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Evaluation of the compatibility of the Digene media when performing the Roche linear array human papillomavirus genotyping test

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Abstract

Purpose

This study was performed to evaluate the compatibility of the Digene media when performing the Roche linear array human papillomavirus (HPV) genotyping test.

Methods

A total of 258 samples from 166 women were tested using the Hybrid Capture 2 (HC2) assay, the Cytyc media-based linear array test, and the Digene media-based linear array test.

Results

The results between the HC2 assay and the Digene media-based linear array test were highly concordant (kappa = 0.78). The Cytyc media-based linear array test and Digene media-based linear array test exhibited substantial agreement in 207/249 cervical samples (kappa = 0.62). The two genotyping test also showed substantial agreement for the detection of HPV genotypes 16, 18, 52, 58 and for 18 HPV genotypes including both high-risk, and possible high-risk genotypes (kappa = 0.74, 0.69, respectively).

Conclusions

We found Digene media to be interchangeable with Cytyc media when performing the Roche linear array genotyping test. This may be clinically meaningful in that we could perform the Roche linear array genotyping test with the same Digene media among women, positive for HC2 assay without the need for a return visit.

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References

  1. Bosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV (2002) The causal relation between human papillomavirus and cervical cancer. J Clin Pathol 55:244–265

    PubMed  CAS  Google Scholar 

  2. Ferlay J, Bray F, Pisani P, Parkin DM (2002) GLOBOCAN: cancer incidence, mortality and prevalence worldwide, version 2.0. IARC Cancer Base No. 5. IARC Press, Lyon. http://www-depdb.iarc.fr/globocan/GLOBOframe.htm

  3. Munoz N (2000) Human papillomavirus and cancer: the epidemiological evidence. J Clin Virol 19:1–5. doi:10.1016/S1386-6532(00)00125-6

    Article  PubMed  CAS  Google Scholar 

  4. Munoz N, Bosch FX, de Sanjose S, Tafur L, Izarzugaza I, Gili M, Viladiu P, Navarro C, Martos C, Ascunce N (1992) The causal link between human papillomavirus and invasive cervical cancer: a population-based case-control study in Colombia and Spain. Int J Cancer 52:743–749. doi:10.1002/ijc.2910520513

    Article  PubMed  CAS  Google Scholar 

  5. Parkin DM, Pisani P, Ferlay J (1999) Estimates of the worldwide incidence of 25 major cancers in 1990. Int J Cancer 80:827–841. doi:10.1002/(SICI)1097-0215(19990315)80:6<827::AID-IJC6>3.0.CO;2-P

    Article  PubMed  CAS  Google Scholar 

  6. Wallin KL, Wiklund F, Angstrom T, Bergman F, Stendahl U, Waldell G, Hallmans G, Dillner J (1999) Type-specific persistence of human papillomavirus DNA before the development of invasive cervical cancer. N Engl J Med 341:1633–1638. doi:10.1056/NEJM199911253412201

    Article  PubMed  CAS  Google Scholar 

  7. 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. J Natl Cancer Inst 87:796–802. doi:10.1093/jnci/87.11.796

    Article  PubMed  CAS  Google Scholar 

  8. Clifford GM, Smith JS, Plummer M, Munoz N, Franceschi S (2003) Human papillomavirus types in invasive cervical cancer worldwide: a meta-analysis. Br J Cancer 88:63–73. doi:10.1038/sj.bjc.6600688

    Article  PubMed  CAS  Google Scholar 

  9. Munoz N, Bosch FX, de Sanjose S, Hererro R, Castellsague 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. doi:10.1056/NEJMoa021641

    Article  PubMed  Google Scholar 

  10. 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. doi:10.1002/(SICI)1096-9896(199909)189:1<12::AID-PATH431>3.0.CO;2-F

    Article  PubMed  CAS  Google Scholar 

  11. Cuschieri KS, Whitley MJ, Cubie HA (2004) Human papillomavirus type specific DNA and RNA persistence-implications for cervical disease progression and monitoring. J Med Virol 73:65–70. doi:10.1002/jmv.20062

    Article  PubMed  CAS  Google Scholar 

  12. Ho GY, Burk RD, Klein S, Kadish AS, Chang CJ, Palan P, Basu J, Tachezy R, Lewis R, Romney S (1995) Persistent genital human papillomavirus infection as a risk factor for persistent cervical dysplasia. J Natl Cancer Inst 87:1365–1371. doi:10.1093/jnci/87.18.1365

    Article  PubMed  CAS  Google Scholar 

  13. Remmink AJ, Walboomers JM, Helmerhorst TJ, Voorhorst FJ, Rozendaal L, Risse EK, Meijer CJ, Kenemans P (1995) The presence of persistent high-risk HPV genotypes in dysplastic cervical lesions is associated with progressive disease: natural history up to 36 months. Int J Cancer 61:306–311. doi:10.1002/ijc.2910610305

