The Human Papillomavirus (HPV) Laboratory e-Manual: A comprehensive guide for HPV testing and research

Laila Sara Arroyo Mühr¹, Carina Eklund¹, Camilla Lagheden¹, Rita Mariel Correa², María Dolores Fellner², Maria Alejandra Picconi², Nazlı Songur³, Murat Gultekin³, Kate Cuschieri⁴, Jean-Luc Prétet⁵, Quentin Lepiller⁵, Alice Baraquin⁶, Steffi Silling⁷, Kristiane Søreng⁸, Milan Stosic⁸, Gro Kummeneje Presthus⁸, Marc Arbyn⁹, Michael Peeters⁹, Steven Van Gucht⁹, Elizaveta Padalko¹⁰, Taeyang Chin¹⁰, Kaat Kehoe¹¹, Ana Rita Pereira¹¹, Nina Redzic¹¹, Davy Vanden Broeck¹¹, Monica Molano¹², Gerald L Murray¹³, Suzanne M Garland¹⁴, Ligia A Pinto¹⁵, Dianna E Wilkinson¹⁶, Mario Poljak¹⁷, Joakim Dillner¹⁸

Affiliations

¹ International HPV Reference Center, Center for Cervical Cancer Elimination, F56, Karolinska Institutet and Karolinska University Hospital, 141 86 Stockholm, Sweden.
² Oncogenic Viruses Service, Argentine HPV Reference Laboratory, National Institute of Infectious Diseases-ANLIS "Dr. Malbrán", Vélez Sarsfield 563 (C1282AFF), Buenos Aires, Argentina.
³ Hacettepe University Faculty of Medicine, Department of Obstetrics and Gynecology, Division of Gynaecological Oncology, Ankara, Turkey.
⁴ Scottish HPV Reference Laboratory, Department of Laboratory Medicine, Royal Infirmary of Edinburgh, EH16 4SA & HPV Research Group, Centre for Reproductive Health, University of Edinburgh, UK.
⁵ CHU Besançon, French National Papillomavirus Reference Center, F-25000 Besançon, France; Université Marie et Louis Pasteur, CHU Besançon, CNRS, Chrono-environnement (UMR 6249), F-25000 Besançon, France.
⁶ CHU Besançon, French National Papillomavirus Reference Center, F-25000 Besançon, France.
⁷ German National Reference Center, Institute of Virology, University Hospital and University of Cologne, Fuerst-Pueckler-Str. 56, 50935 Cologne, Germany.
⁸ Norwegian HPV Reference Laboratory, Department of Microbiology and Infection Control, Akershus University Hospital, Lørenskog, Norway.
⁹ The Belgian Reference Centre for Human Papillomavirus, Sciensano, Infectious Diseases in Humans, Viral Diseases, Brussels, Belgium.
¹⁰ The Belgian Reference Centre for Human Papillomavirus, University Hospital Ghent, Laboratory of Medical Microbiology, Ghent, Belgium.
¹¹ The Belgian Reference Centre for Human Papillomavirus, Algemeen Medisch Laboratorium - Sonic Healthcare Benelux, Antwerp, Belgium.
¹² Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Victoria, Australia.
¹³ Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics, Gynaecology and Newborn Health, University of Melbourne, Parkville, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
¹⁴ Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
¹⁵ Vaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD 21702, USA.
¹⁶ Vaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD 21702, USA; Viral Vaccines-Science, Research and Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, UK.
¹⁷ The Slovenian Reference Center for Human Papillomavirus, Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Slovenia.
¹⁸ International HPV Reference Center, Center for Cervical Cancer Elimination, F56, Karolinska Institutet and Karolinska University Hospital, 141 86 Stockholm, Sweden. Electronic address: joakim.dillner@ki.se.

PMID: 40651060
DOI: 10.1016/j.jcv.2025.105834

Free article

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The Human Papillomavirus (HPV) Laboratory e-Manual: A comprehensive guide for HPV testing and research

Laila Sara Arroyo Mühr et al. J Clin Virol. 2025 Aug.

Free article

. 2025 Aug:179:105834.

doi: 10.1016/j.jcv.2025.105834. Epub 2025 Jul 10.

