The false-positive and false-negative predictive value of HIV antibody test in the Chinese population

Objectives To analyse the relationship between the false-positive/false-negative predictive value (FPPV/FNPV) of the HIV-antibody (HIV-Ab) test and prevalence in different Chinese population groups. Methods HIV prevalence among different population groups was obtained by a screening survey of blood donors and the national HIV/AIDS surveillance programme in China. Given the sensitivity and specificity of a test kit and the prevalence of HIV infection, the estimated values of FPPV/FNPV were calculated using Bayes' formula. The actual value of FPPV of blood donors was obtained by screening 1,195,286 blood donors. Results This study indicates that the FPPV of HIV-Ab enzyme-linked immunosorbent assay (ELISA) assays varies widely in different Chinese populations: about 99.5% in the blood donor population, but only 3.2% in the injecting-drug users in high-risk areas. In 1,195,286 sera specimens from the blood donors, 2439 specimens were HIV-Ab positive by third ELISA, and 11 HIV cases were confirmed by Western blot. The HIV prevalence of the blood donor population in this survey was 0.0009% (11/1,195,286), but the HIV-Ab positive rate of third ELISA is 0.2% (2439/1,195,286) and 222 times higher than the prevalence. Conclusions Evaluation of HIV prevalence through the HIV-Ab positive rate by third ELISA will significantly overestimate the true prevalence in a low-prevalence population. Individual HIV-infection status should be taken into consideration when analysing the results of HIV-Ab tests in a population with low infection.