Abstract
BackgroundSexually transmitted infections, such as HIV and syphilis, are one of the major health care problems worldwide, especially in low- and middle income countries. HIV screening programmes have been widely used for many years. The introduction of rapid point-of-care tests (RDTs) that can detect both HIV and syphilis, using one single blood specimen, would be a promising tool to integrate the detection of syphilis into HIV programmes and so improve the accessibility of syphilis testing and treatment.MethodsAs part of the World Health Organization pre-qualification of in vitro diagnostics assessment, the laboratory performance of four dual HIV-Syphilis 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 assessed using a well characterized multiregional panel of stored sera specimens.ResultsIn total 400 specimens were tested with each assay, resulting in excellent sensitivities and specificities for HIV, ranging from 99.5 to 100% and from 93.5 to 99.5%, respectively. Results obtained for the Treponema pallidum antibodies were lower, with the lowest sensitivity of 73.5% for Multiplo and the highest of 87% for SD Bioline. Specificities ranged from 99.0 to 100%.ConclusionAlthough these results suggest that the tests could further improve in accuracy in detection of treponemal antibodies, their introduction into screening programmes to increase the accessibility of HIV/Syphilis diagnosis and treatment for difficult to reach populations in the world is promising.
Highlights
Transmitted infections, such as HIV and syphilis, are one of the major health care problems worldwide, especially in low- and middle income countries
World Health Organization (WHO) specimen reference panel All 400 specimens of the WHO specimen reference panel were tested by the four Rapid diagnostic test/rapid point-of-care test (RDT)
The control line was present for the 400 panel specimens on SD Bioline HIV/Syphilis Duo, DPP HIV-Syphilis Assay and Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test, indicating 100% valid results
Summary
Transmitted infections, such as HIV and syphilis, are one of the major health care problems worldwide, especially in low- and middle income countries. Untreated syphilis can result in serious adverse outcomes for pregnancy and can increase the risk of mother-to-child transmission of HIV [1] As both HIV and syphilis are transmittable sexually and from mother to child, it is not surprising that co-infections are common [2]. Diagnostic tests are available but often not accessible for populations living in the areas where they are needed the most, highlighting the importance of accessibility to simple and affordable tests, such as rapid diagnostic tests (RDTs) These are tests that can be used for testing at point of care, with no requirement for sophisticated laboratory equipment, or specific storage conditions; making them useful in all kinds (2019) 19:1 of healthcare facilities. Combining detection of antiHIV and anti-treponemal antibodies in one dual RDT can integrate the detection of syphilis into HIV programmes and so improve the accessibility of syphilis testing and treatment
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