Aptima HPV E6/E7 mRNA test is as sensitive as hybrid capture 2 assay but more specific at detecting cervical precancer and cancer

Journal of Clinical Microbiology

Volumn 49, Issue 2, 2011, Pages 557-564

  Ratnam, Samuel ^a,c   Coutlee, Francois ^b   Fontaine, Dan ^c   Bentley, James ^d   Escott, Nicholas ^e   Ghatage, Prafull ^f   Gadag, Veeresh ^c   Holloway, Glen ^e   Bartellas, Elias ^c   Kum, Nick ^c   Giede, Christopher ^g   Lear, Adrian ^h  

^a Newfoundland and Labrador Public Health Laboratory   (Canada)

^b CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^c MEMORIAL UNIVERSITY OF NEWFOUNDLAND   (Canada)

^d QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

^e THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE   (Canada)

^f TOM BAKER CANCER CENTRE   (Canada)

^g ROYAL UNIVERSITY HOSPITAL   (Canada)

^h Dr H Bliss Murphy Cancer Centre   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

PROTEIN E6; PROTEIN E7; VIRUS RNA;

ADOLESCENT; ADULT; AGED; ARTICLE; CANADA; CANCER CYTODIAGNOSIS; CANCER RISK; CANCER SCREENING; COLPOSCOPY; CONTROLLED STUDY; FEMALE; GENOTYPE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; PATIENT REFERRAL; PRECANCER; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; UTERINE CERVIX CARCINOMA IN SITU; WART VIRUS;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; FEMALE; HUMANS; MIDDLE AGED; ONCOGENE PROTEINS, VIRAL; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; RNA, MESSENGER; RNA, VIRAL; SENSITIVITY AND SPECIFICITY; UTERINE CERVICAL NEOPLASMS; YOUNG ADULT;

HUMAN PAPILLOMAVIRUS;

EID: 79951474334     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.02147-10     Document Type: Article

References (48)

