Background: HIV rapid diagnosis in The Gambia is mainly done using Determine HIV-1/2 and First Response HIV 1.2.0 or SD Bioline HIV-1/2 3.0 for screening and sero-typing of HIV respectively among children and adults. Polymerase Chain Reaction (PCR) is used for the detection of the HIV viral genome among infants born to HIV positive mothers. This is the HIV testing Algorithm recommended in the HIV testing guidelines of The Gambia for both HIV Counseling and Testing (HCT), Prevention of Mother-to-Child Transmission of HIV (PMTCT) as well as other clinical requests for HIV testing. At the National Public Health Reference Laboratories (NPHRL), ELISA is the first line of testing for HIV while First Response HIV 1.2.0 or SD Bioline HIV 1/2 3.0 is used for preliminary serotyping. MP Diagnostics HIV Blot 2.2 Western Assay, which is the gold standard for HIV testing in The Gambia, is used as the tie breaker (i.e., when there are discordant results). The aim of this study was to evaluate the sensitivity and specificity of the Wondfo HIV 1/2 rapid test kit for the detection of human antibodies to HIV in serum/plasma/whole blood and dried blood spots. Methods: The sensitivity, specificity,
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