IPVS policy statement on HPV nucleic acid testing guidance for those utilising/considering HPV as primary precancer screening: Quality assurance and quality control issues

Garland SM 1 , Iftner T 2 , Cuschieri K 3 , Kaufmann AM 4 , Arbyn M 5 , de Sanjose S 6 Show all authors , Poljak M 7 , Dillner J 8 , Unger ER 9 , IPVS Policy Committee

Affiliations 

  • 1 Department of Obstetrics and Gynaecology, University of Melbourne, Parkville 3052, Victoria, Australia; Centre for Women's Infectious Diseases Research, The Royal Women's Hospital, Parkville 3052, Victoria, Australia; Infection and Immunity, Murdoch Children's Research Institute, Parkville 3052, Victoria, Australia. Electronic address: suzanneg@unimelb.edu.au
  • 2 Institute Med. Virology and Epidemiology, of Viral Diseases Institut Med. Virologie und Epidemiologie der Viruskrankheiten Elfriede-Aulhorn-Str. 6| 72076 Tübingen, Germany
  • 3 Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, Scotland; HPV Research Group, University of Edinburgh, Edinburgh, Scotland
  • 4 Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Clinic for Gynecology, Augustenburger Platz 1, 13353, Berlin, Germany
  • 5 Unit Cancer Epidemiology, Belgian Cancer Centre, Sciensano, 1050 Brussels, Belgium
  • 6 ISGlobal, Barcelona, Spain
  • 7 Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Slovenia
  • 8 Medical Diagnostics Karolinska| Karolinska University Hospital, Center for Cervical Cancer Prevention, 14186 Stockholm, Sweden
  • 9 Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA
J Clin Virol, 2023 Feb;159:105349.
PMID: 36584621 DOI: 10.1016/j.jcv.2022.105349

Abstract

We advise that only clinically validated HPV assays which have fulfilled internationally accepted performance criteria be used for primary cervical screening. Further, assays should be demonstrated to be fit for purpose in the laboratory in which they will ultimately be performed, and quality materials manuals and frameworks will be helpful in this endeavor. Importantly, there is a fundamental shortage of well validated, low-cost, low complexity HPV tests that have demonstrated utility in a near-patient setting; representing a significant challenge and focus for future development in order to reach the WHO's goal of eliminating cervical cancer.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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