The Role of Anti-HBc Testing on Donor Selection and Its Contribution to Current Alghorithms; Can the Gülhane Experience Be a Model for Turkey?

Abstract

Additional or different test procedures can be applied to maximize transfusion safety by reducing the risk of transfusion-transmitted infections. Antibodies to hepatitis B core antigen (anti-HBc) is one of the most commonly used serologic marker in this context. The aim of the study was to analyse anti-Hbc test results performed within the scope of routine screening tests in our center and to examine the effect of the donor re-entry protocol established. A total of 57191 people who applied to Gülhane Regional Blood Center to donate blood between 2014-2019 were included in the study. All blood donations were screened for anti-HBc by chemiluminescense immunoassay (Architect i2000 SR, AXSYM, Abbott, IL, USA). Hepatitis B surface antibody (anti-HBs) and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) (ABI Prism 7500 Real time PCR system, Applied Biosystems, USA) tests were performed in accordance with the donor recovery protocol for those who could be reached among those with positive for anti-HBc test results. Samples with > 100 IU/ml of anti-HBs levels and negative for HBV DNA test were included in the donor pool. Of the 57 191 blood donors involved in the study, 5125 (8.5%) were found as positive for anti-HBc. Of the donors, 54 035 (94.4%) were male and 3156 (5.5%) were female. The difference was found to be statistically significant in terms of gender distribution between the years of the study (p<0.001). The highest anti-HBc positivity rate (35.7%) was in the age group of 60 years and over while the lowest positivity rate (3.8%) was in the age group of 18-30 years (r= 0.549, p= 0.0001). The year with the highest anti-HBc seroprevalance (10.1%) was 2017, while the year with the lowest (7.9%) was 2014. The distribution of seropositivity over the years was statistically significant (p<0.001). In the study, anti-HBs and HBV-DNA test results of 439 donors were accessible and of which 301 (68.5%) were considered eligible to donate again according to the re-entry protocol. The isolated anti-HBc positivity and HBV-DNA positivity rates were 7.5% (33/430) and 0.2% (1/439) respectively,in blood donors to whom re-entry protocol was performed. The seroprevalance of anti-HBc below 10% during the six-year period in which the study was conducted is a critical data for the evaluation of this test within the scope of routine microbiological screening tests. Moreover, we have observed that donor losses due to the antiHBc testing can be significantly reduced with the implementation of donor re-entry protocols. Anti-HBc screening strategy should be decided by considering of HBV epidemiology, cost-effectivity and possible blood donor losses.