title: Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older.
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.
authors.affiliation: Department of Pathology, VU University Medical Center, 1007 MB Amsterdam, The Netherlands. cjlm.meijer@vumc.nl
authors.forename: Chris J L M
authors.initials: CJ
authors.lastname: Meijer
authors.forename: Johannes
authors.initials: J
authors.lastname: Berkhof
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
authors.forename: Albertus T
authors.initials: AT
authors.lastname: Hesselink
authors.forename: Eduardo L
authors.initials: EL
authors.lastname: Franco
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Ronco
authors.forename: Marc
authors.initials: M
authors.lastname: Arbyn
authors.forename: F Xavier
authors.initials: FX
authors.lastname: Bosch
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
authors.forename: Joakim
authors.initials: J
authors.lastname: Dillner
authors.forename: Daniëlle A M
authors.initials: DA
authors.lastname: Heideman
authors.forename: Peter J F
authors.initials: PJ
authors.lastname: Snijders
mesh_terms: D000328:Adult; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis*; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology*