title: Optimal positive cutoff points for careHPV testing of clinician- and self-collected specimens in primary cervical cancer screening: an analysis from rural China.
abstract: careHPV, a lower-cost DNA test for human papillomavirus (HPV), is being considered for cervical cancer screening in low- and middle-income countries. However, not a single large-scaled study exists to investigate the optimal positive cutoff point of careHPV test. We pooled data for 9,785 women participating in two individual studies conducted from 2007 to 2011 in rural China. Woman underwent multiple screening tests, including careHPV on clinician-collected specimens (careHPV-C) and self-collected specimens (careHPV-S), and Hybrid Capture 2 on clinician-collected specimens (HC2-C) as a reference standard. The primary endpoint was cervical intraepithelial neoplasia grade 3 or more severe (CIN3+) (n = 127), and secondary endpoint was CIN2+ (n = 213). The area under the curves (AUCs) for HC2-C and careHPV-C were similar (0.954 versus 0.948, P = 0.166), and better than careHPV-S (0.878; P < 0.001 versus both). The optimal positive cutoff points for HC2-C, careHPV-C, and careHPV-S were 1.40, 1.74, and 0.85, respectively. At the same cutoff point, careHPV-C was not significantly less sensitive and more specific for CIN3+ than HC2-C, and careHPV-S was significantly less sensitive for CIN3+ than careHPV-C and HC2-C. Raising the cutoff point of careHPV-C from 1.0 to 2.0 could result in nonsignificantly lower sensitivity but significantly higher specificity. Similar results were observed using CIN2+ endpoint. careHPV using either clinician- or self-collected specimens performed well in detecting cervical precancer and cancer. We found that the optimal cutoff points of careHPV were 2.0 on clinician-collected specimens and 1.0 on self-collected specimens.
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Le-Ni
authors.initials: LN
authors.lastname: Kang
authors.affiliation: Program for Appropriate Technology in Health (PATH), Seattle, Washington, USA.
authors.forename: Jose
authors.initials: J
authors.lastname: Jeronimo
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China qiaoy@cicams.ac.cn castle.philip@gmail.com.
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.affiliation: Program for Appropriate Technology in Health (PATH), Seattle, Washington, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Valdez
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Program for Appropriate Technology in Health (PATH), Seattle, Washington, USA.
authors.forename: Pooja
authors.initials: P
authors.lastname: Bansil
authors.affiliation: Program for Appropriate Technology in Health (PATH), Seattle, Washington, USA.
authors.forename: Proma
authors.initials: P
authors.lastname: Paul
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Ping
authors.initials: P
authors.lastname: Bai
authors.affiliation: Program for Appropriate Technology in Health (PATH), Seattle, Washington, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Peck
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.affiliation: Department of Pathology, University of Virginia, Charlottesville, Virginia, USA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.affiliation: Global Cancer Initiative, Chestertown, Maryland, USA qiaoy@cicams.ac.cn castle.philip@gmail.com.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D000328:Adult; D000368:Aged; D002681:China; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D012424:Rural Population; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology