Correlation between Hepatitis B Viral Load and Hepatitis B Surface Antigen Levels in Asymptomatic Seropositive Blood Donors

Abstract

Background and Objectives: Correlation has been shown between hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) levels in different patient categories. However, this has not been studied for donors. The aim of this study was to study the relationship between HBV DNA levels and E ratio obtained for HBsAg testing by chemiluminescence immunoassay (CLIA) performed on donor samples. Methods: A prospective, observational study was conducted in the department of transfusion medicine at a large tertiary health-care setup in North India from 2017 to 2021. Serological testing for HBV included HBsAg testing by CLIA. All reactive samples were tested in duplicate by electro CLIA (eCLIA). All samples found to be reactive in all three tests were then tested by a rapid diagnostic test and quantitative polymerase chain reaction. Results: During the study duration, 251 donors were found to be reactive for HBsAg by CLIA and eCLIA in screening. Of these 251, HBV DNA could not be detected in 85 (33.86%) samples, whereas in rest 166 (66.14%) samples, HBV DNA was detected. Mean E ratio for CLIA for all 251 samples was 5177.45, whereas mean viral copies detected were 19645858.66. The correlation for all 251 samples was found to be weak negative. The correlation for sero-reactive samples with the presence of HBV DNA was also found to be weak negative. Conclusion: In conclusion, we found significant but weak correlation between HBsAg results obtained by CLIA and HBV DNA levels for blood donors. The measurement of HBV DNA level is necessary for all apparently healthy donors coming for blood donation and testing reactive for HBsAg in screening assays.