Journal of Clinical Virology
Volume 42, Issue 1 , Pages 22-26 , May 2008

Comparison of a novel HPV test with the Hybrid Capture II (hcII) and a reference PCR method shows high specificity and positive predictive value for 13 high-risk human papillomavirus infections

  • Cristina Baleriola

      Affiliations

    • Virology Division, Department of Microbiology, South Eastern Area Laboratory Services, Prince of Wales Hospital, Randwick, NSW 2031, Australia
    • ,
  • Douglas Millar

      Affiliations

    • Human Genetic Signatures, Level 4, 11 Julius Ave, North Ryde, NSW 2113, Australia
    • ,
  • John Melki

      Affiliations

    • Human Genetic Signatures, Level 4, 11 Julius Ave, North Ryde, NSW 2113, Australia
    • ,
  • Neralie Coulston

      Affiliations

    • Human Genetic Signatures, Level 4, 11 Julius Ave, North Ryde, NSW 2113, Australia
    • ,
  • Phillip Altman

      Affiliations

    • Altman Biomedical Consulting Pty. Ltd., 152 Cammeray Road, Cammeray, NSW 2062, Australia
    • ,
  • Nikolas Rismanto

      Affiliations

    • Virology Division, Department of Microbiology, South Eastern Area Laboratory Services, Prince of Wales Hospital, Randwick, NSW 2031, Australia
    • ,
  • William Rawlinson

      Affiliations

    • Virology Division, Department of Microbiology, South Eastern Area Laboratory Services, Prince of Wales Hospital, Randwick, NSW 2031, Australia
    • Corresponding Author InformationCorresponding author. Tel.: +61 2 9382 9113; fax: +61 2 9398 4275.

Received 19 September 2007 ,Revised 15 November 2007 ,Accepted 12 December 2007.

