Sensitivity of APTIMA HPV E6/E7 mRNA test in comparison with hybrid capture 2 HPV DNA test for detection of high risk oncogenic human papillomavirus in 396 biopsy confirmed cervical cancers

Journal of Medical Virology

Volumn 88, Issue 7, 2016, Pages 1271-1278

  Basu, Partha ^a   Banerjee, Dipanwita ^a   Mittal, Srabani ^a   Dutta, Sankhadeep ^a   Ghosh, Ishita ^a   Chowdhury, Nilarun ^a   Abraham, Priya ^b   Chandna, Puneet ^c   Ratnam, Sam ^d  

^a CHITTARANJAN NATIONAL CANCER INSTITUTE   (India)

^b CHRISTIAN MEDICAL COLLEGE   (India)

^c AceProbe Technologies (India) Pvt Ltd   (India)

^d MEMORIAL UNIVERSITY OF NEWFOUNDLAND   (Canada)

Author keywords

Aptima; Carcinoma cervix; Cervical cancer screening; HPV; Hybrid capture 2; Linear array

Indexed keywords

KI 67 ANTIGEN; PROTEIN P16; MESSENGER RNA; VIRUS DNA;

ADENOCARCINOMA; ADULT; APTIMA HPV E6 TEST; APTIMA HPV E7 TEST; ARTICLE; CANCER SCREENING; CANCER STAGING; CARCINOMA; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; ENDOMETRIAL BRUSH; FEMALE; GENOTYPE; GENOTYPING TECHNIQUE; HUMAN; HUMAN PAPILLOMAVIRUS DNA TEST; 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 68; HUMAN PAPILLOMAVIRUS TYPE 73; HUMAN PAPILLOMAVIRUS TYPE 82; HUMAN TISSUE; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; POSTMENOPAUSE; PREMENOPAUSE; RAPID TEST; SENSITIVITY ANALYSIS; SENSITIVITY AND SPECIFICITY; UTERINE CERVIX BIOPSY; UTERINE CERVIX CANCER; UTERINE CERVIX CARCINOMA; UTERINE CERVIX CARCINOMA IN SITU; VIRUS DETECTION; AGED; BIOPSY; CLASSIFICATION; COMPARATIVE STUDY; DIAGNOSTIC KIT; EARLY CANCER DIAGNOSIS; EVALUATION STUDY; GENETICS; ISOLATION AND PURIFICATION; MIDDLE AGED; MOLECULAR DIAGNOSIS; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTION; PATHOLOGY; PROCEDURES; UTERINE CERVIX; UTERINE CERVIX TUMOR; VIROLOGY;

ADULT; AGED; BIOPSY; CERVICAL INTRAEPITHELIAL NEOPLASIA; CERVIX UTERI; DNA, VIRAL; EARLY DETECTION OF CANCER; FEMALE; GENOTYPE; HUMAN PAPILLOMAVIRUS DNA TESTS; HUMANS; MIDDLE AGED; MOLECULAR DIAGNOSTIC TECHNIQUES; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; REAGENT KITS, DIAGNOSTIC; RNA, MESSENGER; SENSITIVITY AND SPECIFICITY; UTERINE CERVICAL NEOPLASMS;

EID: 84953931341     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.24453     Document Type: Article

References (46)

