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Effectiveness of the ThinPrep Imaging System: Clinical experience in a low risk screening population
Author(s) -
Papillo Jacalyn L.,
St. John Timothy L.,
Leiman Gladwyn
Publication year - 2008
Publication title -
diagnostic cytopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.417
H-Index - 65
eISSN - 1097-0339
pISSN - 8755-1039
DOI - 10.1002/dc.20779
Subject(s) - medicine , hybrid capture , gynecology , statistical significance , population , cancer , cervical cancer , environmental health , cervical intraepithelial neoplasia
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. Diagn. Cytopathol. 2008;36:155–160. © 2008 Wiley‐Liss, Inc.