Laboratory-Based Evaluation of SD Bioline HIV/Syphilis Duo Rapid Test Kits in the Gambia, November 2019

Abstract

Background: HIV and syphilis are mainly diagnosed using separate rapid test kits for the HIV counseling and testing (HCT), Prevention of Mother-to-Child Transmission of HIV (PMTCT) and other clinical requests in healthcare facilities in The Gambia, as recommended in the HIV testing management guidelines. The goal of this study was to evaluate the performance of SD Bioline HIV/ Syphilis Duo as a single test kit used for the simultaneous detection of HIV & Syphilis antibodies in the laboratory setting. Methods: We determined the sensitivity, specificity, positive and negative predictive values of SD Bioline HIV/Syphilis Duo kits in terms of HIV screening against the GenScreen Ultra HIV Ag-Ab ELISA (Lot 9D0126) using a total of 100 HIV negative and 150 HIV positive serum/plasma specimens that were stored at -20°C. Subtyping of the HIV positive specimens was previously performed using First Response HIV-1/2 test cards and Western Blot assays respectively. Moreover, the SD Bioline HIV/Syphilis Duo kit sensitivity, specificity, positive and negative predictive values in relation to Syphilis screening of 100 specimens was also determined against Treponema Pallidum Heamagglutination Assay (TPHA). Results: In terms of HIV screening (n=250), the sensitivity, specificity, positive and negative predictive values of the SD Bioline HIV/Syphilis Duo Test Kits were 100%, 100%, 100%, and 100% respectively when compared with the GenScreen Ultra HIV Ag-Ab ELISA results in the laboratory setting. Sensitivity for Syphilis screening (n=100) was 95.65%, whilst specificity was 100% when compared with TPHA. Positive predictive value was 100%, whilst the negative predictive value was 98.86%. Conclusions: These findings show that the SD Bioline HIV/Syphilis Duo kits have high sensitivity and specificity when used for the detection of HIV and Syphilis antibodies using human serum and/or plasma. Therefore, these kits could serve as a good alternative for the dual elimination of mother-to-child transmission (e-MTCT) HIV and Syphilis through a one-step timely diagnostic procedure, which is crucial in reducing the turnaround time of laboratory test results.