    Article  PubMed  CAS  Google Scholar 

  14. The Atypical Squamous Intraepithelial Lesions Triage Study (ALTS) Group (2000) Human papillomavirus testing for triage of women with cytologic evidence of low-grade squamous intraepithelial lesions: baseline data from a randomized trial. J Natl Cancer Inst 92:397–402. doi:10.1093/jnci/92.5.397

    Article  Google Scholar 

  15. Meijer CJ, Snijders PJ, van de Brule AJ (2000) Screening for cervical cancer: should we test for infection with high-risk HPV? CMAJ 163:535–538

    PubMed  CAS  Google Scholar 

  16. Wright TC, Schiffman M (2003) Adding a test for human papillomavirus DNA to cervical cancer screening. N Engl J Med 348:489–490. doi:10.1056/NEJMp020178

    Article  PubMed  Google Scholar 

  17. De Roda Husman AM, Walboomers JM, van den Brule AJ, Meijer CJ, Snijders PJ (1995) The use of general primers GP5 and GP6 elongated at their 3′ ends with adjacent highly conserved sequences improves human papillomavirus detection by PCR. J Gen Virol 76:1057–1062. doi:10.1099/0022-1317-76-4-1057

    Article  PubMed  Google Scholar 

  18. Jacobs MV, Snijders PJ, van den Brule AJ, Helmerhorst TJ, Meijer CJ, Walboomers JM (1997) A general primer GP5+/GP6+ mediated PCR-enzyme immunoassay method for rapid detection of 14 high risk and 6 low risk human papillomavirus genotypes in cervical scrapings. J Clin Microbiol 35:791–795

    PubMed  CAS  Google Scholar 

  19. Gravitt PE, Peyton CL, Alessi TQ, Wheeler CM, Coutlee F, Hildesheim A, Shiffman MH, Scott DR, Apple RJ (2000) Improved amplification of genital human papillomavirus. J Clin Microbiol 38:357–361

    PubMed  CAS  Google Scholar 

  20. Gravitt PE, Peyton CL, Apple RJ, Wheeler CM (1998) Genotyping of 27 human papillomavirus types by using L1 consensus PCR products by a single-hybridization, reverse line blot detection method. J Clin Microbiol 36:3020–3027

    PubMed  CAS  Google Scholar 

  21. Kleter B, van Doorn LJ, ter Schegget J, Schrauwen L, van Krimpen K, Burger M, ter Hamsel B, Quint W (1998) Novel short-fragment PCR assay for highly sensitive broad-spectrum detection of anogenital human papillomaviruses. Am J Pathol 153:1731–1739

    PubMed  CAS  Google Scholar 

  22. Perrons C, Jelley R, Kleter B, Quint W, Brink N (2005) Detection of persistent high-risk human papillomavirus infections with hybrid capture II and SPF10/LiPA. J Clin Virol 32:278–285. doi:10.1016/j.jcv.2004.08.009

    Article  PubMed  CAS  Google Scholar 

  23. Perrons C, Kleter B, Jelley R, Jalal H, Quint W, Tedder R (2002) Detection and genotyping of human papillomavirus DNA by SPF10 and MY09/11 primers in cervical cells taken from women attending a colposcopy clinic. J Med Virol 67:246–252. doi:10.1002/jmv.2214

    Article  PubMed  CAS  Google Scholar 

  24. Castle PE, Wheeler CM, Solomon D, Schiffman M, Peyton CL (2004) Interlaboratory reliability of Hybrid Capture 2. Am J Clin Pathol 122:238–245. doi:10.1309/BA43HMCAJ26VWQH3

    Article  PubMed  CAS  Google Scholar 

  25. Polzak M, Fujs K, Seme K, Kocjan BJ, Vrtacnik-Bokal E (2005) Retrospective and prospective evaluation of the Amplicor HPV test for detection of 13 high-risk human papillomavirus genotypes on 862 clinical samples. Acta Dermatovenerol Alp Panonica Adriat 14(4):147–152

    Google Scholar 

  26. Sandri MT, Lentati P, Benini E, Dell’Orto P, Zorzino L, Carozzi FM, Maisonneuve P, Passerini R, Salvatici M, Casadio C, Boveri S, Sideri M (2006) Comparison of the Digene HC2 assay and the Roche AMPLICOR human papillomavirus (HPV) test for detection of high-risk HPV genotypes in cervical samples. J Clin Microbiol 44(6):2141–2146. doi:10.1128/JCM.00049-06

    Article  PubMed  Google Scholar 

  27. Molden T, Kraus I, Karlsen F, Skomedal H, Nygard JF, Hagmar B (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(2):367–372. doi:10.1158/1055-9965.EPI-04-0410

