Evaluation of the SD BIOLINE HIV/syphilis Duo assay at a rural health center in Southwestern Uganda

Abstract

BackgroundPoint-of-care tests have the capacity to improve healthcare delivery by reducing costs and delay associated with care. A novel point-of-care immunochromatographic test for dual diagnosis of both HIV and syphilis by detecting IgG, IgM and IgA antibodies to HIV, and specific and recombinant Treponema pallidum antigens has recently been developed, but has not been evaluated in rural field settings. We evaluated the performance of the SD Bioline Syphilis/HIV Duo (Duo) assay at a healthcare center in rural Uganda.MethodsA convenience sample of pregnant women attending Kinoni Health Centre IV from March to May, 2013 was enrolled. Venous blood was collected and centrifuged for plasma isolation. Samples were tested with the Duo assay and compared with the Treponema pallidum hemaglutination assay and paired HIV rapid antibody tests as the reference standards. The ease of use and time required for the Duo assay were also assessed by laboratory technicians.ResultsTwo hundred twenty women were enrolled with a mean age of 25.00 years (SD 5.41). The sensitivity and specificity of the Duo assay were 100% (95% CI 79.0 – 100%) and 100% (95% CI 97.6 – 100.0) respectively, for syphilis, and, 100% (75.9 – 100%) and 99.5% (96.8 – 99.9%) respectively, for HIV. The duo kit was found to be faster and easier to use than the current HIV and syphilis testing techniques.ConclusionThe sensitivity and specificity of the SD Bioline HIV/Syphilis Duo test were excellent in a field setting in Uganda. The Duo assay should be further evaluated in alternate populations and with point-of-care specimens (e.g. whole blood from finger stick specimens), but shows promise as a tool for improved HIV and syphilis surveillance, diagnosis, and treatment in field settings.

Field evaluation of Standard Diagnostics' Bioline HIV/Syphilis Duo test among female sex workers in Johannesburg, South Africa

“…The performance of the SD Bioline test in our study is lower than that found in a previous evaluation which used laboratory personal and techniques to conduct the tests and reported sensitivities and specificities for both HIV and syphilis of 100% 9 10. Our results for detection of treponemal antibodies by the SD Bioline test are similar to other POCT evaluations where syphilis tests show a lower sensitivity compared with laboratory standards when evaluated in the field rather than the laboratory 11 12.…”

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

“…Our results are comparable to those of laboratory evaluations that were conducted previously with different point-of-care tests for HIV and treponemal antibody detection in sera and whole blood, which also yielded high performance values for sensitivity and specificity (1,(5)(6)(7)(11)(12)(13). In our evaluation, the sensitivity of the Chembio DPP HIV-syphilis rapid test to detect HIV antibodies was somewhat greater than its sensitivity to detect syphilis antibodies, in concurrence with several other studies (5,6,11,12,14).…”

Laboratory Evaluation of a Point-of-Care Downward-Flow Assay for Simultaneous Detection of Antibodies to Treponema pallidum and Human Immunodeficiency Virus

“…Previous studies evaluated dual tests for antibodies to HIV and T. pallidum, including the MedMira Multiplo (MedMira; Halifax, Nova Scotia, Canada), the SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics; Gyeonggi-do, Republic of Korea), and the Chembio DPP HIV-syphilis assay (Chembio Diagnostics; Medford, NY) (7,(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). These dual tests demonstrated sensitivities and specificities for HIV antibody detection ranging from 93.8% to 100% and 91.9% to 100%, respectively.…”