Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda

OBJECTIVE: Efforts to dual eradication of mother-to-child transmission of human immune deficiency virus (HIV) and syphilis have improved in the previous decades. This has however been hindered by limited validation studies. A cross-sectional study was conducted among adult pregnant women attending antenatal care clinic at Mayuge Health Center III. Two milliliters of venous blood were collected into Ethylene di-amine tetra acetic acid vacutainers, and tested for HIV and syphilis using the SD Bioline HIV/Syphilis Duo assay, and the national HIV and syphilis testing algorithm. Sensitivity and specificity were calculated for the Duo Kit against the gold standards within 95% confidence intervals. RESULTS: Three hundred and eighty-two (382) participants were enrolled. Their mean age was 25.8 years. The prevalence of HIV was 1.8% (95% confidence interval 1.23-2.41); while that of syphilis was 2.1% (95% confidence interval 1.81-2.54), and the dual infection was 0.52% (95% confidence interval 0.37-0.92). The sensitivity and specificity of the SD Bioline HIV/Syphilis Duo assay were all 100.0% (95% confidence interval 99.5 to 100.0 and 98.6 to 100.0, respectively). The performance of the SD Bioline HIV/Syphilis Duo Kit was optimal, reassuring its aptness for use, and favorable qualities to a limited resource setting.