1. Arbyn M, Roelens J, Cuschieri K, Cuzick J, Szarewski A, Ratnam S, Reuschenbach M, Belinson S, Belinson JL, Monsonego J. 2013. The APTIMA HPV assay versus the Hybrid Capture 2 test in triage of women with ASC-US or LSIL cervical cytology: A meta-analysis of the diagnostic accuracy. Int J Cancer 132:101-108.
2. Arbyn M, Snijders PJ, Meijer CJ, Berkhof J, Cuschieri K, Kocjan BJ, Poljak M. 2015. Which high risk HPV assays fulfil criteria for use in primary cervical cancer screening? Clin Microbiol Infect 21:817-826.
3. Basu P, Chandna P, Bamezai RN, Siddiqi M, Saranath D, Lear A, Ratnam S. 2011. MassARRAY spectrometry is more sensitive than PreTect HPV-Proofer and consensus PCR for type-specific detection of high risk oncogenic human papillomavirus genotypes in cervical cancer. J Clin Microbiol 49:3537-3544.
4. Basu P, Roychowdhury S, Bafna UD, Chaudhury S, Kothari S, Sekhon R, Saranath D, Biswas S, Gronn P, Silva I, Siddiqi M, Ratnam S. 2009. Human papillomavirus genotype distribution in cervical cancer in India: Results from a multi-center study. Asian Pac J Cancer Prev 10:27-34.
5. Blatt AJ, Kennedy R, Luff RD, Austin RM, Rabin DS. 2015. Comparison of cervical cancer screening results among 256, 648 women in multiple clinical practices. Cancer Cytopathol 123:282-288.
6. Bergeron C, Ikenberg H, Sideri M, Denton K, Bogers J, Schmidt D, Alameda F, Keller T, Rehm S, Ridder R, PALMS Study Group. 2015. Prospective evaluation of p16/Ki-67 dual-stained cytology for managing women with abnormal papanicolaou cytology: PALMS Study Results. Cancer Cytopathol 123:373-381.
7. Bosch FX, Broker TR, Forman D, Moscicki AB, Gillison ML, Doorbar J, Stern PL, Stanley M, Arbyn M, Poljak M, Cuzick J, Castle PE, Schiller JT, Markowitz LE, Fisher WA, Canfell K, Denny LA, Franco EL, Steben M, Kane MA, Schiffman M, Meijer CJ, Sankaranarayanan R, Castellsague X, Kim JJ, Brotons M, Alemany L, Albero G, Diaz M, de Sanjose S. 2013. Comprehensive control of human papillomavirus infections and related diseases. Vaccine 7:H1-31.
8. Bosch FX, Manos MM, Munoz N, Sherman M, Jansen AM, Peto J, Schiffman MH, Moreno V, Kurman R, Shah KV. 1995. Prevalence of human papillomavirus in cervical cancer: A worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst 87:796-802.
9. 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.
10. Castle PE, Solomon D, Wheeler CM, Gravitt PE, Wacholder S, Schiffman M. 2008. Human papillomavirus genotype specificity of hybrid capture 2. J Clin Microbiol 46:2595-2604.
11. Castle P. 2015. Comparison of cervical cancer screening results among 256, 648 women in multiple clinical practices. Cancer Cytopathol 123:566.
12. Coutlee F, Ratnam S, Ramanakumar AV, Insinga RR, Bentley J, Escott N, Ghatage P, Koushik A, Ferenczy A, Franco EL. 2011. Distribution of human papillomavirus genotypes in cervical intraepithelial neoplasia and invasive cervical cancer in Canada. J Med Virol 83:1034-1041.
13. Cuzick J, Arbyn M, Sankaranarayanan R, Tsu V, Ronco G, Mayrand MH, Dillner J, Meijer CJ. 2008. Overview of human papillomavirus-based and other novel options for cervical cancer screening in developed and developing countries. Vaccine 10:K29-K41.
14. Cuzick J, Cadman L, Mesher D, Austin J, Ashdown-Barr L, Ho L, Terry G, Liddle S, Wright C, Lyons D, Szarewski A. 2013. Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer 108:908-913.
15. Dalstein V, Merlin S, Bali C, Saunier M, Dachez R, Ronsin C. 2009. Analytical evaluation of the PapilloCheck test, a new commercial DNA chip for detection and genotyping of human papillomavirus. J Virol Methods 156:77-83.
16. 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, Llave CL, Tzardi M, Agorastos T, Garcia-Barriola V, Clavel C, Ordi J, Andujar M, Castellsague X, Sanchez GI, Nowakowski AM, Bornstein J, Munoz N, Bosch FX. 2010. Human papillomavirus genotype attribution in invasive cervical cancer: A retrospective cross-sectional worldwide study. Lancet Oncol 11:1048-1056.
17. Dockter J, Schroder A, Hill C, Guzenski L, Monsonego J, Giachetti C. 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.
18. Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. 2015. Cancer incidence and mortality worldwide: Sources, methods, and major patterns in GLOBOCAN 2012. Int J Cancer 136:E359-E386.
19. Huang S, Erickson B, Tang N, Mak WB, Salituro J, Robinson J, Abravaya K. 2009. Clinical performance of Abbott RealTime High Risk HPV test for detection of high-grade cervical intraepithelial neoplasia in women with abnormal cytology. J Clin Virol 45:S19-S23.
20. Iftner T, Becker S, Neis KJ, Castanon A, Iftner A, Holz B, Staebler A, Henes M, Rall K, Haedicke J, von Weyhern CH, Clad A, Brucker S, Sasieni P. 2015. Head-to-head comparison of the RNA-based aptima human papillomavirus (HPV) assay and the DNA-based hybrid capture 2 HPV test in a routine screening population of women aged 30 to 60 years in Germany. J Clin Microbiol 53:2509-2516.
21. Ikenberg H, Bergeron C, Schmidt D, Griesser H, Alameda F, Angeloni C, Bogers J, Dachez R, Denton K, Hariri J, Keller T, von Knebel DM, Neumann HH, Puig-Tintore LM, Sideri M, Rehm S, Ridder R. 2013. Screening for cervical cancer precursors with p16/Ki-67 dual-stained cytology: Results of the PALMS study. J Natl Cancer Inst 105:1550-1557.
