Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening.

Autor: Arbyn M; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium., Cuschieri K; Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, Scotland, UK., Bonde J; Department of Pathology, Molecular Pathology Laboratory, AHH-Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark., Schuurman R; Department of Medical Microbiology, University Medical Center Utrecht and Bevolkingsonderzoek Nederland and National Reference Officer HPV for the Dutch Cervical Cancer Screening Program, Utrecht, The Netherlands., Cocuzza C; Department of Medicine and Surgery, Laboratory of Clinical Microbiology and Virology, University of Milano-Bicocca, Monza, Italy., Broeck DV; Department of Molecular Diagnostics (Laboratory of the National Reference Centre for HPV), AML Sonic Healthcare Belgium, Antwerp, Belgium., Zhao FH; Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China., Rezhake R; Cancer Research Institute, Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China., Gultekin M; Hacettepe University Faculty of Medicine, Chair of ESGO Prevention Committee, Ankara, Turkey., de Sanjosé S; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA.; ISGlobal, Barcelona, Spain., Canfell K; The Daffodil Centre, A Joint Venture with Cancer Council NSW, University of Sydney, Sydney, Australia., Hawkes D; Australian Centre for the Prevention of Cervical Cancer, Carlton, Victoria, Australia., Saville M; Australian Centre for the Prevention of Cervical Cancer, Carlton, Victoria, Australia., Hillemanns P; Department of Gynecology and Obstetrics, Hannover Medical School, Hannover, Germany., Dillner J; Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden., Berkhof J; Department of Epidemiology and Data Science, Amsterdam UMC, Amsterdam, The Netherlands., Prétet JL; French National Papillomavirus Reference Center, CHU de Besancon, EA3181, Universite of Franche-Comte, Besancon, France., Gheit T; International Agency for Research on Cancer, Lyon, France., Clifford G; International Agency for Research on Cancer, Lyon, France., Basu P; International Agency for Research on Cancer, Lyon, France., Almonte M; Department of Non-Communicable Diseases, World Health Organisation, Geneva, Switzerland., Wentzensen N; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA., Poljak M; Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Jazyk: angličtina
Zdroj: Journal of medical virology [J Med Virol] 2024 Sep; Vol. 96 (9), pp. e29881.
DOI: 10.1002/jmv.29881
Abstrakt: While HC2 and GP5+/6+ PCR-EIA were pivotal in test validation of new HPV assays, they represent the first generation of comparator tests based upon technologies that are not in widespread use anymore. In the current guideline, criteria for second-generation comparator tests are presented that include more detailed resolution of HPV genotypes. Second-generation comparator tests should preferentially target only the 12 genotypes classified as carcinogenic (IARC-group I), and show consistent non-inferior sensitivity for CIN2+ and CIN3+ and specificity for ≤CIN1 compared to one of the first-generations comparators, in at least three validation studies using benchmarks of 0.95 for relative sensitivity and 0.98 for relative specificity. Validation should take into account used storage media and other sample handling procedures. Meta-analyses were conducted to identify the assays that fulfill these stringent criteria. Four tests fulfilled the new criteria: (1) RealTime High-Risk HPV Test (Abbott), (2) Cobas-4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately.
(© 2024 The Author(s). Journal of Medical Virology published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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