Screening for HIV and syphilis is highly recommended in pregnant women and at-risk groups by the World Health Organization. Recently test developers have created rapid point-of-care tests that can detect multiple infections with a single specimen using a single device. The aim of this study was to evaluate the clinical performance of the BIOLINE HIV/Syphilis Duo test.
Participants included men who have sex with men and transgender women and were recruited at two sexual health clinics in Lima, Peru. Gold standard testing, conducted using blood samples collected by venipuncture, included Treponema Pallidum Particle Agglutination (SERODIA-TPPA, Fujirebio Diagnostics, Inc., Japan) and 4th-generatation enzyme immunoassay (Genscreen™ ULTRA HIV Ag-Ab, Bio-Rad, France) with a confirmation Western Blot test (NEW LAV BLOT I, Bio-Rad, France). The SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics, Korea) uses a solid phase immunochromatographic assay to detect IgG, IgM and IgA antibodies to HIV-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and specific antibodies to recombinant Treponema pallidumantigens (17KDa) in human blood. For the Duo test, a fingerprick blood specimen was used. Sensitivity and specificity were calculated and the exact binomial method was used to determine 95% confidence intervals (CI).
Of the 126 participants, the TPPA was positive in 52 (41.2%) specimens and HIV positive in 20 (15.9%). The Duo test was positive for syphilis antibodies in 46 and positive for HIV antibody in 20 specimens. The Duo test sensitivity for detection of Treponema pallidumantibodies was 88.5% (95% CI: 76.6%,95.7%) and specificity 100% (95% CI: 95.1%,100%). For HIV antibodies, the sensitivity was 100% (95% CI: 83.16%,100%) and specificity 100% (95% CI: 96.6%,100%).
The SD BIOLINE HIV/Syphilis Duo test shows high clinical performance in point-of-care settings in Lima, Peru. This test should be considered for the use in clinical settings to increase dual screening of HIV and syphilis.