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@ARTICLE{Kusters:307245,
      author       = {J. Kusters$^*$ and N. Brenner$^*$ and J. A. Bogaards and S.
                      Silling and M. El-Zein and P. Gray and H. Kann and E. L.
                      Franco and M. O. A. Lehtinen$^*$ and A. Dietz and S. Laban
                      and J. P. Klussmann and U. Wieland and T. Waterboer$^*$},
      title        = {{E}valuation of an {HPV}16-{L}1 antibody rapid test for
                      oropharyngeal cancer diagnosis: diagnostic accuracy and
                      challenges in real-world settings.},
      journal      = {EBioMedicine},
      volume       = {nn},
      issn         = {2352-3964},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2025-02938},
      pages        = {nn},
      year         = {2025},
      note         = {#EA:C230#LA:C230# / epub},
      abstract     = {Diagnostic assays have been introduced to diagnose human
                      papillomavirus (HPV)-driven oropharyngeal cancer (HPV-OPC),
                      including those identifying HPV16-L1 antibodies. This study
                      aims to evaluate the diagnostic accuracy of an HPV16-L1
                      antibody rapid test for HPV-OPC, and its performance in
                      individuals likely to have HPV16-L1 antibodies from causes
                      other than HPV-OPC.Serum samples (n = 235) from three study
                      populations were tested using a CE-certified serological
                      HPV16-L1 antibody rapid test (Prevo-Check®) at the German
                      National Reference Center for Papillomaviruses. Laboratory
                      personnel were blinded to participant characteristics and
                      followed the manufacturer's instructions. The three study
                      populations consisted of: (1) patients with HPV16-positive
                      or -negative OPC (n = 83), (2) bivalent (HPV16/18) vaccine
                      recipients (n = 50), with paired baseline and one-month
                      post-third-dose serum samples, and (3) naturally HPV16
                      infected young adults (n = 26), with paired serum samples
                      before and after HPV16 seroconversion.In the study
                      population with patients with OPC, the sensitivity of the
                      HPV16-L1 antibody rapid test to detect HPV-OPC was $25.0\%$
                      $(95\%$ CI: 13.6, 39.6), and its specificity was $97.1\%$
                      $(95\%$ CI: 85.1, 99.9). The positive predictive value was
                      $92.3\%$ $(95\%$ CI: 64.0, 99.8) and negative predictive
                      value $48.6\%$ $(95\%$ CI: 36.4, 60.8). In the other study
                      populations, the test was negative for all pre-vaccination
                      samples, and all samples collected before incident natural
                      HPV16 infection. Nearly all post-vaccination samples
                      $(98.0\%),$ and one-third of the samples after natural HPV16
                      infection $(34.6\%)$ tested positive in the HPV16-L1
                      antibody rapid test.The HPV16-L1 antibody test has low
                      diagnostic accuracy and cannot reliably distinguish
                      different sources of HPV16-L1 antibodies. Therefore, this
                      type of assays is not suitable for screening and detection
                      of HPV16-driven OPC.This study is supported by the Ministry
                      of Research, Technology and Space (BMFTR) core bvfunding
                      provided to DKFZ. The NRC for Papilloma- and Polyomaviruses
                      is supported by the Ministry of Health (BMG, grant no.
                      1369-401).},
      keywords     = {Antibodies (Other) / Human papillomavirus (Other) /
                      Infection (Other) / Oropharyngeal cancer (Other) / Screening
                      (Other) / Vaccination (Other)},
      cin          = {C230},
      ddc          = {610},
      cid          = {I:(DE-He78)C230-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:41387142},
      doi          = {10.1016/j.ebiom.2025.106057},
      url          = {https://inrepo02.dkfz.de/record/307245},
}