title: Cervical cytological screening: Assessment of the Fournier ® self-sampling device in a cervical pathology outpatient clinic.
abstract: BACKGROUND
  The objective of this study was to investigate the performance of the Fournier(®) self-sampled device in the cytological diagnosis of cervical precursor or neoplastic lesions. The colposcopy and cervical biopsy were used as the gold standard evaluation.
  
  
  METHODS
  This was a case-control study performed at a cervical pathology outpatient clinic from January 2008 to October 2009. Samples were obtained through physician-collected mode before a colposcopic evaluation. Liquid-based cytology slides obtained with the device in question were stained using the Papanicolaou method and anti-p16 immunocytochemistry and were analyzed by two pathologists blind to the histological and colposcopic diagnoses.
  
  
  RESULTS
  Diagnostic performance for Fournier device using Papanicolaou technique was sensitivity 41.1% (Pathologist 1-P1) and 52.9% (Pathologist 2-P2) for diagnosing low-grade intraepithelial lesions; for high-grade lesions and cervical cancer, sensitivity was 68.7% (P1) and 75.0% (P2) and specificity was 81.8% (P1) and 73.8% (P2). When using the anti-p16 immunocytochemistry, the sensitivity for diagnosing low-grade intraepithelial lesions was 57.1% (P1) and 62.9% (P2), and the sensitivity was 87.5% (P1) and 93.8% (P2) for high-grade lesions and cancer. The specificity was 75.0% (P1) and 54.4% (P2).
  
  
  CONCLUSIONS
  These results show that when used with "blind" physician-collected cytology in an outpatient setting, the Fournier(®) device achieved a sensitivity and specificity comparable to those obtained by the Pap test traditionally collected during a speculum examination.
authors.affiliation: Medical Sciences Post-Graduation Program, Universidade Federal Do Rio Grande Do Sul/Brasil, Porto Alegre/RS, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: da Silva Rocha
authors.affiliation: Department of Pathology, Hospital De Clínicas De Porto Alegre, Porto Alegre/RS, Brazil.
authors.forename: Pedro
authors.initials: P
authors.lastname: Guilherme Schaefer
authors.affiliation: Department of Pathology, Universidade Federal Do Rio Grande Do Sul, Porto Alegre/RS, Brazil.
authors.forename: Maria
authors.initials: M
authors.lastname: Isabel Albano Edelweiss
mesh_terms: D000554:Ambulatory Care Facilities; D001706:Biopsy / Q000295:instrumentation* / Q000379:methods; D016022:Case-Control Studies; D002584:Cervix Uteri / Q000166:cytology / Q000473:pathology*; D003127:Colposcopy / Q000295:instrumentation* / Q000379:methods; D019941:Cyclin-Dependent Kinase Inhibitor p16; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods; D009363:Neoplasm Proteins / Q000032:analysis; D065006:Papanicolaou Test / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology; D014626:Vaginal Smears / Q000379:methods; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology
chemical_list: C000614131:CDKN2A protein, human; D019941:Cyclin-Dependent Kinase Inhibitor p16; D009363:Neoplasm Proteins
keywords: cervical smears; diagnostic self evaluation; immunocytochemistry; p16ink4a; pap smear