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A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX.

Thomas W Bauer1, Matthew G Hanna2, Kelly D Smith3

  • 1Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, New York, NY, United States of America.

Journal of Pathology Informatics
|November 28, 2024
PubMed
Summary

Digital pathology systems (DPS) show high diagnostic precision. Pathologists using the Aperio GT 450 DX whole slide imaging (WSI) system accurately identified histological features for anatomic pathology diagnoses.

Keywords:
Analytical precisionAperio GT 450 DXDigital pathologyWhole slide imaging

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Area of Science:

  • Digital pathology
  • Histopathology
  • Medical imaging

Background:

  • Digital pathology systems (DPS) are increasingly adopted for clinical practice.
  • Previous studies focused on diagnostic concordance (accuracy) of whole slide images (WSIs) versus glass slides.
  • This study specifically evaluated the diagnostic reproducibility (precision) of a DPS under varied conditions.

Purpose of the Study:

  • To assess the diagnostic precision of the Aperio GT 450 DX whole slide imaging (WSI) system.
  • To evaluate the reproducibility of pathologists' diagnostic reviews using digital slides.
  • To determine if the system meets predefined criteria for precision in identifying histological features.

Main Methods:

  • An observational study design was employed to test diagnostic precision.
  • Pathologists reviewed fields of view (FOVs) from 69 scanned glass slides containing 23 unique histological features.
  • Precision was evaluated across intra-system, inter-system/site, and intra-/inter-pathologist conditions.

Main Results:

  • All measured endpoints met acceptance criteria, with the lower bound of the 95% confidence interval (CI) for overall agreement (OA) exceeding 85% in all sub-studies.
  • Intra-system OA rate was 95.8%, inter-system was 94.9%, intra-pathologist was 92.4%, and inter-pathologist was 90.6%.
  • These results demonstrate high diagnostic precision across all tested conditions.

Conclusions:

  • The Aperio GT 450 DX WSI system enables precise identification of histological features by pathologists.
  • The system supports accurate diagnoses in anatomic pathology.
  • The findings support the clinical utility of digital pathology for diagnostic reproducibility.