Evidence map›Paper›PMID 41387142›Full record

ArticleEBioMedicine2026

Evaluation of an HPV16-L1 antibody rapid test for oropharyngeal cancer diagnosis: diagnostic accuracy and challenges in real-world settings.

Johannes M A Kusters, Nicole Brenner, Johannes A Bogaards, Steffi Silling, Mariam El-Zein, Penelope Gray, Hanna Kann, Eduardo L Franco, Matti Lehtinen, Andreas Dietz and 4 more

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PubMed Full text at PMC Publisher
In one paragraph

Article in EBioMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Johannes M A KustersInfections and Cancer Epidemiology Division, German Cancer Research Center (DKFZ), Heidelberg, Germany; Department of Epidemiology and Data Science, Amsterdam UMC, Amsterdam, the Netherlands. Electronic address: j.m.a.kusters@amsterdamumc.nl.
Nicole BrennerInfections and Cancer Epidemiology Division, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Johannes A BogaardsDepartment of Epidemiology and Data Science, Amsterdam UMC, Amsterdam, the Netherlands.
Steffi SillingInstitute of Virology, National Reference Center for Papilloma- and Polyomaviruses, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Mariam El-ZeinDivision of Cancer Epidemiology, McGill University, Montreal, QC, Canada.
Penelope GrayCenter for Cervical Cancer Elimination, Department of Clinical Science Intervention & Technology, Karolinska Institutet, Stockholm, Sweden.
Hanna KannDepartment of Microbiology and Immunology, University of Gothenburg, Gothenburg, Sweden.
Eduardo L FrancoDivision of Cancer Epidemiology, McGill University, Montreal, QC, Canada.
Matti LehtinenCenter for Cervical Cancer Elimination, Department of Clinical Science Intervention & Technology, Karolinska Institutet, Stockholm, Sweden; Infections and Cancer Epidemiology Division, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Andreas DietzDepartment of Otolaryngology, Head & Neck Surgery, University Hospital of Leipzig.
Simon LabanDepartment of Otorhinolaryngology and Head & Neck Surgery, University Hospital of Ulm, Ulm, Germany.
Jens Peter KlussmannDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany; Center for Molecular Medicine Cologne (CMMC), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Ulrike WielandInstitute of Virology, National Reference Center for Papilloma- and Polyomaviruses, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Tim WaterboerInfections and Cancer Epidemiology Division, German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: t.waterboer@dkfz-heidelberg.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiagnostic 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.

methodsSerum 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.

findingsIn 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.

interpretationThe 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.

fundingThis 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).

Indexed as

Antibodies, ViralCapsid ProteinsHuman papillomavirus 16Oncogene Proteins, ViralOropharyngeal NeoplasmsPapillomavirus InfectionsAdultAgedFemaleHumansMaleMiddle AgedSensitivity and SpecificityYoung AdultAntibodies, ViralCapsid ProteinsL1 protein, Human papillomavirus type 16Oncogene Proteins, ViralAntibodiesHuman papillomavirusInfectionOropharyngeal cancerScreeningVaccination

Identifiers

PMID41387142
PMCPMC12902241

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.