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Performance evaluation of a self-administered point-of-care test for anal HPV screening in PrEP users: data from a community-based PrEP service
  1. Lorenzo Biasioli1,2,
  2. Roberto Rossotti2,3,
  3. Alessandro Tavelli1,2,
  4. Anna De Bona1,2,
  5. Camilla Tincati1,
  6. Daniele Calzavara2,
  7. Pietro Vinti2,
  8. Chiara Baiguera2,3,
  9. Federico D’Amico3,
  10. Alice Nava3,
  11. Roberto Repossi2,
  12. Simona Bossolasco2,4,
  13. Camilla Muccini2,4,
  14. Giovanni Mulè1,2,
  15. Daniele Tesoro1,2,
  16. Antonella d'Arminio Monforte1,2,
  17. Massimo Cernuschi2,4 the Milano Check Point Group
  1. 1University of Milan, Department of Infectious Diseases, ASST Santi Paolo e Carlo, Milan, Italy
  2. 2Milano Check Point, Milan, Italy
  3. 3Department of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
  4. 4Clinic of Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy
  1. Correspondence to Dr Lorenzo Biasioli, University of Milan, Department of Infectious Diseases, ASST Santi Paolo e Carlo, 20142 Milan, Italy; lorenzo.biasioli{at}unimi.it

Abstract

Objectives In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility.

Methods We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen’s kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).

Results 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen’s kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%.

Conclusions POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.

  • Human Papillomavirus
  • Point-of-Care Testing
  • Pre-Exposure Prophylaxis

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Footnotes

  • Handling editor Lenka Vodstrcil

  • Contributors LB, RR, AT, ADB, FD'A, AN, Ad'AM and MC participated in study design. LB, RR, ADB, CT, DC, PV, CB, RR, SB, CM, GM, DT and MC contributed to participants’ enrolment and data collection. AT performed statistical analysis. LB, RR, AT, ADB and Ad'AM participated in interpretation of the findings. LB drafted the manuscript. All authors critically reviewed and edited the manuscript. Ad'AM was the guarantor for this study. This study was conducted with the non-conditioning contribution of COPAN Italia S.p.A., provider of the swab used for the self-sample collection. Sponsor had no role in study design, data collection and analysis, and manuscript writing.

  • Funding COPAN Italia provided swabs for self-sampling for free.

  • Competing interests None declared.

  • 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.