Evaluation of the SD Bioline Hiv/Syphilis Duo and SD Bioline Syphilis 3.0 Test Kits for Hiv/Aids and Syphilis Screening at Komfo Anokye Teaching Hospital, Kumasi

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Diagnostic tests are needed for the control of sexually transmitted infections, as many infected individuals are asymptomatic. Rapid advances in molecular biology have led to the development of sensitive and specific diagnostic tests. New diagnostics tests must be evaluated in the situations in which they will be deployed. This study evaluated the SD Bioline HIV/syphilis Duo and the SD Bioline syphilis 3.0 test kits in HIV and syphilis testing. A total of 644 well characterised, archived serum samples were used. IMMUTREP® RPR, IMMUTREP® TPHA, Genscreen ULTRA HIV Ag-Ab and First Response® HIV 1-2-0 were used as gold standards. All 644 samples were assayed for the presence of antibodies to HIV and T. Pallidum by the SD Bioline HIV/syphilis Duo, the SD Bioline syphilis 3.0 and the Abbott DetermineTM Syphilis TP. The sensitivity, specificity, positive and negative predictive values of the SD Bioline syphilis 3.0 test kits were 91.67%, 100.00%, 100.00% and 89.29% respectively. The Abbott DetermineTM Syphilis TP had 75.69%, 100.00%, 100.00% and 74.07% respectively. In HIV testing, the SD Bioline HIV/syphilis Duo had 100.00%, 100.00%, 100.00% and 100.00% respectively. In syphilis testing, it had 100.00%, 99.33%, 99.60% and 100.00% respectively. The kappa value for SD Bioline syphilis 3.0 and Abbott DetermineTM Syphilis TP were 0.90 and 0.72 respectively, whiles the SD Bioline HIV/syphilis Duo had 1.00 and 0.99 in HIV and syphilis testing respectively. The SD Bioline HIV/syphilis Duo and SD Bioline syphilis 3.0 compared favourably with the gold standards. They are highly specific and very sensitive. They can be performed in clinics and/or hospitals without laboratory training and require no equipment or refrigeration. The SD Bioline HIV/syphilis Duo can be used for simultaneous screening of HIV and syphilis at antenatal clinics in Ghana. This would increase the coverage of HIV and syphilis screening, which will also increase the proportion of cases treated, facilitating the elimination of mother-to-child transmission of HIV and congenital syphilis.
A thesis submitted to the Department of Clinical Microbiology, Kwame Nkrumah University of Science and Technology, Kumasi in partial fulfilment of the requirements for the degree of Master of Science, May-2014
Gold Standard, Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Kappa Coefficient