A second generation cervico-vaginal lavage device shows similar performance as its preceding version with respect to DNA yield and HPV DNA results

详细信息    查看全文

• 作者：Viola MJ Verhoef (1)
  Maaike G Dijkstra (1)
  Remko P Bosgraaf (2)
  Albertus T Hesselink (1)
  Willem JG Melchers (3)
  Ruud LM Bekkers (2)
  Johannes Berkhof (4)
  Folkert J van Kemenade (1)
  
• 关键词：Human papillomavirus ; Self ; sampling ; HPV DNA testing ; Cervical screening ; Self ; sampling device
• 刊名：BMC Women's Health
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：13
• 期：1
• 全文大小：213KB
• 参考文献：1. Peto J, Gilham C, Fletcher O, Matthews FE: The cervical cancer epidemic that screening has prevented in the UK. / Lancet 2004, 364:249-56. CrossRef
  2. Quinn M, Babb P, Jones J, Allen E: Effect of screening on incidence of and mortality from cancer of cervix in England: evaluation based on routinely collected statistics. / BMJ 1999, 318:904-08. mj.318.7188.904">CrossRef
  3. Van Ballegooijen M, Van Den Akker Van M, Patnick J, Lynge E, Arbyn M, Anttila A: Overview of important cervical cancer screening process values in European Union (EU) countries, and tentative predictions of the corresponding effectiveness and cost-effectiveness. / Eur J Cancer 2000, 36:2177-188. CrossRef
  4. Sigurdsson K: The Icelandic and Nordic cervical screening programs: trends in incidence and mortality rates through 1995. / Acta Obstet Gynecol Scand 1999, 78:478-85. CrossRef
  5. Ronco G, Giorgi-Rossi P, Carozzi F, Confortini M, Dalla PP, Del MA: Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. / Lancet Oncol 2010, 11:249-57. CrossRef
  6. Arbyn M, Sanjose SD, Saraiya M, Sideri M, Palefsky J, Lacey C: EUROGIN 2011 roadmap on prevention and treatment of HPV-related disease. / Int J Cancer 2012, 131:1969-982. CrossRef
  7. Rijkaart DC, Berkhof J, Rozendaal L, van Kemenade FJ, Bulkmans NW, Heideman DA: Human papillomavirus testing for the detection of high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomised controlled trial. / Lancet Oncol 2012, 13:78-8. CrossRef
  8. Sasieni P, Adams J, Cuzick J: Benefit of cervical screening at different ages: evidence from the UK audit of screening histories. / Br J Cancer 2003, 89:88-3. CrossRef
  9. Bos AB, Rebolj M, Habbema JD, van Ballegooijen M: Nonattendance is still the main limitation for the effectiveness of screening for cervical cancer in the Netherlands. / Int J Cancer 2006, 119:2372-375. CrossRef
  10. Bais AG, van Kemenade FJ, Berkhof J, Verheijen RH, Snijders PJ, Voorhorst F: Human papillomavirus testing on self-sampled cervicovaginal brushes: an effective alternative to protect nonresponders in cervical screening programs. / Int J Cancer 2007, 120:1505-510. CrossRef
  11. Gok M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW: HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. / BMJ 2010, 340:c1040. mj.c1040">CrossRef
  12. Gok M, van Kemenade FJ, Heideman DA, Berkhof J, Rozendaal L, Spruyt JW: Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. / Int J Cancer 2012, 130:1128-135. CrossRef
  13. Virtanen A, Anttila A, Luostarinen T, Nieminen P: Self-sampling versus reminder letter: effects on cervical cancer screening attendance and coverage in Finland. / Int J Cancer 2011, 128:2681-687. CrossRef
  14. Virtanen A, Nieminen P, Luostarinen T, Anttila A: Self-sample HPV tests as an intervention for nonattendees of cervical cancer screening in Finland: a randomized trial. / Cancer Epidemiol Biomarkers Prev 2011, 20:1960-969. CrossRef
  15. Wikstrom I, Lindell M, Sanner K, Wilander E: Self-sampling and HPV testing or ordinary Pap-smear in women not regularly attending screening: a randomised study. / Br J Cancer 2011, 105:337-39. CrossRef
  16. Szarewski A, Cadman L, Mesher D, Austin J, Ashdown-Barr L, Edwards R: HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. / Br J Cancer 2011, 104:915-20. CrossRef
  17. Giorgi RP, Marsili LM, Camilloni L, Lossa A, Lattanzi A, Sani C: The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600). / Br J Cancer 2011, 104:248-54. CrossRef
  18. Holanda F Jr, Castelo A, Veras TM, de Almeida FM, Lins MZ, Dores GB: Primary screening for cervical cancer through self sampling. / Int J Gynaecol Obstet 2006, 95:179-84. CrossRef
  19. Qiao YL, Sellors JW, Eder PS, Bao YP, Lim JM, Zhao FH: A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China. / Lancet Oncol 2008, 9:929-36. CrossRef
  20. Lazcano-Ponce E, Lorincz AT, Cruz-Valdez A, Salmeron J, Uribe P, Velasco-Mondragon E: Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial. / Lancet 2011, 378:1868-873. CrossRef
  21. Ogilvie GS, Patrick DM, Schulzer M, Sellors JW, Petric M, Chambers K: Diagnostic accuracy of self collected vaginal specimens for human papillomavirus compared to clinician collected human papillomavirus specimens: a meta-analysis. / Sex Transm Infect 2005, 81:207-12. CrossRef
  22. Stewart DE, Gagliardi A, Johnston M, Howlett R, Barata P, Lewis N: Self-collected samples for testing of oncogenic human papillomavirus: a systematic review. / J Obstet Gynaecol Can 2007, 29:817-28.
  23. Petignat P, Faltin DL, Bruchim I, Tramer MR, Franco EL, Coutlee F: Are self-collected samples comparable to physician-collected cervical specimens for human papillomavirus DNA testing? A systematic review and meta-analysis. / Gynecol Oncol 2007, 105:530-35. CrossRef
  24. Schmeink CE, Bekkers RL, Massuger LF, Melchers WJ: The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. / Rev Med Virol 2011, 21:139-53. mv.686">CrossRef
  25. Brink AA, Meijer CJ, Wiegerinck MA, Nieboer TE, Kruitwagen RF, Van KF: High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. / J Clin Microbiol 2006, 44:2518-523. CrossRef
  26. Dijkstra MG, Heideman DA, Van Kemenade FJ, Hogewoning KJ, Hesselink AT, Verkuijten MC: Brush-based self-sampling in combination with GP5+/6+?PCR-based hrHPV testing: high concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN. / J Clin Virol 2012, 54:147-51. CrossRef
  27. Belinson JL, Du H, Yang B, Wu R, Belinson SE, Qu X: Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing. / Int J Cancer 2012, 130:1855-860. CrossRef
  28. Jolijn Coebergh Van Den B, Corine V, Albert H, Dani?lle H, Ben Willem M: High acceptability of a modified lavage device for self-sampling. / Abstract IPV Conference Berlin 2012.
  29. Jones HE, Brudney K, Sawo DJ, Lantigua R, Westhoff CL: The Acceptability of a Self-Lavaging Device Compared to Pelvic Examination for Cervical Cancer Screening Among Low-Income Women. / J Womens Health (Larchmt) 2012, 21:1275-281. CrossRef
  30. van den Brule AJ, Pol R, Fransen-Daalmeijer N, Schouls LM, Meijer CJ, Snijders PJ: GP5+/6+ PCR followed by reverse line blot analysis enables rapid and high-throughput identification of human papillomavirus genotypes. / J Clin Microbiol 2002, 40:779-87. CrossRef
  31. Hesselink AT, Heideman DA, Steenbergen RD, Coupe VM, Overmeer RM, Rijkaart D: Combined promoter methylation analysis of CADM1 and MAL: an objective triage tool for high-risk human papillomavirus DNA-positive women. / Clin Cancer Res 2011, 17:2459-465. CrossRef
  32. Coupe VM, Berkhof J, Bulkmans NW, Snijders PJ, Meijer CJ: Age-dependent prevalence of 14 high-risk HPV types in the Netherlands: implications for prophylactic vaccination and screening. / Br J Cancer 2008, 98:646-51. CrossRef
  33. The pre-publication history for this paper can be accessed here:medcentral.com/1472-6874/13/21/prepub" class="a-plus-plus">http://www.biomedcentral.com/1472-6874/13/21/prepub
  
