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

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.