Laboratory-based Evaluation of Wondfo HIV1/2 Rapid Test Kits in the Gambia, December 2020

Abstract

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, positive and negative predictive values of Wondfo HIV 1/2 kits were evaluated in terms of HIV screening against Determine HIV1/2, GenScreen Ultra HIV Ag-Ab ELISA and First Response HIV 1.2.0 using a total of 401 samples. Of these, 351 were sera/plasma samples {100 HIV negative, 250 HIV positive and 1 indeterminate that were stored at -20°C, 26 were whole blood samples (4 negative, 22 positive), and 24 were dried blood spot (DBS) specimens (16 negative and 8 positive) were used for this evaluation. HIV positive specimens were previously sero-typed using First Response HIV-1.2.0 test cards and MP Diagnostics HIV Blot 2.2 Western Assay. Results: The evaluation shows that the sensitivity, specificity, positive and negative predictive values of Wondfo HIV 1/2 Test Kits with regards to HIV Screening when compared with the GenScreen Ultra HIV Ag-Ab ELISA and First Response 1.2.O (n=401) were 100%, 100%, 100%, and 100% respectively. Similarly, the sensitivity, specificity, positive and negative predictive values of Wondfo HIV 1/2 Test Kits with regards to HIV Screening compared to Determine HIV1/2 (n=401) were 99.64%, 100%, 100%, and 99.17% respectively. Conclusions: This study demonstrates that Wondfo HIV 1/2 test kits have a high sensitivity and specificity when used for the detection of HIV antibodies using human serum/plasma, whole blood or DBS.