Human Papillomavirus (HPV) and Pap Testing Information from Cytyc



ThinPrep System Instrumentation Product Catalog Human Papillomavirus (HPV) Testing Education Information Request HPV & Pap Testing as Primary Screening Human papillomavirus (HPV) is the primary cause for the development of cervical cancer. Ledger and colleagues discussed the issues surrounding HPV infection and cervical screening.¹ They pointed out that persistent HPV infection with high-risk subtypes could lead to abnormal changes in cervical cells. The authors noted that testing for human papillomavirus in women with abnormal Pap results has decreased the relative use of colposcopy because a negative HPV finding eliminates the need for most women to have more invasive procedures such as colposcopy. HPV DNA testing is now approved by the Food and Drug Administration (FDA) for two uses. In 2001, it was approved for the resolution of Pap tests interpreted as ASCUS. In 2003, it was approved for primary screening together with the Pap test in women age 30 and older. Only the HPV DNA test manufactured by Digene® is FDA approved. The test reports 96% sensitivity and 99% negative predictive value.² ASCUS Triage The ASCUS/LSIL Triage Study for Cervical Cancer (ALTS) showed that after one ASCUS Pap test, repeating the Pap test in 6 months, proceeding directly to colposcopy, or triaging women with a high-risk HPV test all had the same statistical referral percentage (sensitivity) for colposcopy. The triage method used should be the woman's decision made in conjunction with her physician. Harper's group has shown that approximately one third of women prefer repeating the Pap test, one third prefer an immediate colposcopy, and one third prefer having a high-risk HPV test for triage.³ The consensus guidelines of the American Society for Colposcopy and Cervical Pathology (ASCCP) recommend HPV testing as one of the triage options in the management of patients with an initial ASCUS Pap.⁴ The American Society of Cytopathology suggests HPV testing be used as an adjunctive test following a finding of ASCUS on cytology, but not in primary screening.⁵ Cuzick and colleagues, as a result of a systematic review for the Health Technology Assessment Committee of the U.K Department of Health, came to a similar conclusion and stated that the "clearest role of HPV testing at the moment is in the management of women with borderline or mildly dyskaryotic smears."⁶ These are generally equivalent to ASCUS in Bethesda terminology. ¹ Ledger WJ, Jeremias J, Witkin SS. Testing for high-risk human papillomavirus types will become a standard of clinical care. Am J Obstet Gynecol. 2000;182(4):860-865. ² Wright TC et al. 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. ³ Harper DM, Longacre MR, Tosteson ANA, O'Connor A, Llewellyn-Thomas H. The ASCUS Pap Smear Result: What do Women Want to Know? International Papillomavirus Report, Spring 2004. ⁴ Wright TC, Cox JT, Massad LS, et al for the ASCCP-sponsored Consensus Conference. 2001 Consensus guidelines for the management of women with cervical cytological abnormalities. J Am Med Assoc. 2002;287(16):2120-2129. ⁵ American Society of Cytopathology. American Society of Cytopathology statement on new technologies in cervical cytology screening. June 2000. Acta Cytol. 2000;44(4):693. ⁶ Cuzick J, Sasieni P, Davies P, et al. A systematic review of the role of human papillomavirus (HPV) testing within a cervical screening programme: summary and conclusions. Br J Cancer. 2000;83(5):561-565.

HPV & Pap Testing as Primary Screening