The CE IVD, lateral flow, immunochromatographic HIV rapid test [Exacto\u00ae PRO Test HIV, Biosynex, Strasbourg, France], was adapted as a prototype finger-stick whole-blood HIV self-test (Exacto\u00ae Test HIV, Biosynex). The test uses a combination of a specific antibody binding protein that is conjugated to colloidal gold dye particles and synthetic antigens (gp41, gp36) able to detect antibodies against HIV-1 or HIV-2 in whole-blood, serum or plasma, which are bound to the solid phase membrane. The Exacto\u00ae Test HIV fulfilled the following criteria: i) Capillary blood-based test detecting early HIV infection with analytical sensitivity in primary HIV infection previously evaluated at 92%; ii) Sterile safety lancet; iii) Simplified blood sampling system; iv) Simplified buffer delivery system; v) Specimen presence control by blood deposit assessment and migration control band; vi) Results in 10 minutes. The virological validation of HIVST was assessed in Democratic Republic of Congo, according to WHO recommendations of December 2016. The sensitivity and specificity of the Exacto\u00ae Test HIV read by observers were calculated according to the results the serological testing algorithms or the molecular biology for HIV RNA load measurement as reference diagnosis methods for HIV infection.