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Title: Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older.
Authors: Meijer CJ,  Berkhof J,  Castle PE,  Hesselink AT,  Franco EL,  Ronco G,  Arbyn M,  Bosch FX,  Cuzick J,  Dillner J,  Heideman DA,  Snijders PJ
Journal: Int J Cancer
Date: 2009 Feb 1
Branches: MEB
PubMed ID: 18973271
PMC ID: PMC2789446
Abstract: 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.