RESUMO
【Objective】 To evaluate the performance of electrochemiluminescence immunoassay (ECLIA) in detecting HIV antigen/antibody in blood screening. 【Methods】 A total of 128 donors, reactive to anti-HIV(ELISA)testing, from September 2016 to September 2020 were enrolled, and seven samples were reactive to double anti-HIV reagents, among which 6 were confirmed by WB, 1 confirmed by NAT as negative.Two group of donors, reactive to solo anti-HIV reagent but being confirmed negative by WB(n=121) vs.randomly selected donors non-reactive to ELISA + NAT(June to September 2020, n=1360), were subjected to HIV antigen/antibody testing using ECLIA to compare the testing results, including concordance rate, sensitivity and specificity. 【Results】 The ECLIA results remained non-reactive for 1360 samples initially non-reactive to both ELISA and NAT.The concordance rate of anti-HIV reactivity by ECLIA and ELISA+ WB were 100%(6/6). For 122 samples, reactive to ELISA anti-HIV testing but nonreactive to confirmatory testing, 4(3.28%)of them were reactive to HIV antigen/antibody testing and 118(96.72%) nonreactive, with the concordance rate of ECLIA and ELISA at 96.88%(124/128). The sensitivity, specificity and false positive rate of ECLIA and ELISA were 100% vs 100%, 99.73% vs 91.77%, and 0.27% vs 8.23%, respectively. 【Conclusion】 ECLIA for HIV antigen/antibody detection has good sensitivity and specificity, which can meet the requirements of blood screening, and the false positive rate is lower than that of ELISA, adopted commonly in blood bank at present.
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.