A Multicenter Study to Evaluate Diagnostic Accuracy by Pathologists Using the Aperio GT 450 DX in Local and Remote...

Area of Science:

• Digital Pathology
• Medical Imaging
• Diagnostic Accuracy

Background:

• Digital pathology enables remote and local whole slide image (WSI) viewing for primary diagnosis.
• This technology aims to improve logistical efficiency and convenience in pathology workflows.

Purpose of the Study:

• To evaluate the diagnostic performance of the Aperio GT 450 DX whole slide imaging system.
• To compare local intranet-based and remote internet-based WSI viewing against manual glass slide light microscopy.

Main Methods:

• 1161 curated cases with complex diagnoses were scanned using three Aperio GT 450 DX instruments.
• Ten pathologists reviewed WSI locally and remotely; diagnoses were adjudicated by a separate team.
• Diagnostic accuracy was assessed by comparing WSI review diagnoses with conventional light microscopy diagnoses.

Main Results:

• The major discrepancy rate for WSI diagnosis was 2.40%, meeting the acceptance criterion (upper bound ≤4%).
• Both local and remote viewing met secondary endpoints, with discrepancy rates ≤4% for each.
• Remote viewing showed slightly lower major discrepancies (2.17%) than local viewing (2.61%); reading time was similar.

Conclusions:

• Diagnoses made with the Aperio GT 450 DX system, via local and remote access, are non-inferior to conventional light microscopy.
• The Aperio GT 450 DX system is a viable tool for primary diagnosis in digital pathology settings.