Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older


  • Conflict of Interest: C.J.L.M. Meijer is member of the advisory board of Qiagen (formerly Digene) and received lecture fee from GSK. E.L. Franco provided occasional consultation to Gen-Probe and Roche. G. Ronco provided occasional consultation to Gen-Probe. F.X. Bosch provided occasional consultation to Qiagen and Roche. J. Cuzick is member of the advisory boards of Qiagen, Roche and Gen-Probe. P.J.F. Snijders provided occasional consultation to Roche and Gen-Probe. Qiagen, Gen-Probe and Roche are companies involved with HPV diagnostics.


Given the strong etiologic link between high-risk HPV infection and cervical cancer high-risk HPV testing is now being considered as an alternative for cytology-based cervical cancer screening. Many test systems have been developed that can detect the broad spectrum of hrHPV types in one assay. However, for screening purposes the detection of high-risk HPV is not inherently useful unless it is informative for the presence of high-grade cervical intraepithelial neoplasia (CIN 2/3) or cancer. Candidate high-risk HPV tests to be used for screening should reach an optimal balance between clinical sensitivity and specificity for detection of high-grade CIN and cervical cancer to minimize redundant or excessive follow-up procedures for high-risk HPV positive women without cervical lesions. Data from various large screening studies have shown that high-risk HPV testing by hybrid capture 2 and GP5+/6+-PCR yields considerably better results in the detection of CIN 2/3 than cytology. The data from these studies can be used to guide the translation of high-risk HPV testing into clinical practice by setting standards of test performance and characteristics. On the basis of these data we have developed guidelines for high-risk HPV test requirements for primary cervical screening and validation guidelines for candidate HPV assays. © 2008 Wiley-Liss, Inc.