    Article  PubMed  CAS  Google Scholar 

  28. Molden T, Nygard JF, Kraus I, Kralsen F, Nygard M, Skare GB, Skomedal H, Thoresen SO, Hagmar B (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(6):973–976. doi:10.1002/ijc.20839

    Article  PubMed  CAS  Google Scholar 

  29. Castellsague X, Diaz M, de Sanjose S, Munoz N, Herrero R, Franceschi S, Peeling RW, Ashley R, Smith JS, Snijders PJ, Meijer CJ, Bosch FX (2006) Worldwide human papillomavirus etiology of cervical adenocarcinoma and its cofactors: implications for screening and prevention. J Natl Cancer Inst 98(5):303–315

    Article  PubMed  Google Scholar 

  30. Clifford GM, Rana RK, Franceschi S, Smith JS, Gough G, Pimenta JM (2005) Human papillomavirus genotype distribution in low-grade cervical lesions: comparison by geographic region and with cervical cancer. Cancer Epidemiol Biomarkers Prev 14(5):1157–1164. doi:10.1158/1055-9965.EPI-04-0812

    Article  PubMed  Google Scholar 

  31. 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(3):621–632. doi:10.1002/ijc.22527

    Article  PubMed  CAS  Google Scholar 

  32. Woo YL, Damay I, Stanley M, Crawford R, Sterling J (2007) The use of HPV linear array assay for multiple HPV typing on archival frozen tissue and DNA specimens. J Virol Methods 142:226–230. doi:10.1016/j.jviromet.2007.01.029

    Article  PubMed  CAS  Google Scholar 

  33. Feng J, Husain M (2005) Reflex high-risk human papillomavirus DNA testing (Hybrid Capture 2) of bloody ThinPrep specimens with atypical squamous cells of undetermined significance interpretation: does pretreatment with acetic acid affect test performance? Cancer 105:452–456. doi:10.1002/cncr.21349

    Article  PubMed  Google Scholar 

  34. The ASCUS-LSIL Triage study (ALTS) group (2003) Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance. Am J Obstet Gynecol 188:1383–1392

    Google Scholar 

  35. Stevens MP, Garland SM, Rudland E, Tan J, Quinn MA, Tabrizi SN (2007) Comparison of the Digene Hybrid Capture 2 assay and Roche AMPLICOR and LINEAR ARRAY human papillomavirus (HPV) tests in detecting high-risk HPV genotypes in specimens from women with previous abnormal Pap smear results. J Clin Microbiol 45:2130–2137. doi:10.1128/JCM.02438-06

    Article  PubMed  Google Scholar 

  36. 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(8):2595–2604. doi:10.1128/JCM.00824-08

    Article  PubMed  Google Scholar 

  37. Poljak M, Marin IJ, Seme K, Vince A (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(Suppl 3):89–97. doi:10.1016/S1386-6532(02)00187-7

    Article  Google Scholar 

  38. Seme K, Fujs K, Kocjan BJ, Poljak M (2006) Resolving repeatedly borderline results of Hybrid Capture 2 HPV DNA test using polymerase chain reaction and genotyping. J Virol Methods 134(1–2):252–256. doi:10.1016/j.jviromet.2005.12.004

    Article  PubMed  CAS  Google Scholar 

  39. Clifford GM, Smith JS, Aguado T, Franceschi S (2003) Comparison of HPV type distribution in high-grade cervical lesions and cervical cancer: a meta-analysis. Br J Cancer 89:101–105. doi:10.1038/sj.bjc.6601024

    Article  PubMed  CAS  Google Scholar 

  40. Munoz N, Bosch FX, Castellsague X, Diaz 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. doi:10.1002/ijc.20244

    Article  PubMed  CAS  Google Scholar 

  41. Denis F, Hanz S, Alain S (2008) Clearance, persistence and recurrence of HPV infection. Gynecol Obstet Fertil 36(4):430–440. doi:10.1016/j.gyobfe.2008.02.008

    Article  PubMed  CAS  Google Scholar 

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Acknowledgments

This work was supported by a Korea Science and Engineering Foundation (KOSEF) grant funded by the Korean government (MOST) (R01-2006-000-10621-0). We also thank Ms Young Mi Yun for her considerable devotion in statistical analysis of data.

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Correspondence to Mi Kyung Kim.

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Hong, J.H., Lee, J.K., Song, ES. et al. Evaluation of the compatibility of the Digene media when performing the Roche linear array human papillomavirus genotyping test. Arch Gynecol Obstet 280, 613–618 (2009). https://doi.org/10.1007/s00404-009-0974-7

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  • DOI: https://doi.org/10.1007/s00404-009-0974-7

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