title: A new PCR-based mass spectrometry system for high-risk HPV, part II: clinical trial.
abstract: This was a population-based clinical trial of a polymerase chain reaction-based multiplex high-risk human papillomavirus (HR-HPV) assay using mass spectrometry (MassARRAY [Sequenom, San Diego, CA] matrix-assisted laser desorption/ionization time-of-flight mass spectrometry system [MALDI-TOF]). Participants were 10,000 women between the ages of 25 and 59 years in Guangdong Province, China (SHENCCAST II Study). All women collected a self-sample (tested with Cervista [Hologic, Marlborough, MA] and MALDI-TOF) followed by a clinician-collected cervical sample (for cytology, Hybrid Capture 2 [HC2; Qiagen, Gaithersburg, MD], Cervista, and MALDI-TOF). Patients with any abnormal result were asked to return for colposcopy and biopsies. This analysis included the data for 8,556 women. The sensitivity values for cervical intraepithelial neoplasia (CIN) 3 or worse for a direct cervical sample were 97.9%, 95.1%, and 94.3 for HC2, Cervista, and MALDI-TOF, respectively (P > .05). The sensitivity for CIN 3 or worse for a self-collected sample tested with MALDI-TOF was also 94.3%, which was similar to a clinician-obtained endocervical sample assayed with the 3 HR-HPV assays. MALDI-TOF combined with a self-collected sample provides a highly sensitive, high-throughput, low-cost-per-case assay for mass screening.
authors.affiliation: Peking University Shenzhen Hospital, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Du
authors.forename: Ji
authors.initials: J
authors.lastname: Yi
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Belinson
authors.forename: Xinfeng
authors.initials: X
authors.lastname: Qu
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.forename: Xin
authors.initials: X
authors.lastname: Yi
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000821:virology; D002681:China; D004279:DNA, Viral / Q000032:analysis* / Q000737:chemistry; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology*; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology*
chemical_list: D004279:DNA, Viral