title: Validation of whole slide imaging in the primary diagnosis of gynaecological pathology in a University Hospital.
abstract: OBJECTIVE
  Experience in the use of whole slide imaging (WSI) for primary diagnosis in pathology is very limited. We aimed to determine the accuracy of interpretation of WSI compared with conventional light microscopy (CLM) in the diagnosis of routine gynaecological biopsies.
  
  
  METHODS
  All gynaecological specimens (n=452) received over a 2-month period at the Department of Pathology of the Hospital Clinic of Barcelona were analysed blindly by two gynaecological pathologists, one using CLM and the other WSI. All slides were digitised in a Ventana iScan HT (Roche diagnostics) at 200×. All discrepant diagnoses were reviewed, and a final consensus diagnosis was established. The results were evaluated by weighted κ statistics for two observers.
  
  
  RESULTS
  The level of interobserver agreement between WSI and CLM evaluations was almost perfect (κ value: 0.914; 95% CI 0.879 to 0.949) and increased during the study period: κ value 0.890; 95% CI 0.835 to 0.945 in the first period and 0.941; 95%; CI 0.899 to 0.983 in the second period. Major discrepancies (differences in clinical management or prognosis) were observed in 9 cases (2.0%). All discrepancies consisted of small lesions (8 high grade squamous intraepithelial lesions of the uterine cervix, one lymph node micrometastasis of an ovarian carcinoma) underdiagnosed or missed in the WSI or the CLM evaluation. Discrepancies with no or minor clinical relevance were identified in 3.8% of the biopsies. No discrepancy was related to the poor quality of the WSI image.
  
  
  CONCLUSIONS
  Diagnosis of gynaecological specimens by WSI is accurate and may be introduced into routine diagnosis.
authors.affiliation: Department of Pathology, Hospital Clínic, Barcelona, Spain University of Barcelona, School of Medicine, Barcelona, Spain Centre de Recerca en Salut Internacional de Barcelona (CRESIB), Barcelona, Spain.
authors.forename: Jaume
authors.initials: J
authors.lastname: Ordi
authors.affiliation: Department of Pathology, Hospital Clínic, Barcelona, Spain Centre de Recerca en Salut Internacional de Barcelona (CRESIB), Barcelona, Spain.
authors.forename: Paola
authors.initials: P
authors.lastname: Castillo
authors.affiliation: Department of Pathology, Hospital Clínic, Barcelona, Spain.
authors.forename: Adela
authors.initials: A
authors.lastname: Saco
authors.affiliation: Institute of Gynecology, Obstetrics and Neonatology, Hospital Clínic-Institut d´Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Faculty of Medicine-University of Barcelona, Barcelona, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Del Pino
authors.affiliation: University of Barcelona, School of Medicine, Barcelona, Spain.
authors.forename: Oriol
authors.initials: O
authors.lastname: Ordi
authors.affiliation: Department of Pathology, Hospital Clínic, Barcelona, Spain.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Rodríguez-Carunchio
authors.affiliation: Department of Pathology, Hospital Clínic, Barcelona, Spain University of Barcelona, School of Medicine, Barcelona, Spain.
authors.forename: Jose
authors.initials: J
authors.lastname: Ramírez
mesh_terms: D000328:Adult; D000368:Aged; D003581:Cytodiagnosis / Q000379:methods*; D003952:Diagnostic Imaging / Q000379:methods*; D005260:Female; D005831:Genital Diseases, Female / Q000175:diagnosis*; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000379:methods*; D008875:Middle Aged; D015588:Observer Variation; D010338:Pathology, Clinical / Q000379:methods*
keywords: DIAGNOSIS; DIGITAL PATHOLOGY; GYNAECOLOGICAL PATHOLOGY