Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older.
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.
Meijer
Chris J L M
CJ
Department of Pathology, VU University Medical Center, 1007 MB Amsterdam, The Netherlands. cjlm.meijer@vumc.nl
Berkhof
Johannes
J
Castle
Philip E
PE
Hesselink
Albertus T
AT
Franco
Eduardo L
EL
Ronco
Guglielmo
G
Arbyn
Marc
M
Bosch
F Xavier
FX
Cuzick
Jack
J
Dillner
Joakim
J
Heideman
Daniëlle A M
DA
Snijders
Peter J F
PJ
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*