{
  "abstract": "Objective The study was conducted to assess the diagnostic performance of the Hightop Syphilis Rapid Diagnostic Test (RDT) in comparison with the ELISA test used as a reference method.Design A laboratory-based cross-sectional and comparative study was conducted to assess the diagnostic performance of the Hightop Syphilis RDT.Setting Blood samples obtained from adult participants in eight health facilities were analysed at the National Public Health Laboratory (NPHL), Ministry of Public Health, Yaounde, Cameroon.Participants From 29 April to 25 August 2023, 583 adult participants of both sexes (aged ≥21 years), including both syphilis positive and syphilis negative, were recruited consecutively in eight health facilities in eight regions of Cameroon.Outcome measures Blood samples were screened for the detection of anti- Treponema pallidum antibodies using the One Step Rapid Test (Qingdao Hightop Biotech), a non-treponemal test and ELISA (Biorex Diagnostics, UK), a treponemal test used as a reference method. Diagnostic performance of the Syphilis RDT was analysed using Epi Info V.7 and validated through online statistical tools such as StatPages, GraphPad, QuickCalcs and MedCalc software.Results Of the 583 samples tested, the Hightop Syphilis RDT revealed a sensitivity of 84.6% (95% CI: 74.8% to 91.1%) and specificity of 98.5% (95% CI: 97.5% to 99.1%). The positive predictive value (PPV) and negative predictive value (NPV) were 84.6% (95% CI: 74.8% to 91.1%) and 98.5% (95% CI: 97.5% to 99.1%), respectively. Regarding the stratification of diagnostic performance by clinical stage, the test showed a sensitivity of 100.0% (95% CI: 71.51% to 100.0%) and specificity of 99.06% (95% CI: 94.86% to 99.98%). The PPV and NPV were 91.67% (95% CI: 61.00% to 98.72%) and 100.0% (95% CI: 96.55% to 100.0%), respectively, in symptomatic individuals. Among asymptomatic individuals, sensitivity was 97.56% (95% CI: 87.14% to 99.94%) and specificity was 100.0% (95% CI: 99.14% to 100.0%). The PPV and NPV were 100.0% (95% CI: 91.19% to 100.0%) and 99.77% (95% CI: 98.40% to 99.97%), respectively.Conclusions The Hightop Syphilis RDT demonstrated adequate diagnostic performance, particularly among symptomatic individuals, supporting its utility as a reliable tool for syphilis detection in clinical settings.",
  "authors": [
    {
      "affiliations": [
        "Higher Institute of Sciences and Techniques Applied to Health, Yaounde, Cameroon",
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Christian Taheu Ngounouh"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Philippe Salomon Nguwoh"
    },
    {
      "affiliations": [
        "Faculty of Health Sciences, University of Buea, Chantal BIYA International Reference Centre for research on HIV/AIDS prevention and Management, Yaounde, Cameroon"
      ],
      "name": "Joseph Fokam"
    },
    {
      "affiliations": [
        "Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaounde, Cameroon"
      ],
      "name": "René Ghislain Essomba"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Ibrahima Halilou"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Amina Al-Mayé Bit Younouss"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Nafissatou Ibnou Moussa"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Emile Yuosembom"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Solange Pepa"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Marcel Mbarga Foe"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Emmanuel Orock Eta"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Guianni Mpiwouo Panyere"
    },
    {
      "affiliations": [
        "Laboratory Service, National Insurance Fund Welfare Hospital, Yaounde, Cameroon"
      ],
      "name": "Corine Madie Tamo"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Jérôme Ngantchui Tchuisseu"
    },
    {
      "affiliations": [
        "Maroua Regional Hospital, Ministry of Public Health, Maroua, Cameroon"
      ],
      "name": "Aboubakar Moussa"
    },
    {
      "affiliations": [
        "Bertoua Regional Hospital, Ministry of Public Health, Bertoua, Cameroon"
      ],
      "name": "Elie Zotie"
    },
    {
      "affiliations": [
        "Nkongsamba Regional Hospital, Ministry of Public Health, Nkongsamba, Cameroon"
      ],
      "name": "John Francois Ndombol Tembten"
    },
    {
      "affiliations": [
        "Ebolowa Regional Hospital, Ministry of Public Health, Ebolowa, Cameroon"
      ],
      "name": "Lydie Nyatte"
    },
    {
      "affiliations": [
        "Regional Hospital Bamenda Laboratory, Bamenda, North West Region, Cameroon"
      ],
      "name": "Victor Fondoh"
    },
    {
      "affiliations": [
        "Limbe Regional Hospital, Ministry of Public Health, Limbe, Cameroon"
      ],
      "name": "Constance Nyanda Nyeng"
    },
    {
      "affiliations": [
        "Garoua Regional Hospital, Ministry of Public Health, Garoua, Cameroon"
      ],
      "name": "Youssoufa Taoufick"
    },
    {
      "affiliations": [
        "Garoua Regional Hospital, Ministry of Public Health, Garoua, Cameroon"
      ],
      "name": "Dodo Nyako Balkissou"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Blaise Akenji Mboringong"
    },
    {
      "affiliations": [
        "National Public Health Laboratory, Yaounde, Cameroon"
      ],
      "name": "Hamsatou Hadja"
    },
    {
      "affiliations": [
        "Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaounde, Cameroon"
      ],
      "name": "Marie Claire Okomo Assoumou"
    }
  ],
  "title": "Diagnostic performance of the Hightop Rapid Diagnostic Test for the detection of anti-Treponema pallidum antibodies in Cameroon: a laboratory-based cross-sectional and comparative study",
  "uid": "56961ddc-e4bf-53d2-b858-bec671f0eda3"
}