ArticlePloS one2018
Field evaluation of SD BIOLINE HIV/Syphilis Duo assay among pregnant women attending routine antenatal care in Juba, South Sudan.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Multiplexed technologies for sexually transmitted infections: global evidence on patient-centered and clinical health outcomes.BMJ global health · 2021Pooled it
- Rapid/point-of-care syphilis testing in high-income countries: insights and implementation challenges from the authors' experience in Canada.Journal of clinical microbiology · 2026Review
- Diagnostic performance evaluation of the Abbott Bioline™ HIV/Syphilis Duo rapid test at the national public health laboratory, Yaounde-Cameroon.BMC infectious diseases · 2026Article
- Diagnostic performance of the Hightop Rapid Diagnostic Test for the detection of antiBMJ open · 2025Article
- Feasibility, Preference, and Impact of a Rapid Multiplexed Point-of-Care Digital Innovation (AideSmart!) to Expedite Screening of Sexually Transmitted Blood-Borne Infections in At-Risk Populations in Canada: Cross-Sectional Study.Journal of medical Internet research · 2024Article
- Systematic review and meta-analysis of seroprevalence of human immunodeficiency virus serological markers among pregnant women in Africa, 1984-2020.World journal of critical care medicine · 2023Article
- Assessment of the Accuracy, Usability and Acceptability of a Rapid Test for the Simultaneous Diagnosis of Syphilis and HIV Infection in a Real-Life Scenario in the Amazon Region, Brazil.Diagnostics (Basel, Switzerland) · 2023Article
- Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda.BMC research notes · 2019Article
- Diagnostic Performances of Three Rapid Diagnostic Tests for Detecting HIV Infections in Mali.Infectious diseases diagnosis & treatment · 2019Article
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Authors and funding
9 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The SD BIOLINE HIV/Syphilis Duo assay is the first World Health Organization prequalified dual rapid diagnostic test for simultaneous detection of HIV and Treponema pallidum antibodies in human blood. Prior to introducing the test into antenatal clinics across South Sudan, a field evaluation of its clinical performance in diagnosing both HIV and syphilis in pregnant women was conducted. SD Bioline test performance on venous blood samples was compared with (i) Vironostika HIV1/2 Uniform II Ag/Ab reference standard and Alere Determine HIV 1/2 non-reference standard for HIV diagnosis, and (ii) Treponema pallidum hemagglutination reference standard and Rapid plasma reagin non-reference standard for syphilis. Sensitivity, specificity, positive predictive value (PPN), negative predictive value (NPV) and kappa (κ) value were calculated for each component against the reference standards within 95% confidence intervals (CIs); agreements between Determine HIV 1/2 and SD Bioline HIV tests were also calculated. Of 442 pregnant women recruited, eight (1.8%) were HIV positive, 22 (5.0%) had evidence of syphilis exposure; 14 (3.2%) had active infection. For HIV diagnosis, the sensitivity, specificity, PPV and NPV were 100% (95% CI: 63.1-100), 100% (95% CI: 99.2-100), 100% (95% CI: 63.1-100) and 100% (95% CI: 99.2-100) respectively with κ value of 1 (95% CI: 0.992-1.000). Overall agreement of the Duo HIV component and Determine test was 99.1% (95% CI: 0.977-0.998) with 66.7% (95% CI: 34.9-90.1) positive and 100% (95% CI: 0.992-1.000) negative percent agreements. For syphilis, the Duo assay sensitivity was 86.4% (95% CI: 65.1-97.1) and specificity 100% (95% CI: 99.1-100) with PPV 100% (95% CI: 82.4-100), NPV 99.2% (95% CI: 97.9-99.9) and κ value 0.92 (95% CI: 0.980-0.999). Our findings suggest the SD Bioline HIV/Syphilis Duo Assay could be suitable for HIV and syphilis testing in women attending antenatal services across South Sudan. Women with positive syphilis results should receive treatment immediately, whereas HIV positive women should undergo confirmatory testing following national HIV testing guidelines.
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