Early Detection and Diagnosis

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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

  1. Tor Molden1,†,*,
  2. Jan F. Nygård3,
  3. Irene Kraus1,
  4. Frank Karlsen2,
  5. Mari Nygård3,
  6. Gry Baadstrand Skare3,
  7. Hanne Skomedal2,
  8. Steinar Ø. Thoresen3,
  9. Bjørn Hagmar1

Article first published online: 11 JAN 2005

DOI: 10.1002/ijc.20839

Issue

International Journal of Cancer

International Journal of Cancer

Volume 114, Issue 6, pages 973–976, 10 May 2005

Additional Information

How to Cite

Molden, T., Nygård, J. F., Kraus, I., Karlsen, F., Nygård, M., Skare, G. B., Skomedal, H., Thoresen, S. Ø. and 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: 973–976. doi: 10.1002/ijc.20839

Author Information

  1. 1

    Institute of Pathology, The National University Hospital, Oslo, Norway

  2. 2

    NorChip AS, Klokkarstua, Norway

  3. 3

    Cancer Registry of Norway, Institute of Population-Based Cancer Research, Oslo, Norway

  1. †

    Fax: +47-32798801

*Institute of Pathology, The National University Hospital, Sognsveien 20, 0027 Oslo, Norway

Publication History

  1. Issue published online: 11 MAR 2005
  2. Article first published online: 11 JAN 2005
  3. Manuscript Accepted: 20 OCT 2004
  4. Manuscript Received: 20 JUL 2004

Funded by

  • Research Council of Norway. Grant Number: 145316/213

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Keywords:

  • HPV;
  • human papillomavirus;
  • DNA;
  • mRNA;
  • PreTect HPV-Proofer;
  • NASBA;
  • PCR;
  • ASCUS;
  • LSIL

Abstract

It has been suggested that human papillomavirus (HPV) testing improves follow-up of atypical cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) in cervical cancer screening programs. To evaluate the prognostic value of including HPV testing as an adjunct to cytology, we carried out a 2-year follow-up study of 77 women with ASCUS or LSIL Papanicolaou (Pap) smear in the Norwegian Cervical Cancer Screening Program (NCCSP) for detection of histological cervical intraepithelial neoplasia (CIN) 2+. The study includes a comparison between viral mRNA and DNA detection. PreTect HPV-Proofer was used for HPV E6/E7 mRNA detection from the 5 high-risk types 16, 18, 31, 33 and 45, and Gp5+/6+ consensus PCR was used for HPV DNA detection. Twice as many women were positive for HPV DNA (54.6%) than for HPV mRNA (23.4%). PreTect HPV-Proofer and consensus PCR had a sensitivity of 85.7% (95% confidence interval [CI] = 42.1–99.6) for detecting CIN2+ during follow-up. The specificity was significantly higher for PreTect HPV-Proofer, 84.9% (95% CI = 73.9–92.5), than for consensus PCR, 50.0% (95% CI = 37.4–62.6). PreTect HPV-Proofer positive women were 69.8 times (95% CI = 4.3–1137.3) more likely to be diagnosed with CIN2+ within 2 years than PreTect HPV-Proofer negative women. Consensus PCR-positive women were 5.7 times (95% CI = 0.6–52.0) more likely to be diagnosed with CIN2+ within 2 years than PCR-negative women. With equal sensitivity and higher specificity than consensus PCR, the PreTect HPV-Proofer might offer an improvement for the triage of women with ASCUS or LSIL Pap smear. © 2004 Wiley-Liss, Inc.

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