Analytical performances of Exacto(®) HIV self-test in the Central African Republic

We herein evaluated the analytical performances of the CE-IVD capillary blood Exacto(®) HIV self-test (Biosynex, Strasbourg, France) in the Central African Republic (CAR). A cross-sectional study was conducted on a representative national panel of 200 sera positive for HIV and 200 negative for HIV, randomly selected thorough the CAR for HIV seroprevalence surveillance survey, according to reference test. The Exacto(®) HIV self-test showed 99.5% (95% CI: 98.2-99.9) sensitivity and 100.0% (95% CI: 99.0-100.0) specificity. The Youden´s J index and Cohen´s Kappa coefficient were 0.995. At HIV-1 seroprevalence of 3.5% in the general adult population of the CAR, the positive and negative predictive values were 100% (95% CI: 99.0-100) and 99.9% (95% CI: 98.9-100), respectively. The results are within the limits required by the WHO (i.e. sensitivity ≥ 99.0% and specificity ≥ 98.0%), making Exacto(®) HIV self-test suitable for routine use in the CAR.