Human papillomavirus negative high grade cervical lesions and cancers: Suggested guidance for HPV testing quality assurance.

Autor: Prétet JL; French National Papillomavirus Reference Center, CHU de Besançon, EA3181, Université of Franche-Comté, F-25000 Besançon, France., Arroyo Mühr LS; Swedish National HPV Reference Laboratory, Center for Cervical Cancer Elimination, Karolinska Institutet and Karolinska University Hospital F56, 141 86 Stockholm, Sweden., Cuschieri K; Scottish HPV Reference Laboratory, Deptartment of Lab Medicine, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK., Fellner MD; Laboratorio Nacional y Regional de Referencia de Papilomavirus Humanos, Instituto Nacional de Enfermedades Infecciosas-ANLIS 'Dr Malbrán', C1282AFF Buenos Aires, Argentina., Correa RM; Laboratorio Nacional y Regional de Referencia de Papilomavirus Humanos, Instituto Nacional de Enfermedades Infecciosas-ANLIS 'Dr Malbrán', C1282AFF Buenos Aires, Argentina., Picconi MA; Laboratorio Nacional y Regional de Referencia de Papilomavirus Humanos, Instituto Nacional de Enfermedades Infecciosas-ANLIS 'Dr Malbrán', C1282AFF Buenos Aires, Argentina., Garland SM; Royal Women's Hospital, Parkville 3052 VIC, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Parkville 3052 VIC, Australia., Murray GL; Royal Women's Hospital, Parkville 3052 VIC, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Parkville 3052 VIC, Australia., Molano M; Royal Women's Hospital, Parkville 3052 VIC, Australia., Peeters M; National Reference Centre for Human Papillomaviruses, Viral Diseases, Infectious Diseases in Humans, Sciensano. Rue Juliette Wytsman 14, 1050 Brussels, Belgium., Van Gucht S; National Reference Centre for Human Papillomaviruses, Viral Diseases, Infectious Diseases in Humans, Sciensano. Rue Juliette Wytsman 14, 1050 Brussels, Belgium., Lambrecht C; National Reference Centre for Human Papillomaviruses, Algemeen Medisch Laboratorium. Emiel Vloorsstraat 9, 2020 Antwerp, Belgium., Broeck DV; National Reference Centre for Human Papillomaviruses, Algemeen Medisch Laboratorium. Emiel Vloorsstraat 9, 2020 Antwerp, Belgium., Padalko E; National Reference Centre for Human Papillomaviruses, Laboratory of Medical Microbiology, University Hospital Ghent. C. Heymanslaan 10, 9000 Ghent, Belgium., Arbyn M; Unit Cancer Epidemiology, Cancer centre, Sciensano. Rue Juliette Wytsman 14, 1050 Brussels, Belgium., Lepiller Q; French National Papillomavirus Reference Center, CHU de Besançon, EA3181, Université of Franche-Comté, F-25000 Besançon, France., Brunier A; French National Papillomavirus Reference Center, CHU de Besançon, EA3181, Université of Franche-Comté, F-25000 Besançon, France., Silling S; Institute of Virology, National Reference Center for Papilloma- and Polyomaviruses, University of Cologne, Faculty of Medicine and University Hospital of Cologne, 50935 Cologne, Germany., Søreng K; Norwegian HPV Reference Laboratory, Department of Microbiology and Infection Control, Akershus University Hospital, Lørenskog, Norway., Christiansen IK; Norwegian HPV Reference Laboratory, Department of Microbiology and Infection Control, Akershus University Hospital, Lørenskog, Norway., Poljak M; Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloška 4, 1000 Ljubljana, Slovenia., Lagheden C; Swedish National HPV Reference Laboratory, Center for Cervical Cancer Elimination, Karolinska Institutet and Karolinska University Hospital F56, 141 86 Stockholm, Sweden., Yilmaz E; Swedish National HPV Reference Laboratory, Center for Cervical Cancer Elimination, Karolinska Institutet and Karolinska University Hospital F56, 141 86 Stockholm, Sweden., Eklund C; Swedish National HPV Reference Laboratory, Center for Cervical Cancer Elimination, Karolinska Institutet and Karolinska University Hospital F56, 141 86 Stockholm, Sweden., Thapa HR; Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA., Querec TD; Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA., Unger ER; Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA., Dillner J; Swedish National HPV Reference Laboratory, Center for Cervical Cancer Elimination, Karolinska Institutet and Karolinska University Hospital F56, 141 86 Stockholm, Sweden. Electronic address: Joakim.dillner@ki.se.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2024 Apr; Vol. 171, pp. 105657. Date of Electronic Publication: 2024 Feb 20.
DOI: 10.1016/j.jcv.2024.105657
Abstrakt: Background: Some high-grade cervical lesions and cervical cancers (HSIL+) test negative for human papillomavirus (HPV). The HPV-negative fraction varies between 0.03 % and 15 % between different laboratories. Monitoring and extended re-analysis of HPV-negative HSIL+ could thus be helpful to monitor performance of HPV testing services. We aimed to a) provide a real-life example of a quality assurance (QA) program based on re-analysis of HPV-negative HSIL+ and b) develop international guidance for QA of HPV testing services based on standardized identification of apparently HPV-negative HSIL+ and extended re-analysis, either by the primary laboratory or by a national HPV reference laboratory (NRL).
Methods: There were 116 initially HPV-negative cervical specimens (31 histopathology specimens and 85 liquid-based cytology samples) sent to the Swedish HPV Reference Laboratory for re-testing. Based on the results, an international QA guidance was developed through an iterative consensus process.
Result: Standard PCR testing detected HPV in 55.2 % (64/116) of initially "HPV-negative" samples. Whole genome sequencing of PCR-negative samples identified HPV in an additional 7 samples (overall 61.2 % HPV positivity). Reasons for failure to detect HPV in an HSIL+ lesion are listed and guidance to identify cases for extended re-testing, including which information should be included when referring samples to an NRL are presented.
Conclusion: Monitoring the proportion of and reasons for failure to detect HPV in HSIL+ will help support high performance and quality improvement of HPV testing services. We encourage implementation of QA strategies based on re-analysis of "HPV negative" HSIL+ samples.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: K Cuschieri'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, Hologic and Vaccitech. M.P.’s institution received research funding, free-of-charge reagents, and consumables to support research in the last 3 years from Qiagen, Seegene, Abbott, and Roche, all paid to his employer. Sciensano the employer of M.A. received funding in the framework of Valgent and VALHUDES, which are 2 researcher induced protocols for evaluation of HPV tests on cervical and vaginal samples respectively (see Arbyn et J Clin Virol 2016 & 2018). M.A, did not receive any financial or material benefit from these projects.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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