Viviane Bremer, Heinrich Scheiblauer, Maximilian Muenchhoff, Christian Schüttler, Jörg Timm, Michael Baier, Susanne Buder, Kristin Meyer-Schlinkmann, Thomas Neiße, Roger Dumke, Thomas Meyer, Gyde Steffen, Klaus Jansen, Norbert Brockmeyer
{"title":"[Point-of-care tests for sexually transmitted infections-what is the current status?]","authors":"Viviane Bremer, Heinrich Scheiblauer, Maximilian Muenchhoff, Christian Schüttler, Jörg Timm, Michael Baier, Susanne Buder, Kristin Meyer-Schlinkmann, Thomas Neiße, Roger Dumke, Thomas Meyer, Gyde Steffen, Klaus Jansen, Norbert Brockmeyer","doi":"10.1007/s00103-025-04067-9","DOIUrl":null,"url":null,"abstract":"<p><p>Point-of-care tests (PoCTs) enable the rapid diagnosis of sexually transmitted infections (STIs) directly at the point of care and play a central role in achieving the goals of the World Health Organization (WHO) for the global elimination of AIDS and hepatitis and the reduction of STIs by 2030.The European Union's new regulation for in vitro diagnostics raises the quality standards for PoCTs. All STI tests must now undergo more rigorous reviews. Advances in PoCT development have improved testing options for HIV, syphilis, and hepatitis C, particularly through WHO prequalified tests. However, the HIV self-tests available in Germany only detect the antibody component, which means that a negative result is only reliably conclusive 12 weeks after exposure. For syphilis, PoCTs are available for antibody screening, but these still require subsequent laboratory confirmation. For infections with chlamydia, gonococci, and mycoplasma, the quality of PoCTs is still largely inadequate. Further developments in the field of nucleic acid amplification tests (NATs) show promising approaches.PoCTs are particularly beneficial for low-threshold services aimed at marginalized groups, as they enable swift diagnosis and timely treatment within the test setting. However, challenges remain, including quality assurance and potential psychological stress due to false-positive results. There remains a need for continuous development and the integration of PoCTs into the healthcare system in order to improve access to diagnostics and to reduce the spread of infections.</p>","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":""},"PeriodicalIF":1.7000,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00103-025-04067-9","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
Abstract
Point-of-care tests (PoCTs) enable the rapid diagnosis of sexually transmitted infections (STIs) directly at the point of care and play a central role in achieving the goals of the World Health Organization (WHO) for the global elimination of AIDS and hepatitis and the reduction of STIs by 2030.The European Union's new regulation for in vitro diagnostics raises the quality standards for PoCTs. All STI tests must now undergo more rigorous reviews. Advances in PoCT development have improved testing options for HIV, syphilis, and hepatitis C, particularly through WHO prequalified tests. However, the HIV self-tests available in Germany only detect the antibody component, which means that a negative result is only reliably conclusive 12 weeks after exposure. For syphilis, PoCTs are available for antibody screening, but these still require subsequent laboratory confirmation. For infections with chlamydia, gonococci, and mycoplasma, the quality of PoCTs is still largely inadequate. Further developments in the field of nucleic acid amplification tests (NATs) show promising approaches.PoCTs are particularly beneficial for low-threshold services aimed at marginalized groups, as they enable swift diagnosis and timely treatment within the test setting. However, challenges remain, including quality assurance and potential psychological stress due to false-positive results. There remains a need for continuous development and the integration of PoCTs into the healthcare system in order to improve access to diagnostics and to reduce the spread of infections.
期刊介绍:
Die Monatszeitschrift Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - umfasst alle Fragestellungen und Bereiche, mit denen sich das öffentliche Gesundheitswesen und die staatliche Gesundheitspolitik auseinandersetzen.
Ziel ist es, zum einen über wesentliche Entwicklungen in der biologisch-medizinischen Grundlagenforschung auf dem Laufenden zu halten und zum anderen über konkrete Maßnahmen zum Gesundheitsschutz, über Konzepte der Prävention, Risikoabwehr und Gesundheitsförderung zu informieren. Wichtige Themengebiete sind die Epidemiologie übertragbarer und nicht übertragbarer Krankheiten, der umweltbezogene Gesundheitsschutz sowie gesundheitsökonomische, medizinethische und -rechtliche Fragestellungen.