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Original research
Agreement between L1 and E6/E7-based assays for detection of high-risk HPV in cervical, oropharyngeal and penile cancers
  1. Elia Alcaniz Boada1,
  2. Kate Cuschieri2,
  3. Catriona Graham3,
  4. Sharon Moncur1,
  5. Ramya Bhatia1,2
  1. 1 HPV Research Group, The University of Edinburgh MRC Centre for Reproductive Health, Edinburgh, UK
  2. 2 Laboratory Medicine, SHPVRL, NHS Lothian, Edinburgh, UK
  3. 3 University of Edinburgh, Clinical Research Facility, Edinburgh, UK
  1. Correspondence to Dr Ramya Bhatia, The University of Edinburgh MRC Centre for Reproductive Health, Edinburgh, Edinburgh, UK; ramya.bhatia{at}ed.ac.uk

Abstract

Aims Human papillomavirus (HPV) molecular testing targets either the late gene L1 or early genes E6 and/or E7. Loss of L1 during integration is suggested to compromise sensitivity in samples associated with cancer, however, clear evidence for this is lacking. Our aim is to address this by performing a head-to-head comparison between assays targeting L1 vs E6/E7, using a series of high-grade and invasive disease samples within different biological matrices and anatomical sites.

Methods We obtained 298 samples comprising of liquid-based cytology and biopsies of cervical cancer and cervical intraepithelial neoplasia grade 3, in addition to biopsies of penile and oropharyngeal cancers. Two commercially available HPV primary screening assays and two assays with extended genotyping were applied to the sample set targeting L1 (Abbott RealTime HR HPV Assay and Optiplex HPV Genotyping Test) and E6/E7 genes (Xpert HPV Test and EuroArray HPV Test).

Results Agreement for high-risk HPV (hrHPV) for all samples types between the screening assays is over 88% and over 96% for the two genotyping assays. For HPV 16 agreement is over 90% for both screening and genotyping assays. Kappa statistics show good to very good agreement between the screening and genotyping assays for hrHPV and HPV 16.

Conclusions Analysis of the valid results from our data indicates that L1 and E6/E7 targeting assays show similar performance for detection of hrHPV in high grade cervical lesions and cancers of cervix, penis and oropharynx.

  • papillomavirus infections
  • diagnostic techniques and procedures
  • viruses

Data availability statement

Data are available on reasonable request.

https://doi.org/10.1136/jclinpath-2021-208054

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • Handling editor Runjan Chetty.

    • Contributors KC and RB planned the study. EAB and SM carried out the testing. CG carried out the statistical analysis. All authors contributed to the preparation of the manuscript. KC has overall responsibility for the data in the study.

    • Funding This study was funded through an investigator led study grant from Euroimmune.

    • Competing interests KC, RB, SM and EAB’s institution has received research funding or gratis consumables to support research from the following commercial entities in the last 3 years: Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Abbott and Hologic.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.