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

Background: Digital pathology systems (DPS) are emerging as capable technologies for clinical practice. Studies have analyzed pathologists' diagnostic concordance by comparing reviews of whole slide images (WSIs) to glass slides (e.g., accuracy). This observational study evaluated the reproduci...

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Main Authors: Thomas W. Bauer, Matthew G. Hanna, Kelly D. Smith, S. Joseph Sirintrapun, Meera R. Hameed, Deepti Reddi, Bernard S. Chang, Orly Ardon, Xiaozhi Zhou, Jenny V. Lewis, Shubham Dayal, Joseph Chiweshe, David Ferber, Aysegul Ergin Sutcu, Michael White
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:Journal of Pathology Informatics
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Online Access:http://www.sciencedirect.com/science/article/pii/S2153353924000403
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author Thomas W. Bauer
Matthew G. Hanna
Kelly D. Smith
S. Joseph Sirintrapun
Meera R. Hameed
Deepti Reddi
Bernard S. Chang
Orly Ardon
Xiaozhi Zhou
Jenny V. Lewis
Shubham Dayal
Joseph Chiweshe
David Ferber
Aysegul Ergin Sutcu
Michael White
author_facet Thomas W. Bauer
Matthew G. Hanna
Kelly D. Smith
S. Joseph Sirintrapun
Meera R. Hameed
Deepti Reddi
Bernard S. Chang
Orly Ardon
Xiaozhi Zhou
Jenny V. Lewis
Shubham Dayal
Joseph Chiweshe
David Ferber
Aysegul Ergin Sutcu
Michael White
author_sort Thomas W. Bauer
collection DOAJ
description Background: Digital pathology systems (DPS) are emerging as capable technologies for clinical practice. Studies have analyzed pathologists' diagnostic concordance by comparing reviews of whole slide images (WSIs) to glass slides (e.g., accuracy). This observational study evaluated the reproducibility of pathologists' diagnostic reviews using the Aperio GT 450 DX under slightly different conditions (precision). Method: Diagnostic precision was tested in three conditions: intra-system (within systems), inter-system/site (between systems/sites), and intra- and inter-pathologist (within and between pathologists). A total of five study/reading pathologists (one pathologist each for intra-system, inter-system/site, and three for intra-pathologist/inter-pathologist analyses) were assigned to the respective sub-studies.A panel of 69 glass slides with 23 unique histological features was used to evaluate the WSI system's precision. Each glass slide was scanned to generate a unique WSI. From each WSI, the field of view (FOV) was generated (at least 2 FOVs/WSI), which included the selected features (1–3 features/FOV). Each pathologist reviewed the digital slides and identified which morphological features, if any, were present in each defined FOV. To minimize recall bias, an additional 12 wild card slides from different organ types were used for which FOVs were extracted. The pathologists also read these wild card slides FOVs; however, the corresponding feature identification was not included in the final data analysis. Results: Each measured endpoint met the pre-defined acceptance criteria of the lower bound of the 95% confidence interval (CI) overall agreement (OA) rate being ≥85% for each sub-study. The lower bound of the 95% CI for the intra-system OA rate was 95.8%; for inter-system analysis, it was 94.9%; for intra-pathologist analysis, 92.4%, whereas for inter-pathologist analyses, the lower bound of the 95% CI of the OA was 90.6%. Conclusion: The study results indicate that pathologists using the Aperio GT 450 DX WSI system can precisely identify histological features that may be required for accurately diagnosing anatomic pathology cases.
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spelling doaj-art-cfa8cec0848f4b51b0e62b618d545a502025-08-20T02:38:05ZengElsevierJournal of Pathology Informatics2153-35392024-12-011510040110.1016/j.jpi.2024.100401A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DXThomas W. Bauer0Matthew G. Hanna1Kelly D. Smith2S. Joseph Sirintrapun3Meera R. Hameed4Deepti Reddi5Bernard S. Chang6Orly Ardon7Xiaozhi Zhou8Jenny V. Lewis9Shubham Dayal10Joseph Chiweshe11David Ferber12Aysegul Ergin Sutcu13Michael White14Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, New York, NY, United States of America; Corresponding author at: Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021, USA.Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USADepartment of Laboratory Medicine and Pathology, University of Washington, School of Medicine (UW) 1959 NE Pacific St., 2nd Floor, Seattle, WA 98195, USADepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USADepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USADepartment of Laboratory Medicine and Pathology, University of Washington, School of Medicine (UW) 1959 NE Pacific St., 2nd Floor, Seattle, WA 98195, USAScripps Health, La Jolla, CA, USADepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USAGlobal Clinical Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USAGlobal Clinical Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USAMedical and Scientific Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USAMedical and Scientific Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USAMedical and Scientific Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USAGlobal Clinical Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USAGlobal Clinical Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USABackground: Digital pathology systems (DPS) are emerging as capable technologies for clinical practice. Studies have analyzed pathologists' diagnostic concordance by comparing reviews of whole slide images (WSIs) to glass slides (e.g., accuracy). This observational study evaluated the reproducibility of pathologists' diagnostic reviews using the Aperio GT 450 DX under slightly different conditions (precision). Method: Diagnostic precision was tested in three conditions: intra-system (within systems), inter-system/site (between systems/sites), and intra- and inter-pathologist (within and between pathologists). A total of five study/reading pathologists (one pathologist each for intra-system, inter-system/site, and three for intra-pathologist/inter-pathologist analyses) were assigned to the respective sub-studies.A panel of 69 glass slides with 23 unique histological features was used to evaluate the WSI system's precision. Each glass slide was scanned to generate a unique WSI. From each WSI, the field of view (FOV) was generated (at least 2 FOVs/WSI), which included the selected features (1–3 features/FOV). Each pathologist reviewed the digital slides and identified which morphological features, if any, were present in each defined FOV. To minimize recall bias, an additional 12 wild card slides from different organ types were used for which FOVs were extracted. The pathologists also read these wild card slides FOVs; however, the corresponding feature identification was not included in the final data analysis. Results: Each measured endpoint met the pre-defined acceptance criteria of the lower bound of the 95% confidence interval (CI) overall agreement (OA) rate being ≥85% for each sub-study. The lower bound of the 95% CI for the intra-system OA rate was 95.8%; for inter-system analysis, it was 94.9%; for intra-pathologist analysis, 92.4%, whereas for inter-pathologist analyses, the lower bound of the 95% CI of the OA was 90.6%. Conclusion: The study results indicate that pathologists using the Aperio GT 450 DX WSI system can precisely identify histological features that may be required for accurately diagnosing anatomic pathology cases.http://www.sciencedirect.com/science/article/pii/S2153353924000403Aperio GT 450 DXDigital pathologyWhole slide imagingAnalytical precision
spellingShingle Thomas W. Bauer
Matthew G. Hanna
Kelly D. Smith
S. Joseph Sirintrapun
Meera R. Hameed
Deepti Reddi
Bernard S. Chang
Orly Ardon
Xiaozhi Zhou
Jenny V. Lewis
Shubham Dayal
Joseph Chiweshe
David Ferber
Aysegul Ergin Sutcu
Michael White
A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX
Journal of Pathology Informatics
Aperio GT 450 DX
Digital pathology
Whole slide imaging
Analytical precision
title A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX
title_full A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX
title_fullStr A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX
title_full_unstemmed A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX
title_short A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX
title_sort multicenter study to evaluate the analytical precision by pathologists using the aperio gt 450 dx
topic Aperio GT 450 DX
Digital pathology
Whole slide imaging
Analytical precision
url http://www.sciencedirect.com/science/article/pii/S2153353924000403
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