VALGENT: A protocol for clinical validation of human papillomavirus assays

Journal of Clinical Virology

Volumn 76, Issue , 2016, Pages S14-S21

  Arbyn, Marc ^a   Depuydt, Christophe ^b   Benoy, Ina ^b   Bogers, Johannes ^b   Cuschieri, Kate ^c   Schmitt, Markus ^d   Pawlita, Michael ^d   Geraets, Daan ^e   Heard, Isabelle ^f   Gheit, Tarik ^g   Tommasino, Massimo ^g   Poljak, Mario ^h   Bonde, Jesper ⁱ   Quint, Wim ^e  

^a SCIENTIFIC INSTITUTE OF PUBLIC HEALTH   (Belgium)

^b AML Laboratory   (Belgium)

^c ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

^d GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^e DDL DIAGNOSTIC LABORATORY   (Netherlands)

^f INSTITUT PASTEUR   (France)

^g INTERNATIONAL AGENCY FOR RESEARCH ON CANCER   (France)

^h UNIVERSITY OF LJUBLJANA   (Slovenia)

ⁱ Mental Health Center Glostrup   (Denmark)

Author keywords

Cervical cancer; Cervical cancer screening; Diagnostic test accuracy; Human papillomavirus; Quality control; Test validation

Indexed keywords

CANCER SCREENING; CLINICAL PROTOCOL; CONCEPTUAL FRAMEWORK; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; GENOTYPE; HUMAN; HUMAN PAPILLOMAVIRUS DNA TEST; INTERMETHOD COMPARISON; NONHUMAN; POLYMERASE CHAIN REACTION; PRACTICE GUIDELINE; PRECANCER; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SENSITIVITY AND SPECIFICITY; UTERINE CERVIX CANCER; UTERINE CERVIX CARCINOMA IN SITU; UTERINE CERVIX CYTOLOGY; VALIDATION STUDY; WART VIRUS; ADULT; CERVICAL INTRAEPITHELIAL NEOPLASIA; CLASSIFICATION; COMPLICATION; DIAGNOSTIC KIT; EARLY CANCER DIAGNOSIS; FEMALE; GENETICS; GENOTYPING TECHNIQUE; ISOLATION AND PURIFICATION; MASS SCREENING; MIDDLE AGED; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; PROCEDURES; STANDARDS; SUPPLY AND DISTRIBUTION; UTERINE CERVICAL NEOPLASMS; VAGINA SMEAR; VIROLOGY;

DIAGNOSTIC KIT;

ADULT; CERVICAL INTRAEPITHELIAL NEOPLASIA; EARLY DETECTION OF CANCER; FEMALE; GENOTYPING TECHNIQUES; HUMAN PAPILLOMAVIRUS DNA TESTS; HUMANS; MASS SCREENING; MIDDLE AGED; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; REAGENT KITS, DIAGNOSTIC; UTERINE CERVICAL NEOPLASMS; VAGINAL SMEARS; VALIDATION STUDIES AS TOPIC;

EID: 84960460457     PISSN: 13866532     EISSN: 18735967     Source Type: Journal    
DOI: 10.1016/j.jcv.2015.09.014     Document Type: Review

References (43)

