Onsite HIV/Syphilis Ab Combo Rapid Test
Abstract
Background
Sexually transmitted infections, such as HIV and syphilis, are one of the major healthcare problems worldwide, especially in low- and middle-income countries. HIV testing programs have been widely used for many years. The introduction of rapid point-of-care (RPT) tests that can detect both HIV and syphilis, using a single blood sample, would be a promising tool to integrate syphilis screening into HIV programs and thus improve the accessibility of syphilis testing and treatment.
Methods
As part of the World Health Organization prequalification for in vitro diagnostic evaluation, the laboratory performance of four HIV-syphilis dual rapid diagnostic tests (SD Bioline HIV/Syphilis Duo, DPP HIV-Syphilis Assay, Multiplo Rapid TP/HIV Antibody Test and Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test) was evaluated using a well-characterized multiregional panel of pooled serum samples.
Results
In total, 400 samples were tested with each assay, resulting in excellent sensitivities and specificities for HIV, ranging from 99.5 to 100% and 93.5 to 99.5%, respectively. The results obtained for antibodies against Treponema pallidum were inferior, with the lowest sensitivity of 73.5% for Multiplo and the highest of 87% for SD Bioline. The specificities ranged from 99.0 to 100%.
Conclusion
Although these results suggest that the tests could further improve the accuracy of treponemal antibody detection, their introduction into screening programs to increase the accessibility of HIV/syphilis diagnosis and treatment for hard-to-reach populations around the world holds promise.
