Comparison of nucleic acid testing and enzyme-linked immunosorbent assay in screening Hepatitis-B Virus in blood samples

Abstract

Objective: To investigate the value of nucleic acid testing (NAT) and enzyme-linked immunosorbent assay (ELISA) in the screening of Hepatitis-B virus (HBV) in blood samples from voluntary blood donors.

Methodology: This was a retrospective observational study. Five hundred blood samples from healthy blood donors collected by the Baoding No.1 Central Hospital between from January, 2024 to January, 2025 were selected as the study subjects, and each sample was divided into two groups, one for HBV NAT and the other for ELISA. Afterward, based on the diagnostic results of the gold label test paper, the diagnostic efficacy of two detection methods for HBV was compared using sensitivity, specificity, and accuracy, compared their respective window periods for HBV using t-test.

Results: The sensitivity, specificity, and accuracy of HBV NAT were higher than those of ELISA, and the window phase for NAT of the virus was shorter than that of ELISA (p < 0.05). The HBV-DNA levels were significantly different between patients with HBsAg (+)/HBeAg (+)/Anti-HBc (+), HBsAg(+)/Anti-HBe(+)/Anti-HBc (+), and infection (p=0.00), showing a positive correlation with disease severity (r =0.73, p = <0.001).

Conclusion: NAT may significantly improve the specificity, sensitivity, and accuracy of HBV detection in blood samples from voluntary blood donors, with a shorter window phase than ELISA, which can better ensure blood safety.