title: Evaluation of novel assays for the detection of human papilloma virus in self-collected samples for cervical cancer screening.
abstract: The aim of this study was to evaluate the performance of three new high-risk human papillomavirus (HPV) assays for primary cervical cancer screening, by using self-collected samples, and to identify an HPV assay that could overcome the major obstacles faced during large-scale population-based screening. Two hundred and ten women showing abnormal cervical cytology (and referred for a colposcopy) were recruited in this study. Self-collected samples obtained from all women were tested with the Cobas, Seq, and BioPerfectus Multiplex Real Time HPV assays; simultaneously, clinician-collected samples (from the same women) were tested with the gold-standard Cobas HPV assay. The results of all the assays were consistent. The sensitivity, positive predictive value, and negative predictive value for cervical intraepithelial neoplasia 2+ (CIN2+) and CIN3+ were comparable between the self-collected samples tested with the three new assays and the clinician-collected samples tested with the Cobas HPV assay (P > 0.05). The single-genotype HPV load per sample did not differ significantly between the self- and clinician-collected samples (P = 0.195). In conclusion, the results of this study demonstrated the applicability of the three new HPV assays for primary cervical cancer screening based on self-collection.
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Chen
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen, China.
authors.forename: H
authors.initials: H
authors.lastname: Du
authors.affiliation: Jiangsu BioPerfectus Technologies, Jiangsu, China.
authors.forename: R
authors.initials: R
authors.lastname: Zhang
authors.affiliation: Human Assisted Reproduction Center, Shanxi Women & Children's Hospital, China.
authors.forename: J H
authors.initials: JH
authors.lastname: Zhao
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen, China.
authors.forename: Q C
authors.initials: QC
authors.lastname: Hu
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen, China.
authors.forename: C
authors.initials: C
authors.lastname: Wang
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen, China.
authors.forename: G X
authors.initials: GX
authors.lastname: Wang
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen, China.
authors.forename: J L
authors.initials: JL
authors.lastname: Tang
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, China.|Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen, China.
authors.forename: R F
authors.initials: RF
authors.lastname: Wu
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D061809:Human Papillomavirus DNA Tests / Q000379:methods* / Q000592:standards; D006801:Humans; D008875:Middle Aged; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods / Q000592:standards; D016353:Self-Examination / Q000379:methods* / Q000592:standards; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods* / Q000592:standards; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*