Evaluation of the SD Bioline Syphilis 3.0 rapid immunochromatographic test for syphilis screening in Burkina Faso

Abstract

Syphilis remains a global health problem. In Burkina Faso, cases of syphilis are still prevalent despite concerted effort in the fight against sexually transmitted infections. The availability of Treponema pallidum haemagglutination assay in the diagnosis of syphilis has not eliminated the challenges encountered in the diagnosis of syphilis in Burkina Faso, hence the difficulty in case management. This study evaluated the diagnostic performance of SD Bioline syphilis 3.0 test against the combination of venereal disease research laboratory (VDRL) and Treponema pallidum haemagglutination assay (TPHA) a reference test used routinely in Burkina Faso. A total of 633 serum samples collected from suspected syphilis infected participants were tested for syphilis using the combination of VDRL, TPHA and SD Bioline syphilis 3.0, a rapid immunochromatographic test (ICT). The sensitivity and specificity of SD Bioline syphilis 3.0 test were 100% and 92%, and the positive and negative predictive values were 85.95% and 100%, respectively, compared to the classical TPHA test used for screening/diagnosis of syphilis. The SD Bioline Syphilis 3.0 test gave good diagnostic accuracy compared to the VDRL and TPHA tests (p<0.001). SD Bioline syphilis ICT test could be used in health facilities for screening and diagnosis of syphilis in Burkina Faso.