1. IARC Monograph Working Group IARC Monographs on the evaluation of carcinogenic risks to humans. Human Papillomaviruses 2007, vol. 90. IARC Press, Lyon.
2. Bouvard V., Baan R., Straif K., et al. A review of human carcinogens-part B: biological agents. Lancet Oncol. 2009, 10:321-322.
3. Arbyn M., Ronco G., Anttila A., et al. Evidence regarding HPV testing in secondary prevention of cervical cancer. Vaccine 2012, 30(Suppl. 5):F88-F99.
4. Ronco G., Dillner J., Elfstrom K.M., et al. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet 2014, 383:524-532.
5. Poljak M., Cuzick J., Kocjan B.J., Iftner T., Dillner J., Arbyn M. Nucleic acid tests for the detection of human papillomaviruses. Vaccine 2012, 30(Suppl. 5):F100-F106.
6. Meijer C.J.L.M., Castle P.E., Hesselink A.T., et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int. J. Cancer 2009, 124:516-520.
7. Arbyn M., Snijders P.J., Meijer C.J., et al. Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening?. Clin. Microbiol. Infect. 2015.
8. Khan M.J., Castle P.E., Lorincz A.T., et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J. Natl. Cancer Inst. 2005, 97:1072-1079.
9. Li N., Franceschi S., Howell-Jones R., Snijders P.J., Clifford G.M. Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: variation by geographical region, histological type and year of publication. Int. J. Cancer 2011, 128:927-935.
10. Bzhalava D., Guan P., Franceschi S., Dillner J., Clifford G. A systematic review of the prevalence of mucosal and cutaneous human papillomavirus types. Virology 2013, 445:224-231.
11. Arbyn M., Tommasino M., Depuydt C., Dillner J. Are twenty human papillomavirus types causing cervical cancer. J. Pathol. 2014, 234:431-435.
12. Huh W.K., Ault K.A., Chelmow D., et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening interim clinical guidance. Obstet. Gynecol. 2015, 125:330-337.
13. Unger E., Dillner J. Human Papillomavirus Laboratory Manual 2010, WHO (Quality, Safety and Standards (QSS) team of the Department of Immunization, Vaccines and Biologicals), Geneva. 1st ed.
14. Arbyn M., Anttila A., Jordan J., et al. European guidelines for quality assurance in cervical cancer screening: second edition-summary document. Ann. Oncol. 2010, 21:448-458.
15. von Karsa L., Arbyn M., De Vuyst H., et al. European guidelines for quality assurance in cervical cancer screening. Summary of the supplements on HPV screening and vaccination. Papillomavir. Res. 2015, 1:22-31.
16. Micalessi I.M., Boulet G.A., Bogers J.J., Benoy I.H., Depuydt C.E. High-throughput detection, genotyping and quantification of the human papillomavirus using real-time PCR. Clin. Chem. Lab Med. 2012, 50:655-661.
17. Depuydt C.E., Benoy I.H., Beert J.F., Criel A.M., Bogers J.J., Arbyn M. Clinical validation of a type-specific real time quantitative human papillomavirus PCR to the performance of hybrid capture 2 for the purpose of cervical cancer screening. J. Clin. Microbiol. 2012, 50:4073-4077.
18. Schmitt M., Dondog B., Waterboer T., Pawlita M. Homogeneous amplification of genital human alpha papillomaviruses by PCR using novel broad-spectrum GP5+ and GP6+ primers. J. Clin. Microbiol. 2008, 46:1050-1059.
19. Schmitt M., Depuydt C.E., Benoy I., et al. Viral load of high-risk human papillomaviruses as reliable clinical predictor for the presence of cervical lesions. Cancer Epidemiol. Biomarkers Prev. 2013, 22:406-414.
20. Snijders P.J., van den Brule A.J., Jacobs M.V., Pol R.P., Meijer C.J. HPV DNA detection and typing in cervical scrapes. Methods Mol. Med. 2005, 119:101-114.
21. Geraets D.T., Heideman D.A., de Koning M.N., et al. High-throughput genotyping of high-risk HPV by the digene HPV genotyping LQ test using GP5+/6+-PCR and xMAP technology. J. Clin. Virol. 2009, 46(Suppl. 3):S21-S26.