References 

  1. Albrecht V, Chevallier A, Magnone V, Barbry P, Vandenbos F, Bongain A, et al. Easy and fast detection and genotyping of high-risk human papillomavirus by dedicated DNA microarrays. J Virol Methods. 2006;137(2):236–244
  2. An HJ, Cho NH, Lee SY, Kim IH, Lee C, Kim SJ, et al. Correlation of cervical carcinoma and precancerous lesions with human papillomavirus (HPV) genotypes detected with the HPV DNA chip microarray method. Cancer. 2003;97:1672–1680
  3. Bosch FX, Manos MM, Muñoz N, Sherman M, Jansen AM, Peto J, et al. Prevalence of human papillomavirus in cervical cancer: a worldwide perspective international biological study on cervical cancer. J Natl Cancer Inst. 1995;87:796–802
  4. Chacón J, Sanz I, Rubio MD, De la Morena ML, Díaz E, Mateos ML, et al. Detection and genotyping of high-risk human papillomavirus in cervical specimens. Enferm Infect Microbiol Clin. 2007;25(5):311–316
  5. Clavel C, Masure M, Putaud I, Thomas K, Bory JP, Gabriel R, et al. Hybrid capture II, a new sensitive test for human papillomavirus detection Comparison with hybrid capture I and PCR results in cervical lesions. J Clin Pathol. 1998;51:737–740
  6. Clavel C, Masure M, Levert M, Putaud I, Manjeonjean C, Lorenzato M, et al. Human papillomavirus detection by the Hybrid Capture assay: a reliable test to select women with normal cervical smears at risk for developing cervical lesions. Diagn Mol Pathol. 2000;9:145–150
  7. Clifford GM, Smith JS, Plummer M, Muñoz N, Franceschi S. Human papillomavirus types in invasive cervical cancer worldwide: a meta-analysis. Br J Cancer. 2003;88:63–73
  8. Coutlée F, et al. Use of PGMY Primers in L1 consensus PCR improves detection of human papillomavirus DNA in genital samples. J Clin Microbiol. 2002;40:902–907
  9. Cuschieri KS, Whitley MJ, Cubie HA. Human papillomavirus type specific DNA and RNA persistence-implications for cervical disease progression and monitoring. J Med Virol. 2004;73:65–70
  10. Del Mistro A, Salamanca HF, Trevisan R, Bertorelle R, Parenti A, Bonoldi E, et al. Human papillomavirus typing of invasive cervical cancers in Italy. Infect Agent Cancer. 2006;1:9
  11. Fontaine V, Mascaux C, Weyn C, Bernis A, Celio N, Lefèvre P, et al. Evaluation of combined general primer-mediated PCR sequencing and type-specific PCR strategies for determination of human papillomavirus genotypes in cervical cell specimens. J Clin Microbiol. 2007;45(3):928–934
  12. Gheit T, Landi S, Gemignani F, Snijders PJ, Vaccarella S, Franceschi S, et al. Development of a sensitive and specific assay combining multiplex PCR and DNA microarray primer extension to detect high-risk mucosal human papillomavirus types. J Clin Microbiol. 2006;44(6):2025–2031
  13. Giovannelli L, Lama A, Capra G, Giordano V, Arico P, Ammatuna P. Detection of human papillomavirus DNA in cervical samples: analysis of the new PGMY-PCR compared to the hybrid capture II and MY-PCR assays and a two-step nested PCR assay. J Clin Microbiol. 2004;42(8):3861–3864
  14. Gravitt PE, Peyton CL, Alessi TQ, Wheeler CM, Coutléee F, Hildesheim A, et al. Improved amplification of genital human papillomaviruses. J Clin Microbiol. 2000;38:357–361
  15. Josefsson AM, Magnusson PK, Ylitalo N, et al. Viral load of human papillomvirus 16 as a determinant for development of cervical carcinoma in situ: a nested case-control study. Lancet. 2000;355:2189
  16. Kornegay JR, Roger M, Davies PO, Shepard AP, Guerrero NA, Lloveras B, et al. International proficiency study of a consensus L1 PCR assay for the detection and typing of human papillomavirus DNA: evaluation of accuracy and intralaboratory and interlaboratory agreement. J Clin Microbiol. 2003;41:1080–1086
  17. Kulmala S-M, Syrjänen S, Shabalova I, Petrovichev N, Kozachenko V, Podistov J, et al. NIS Cohort Study Group Human papillomavirus testing with the Hybrid Capture 2 assay and PCR as screening tools. J Clin Microbiol. 2004;42:2470–2475
  18. Lai CH, Chang CJ, Huang HJ, Hsueh S, Chao A, Yang JE, et al. Role of human papillomavirus genotype in prognosis of early-stage cervical cancer undergoing primary surgery. J Clin Oncol. 2007;25:3628–3634
  19. Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345–351
  20. Manos MM, Ting Y, Wright DK, Lewis AJ, Broker TR, Wolinsky SM. Use of polymerase chain reaction amplification for the detection of genital human papillomaviruses. Cancer Cells. 1989;7:209–214
  21. Moskowitz CS, Pepe MS. Comparing the predictive values of diagnostic tests: sample size and analysis for pair study designs. Clin Trials. 2006;3:272–279
  22. Muldrew KL, Beqaj SH, Han J, Lum SH, Clinard V, Schultenover SJ, et al. Evaluation of a Digene-recommended algorithm for human papillomavirus low-positive results present in a “retest zone”. Am J Clin Pathol. 2007;127(1):97–102
  23. Nelson JH, Hawkins GA, Edlung K, Evander M, Kjellberg L, Wadell G, et al. Rapid PCR-based method for genotyping human papillomaviruses in clinical samples. J Clin Microbiol. 2000;38:688–695
  24. Oh Y, Bae SM, Kim YW, Choi HS, Nam GH, Han SJ, et al. Polymerase chain reaction-based fluorescent Luminex assay to detect the presence of human papillomavirus types. Cancer Sci. 2007;98(4):549–554
  25. Pilch H, Günzel S, Schäffer U, Tanner B, Brockerhoff P, Maeurer M, et al. Human papillomavirus (HPV) DNA in primary cervical cancer and in cancer free pelvic lymph nodes—correlation with clinico-pathological parameters and prognostic significance. Zentralbl Gynakol. 2001;123:91–101
  26. Poljak M, Brencic A, Seme K, Vince A, Marin IJ. Comparative evaluation of first and second-generation digene hybrid capture assays for detection of human papillomaviruses associated with high or intermediate risk for cervical cancer. J Clin Microbiol. 1999;37(3):796–797
  27. Poljak M, Marin IJ, Seme K, Vince A. Hybrid Capture II HPV Test detects at least 15 human papillomavirus genotypes not included in its current high-risk probe cocktail. J Clin Virol. 2002;25(Suppl 3):S89–S97
  28. Qu W, Jiang G, Cruz Y, Chang CJ, Ho GYF, Klein RS, et al. PCR detection of human papillomavirus: comparison between MY09/MY11 and GP51/GP61 Primer Systems. J Clin Mirobiol. 1997;35:1304–1310
  29. Schwartz SM, Daling JR, Shera KA, Madeleine MM, McKnight B, Galloway DA, et al. Human papillomavirus and prognosis of invasive cervical cancer: a population-based study. J Clin Oncol. 2001;19:1906–1915
  30. Seme K, Fujs K, Kocjan BJ, Poljak M. Resolving repeatedly borderline results of Hybrid Capture 2 HPV DNA Test using polymerase chain reaction and genotyping. J Virol Methods. 2006;134(1/2):252–256
  31. Snliders PJF, Van Den Brule AJC, Schrijnemakers HFJ, Snow G, Meijer CJLM, Walboomers JMM. The use of general primers in the polymerase chain reaction permits the detection of a broad spectrum of human papillomavirus genotypes. J Gen Virol. 1990;71:173–181
  32. Soderlund-Strand A, Rymark P, Andersson P, Dillner J, Dillner L. Comparison between the Hybrid Capture II Test and a PCR-based human papillomavirus detection method for diagnosis and posttreatment follow-up of cervical intraepithelial neoplasia. J Clin Microbiol. 2005;43:3260–3266
  33. Sotlar K, Diemer D, Dethleffs A, Hack Y, Stubner A, Vollmer N, et al. Detection and typing of human papillomavirus by E6 Nested Multiplex PCR. J Clin Microbiol. 2004;42:3176–3184
  34. van Doorn LJ, Molijn A, Kleter B, Quint W, Colau B. Highly effective detection of human papillomavirus 16 and 18 DNA by a testing algorithm combining broad-spectrum and type-specific PCR. J Clin Microbiol. 2006;44(September 9):3292–3298
  35. Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines 2006. MMWR Recomm Rep. 2006;55:1
  36. Wright TC, Shiffman M, Solomon D, Cox JT, García F, Goldie S, et al. Interim guidance for the use of human papillomavirus DNA testing as an adjunct to cervical cytology for screening. Obstet Gynecol. 2004;103:304–309

PII: S1386-6532(07)00474-X

doi: 10.1016/j.jcv.2007.12.008

Journal of Clinical Virology
Volume 42, Issue 1 , Pages 22-26 , May 2008

Article Tools