title: Effectiveness of the ThinPrep Imaging System: clinical experience in a low risk screening population.
abstract: The Cytyc ThinPrep Imaging System was FDA approved based on a multi-institutional clinical trial, in which the HSIL+ prevalence rate was 0.7%. This study determines the effectiveness of the Imager in clinical practice at an academic medical center with a historical HSIL+ rate of 0.25%. Cytological interpretations were compared for two 12-month periods pre- and post-Imager implementation. Data was compiled by cytologic diagnoses, and variations in prevalence rates were analyzed for statistical significance. Interpretations of ASC-US, ASC-H, and LSIL were correlated with Digene Hybrid Capture2 High Risk HPV DNA testing; interpretations of ASC-H, LSIL, and HSIL+ were correlated with subsequent surgical follow-up. ASC-US, ASC-H, and LSIL detection rates increased 34, 48, and 29%, respectively, with the Imager (P<0.001); whereas the detection of HSIL increased 24% (P<0.051). Surgical correlation revealed no statistical differences in the positive predictive value (PPV) for ASC-H and LSIL. However, an increase in the PPV of HSIL was found (P<0.05). High risk HPV results were lower for ASC-US (P<0.001), but statistically equivalent for ASC-H and LSIL. Results of surgical correlation and HPV testing validated an increase in detection rates of ASC-H, LSIL, and HSIL, as well as increased PPV of HSIL with the ThinPrep Imaging System.
authors.affiliation: Cytopathology Department, Fletcher Allen Health Care, Burlington, Vermont 05401, USA. jacalyn.papillo@vtmednet.org
authors.forename: Jacalyn L
authors.initials: JL
authors.lastname: Papillo
authors.forename: Timothy L
authors.initials: TL
authors.lastname: St John
authors.forename: Gladwyn
authors.initials: G
authors.lastname: Leiman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D008403:Mass Screening / Q000295:instrumentation / Q000379:methods*; D008875:Middle Aged; D018307:Neoplasms, Squamous Cell / Q000175:diagnosis*; D011230:Precancerous Conditions / Q000175:diagnosis*; D015203:Reproducibility of Results; D012189:Retrospective Studies; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears / Q000295:instrumentation / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*