RESUMO
BACKGROUND: Previously developed diagnostic assays to detect antibodies against HIV have difficulties in diagnosing the infected blood prior to seroconversion. Various 3.5 generation HIV diagnostic assays developed in the Republic of Korea also have the same problem. Newly developed LG HIV Ag-Ab Plus (LG Life Science, Seoul, Korea) is the product to overcome this limitation. METHODS: Sensitivity of both LG HIV Ag-Ab Plus and Enzygnost HIV Integral (Dade Behring, Marburg, Germany) were evaluated by using 82 anti-HIV 1 positive samples, 2 anti-HIV 1 group O positive samples (Vital products, Boynton Beach, FL, USA), 25 anti-HIV 2 positive samples, 5 anti-HIV panels (Boston Biomedica, Inc., MA, USA). Specificity of both product were evaluated using 1081 Anti-HIV negative samples (1000 healthy donors, 13 alcoholics sera, 20 end-stage renal disease sera, 20 HBsAg positive sera, 22 anti-HBs antibody positive sera, 6 anti-HCV positive sera). Seroconversion window was evaluated by using 4 seroconversion panels. Intrapersonal and interpersonal reproducibility of the test were also evaluated. RESULTS: Sensitivity of LG HIV Ag-Ab Plus to sera of healthy donor was 99.9% and that to sera of patients with other underlying diseases was 100%. Sensitivity of both LG HIV Ag-Ab plus and Enzygnost HIV integral assays to sera of HIV infected patients was 100%. Sensitivity of LG HIV Ag-Ab Plus to BBI panel was comparable or better than that of Enzygnost HIV Integral. Analysis of window period using seroconversion panels showed no difference between both tests. CONCLUSION: Sensitivity and specificity of LG HIV Ag-Ab Plus was comparable to that of Enzygnost HIV Integral. It also had an excellent result in analysis of window period using seroconversion panels. So, newly developed LG HIV Ag-Ab Plus assay, by using it in screening donated blood, may provide significant contribution in safety of donated blood.