Advancing blood transfusion safety using molecular detection in the country of Georgia.

Abstract

In 2015, the country of Georgia initiated its hepatitis C virus (HCV) elimination program. Given a high background incidence of HCV infection, centralized nucleic acid testing (NAT) of blood donations was prioritized for implementation. Multiplex NAT screening for HIV, HCV and hepatitis B virus (HBV) was launched in January 2020. An analysis was conducted of serological and NAT donor/donation data for the first year of screening (through December 2020). A total of 54,116 donations representing 39,164 unique donors were evaluated. Overall, 671 donors (1.7%) tested positive for at least one infectious marker by serology or NAT, with the highest prevalence among donors aged 40-49years (2.5%; n=200), male (1.9%; n=524), replacement (2.8%; n=153) and first time (2.1%; n=642) donors. Sixty donations were seronegative but NAT positive, and therefore would not have been found by traditional serology testing alone. These were more likely among female vs. male (adjusted odds ratio [aOR] 2.06; 95% confidence interval [95%CI]: 1.05-4.05), paid (aOR 10.15; 95%CI: 2.80-36.86) or voluntary (aOR 4.30; 95%CI: 1.27-14.56) vs replacement, and repeat vs. first time (aOR 13.98; 95%CI: 4.06-48.12) donors. On repeat serological testing (including HBV core antibody [HBcAb] testing), 6 HBV+donations, 5 HCV+donations and 1 HIV+donations were deemed NAT yield (detected through the implementation of NAT, and would have otherwise been missed by serology screening alone). This analysis offers a regional model for NAT implementation, demonstrating the feasibility and clinical utility in a nationwide blood program.