22. Schmitt M., Dondog B., Waterboer T., Pawlita M., Tommasino M., Gheit T. Abundance of multiple high-risk human papillomavirus (HPV) infections found in cervical cells analyzed by use of an ultrasensitive HPV genotyping assay. J. Clin. Microbiol. 2010, 48:143-149.
23. Ejegod D.M., Serrano I., Cuschieri K., et al. Clinical validation of the BD Onclarity™ HPV assay using a non-inferiority test. J. Med. Microbiol. Diagn. 2014, S3(003):1-4.
24. Castle P.E., Smith K.M., Davis T.E., et al. Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population. Am. J. Clin. Pathol. 2015, 143:126-133.
25. Hesselink A.T., Heideman D.A., Berkhof J., et al. Comparison of the clinical performance of PapilloCheck human papillomavirus detection with that of the GP5+/6+-PCR-enzyme immunoassay in population-based cervical screening. J. Clin. Microbiol. 2010, 48:797-801.
26. Geraets D., Cuschieri K., Koning M., et al. Clinical evaluation of a GP5+/6+-based Luminex assay having full high-risk HPV genotyping capability and an internal control. J. Clin. Microbiol. 2014, 52:3996-4002.
27. Arbyn M., Schneider A., Gissmann L., Kaufmann A.M. Highlights of the 27th International Papillomavirus Conference and Clinical Workshop (Berlin, 17-22 September 2011)-Part 2: Applied Clinical Science. Future Virol. 2012, 7:19-24.
28. Schmitt M., Depuydt C., Benoy I., et al. Multiple infections with high viral loads are associated with cervical lesions but do not differentiate grades of cervical abnormalities. J. Clin. Microbiol. 2013, 51:1458-1464.
29. Schmitt M., Depuydt C., Benoy I., et al. Prevalence and viral load of 51 genital human papillomavirus types and 3 subtypes. Int. J. Cancer 2013, 132:2395-2403.
30. Cuschieri K., Geraets D., Moore C., Quint W., Duvall E., Arbyn M. Clinical and analytical performance of the onclarity HPV assay using the VALGENT framework. J. Clin. Microbiol. 2015, 53:3272-3279.
31. Rebolj M., Preisler S., Ejegod D.M., Rygaard C., Lynge E., Bonde J. Disagreement between human papillomavirus assays: an unexpected challenge for the choice of an assay in primary cervical screening. PLoS One 2014, 9:e86835.
32. Eklund C., Zhou T., Dillner J.A. A global proficiency study of human papillomavirus genotyping. J. Clin. Microbiol. 2010, 48:4147-4155.
33. Eklund C., Forslund O., Wallin K.L., Dillner J. Global improvement in genotyping of human papillomavirus DNA: the 2011 HPVlabnet international proficiency study. J. Clin. Microbiol. 2014, 52:449-459.
34. Snijders P.J., van den Brule A.J., Meijer C.J.L.M. The clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivity. J. Pathol. 2003, 201:1-6.
35. Arbyn M., Ronco G., Cuzick J., Wentzensen N., Castle P.E. How to evaluate emerging technologies in cervical cancer screening?. Int. J. Cancer 2009, 125:2489-2496.
36. Arbyn M., Verdoodt F., Snijders P.J.F., et al. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014, 15:172-183.
37. Arbyn M., Andersson K., Bergeron C., Bogers J.P., von Knebel-Doeberitz M., Dillner J. Cervical cytology biobanks as a resource for molecular epidemiology. Methods Mol. Biol. 2011, 675:279-298.
38. Caldwell D.M., Ades A.E., Higgins J.P. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ 2005, 331:897-900.
39. Saslow D., Solomon D., Lawson H.W., et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J. Clin. 2012, 62:147-172.
40. WHO Who Guidelines for Screening and Treatment of Precancerous Lesions for Cervical Cancer Prevention 2013, 1-40. World Health Organisation, Geneva. N. Broutet (Ed.).
41. Landis J.R., Koch G.G. The measurement of observer agreement for categorical data. Biometrics 1977, 33:159-174.
42. Fleiss J.L. Statistical Methods for Rates and Proportions 1981, John Wiley & Sons, New York. 2nd ed.
43. Tang N.S., Tang M.L., Chan I.S. On tests of equivalence via non-unity relative risk for matched-pair design. Stat. Med. 2003, 22:1217-1233.