22. Kitchener HC, Almonte M, Thomson C, Wheeler P, Sargent A, Stoykova B, Gilham C, Baysson H, Roberts C, Dowie R, Desai M, Mather J, Bailey A, Turner A, Moss S, Peto J. 2009. HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): A randomised controlled trial. Lancet Oncol 10:672-682.
23. Kraus I, Molden T, Holm R, Lie AK, Karlsen F, Kristensen GB, Skomedal H. 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.
24. Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, Ratnam S, Coutlee F, Franco EL. 2007. Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer. N Engl J Med 357:1579-1588.
25. 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.
26. Monsonego J, Hudgens MG, Zerat L, Zerat JC, Syrjanen K, Halfon P, Ruiz F, Smith JS. 2011. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: The FASE study. Int J Cancer 129:691-701.
27. Munger K, Baldwin A, Edwards KM, Hayakawa H, Nguyen CL, Owens M, Grace M, Huh K. 2004. Mechanisms of human papillomavirus-induced oncogenesis. J Virol 78:11451-11460.
28. Mulvany NJ, Allen DG, Wilson SM. 2008. Diagnostic utility of p16INK4a: A reappraisal of its use in cervical biopsies. Pathology 40:335-344.
29. Naucler P, Ryd W, Tornberg S, Strand A, Wadell G, Elfgren K, Radberg 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.
30. Petry KU, Menton S, Menton M, van Loenen-Frosch F, de Carvalho GH, Holz B, Schopp B, Garbrecht-Buettner S, Davies P, Boehmer G, van den Akker E, Iftner T. 2003. Inclusion of HPV testing in routine cervical cancer screening for women above 29 years in Germany: Results for 8466 patients. Br J Cancer 88:1570-1577.
31. Pirog EC, Lloveras B, Molijn A, Tous S, Guimera N, Alejo M, Clavero O, Klaustermeier J, Jenkins D, Quint WG, Xavier BF, Alemany L, de Sanjose S. 2014. HPV prevalence and genotypes in different histological subtypes of cervical adenocarcinoma, a worldwide analysis of 760 cases. Mod Pathol 27:1559-1567.
32. Poljak M, Cuzick J, Kocjan BJ, Iftner T, Dillner J, Arbyn M. 2012. Nucleic acid tests for the detection of alpha human papillomaviruses. Vaccine 30:F100-F106.
33. Ratnam S, Coutlee F, Fontaine D, Bentley J, Escott N, Ghatage P, Gadag V, Holloway G, Bartellas E, Kum N, Giede C, Lear A. 2010. Clinical performance of the PreTect 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.
34. Ratnam S, Coutlee F, Fontaine D, Bentley J, Escott N, Ghatage P, Gadag V, Holloway G, Bartellas E, Kum N, Giede C, Lear A. 2011. Aptima HPV E6/E7 mRNA test is as sensitive as Hybrid Capture 2 Assay but more specific at detecting cervical precancer and cancer. J Clin Microbiol 49:557-564.
35. Ronco G, Dillner J, Elfstrom KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ. 2014. Efficacy of HPV-based screening for prevention of invasive cervical cancer: Follow-up of four European randomised controlled trials. Lancet 383:524-532.
36. Safaeian M, Sherman ME. 2013. From Papanicolaou to papillomaviruses: Evolving challenges in cervical cancer screening in the era of human papillomavirus vaccination. J Natl Cancer Inst 105:1524-1526.
37. Shrivastava S, Mahantshetty U, Engineer R, Tongaonkar H, Kulkarni J, Dinshaw K. 2013. Treatment and outcome in cancer cervix patients treated between 1979 and 1994: A single institutional experience. J Cancer Res Ther 9:672-679.
38. Sotlar K, Stubner A, Diemer D, Menton S, Menton M, Dietz K, Wallwiener D, Kandolf R, Bultmann B. 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.
39. Stoler MH, Castle PE, Solomon D, Schiffman M. 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.
40. Stoler MH, Wright TC, Jr., Sharma A, Apple R, Gutekunst K, Wright TL. 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.
41. Szarewski A, Mesher D, Cadman L, Austin J, Ashdown-Barr L, Ho L, Terry G, Liddle S, Young M, Stoler M, McCarthy J, Wright C, Bergeron C, Soutter WP, Lyons D, Cuzick J. 2012. Comparison of seven tests for high-grade cervical intraepithelial neoplasia in women with abnormal smears: The Predictors 2 study. J Clin Microbiol 50:1867-1873.
42. Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. 1999. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 189:12-19.
43. Wiebe E, Denny L, Thomas G. 2012. Cancer of the cervix uteri. Int J Gynaecol Obstet 119:S100-S109.
44. Wright TC, Jr., Stoler MH, Agreda PM, Beitman GH, Gutierrez EC, Harris JM, Koch KR, Kuebler M, LaViers WD, Legendre BL, Jr., Leitch SV, Maus CE, McMillian RA, Nussbaumer WA, Palmer ML, Porter MJ, Richart GA, Schwab RJ, Vaughan LM. 2014. Clinical performance of the BD Onclarity HPV assay using an adjudicated cohort of BD SurePath liquid-based cytology specimens. Am J Clin Pathol 142:43-50.
45. Zheng B, Li Z, Griffith CC, Yan S, Chen C, Ding X, Liang X, Yang H, Zhao C. 2015. Prior high risk HPV testing and Pap test results for 427 invasive cervical cancers in China's largest CAP-certified laboratory. Cancer Cytopathol 123:428-434.
46. Zubach V, Smart G, Ratnam S, Severini A. 2012. Novel microsphere-based method for detection and typing of 46 mucosal human papillomavirus types. J Clin Microbiol 50:460-464.