Analysis of NAT non-reactive results implicated in HBsAg ELISA reactive blood donors by multi-assays
10.13303/j.cjbt.issn.1004-549x.2021.12.008
- VernacularTitle:HBsAg反应性/核酸筛查无反应性献血者乙肝感染多方法确认研究
- Author:
Xiaoxuan XU
1
;
Xianlin YE
1
;
Xin ZHENG
1
;
Tong LI
1
;
Binghuan YU
2
;
Yu ZHAO
1
;
Ran LI
1
;
Jinfeng ZENG
1
Author Information
1. Department of Blood Transfusion, Shenzhen Blood Center, Shenzhen 518035, China
2. Dalian Medical University
- Publication Type:Journal Article
- Keywords:
HBsAg;
blood donors;
time resolved fluoroimmunoassay(TRFIA);
electrochemiluminescence immunoassay(ECLIA)
- From:
Chinese Journal of Blood Transfusion
2021;34(12):1310-1313
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To investigate NAT non-reactive results implicated in HBsAg ELISA reactive voluntary blood donors in Shenzhen. 【Methods】 HBsAg ELISA+ but NAT-blood samples were collected, and HBsAg was further retested by TRFIA, Roche ECLIA and neutralization test. HBV DNA of individual donation was detected by commercial Roche MPX and Uultrio Elite, and virus nucleic acid was extracted via 2.5 mL. Molecular characterizations of HBsAg+ /NAT-samples were determined by quantitative polymerase chain reaction(qPCR) and nested PCR amplifification of the precore and core promoter regions and HBsAg(S) region. HBV serological markers were detected, and the samples with suspicious results were followed up and detected by multi-assay. 【Results】 Among 67 602 samples, 73(0.11%) HBsAg ELISA+ and NAT-blood samples were enrolled in the study. 15(20.5%, 15/73) were confirmed HBsAg+ by TRFIA, ECLI and five alternative DNA assays, and the other 2(2.7%, 2/73) were further identified as HBsAg+ by follow-up study. In 17 confirmed HBsAg+ samples, the viral loads ranged undetectable to 378 IU/mL, with the median of 10.1 IU/mL. Weak correlation was found between HBsAg and HBV DNA load(R2=0.394 4). 【Conclusion】 Some Hepatitis B virus infected blood samples may miss even with different HBsAg assays. Multi-assays with high sensitivity should be combined for blood screening to ensure blood safety..The inconsistent results should be followed up and further tested for hepatitis B serological markers to assist the confirmation.