Authors

Affiliations

¹ International HPV Reference Center, Center for Cervical Cancer Elimination, F56, Karolinska Institutet and Karolinska University Hospital, 141 86 Stockholm, Sweden.
² Oncogenic Viruses Service, Argentine HPV Reference Laboratory, National Institute of Infectious Diseases-ANLIS "Dr. Malbrán", Vélez Sarsfield 563 (C1282AFF), Buenos Aires, Argentina.
³ Hacettepe University Faculty of Medicine, Department of Obstetrics and Gynecology, Division of Gynaecological Oncology, Ankara, Turkey.
⁴ Scottish HPV Reference Laboratory, Department of Laboratory Medicine, Royal Infirmary of Edinburgh, EH16 4SA & HPV Research Group, Centre for Reproductive Health, University of Edinburgh, UK.
⁵ CHU Besançon, French National Papillomavirus Reference Center, F-25000 Besançon, France; Université Marie et Louis Pasteur, CHU Besançon, CNRS, Chrono-environnement (UMR 6249), F-25000 Besançon, France.
⁶ CHU Besançon, French National Papillomavirus Reference Center, F-25000 Besançon, France.
⁷ German National Reference Center, Institute of Virology, University Hospital and University of Cologne, Fuerst-Pueckler-Str. 56, 50935 Cologne, Germany.
⁸ Norwegian HPV Reference Laboratory, Department of Microbiology and Infection Control, Akershus University Hospital, Lørenskog, Norway.
⁹ The Belgian Reference Centre for Human Papillomavirus, Sciensano, Infectious Diseases in Humans, Viral Diseases, Brussels, Belgium.
¹⁰ The Belgian Reference Centre for Human Papillomavirus, University Hospital Ghent, Laboratory of Medical Microbiology, Ghent, Belgium.
¹¹ The Belgian Reference Centre for Human Papillomavirus, Algemeen Medisch Laboratorium - Sonic Healthcare Benelux, Antwerp, Belgium.
¹² Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Victoria, Australia.
¹³ Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics, Gynaecology and Newborn Health, University of Melbourne, Parkville, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
¹⁴ Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
¹⁵ Vaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD 21702, USA.
¹⁶ Vaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD 21702, USA; Viral Vaccines-Science, Research and Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, UK.
¹⁷ The Slovenian Reference Center for Human Papillomavirus, Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Slovenia.
¹⁸ International HPV Reference Center, Center for Cervical Cancer Elimination, F56, Karolinska Institutet and Karolinska University Hospital, 141 86 Stockholm, Sweden. Electronic address: joakim.dillner@ki.se.

PMID: 40651060
DOI: 10.1016/j.jcv.2025.105834

Abstract

Background: Human Papillomavirus (HPV) vaccination and HPV-based cervical cancer screening are central pillars of the World Health Organization (WHO) global cervical cancer elimination strategy. The WHO HPV Laboratory Manual, published in 2009, has provided essential guidance to promote an internationally comparable quality of HPV testing for many years. As the development in this area is rapid, the Global Network of National HPV Reference Laboratories considered that there is a need for an updated HPV Laboratory e-Manual to serve as a comprehensive and interactive resource for professionals engaged in quality-assured HPV testing for research and/or HPV-based cancer control.

Content: The HPV Laboratory e-Manual covers key areas, including laboratory quality assurance, HPV taxonomy and risk association, collection and handling of specimens, nucleic acid extraction, HPV detection and typing, HPV serology, data management, and the use of international standards. It provides up-to-date protocols and best practices to enhance accuracy and reliability of HPV testing. Interactive features allow for real-time updates, making it a dynamic resource for laboratories worldwide. The e-Manual is freely available at: https://www.hpvcenter.se/hpv-laboratory-manual/.

Collaborators: The e-Manual has been developed by international experts from 11 countries, including contributors from the International HPV Reference Center (IHRC, Sweden), the CDC's Global HPV Reference Laboratory (USA), and multiple National HPV Reference Laboratories (NRLs). The standard procedure for writing a chapter was that 2 NRLs authored the chapter and 1 other NRL reviewed it.

Conclusion: The HPV Laboratory e-Manual represents a step toward global harmonization in laboratory methodologies for HPV testing, underpinning both research and cervical cancer control efforts.

Keywords: Cervical screening; Quality assurance; Reproducibility; Standardization; Vaccination.

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Conflict of interest statement

Declaration of Competing Interest Jean-Luc Pretet´s institution received funding, free‐of‐charge reagents and consumables from Fujirebio, Primadiag, Genfirst, Atila BioSystems and Sansure. Sciensano, the employer of Marc Arbyn has received support from the VALGENT and VALHUDES which are networks for validation and comparison of HPV tests on clinician-collected and self-collected specimens. Elizaveta Padalko’s institution has received consumables to support research from Seegene and Copan in the last 3 years. Kate Cuschieri’s institution has received research funding or gratis consumables to support research from the following commercial entities in the last 3 years: Abbott, Euroimmun, GeneFirst, Qiagen, Hiantis, Seegene, Roche, Hologic, Barinthus Biotherapeutics PLC & Daye. Kate Cuschieri has attended advisory board meetings for Hologic, Becton Dickinson and Barinthus Biotherapeutics PLC (no personal remuneration received; UK travel supported for Hologic). Mario Poljak’s institution has received research funding, free-of-charge reagents, and consumables to support research from the following commercial entities in the last 3 years: Qiagen, Self-screen, Seegene, Abbott, Roche, Liferiver and Hybribio, all paid to his employer. Dr. Davy Vanden Broeck’s laboratory has received funding and/or gratis reagents/consumables to support research from the following commercial entities during the last 3 years: Abbott, Seegene, LifeRiver, Sansure, Bioperfectus, ACON, Genefirst, Euroimmun, Elitech. The rest of authors have nothing to declare.

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The Human Papillomavirus (HPV) Laboratory e-Manual: A comprehensive guide for HPV testing and research

Affiliations

The Human Papillomavirus (HPV) Laboratory e-Manual: A comprehensive guide for HPV testing and research

Authors

Affiliations

Abstract

Conflict of interest statement

Publication types

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LinkOut - more resources

Full Text Sources

Research Materials