Assessing donor suitability for blood donation: Utility of Geenius HIV 1/2 confirmatory assay.

ABSTRACT

BACKGROUND: Blood donor care and blood safety require a quick and accurate decision on the presence or absence of Human Immunodeficiency Virus (HIV) infection, based on the proper selection of blood donors, serological and molecular HIV testing as well as western blot test. The aim was investigating the possibility of inclusion of Geenius HIV 1/2 Confirmatory Assay in blood donor testing algorithm in order to shorten test time and decrease the number of indeterminate results. METHODS: A total of 75 archived serum/plasma samples were tested. Their previous serological and molecular HIV results were 3 negative samples, 7 positive samples, 65 serological indeterminate or positive but confirmatory testing and NAT negative samples. RESULTS: Geenius assay confirmed the presence of antibodies in all blood donors with HIV positive serology and Nucleic Acid Testing (NAT). HIV-1 gp160 and gp41 antibodies were detected in these donors, while p31 and p24 antibodies were not detected in two and three donors, respectively. HIV-2 antibodies gp36 and gp140 were not found. Blood donor with HIV indeterminate or positive serology but negative confirmatory testing and NAT, were negative in Geenius assay. Conclusion The results obtained are consistent with western blot results. The assay proved simple and quick to perform. Studies have confirmed the possibility of introducing Bio-Rad Geenius into a routine blood donor testing protocol.