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Cancer Cytopathol. 2013 Apr;121(4):189-96. doi: 10.1002/cncy.21271. Epub 2013 Jan 29.

A validation study of the FocalPoint GS imaging system for gynecologic cytology screening.

Author information

1
Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada. tcolgan@mtsinai.on.ca

Abstract

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.

PMID:
23361915
DOI:
10.1002/cncy.21271
[Indexed for MEDLINE]
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