276 HBsAg single-ELISA-reactive samples, 14 were NAT reactive, with the positive rate of 5.07% (14/276). Fisher′s exact test was used to compare the compliance of reagents A and B with NAT reactivity, and the difference was not statistically significant (P<0.05). Among 14 HBsAg+ /NAT+ samples retested by CLIA, 2 were HBsAg reactive(14.29%, 2/14), 13 were anti-HBc reactive (92.86%, 13/14), 9 had the quantitative value of anti-HBs <10 mIU/mL, 5 had the quantitative value of anti-HBs between 10 to 100mIU/ mL. A total of 5 serological patterns were detected, and anti-HBe+ /anti-HBc+ pattern was the dominant. There were 262 cases of HBsAg+ /NAT- samples, but only 1 (0.38%, , 1/262) case was HBsAg reactive by CLIA, 100 were anti-HBc reactive (38.17%, 100/262), 144 (54.96%, 144/262) were anti-HBs reactive, and 1 was HBeAg reactive. A total of 8 serological patterns were detected. Conclusion Most of HBsAg single-ELISA-reactive results are false, and NAT could effectively reduce the residual risk of transfusion transmitted diseases.
Authors and Affiliations
Jiayi SUN, Xiuwen NI, Zhen LUO, Chengkuan HUANG, Jiayan TU, Xiaoyuan LI, Wen GAO, Rui XU
Keywords
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- EP ID EP738371
- DOI 10.13303/j.cjbt.issn.1004-549x.2022.10.005
- Views 53
- Downloads 0
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