title: A novel highly sensitive and specific flow cytometry system for cervical cancer screening.
abstract: OBJECTIVE
  This study assessed the performance of a novel flow cytometry (FCM) cervical cancer screening system compared with human papillomavirus (HPV) Hybrid Capture 2 (HC2).
  
  
  METHODS
  Chinese women aged 20years or older were enrolled in this study at Fudan University Shanghai Cancer Center. All participants underwent cytology/pathology testing (gold standard), HPV HC2 testing and FCM testing involving analysis of cell proliferation index (CPIx).
  
  
  RESULTS
  Among 437 women enrolled in this study, 185 women (42.3%) were diagnosed as "gold standard positive" by pathology with diseases including cervical intraepithelial neoplasia (CIN) grade 2 (n=11), CIN3 (n=41), squamous cell carcinoma (SCC; n=115), adenocarcinoma in situ (n=2) and adenocarcinoma (n=16). The remaining 252 cases were deemed "gold standard negative". The sensitivity was 87.6% (95% CI, 82.8-92.3) for FCM testing and 89.7% (95% CI, 85.4-94.1; p=0.5121) for HPV HC2 testing. The specificity of FCM testing was 90.5% (95% CI, 86.2-94.7), which was superior to the specificity of HPV HC2 testing (84.5%, 95% CI, 79.3-89.7; p=0.04). In the 20-29years old group, the sensitivity and the specificity of FCM testing were 90.0% (95% CI, 71.4-100.0) and 92.9% (95% CI, 76.9-100.0), respectively. The FCM testing CPIx statistically increased with the transition from normal cervical specimens to SCC specimens.
  
  
  CONCLUSIONS
  Our results showed that the FCM screening system had high sensitivity and specificity for women of various ages. The FCM CPIx was able to evaluate the severity of disease quantitatively.
authors.affiliation: Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, PR China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, PR China.
authors.forename: Xiaotian
authors.initials: X
authors.lastname: Han
authors.affiliation: Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, PR China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai 200032, PR China.
authors.forename: Bo
authors.initials: B
authors.lastname: Ping
authors.affiliation: Product Development, UB Product Engineering, HU Business Unit, Sysmex Corporation, Kobe, Japan.
authors.forename: Masakatsu
authors.initials: M
authors.lastname: Morita
authors.affiliation: Product Development, UB Product Engineering, HU Business Unit, Sysmex Corporation, Kobe, Japan.
authors.forename: Ryuichiro
authors.initials: R
authors.lastname: Ebi
authors.affiliation: Product Development, UB Product Engineering, HU Business Unit, Sysmex Corporation, Kobe, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Inoue
authors.affiliation: Product Development, UB Product Engineering, HU Business Unit, Sysmex Corporation, Kobe, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, PR China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai 200032, PR China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, PR China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai 200032, PR China.
authors.forename: Xiaochun
authors.initials: X
authors.lastname: Wan
authors.affiliation: Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, PR China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai 200032, PR China.
authors.forename: Wentao
authors.initials: W
authors.lastname: Yang
authors.affiliation: Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, PR China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai 200032, PR China.
authors.forename: Bin
authors.initials: B
authors.lastname: Chang
authors.affiliation: Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, PR China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, PR China. Electronic address: docwuxh@hotmail.com.
authors.forename: Xiaohua
authors.initials: X
authors.lastname: Wu
mesh_terms: D000328:Adult; D004279:DNA, Viral / Q000032:analysis; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005434:Flow Cytometry / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000473:pathology / Q000821:virology; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000821:virology
chemical_list: D004279:DNA, Viral
keywords: Cervical cancer; Flow cytometry; Human papillomavirus