Interim guidance for the use of human papillomavirus DNA testing as an adjunct to cervical cytology for screening

Obstet Gynecol. 2004 Feb;103(2):304-9. doi: 10.1097/01.AOG.0000109426.82624.f8.


Human papillomavirus (HPV) DNA testing was recently approved by the Food and Drug Administration for use as an adjunct to cytology for cervical cancer screening. To help provide guidance to clinicians and patients when using HPV DNA testing as an adjunct to cervical cytology for screening, a workshop was cosponsored by the National Institutes of Health-National Cancer Institute, American Society of Colposcopy and Cervical Pathology (ASCCP), and American Cancer Society. Consensus was reached based on a literature review, expert opinion, and unpublished results from large ongoing screening studies. The conclusions of the workshop were that HPV DNA testing may be added to cervical cytology for screening in women aged 30 years or more. Women whose results are negative by both HPV DNA testing and cytology should not be rescreened before 3 years. Women whose results are negative by cytology, but are high-risk HPV DNA positive, are at a relatively low risk of having high-grade cervical neoplasia, and colposcopy should not be performed routinely in this setting. Instead, HPV DNA testing along with cervical cytology should be repeated in these women at 6 to 12 months. If test results of either are abnormal, colposcopy should then be performed. This guidance should assist clinicians in utilizing HPV DNA testing in an effective manner, while minimizing unnecessary evaluations and treatments.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Adult
  • Aged
  • Biopsy, Needle
  • Colposcopy
  • Cytodiagnosis / methods
  • DNA Probes, HPV*
  • DNA, Viral / analysis
  • Female
  • Humans
  • Mass Screening / methods*
  • Middle Aged
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis*
  • Sensitivity and Specificity
  • United States
  • Uterine Cervical Dysplasia / pathology*
  • Vaginal Smears


  • DNA Probes, HPV
  • DNA, Viral