The efficacy of HBsAg detection using electro-chemiluminescence immunoassay for blood donor screening in China

Yaling Wu, Xia Ling, Guangshu Yu, Hong Zhu, Wei Hu, Cunying Pu, Faming Zhu

Abstract

Background: The chemiluminescence immunoassay (CLIA) has been a well-established method for HBsAg detection in blood donors worldwide. However, only enzyme-linked immunosorbent assay (ELISA) method was permitted to use for blood donor HBsAg screening in China. In this study, the efficacy of HBsAg detection using electro-CLIA (ECLIA) for blood donor in China was evaluated.
Methods: A total of 5,021 samples were tested for HBsAg with one ECLIA (Elescys) and two ELISAs (ELISA 1 and ELISA 2). A pre-defined confirmatory algorithm was used for test result confirmation. The sensitivity and specificity of these assays for HBsAg screening were compared.
Results: A total of 23 among the 5,021 screened samples were confirmed positive and 4,998 were confirmed negative. The sensitivities of the Elecsys, ELISA 1 and ELISA 2 were 100% (95% CI, 85.18–100%), 73.91% (95% CI, 51.59–89.77%) and 65.22% (95% CI, 42.73–83.62%) respectively. The coefficient of variation for Elecsys is lower than those of ELISA methods. Two false positives and 6 false negatives results were found in the ELISA 1; 5 false positives and 8 false negative were found in the ELISA 2.
Conclusions: The ECLIA is sufficient for HBsAg screening, which can increase the efficacy of HBsAg detection in the Chinese blood donor.