Validation of digital microscopy in the histopathological diagnoses of oral diseases
Whole slide imaging (WSI) systems are being increasingly used in educational and professional settings, highlighting the value of digital microscopy and favouring its acceptance for use in primary diagnosis. There has been a reluctance to introduce diagnostic applications due to a lack of validation and regulation of these devices. This study aims to provide information regarding the performance of WSI and to validate it for use in the diagnosis of oral diseases, using the intraobserver variability as the primary form of analysis. Seventy (n = 70) H&E-stained glass slides of oral biopsies were scanned using the Aperio Digital Pathology System at a magnification of × 20. Two experienced oral pathologists blindly analysed all H&E-stained sections with a conventional light microscope (CLM) and, after 3-month washout, with WSI. Clinical information was provided along with the cases in both analyses. The intraobserver agreement between CLM and WSI was 97% (κ = 0.9) for both pathologists. The majority of preferred diagnoses were by CLM. Both pathologists had the same discordances in different cases. Challenging cases and cases with insufficient quantity of tissue for analyses were considered the main reasons for disagreement rather than the diagnostic methods. Median time taken to make a diagnosis was higher only in CLM for one pathologist. Time outliers occurred in discordant cases and in other difficult cases. This study provides evidence of a high performance of WSI for diagnostic purposes in clinical practice, routine pathology and primary diagnosis in the field of oral pathology.
KeywordsValidation Whole slide imaging Digital pathology Intraobserver agreement
All authors had substantial contributions to the conception (Anna Luíza Damaceno Araújo, Felipe Paiva Fonseca, Paul M. Speight and Alan Roger Santos-Silva), draft and design (Marcio Ajudarte Lopes, Oslei Paes de Almeida and Pablo Agustin Vargas) of this work, as well as participation of the acquisition (Natália Rangel Palmier and Gleyson Kleber Amaral-Silva), analysis (Oslei Paes de Almeida and Pablo Agustin Vargas) and interpretation (Anna Luíza Damaceno Araújo, Paul M. Speight and Alan Roger Santos-Silva) of data for the work. The final version of this work was reviewed and approved for publication by all parts included. Authors Anna Luíza Damaceno Araújo and Alan Roger Santos-Silva takes full responsibility for the work as a whole, including the study design, access to data and the decision to submit and publish the manuscript. If there is a need, all authors agree to be accountable for any aspects of the work and we ensure that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The authors also state that the material is original, has not been published elsewhere and is being submitted only to the Virchows Archiv.
This study was funded by the Coordination for the Improvement of Higher Education Personnel (CAPES/PROEX, Brazil), the National Council for Scientific and Technological Development (CNPq, Brazil) and the grants from São Paulo Research Foundation (FAPESP, Brazil) process number: 2009/53839-2, which supported the acquisition of the equipment used.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
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