Development and characterization of the cobas human papillomavirus test

Journal of Clinical Microbiology

Volumn 51, Issue 5, 2013, Pages 1478-1484

  Rao, Arundhati ^a   Young, Stephen ^b   Erlich, Henry ^c   Boyle, Sean ^c   Krevolin, Mark ^c   Sun, Rita ^c   Apple, Raymond ^c   Behrens, Catherine ^c  

^a SCOTT AND WHITE MEMORIAL HOSPITAL   (United States)

^b TRICORE REFERENCE LABORATORIES   (United States)

^c ROCHE MOLECULAR SYSTEMS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; AUTOMATION; BETA GLOBIN GENE; CANCER GRADING; CONTROLLED STUDY; CYTOLOGY; DIAGNOSTIC TEST; DIAGNOSTIC TEST ACCURACY STUDY; FEMALE; FOOD AND DRUG ADMINISTRATION; GENE; GENOTYPE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 31; HUMAN PAPILLOMAVIRUS TYPE 33; HUMAN PAPILLOMAVIRUS TYPE 35; HUMAN PAPILLOMAVIRUS TYPE 39; HUMAN PAPILLOMAVIRUS TYPE 45; HUMAN PAPILLOMAVIRUS TYPE 51; HUMAN PAPILLOMAVIRUS TYPE 52; HUMAN PAPILLOMAVIRUS TYPE 56; HUMAN PAPILLOMAVIRUS TYPE 58; HUMAN PAPILLOMAVIRUS TYPE 59; HUMAN PAPILLOMAVIRUS TYPE 66; HUMAN PAPILLOMAVIRUS TYPE 68; LABORATORY TEST; LIMIT OF DETECTION; MAJOR CLINICAL STUDY; NONHUMAN; PRIORITY JOURNAL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SQUAMOUS CELL; UTERINE CERVIX CARCINOMA IN SITU; VIRUS GENE; VIRUS IDENTIFICATION; VIRUS LOAD; WART VIRUS; CERVICAL INTRAEPITHELIAL NEOPLASIA; CLASSIFICATION; CYTODIAGNOSIS; EVALUATION STUDY; GENETICS; PAPILLOMA VIRUS; PAPILLOMAVIRUS INFECTIONS; POLYMERASE CHAIN REACTION; UTERINE CERVICAL NEOPLASMS; VIROLOGY;

HUMAN PAPILLOMAVIRUS;

HEMOGLOBIN BETA CHAIN; VIRUS DNA;

BETA-GLOBINS; CERVICAL INTRAEPITHELIAL NEOPLASIA; CYTODIAGNOSIS; DNA, VIRAL; FEMALE; GENOTYPE; HUMANS; LIMIT OF DETECTION; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; POLYMERASE CHAIN REACTION; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; UTERINE CERVICAL NEOPLASMS;

EID: 84876746831     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.03386-12     Document Type: Article

References (28)

