title: Evaluation of The Cervista HPV A9 group In Screening Patients for Cervical Cancer.
abstract: OBJECTIVE
  To exploit the prevalence of HPV genotypes 52/58 in a Chinese population, we evaluated algorithms that the use the Cervista Assay A9 group for primary cervical cancer screening.
  
  
  METHODS
  The SHENCCAST II trial database was re-analyzed, focussing on the A9 pool of the Cervista HR-HPV Assay. Results for the detection CIN2+ and CIN3+ were correlated with a genotyping assay (MALDI-TOF) and cervical cytology to explore various screening algorithms.
  
  
  RESULTS
  This analysis included 8,556 women with a mean age of 38.9. CIN 2+ rates were 2.7% (233/8556); CIN 3+ rates were 1.7% (141/8556). Overall HPV infection rates were 11.1% (950/8556) for Cervista, in which A5/A6, A7 and A9 groups were 26.5% (227/950), 22.9% (218/950) and 67.8% (644/950), respectively. The HPV A9 group is highly predictive of high-grade cervical lesions (CIN2+ OR = 103.61, CIN3+ OR = 128.059). Sensitivity and specificity for Cervista A9 group for CIN 2+ was 85.4% and 94.7%, and for CIN 3+ 89.4% and 93.8% respectively. Cervista A9 Assay followed by triage cytology for non-A9 positives has sensitivity and specificity for CIN2+ of 91.5% of 93.5%, and for CIN 3+ 94.3% and 92.6%.
  
  
  CONCLUSIONS
  Using the Cervista A9 as the primary screen instead of the full Cervista assay, the percentage referred to colposcopy would decrease from 11.1% to 8.8% and percentage requiring cytology would decrease from 11.1% to 3.6%. Sensitivity of detecting CIN 2+(91.5%), CIN3+(94.3%) would remain similar to the complete Cervista HR-HPV assay for CIN 2+(93.1%), CIN3+(95.0%).
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, PR China.
authors.forename: Jinghui
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, PR China Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Hui
authors.initials: H
authors.lastname: Du
authors.affiliation: Preventive Oncology International, Inc. Cleveland Heights, USA and Cleveland Clinic, Women's Health Institute, Cleveland, USA.
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
authors.affiliation: Preventive Oncology International, Inc. Cleveland Heights, USA and Cleveland Clinic, Women's Health Institute, Cleveland, USA.
authors.forename: Xinfeng
authors.initials: X
authors.lastname: Qu
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, PR China Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, PR China.
authors.forename: Jing
authors.initials: J
authors.lastname: Mei
authors.affiliation: Cleveland Clinic, Department of Anatomic Pathology, Cleveland, USA.
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, PR China Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, PR China Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
authors.forename: Lijie
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Peking University Shenzhen Hospital, Shenzhen, PR China Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China wurf100@126.com.
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
mesh_terms: D000328:Adult; D002681:China / Q000453:epidemiology; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis*; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005838:Genotype; D006801:Humans; D060885:Multiplex Polymerase Chain Reaction; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D015995:Prevalence; D012017:Referral and Consultation; D012680:Sensitivity and Specificity; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears
chemical_list: D004279:DNA, Viral
keywords: Cervical Cancer; Cervista; HPV A9 group; Human Papillomavirus (HPV)