Evaluation of an HPV16-L1 antibody rapid test for oropharyngeal cancer diagnosis: diagnostic accuracy and challenges in real-world settings
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Le résumé fourni par la source
BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: 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).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Evaluation of an HPV16-L1 antibody rapid test for oropharyngeal cancer diagnosis: diagnostic accuracy and challenges in real-world settings
- Date Crossref
- 01/01/2026
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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German Cancer Research Center Infections and Cancer Epidemiology Division pays non établi dans la noticeStructure de recherche
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Heidelberg University pays non établi dans la noticeUniversité ou école supérieure
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Amsterdam University Medical Centers pays non établi dans la noticeÉtablissement de santé
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University of Cologne Institute of Virology pays non établi dans la noticeUniversité ou école supérieure
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University Hospital Cologne pays non établi dans la noticeÉtablissement de santé
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McGill University Division of Cancer Epidemiology pays non établi dans la noticeUniversité ou école supérieure
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Karolinska Institutet pays non établi dans la noticeUniversité ou école supérieure
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University of Gothenburg Department of Microbiology and Immunology pays non établi dans la noticeUniversité ou école supérieure
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University Hospital Leipzig pays non établi dans la noticeÉtablissement de santé
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University Hospital Ulm pays non établi dans la noticeÉtablissement de santé
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Department of Epidemiology and Data Science pays non établi dans la noticeInstitution
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Department of Clinical Science Intervention & Technology Center for Cervical Cancer Elimination pays non établi dans la noticeÉtablissement de santé
Infections and Cancer Epidemiology Division — German Cancer Research Center, Heidelberg University et Amsterdam University Medical Centers, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.