• 作者单位：Viola MJ Verhoef (1)
  Maaike G Dijkstra (1)
  Remko P Bosgraaf (2)
  Albertus T Hesselink (1)
  Willem JG Melchers (3)
  Ruud LM Bekkers (2)
  Johannes Berkhof (4)
  Folkert J van Kemenade (1)
  
  1. Department of Pathology, VU University Medical Center, (VUmc) De Boelelaan 1117, Amsterdam, 1007, MB, The Netherlands
  2. Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  3. Department of Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  4. Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
  

文摘

Background Attendance rates of cervical screening programs can be increased by offering HPV self-sampling to non-attendees. Acceptability, DNA yield, lavage volumes and choice of hrHPV test can influence effectiveness of the self-sampling procedures and could therefore play a role in recruiting non-attendees. To increase user-friendliness, a frequently used lavage sampler was modified. In this study, we compared this second generation lavage device with the first generation device within similar birth cohorts. Methods Within a large self-sampling cohort-study among non-responders of the Dutch cervical screening program, a subset of 2,644 women received a second generation self-sampling lavage device, while 11,977 women, matched for age and ZIP-code, received the first generation model. The second generation device was different in shape, color, lavage volume, and packaging, in comparison to its first generation model. The Cochran’s test was used to compare both devices for hrHPV positivity rate and response rate. To correct for possible heterogeneity between age and ZIP codes in both groups the Breslow-Day test of homogeneity was used. A T-test was utilized to compare DNA yields of the obtained material in both groups. Results Median DNA yields were 90.4 μg/ml (95% CI 83.2-97.5) and 91.1 μg/ml (95% CI 77.8-104.4, p= 0.726) and hrHPV positivity rates were 8.2% and 6.9% (p= 0.419) per sample self-collected by the second - and the first generation of the device (p= 0.726), respectively. In addition, response rates were comparable for the two models (35.4% versus 34.4%, p= 0.654). Conclusions Replacing the first generation self-sampling device by an ergonomically improved, second generation device resulted in equal DNA yields, comparable hrHPV positivity rates and similar response rates. Therefore, it can be concluded that the clinical performance of the first and second generation models are similar. Moreover, participation of non-attendees in cervical cancer screening is probably not predominantly determined by the type of self-collection device.