1. Kitchener HC, Castle PE, Cox JT. 2006. Chapter 7: achievements and limitations of cervical cytology screening. Vaccine 24 (Suppl 3):S3/63-S3/ 70. doi:10.1016/j.vaccine.2006.05.113.
2. Bulkmans NW, Berkhof J, Rozendaal L, van Kemenade FJ, Boeke AJ, Bulk S, Voorhorst FJ, Verheijen RH, van Groningen K, Boon ME, Ruitinga W, van Ballegooijen M, Snijders PJ, Meijer CJ. 2007. Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial. Lancet 370:1764-1772.
3. Naucler P, Ryd W, Törnberg S, Strand A, Wadell G, Elfgren K, Rádberg T, Strander B, Johansson B, Forslund O, Hansson BG, Rylander E, Dillner J. 2007. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N. Engl. J. Med. 357:1589-1597.
4. Castle PE, Stoler MH, Wright TC, Jr, Sharma A, Wright TL, Behrens CM. 2011. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. Lancet Oncol. 12:880-890.
5. Khan MJ, Castle PE, Lorincz AT, Wacholder S, Sherman M, Scott DR, Rush BB, Glass AG, Schiffman M. 2005. 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-specificHPVtesting in clinical practice. J. Natl. Cancer Inst. 97:1072-1079.
6. Wright TC, Jr, Stoler MH, Sharma A, Zhang G, Behrens C, Wright TL, ATHENA (Addressing THE Need for Advanced HPV Diagnostics) Study Group. 2011. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV-cytology-negative results. Am. J. Clin. Pathol. 136:578-586.
7. Stoler MH, Wright TC, Jr, Sharma A, Apple R, Gutekunst K, Wright TL, ATHENA (Addressing THE Need for Advanced HPV Diagnostics) HPV Study Group. 2011. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am. J. Clin. Pathol. 135:468-475.
8. Kjaer SK, Frederiksen K, Munk C, Iftner T. 2010. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence. J. Natl. Cancer Inst. 102: 1478-1488.
9. Rao A, Young S, Krevolin M, Sun R, Purner MB, Sharma A, Behrens CM. 2012. Comparison of cobas human papillomavirus test results from primary versus secondary vials of PreservCyt specimens and evaluation of potential cross-contamination. Cancer Cytopathol. 120:380-389.
10. Roche Molecular Diagnostics. 2009. cobas 4800 system manual 1.0. Roche Molecular Diagnostics, Pleasanton, CA.
11. Holland PM, Abramson RD, Watson R, Gelfand DH. 1991. Detection of specific polymerase chain reaction product by utilizing the 5=-3= exonuclease activity of Thermus aquaticusDNApolymerase. Proc. Natl. Acad. Sci. U. S. A. 88:7276-7280.
12. Meijer CJ, Berkhof J, Castle PE, Hesselink AT, Franco EL, Ronco G, Arbyn M, Bosch FX, Cuzick J, Dillner J, Heideman DA, Snijders PJ. 2009. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int. J. Cancer 124:516-520.
13. Digene Corporation. 2012. Hybrid Capture 2 High-Risk HPV DNA Test package insert. Digene Corporation, Gaithersburg, MD. http://www .thehpvtest.com/-/ media/5C4BD0982BED4E3788F65B36AF829AAD .ashx.
14. Wright TC, Jr, Stoler MH, Behrens CM, Apple R, Derion T, Wright TL. 2012. The ATHENA human papillomavirus study: design, methods, and baseline results. Am. J. Obstet. Gynecol. 206:46.e1-46.e11. doi:10.1016/j .ajog.2011.07.024.
15. Kondratovich MV, Yousef WA. 2005. Evaluation of accuracy and optimal cutoff of diagnostic devices in the same study, p 2547-2551. In ASA section on statistics in epidemiology. Proceedings of the 2005 Joint Statistical Meeting, Biopharmaceutical Section, Minneapolis, MN.
16. Gravitt PE, Peyton CL, Alessi TQ, Wheeler CM, Coutlee F, Hildesheim A, Schiffman MH, Scott DR, Apple RJ. 2000. Improved amplification of genital human papillomaviruses. J. Clin. Microbiol. 38:357-361.
17. Roche Molecular Systems, Inc. 2011. cobas HPV Test package insert. Roche Molecular Systems, Inc., Pleasanton, CA. http://www.accessdata .fda.gov/cdrh-docs/pdf10/P100020c.pdf.
18. de Villiers EM, Fauquet C, Broker TR, Bernard HU, zur Hausen H. 2004. Classification of papillomaviruses. Virology 324:17-27.
19. Muñoz N, Bosch FX, de Sanjosé S, Herrero R, Castellsagué X, Shah KV, Snijders PJ, Meijer CJ, International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. 2003. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N. Engl. J. Med. 348:518-527.
20. Bouvard V, Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F, Benbrahim-Tallaa L, Guha N, Freeman C, Galichet L, Cogliano V, WHO International Agency for Research on Cancer Monograph Working Group. 2009. A review of human carcinogens-part B: biological agents. Lancet Oncol. 10:321-322.
21. de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, Vallejos CS, de Ruiz PA, Lima MA, Guimera N, Clavero O, Alejo M, Llombart-Bosch A, Cheng-Yang C, Tatti SA, Kasamatsu E, Iljazovic E, Odida M, Prado R, Seoud M, Grce M, Usubutun A, Jain A, Suarez GA, Lombardi LE, Banjo A, Menendez C, Domingo EJ, Velasco J, Nessa A, Chichareon SC, Qiao YL, Lerma E, Garland SM, Sasagawa T, Ferrera A, Hammouda D, Mariani L, Pelayo A, Steiner I, Oliva E, Meijer CJ, Al-Jassar WF, Cruz E, Wright TC, Puras A, et al. 2010. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 11:1048-1056.
22. Munñoz N, Bosch FX, Castellsagué X, Díaz M, de Sanjose S, Hammouda D, Shah KV, Meijer CJ. 2004. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int. J. Cancer 111:278-285.
23. Clifford GM, Smith JS, Plummer M, Muñoz N, Franceschi S. 2003. Human papillomavirus types in invasive cervical cancer worldwide: a meta-analysis. Br. J. Cancer. 88:63-73.
24. Smith JS, Lindsay L, Hoots B, Keys J, Franceschi S, Winer R, Clifford GM. 2007. Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update. Int. J. Cancer 121:621-632.
25. Naucler P, Ryd W, Törnberg S, Strand A, Wadell G, Elfgren K, Radberg T, Strander B, Forslund O, Hansson BG, Hagmar B, Johansson B, Rylander E, Dillner J. 2009. Efficacy of HPV DNA testing with cytology triage and/or repeat HPV DNA testing in primary cervical cancer screening. J. Natl. Cancer Inst. 101:88-99.
26. Hesselink AT, van Ham MA, Heideman DA, Groothuismink ZM, Rozendaal L, Berkhof J, van Kemenade FJ, Massuger LA, Melchers WJ, Meijer CJ, Snijders PJ. 2008. Comparison of GP5-/6-PCR and SPF10-line blot assays for detection of high-risk human papillomavirus in samples from women with normal cytology results who develop grade 3 cervical intraepithelial neoplasia. J. Clin. Microbiol. 46:3215-3221.
27. Bulkmans NW, Rozendaal L, Snijders PJ, Voorhorst FJ, Boeke AJ, Zandwijken GR, van Kemenade FJ, Verheijen RH, Groningen K, Boon ME, Keuning HJ, van Ballegooijen M, van den Brule AJ, Meijer CJ. 2004. POBASCAM, a population-based randomized controlled trial for implementation of high-risk HPV testing in cervical screening: design, methods and baseline data of 44,102 women. Int. J. Cancer 110:94-101.
28. Kitchener HC, Gilham C, Sargent A, Bailey A, Albrow R, Roberts C, Desai M, Mather J, Turner A, Moss S, Peto J. 2011. A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: extended follow up in the ARTISTIC trial. Eur. J. Cancer. 47:864-871.