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A validation study of the FocalPoint GS imaging system for gynecologic cytology screening
Author(s) -
Colgan Terence J.,
Bon Nereo,
Clipsham Susan,
Gardiner Geoffrey,
Sumner Jeff,
Walley Virginia,
McLachlin C. Meg
Publication year - 2013
Publication title -
cancer cytopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.29
H-Index - 57
eISSN - 1934-6638
pISSN - 1934-662X
DOI - 10.1002/cncy.21271
Subject(s) - medicine , squamous intraepithelial lesion , cytology , radiology , oncology , cancer , pathology , cervical intraepithelial neoplasia , cervical cancer
BACKGROUND: Studies of the performance of the automated FocalPoint Guided Screening (FPGS) imaging system in gynecologic cytology screening relative to manual screening have yielded conflicting results. In view of this uncertainty, a validation study of the FPGS was conducted before its potential adoption in 2 large laboratories in Ontario. METHODS: After an intense period of laboratory training, a cohort of 10,233 current and seeded abnormal slides were classified initially by FPGS. Manual screening and reclassification blinded to the FPGS results were then performed. Any adequacy and/or cytodiagnostic discrepancy between the 2 screening methods subsequently was resolved through a consensus process (truth). The performance of each method's adequacy and cytodiagnosis vis‐a‐vis the truth was established. The sensitivity and specificity of each method at 4 cytodiagnostic thresholds (atypical squamous cells of undetermined significance or worse [ASC‐US+], low‐grade squamous intraepithelial lesion or worse [LSIL+], high‐grade squamous intraepithelial lesion or worse [HSIL+], and carcinoma) were compared. The false‐negative rate for each cytodiagnosis was determined. RESULTS: The performance of FPGS in detecting carcinoma, HSIL+, and LSIL+ was no different from the performance of manual screening, but the false‐negative rates for LSIL and ASC‐US were higher with FPGS than with manual screening. CONCLUSIONS: The results from this validation study in the authors' laboratory environment provided no evidence that FPGS has diagnostic performance that differs from manual screening in detecting LSIL+, HSIL+, or carcinoma. Cancer (Cancer Cytopathol) 2013;121:189–196. © 2013 American Cancer Society.