Evaluation of Vironostika HIV Uni-Form II Ag/Ab Enzyme Immunoassay Kit for Simultaneous Detection of Antigen and Antibody of HIV / 대한수혈학회지

ABSTRACT

BACKGROUND: It has been estimated that 1 unit per 493,000 blood donations could transmit HIV by infected persons in seroconversion window in America. The 4th generation enzyme immunoassay (EIA) kits which are designed to detect HIV antigen and antibody simultaneously, could reduce the period of seroconversion window and thereby increase the safety of donated bloods without additional expenses. METHODS: Sensitivity and specificity of Vironostika HIV Uni-Form II Ag/Ab (Organon Technika, Boxtel, Netherlands) were evaluated using 53 samples (11 western blot positive samples and 42 sera from BBI panel) and 391 samples (282 healthy donors, 20 anti-HCV positive sera and 89 FANA positive sera), respectively. Seroconversion window was compared with that of COBAS CORE Anti-HIV-1/HIV-2 EIA DAGS (Roche Diagnostics, Basel, Switzerland) using 6 kinds of BBI seroconversion panel. RESLUTS Sensitivity was 100% (53/53). Aggregated specificity was 99.5% (389/391), while all the samples from the healthy donors showed negative (282/282). COBAS CORE Anti-HIV-1/HIV-2 EIA DAGS also showed 100% sensitivity (53/53) and 100% specificity (391/391). Vironostika HIV kit detected HIV-1 infection earlier about 9.8 days than COBAS CORE Anti-HIV-1/HIV-2 EIA DAGS. CONCLUSION: Sensitivity and specificity of Vironostika HIV kit were as good as those of COBAS CORE kit. Vironostika HIV kit, however, could get more safety of donated bloods than the 3rd generation EIA such as COBAS CORE Anti-HIV-1/HIV-2 EIA DAGS, in that it can reduce seroconversion window of HIV infection.