1. Anttila, A., et al. 2010. Rate of cervical cancer, severe intraepithelial neoplasia, and adenocarcinoma in situ in primary HPV DNA screening with cytology triage: randomised study within organized screening programme. BMJ 340:c1804.
2. Bosch, F. X., et al. 2008. Epidemiology and natural history of human papillomavirus infections and type-specific implications in cervical neoplasia. Vaccine 26S:K1-K16.
3. Bouvard, V., et al. 2009. A review of human carcinogens. Part B. Biological agents. Lancet Oncol. 10:321-322.
4. Bulkmans, N. W. J., et al. 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.
5. Castle, P. E., et al. 2008. Human papillomavirus genotype specificity of Hybrid Capture 2. J. Clin. Microbiol. 46:2595-2604.
6. Clad, A., et al. 2010. EUROGIN 2010, abstr. P HT-1.
7. Clifford, G. M., J. S. Smith, T. Aguado, and S. Franceschi. 2003. Comparison of HPV type distribution in high-grade cervical lesions and cervical cancer: a meta-analysis. Br. J. Cancer 89:101-105. (Pubitemid 36897943)
8. Cogliano, V., et al. 2005. Carcinogenicity of human papillomaviruses. Lancet Oncol. 6:204. (Pubitemid 40450709)
9. Coutlée, F., et al. 2007. Confirmatory real-time PCR assay for human papillomavirus (HPV) type 52 infection in anogenital specimens screened for HPV infection with the Linear Array HPV genotyping test. J. Clin. Microbiol. 45:3821-3823.
10. Coutlée, F., et al. 2006. Enhanced detection and typing of human papillomavirus DNA in anogenital samples with PGMY primers and the linear array HPV genotyping test. J. Clin. Microbiol. 44:1998-2006.
11. Cuzick, J., et al. 2008. Overview of human papillomavirus-based and other novel options for cervical cancer screening in developed and developing countries. Vaccine 26S:K29-K41.
12. Cuzick, J., et al. 2006. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. Int. J. Cancer 199:1095-1101. (Pubitemid 44116919)
13. Dockter, J., et al. 2009. Clinical performance of the APTIMA® HPV assay for the detection of high-risk HPV and high-grade cervical lesions. J. Clin. Virol. 45:S55-S61.
14. Franco, E. L., J. Cuzick, A. Hildesheim, and S. De Sanjosé. 2006. Issues in planning in cervical cancer screening in the era of HPV vaccination. Vaccine 24S3:S3/171-S3/177.
15. Khan, M. J., et al. 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-specific HPV testing in clinical practice. J. Natl. Cancer Inst. 97:1072-1079.
16. Koliopoulos, G., et al. 2007. Diagnostic accuracy of human papillomavirus testing in primary cervical screening: a systematic review and meta-analysis of non-randomized studies. Gynecol. Oncol. 104:232-246.
17. Kraus, I., et al. 2004. Human papillomavirus oncogenic expression in the dysplastic portio; an investigation of biopsies from 190 cervical cones. Br. J. Cancer 90:1407-1413. (Pubitemid 38586270)
18. Kraus, I., et al. 2006. Presence of E6 and E7 mRNA from human papillomavirus types 16, 18, 31, 33, and 45 in the majority of cervical carcinomas. J. Clin. Microbiol. 44:1310-1317.
19. Lie, A. K., and G. Kristensen. 2008. Human papillomavirus E6/E7 mRNA testing as a predictive marker for cervical carcinoma. Expert Rev. Mol. Diagn. 8:405-415.
20. Lie, A. K., et al. 2005. DNA- versus RNA-based methods for human papillomavirus detection in cervical neoplasia. Gynecol. Oncol. 97:908-915.
21. Mayrand, M. H., et al. 2007. Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer. N. Engl. J. Med. 357:1579-1588.
22. Meijer, C. J. L. M., et al. 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.
23. Molden, T., et al. 2005. Comparison of human papillomavirus messenger RNA and DNA detection: a cross sectional study of 4,136 women >30 years of age with a 2-year follow-up of high-grade squamous intraepithelial lesion. Cancer Epidemiol. Biomarkers Prev. 14:367-372.
24. Molden, T., I. Kraus, H. Skomedal, T. Nordstrøm, and F. Karlsen. 2007. PreTect™ HPV-Proofer: real-time detection and typing of E6/E7 mRNA from carcinogenic human papillomaviruses. J. Virol. Methods 142:204-212. (Pubitemid 46590424)
25. Molden, T., et al. 2005. Predicting CIN2+ when detecting HPV mRNA and DNA by PreTect HPV-Proofer and consensus PCR: a 2-year follow-up of women with ASCUS or LSIL Pap smear. Int. J. Cancer 114:973-976.
26. Monsonego, J., et al. 12 October 2010, posting date. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid based cytology in primary cervical cancer screening (the FASE study). Int. J. Cancer. doi: 10.1002/ijc.25726.
27. Münger, K., et al. 2004. Mechanisms of human papillomavirus-induced oncogenesis. J. Virol. 78:11451-11460. (Pubitemid 39390733)
28. Naucler, P., et al. 2007. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N. Engl. J. Med. 357:1589-1597.
29. Poljak, M., I. J. Marin, K. Seme, and A. Vince. 2002. Hybrid Capture II HPV test detects at least 15 human papillomavirus genotypes not included in its current high-risk probe cocktail. J. Clin. Virol. 25:S89-S97.
30. Ratnam, S., et al. 2010. Clinical performance of the Pre-Tect HPV-Proofer E6/E7 mRNA assay in comparison with that of the Hybrid Capture 2 test for identification of women at risk of cervical cancer. J. Clin. Microbiol. 48:2779-2785.
31. Ratnam, S., et al. 2010. Clinical correlation of Aptima HPV E6/E7 mRNA test in cervical cancer screening: preliminary results from a multicentre Canadian study. EUROGIN, abstr. SS 8-6.
32. Ronco, G., et al. 2008. Results at recruitment from a randomized controlled trial comparing human papillomavirus testing alone with conventional cytology as the primary cervical cancer screening test. J. Natl. Cancer Inst. 100:492-501.
33. 10-LiPA system to the Hybrid Capture 2 assay for detection of carcinogenic human papillomavirus genotypes among 5,683 young women in Guanacaste, Costa Rica. J. Clin. Microbiol. 45:1447-1454.
34. Sankaranarayanan, R., et al. 2009. HPV screening for cervical cancer in rural India. N. Engl. J. Med. 360:1385-1394.
35. Saslow, D., et al. 2002. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J. Clin. 52:342-362.
36. Schiffman, M. H., et al. 1993. Epidemiologic evidence showing that human papillomavirus infection causes most cervical intraepithelial neoplasia. J. Natl. Cancer Inst. 85:958-964.
37. Schiffman, M., P. E. Castle, J. Jeronimo, A. C. Rodriquez, and S. Wacholder. 2007. Human papillomavirus and cervical cancer. Lancet 370:890-907. (Pubitemid 47371147)
38. Smith, J. S., et al. 2007. Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update. Int. J. Cancer 121:621-632. (Pubitemid 46986496)
39. Solomon, D., et al. 2002. The 2001 Bethesda system: terminology for reporting results of cervical cytology. JAMA 287:2114-2119. (Pubitemid 34437346)
40. Sotlar, K., et al. 2004. Detection of high-risk human papillomavirus E6 and E7 oncogene transcripts in cervical scrapes by nested RT-polymerase chain reaction. J. Med. Virol. 74:107-116.
41. Stoler, M. H., P. E. Castle, D. Solomon, and M. Schiffman. 2007. The expanded use of HPV testing in gynecologic practice per ASCCP-guided management requires the use of well-validated assays. Am. J. Clin. Pathol. 127:335-337.
42. Szarewski, A., et al. 2008. Comparison of predictors for high-grade cervical intraepithelial neoplasia in women with abnormal smears. Cancer Epidemiol. Biomarkers Prev. 17:3033-3042.
43. 10-INNO LiPA human papillomavirus (HPV) genotyping test and the Roche Linear Array HPV genotyping test. J. Clin. Microbiol. 44:3122-3129.
44. Walboomers, J. M. M., et al. 1999. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J. Pathol. 189:12-19. (Pubitemid 29406813)
45. Wright, T. C., et al. 2007. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am. J. Obstet. Gynecol. 197:346-355.
46. Wright, T. C., et al. 2007. 2006 consensus guidelines for the management of women with cervical intraepithelial neoplasia or adenocercinoma in situ. Am. J. Obstet. Gynecol. 197:340-345.
47. Wulan, N., et al. 2010. EUROGIN 2010, abstr. SS 23/24-13.
48. zur Hausen, H. 1994. Molecular pathogenesis of cancer of the cervix and its causation by specific human papillomavirus types. Curr. Top. Microbiol. Immunol. 186:131-156.