Validation of digital image slides for diagnosis in cervico-vaginal cytology.

OBJECTIVE:To test the diagnostic concordance between microscopic (MI) and digital (DG) observation of cervico-vaginal (CV) cytology in a validation study of the technique. METHODS:Five cytotechnologists (CT) reviewed 888 routine CV cytology cases from the Cervical Pathology Unit of our center over a 2-week period of time. The cases were first observed by MI and at the end of the day the cases were observed by DG. STATISTICAL ANALYSIS USED:Agreement calculated using the Kappa index. RESULTS:Most of the diagnoses corresponded to benign (64%) or inflammatory conditions (14%) and 24% corresponded to the intraepithelial lesion or malignancy (ILM) category. The overall kappa coefficient of concordance was strong (0.87). Among the different CTs it was almost perfect in two, strong in two and moderate in one. In 18 cases (10%) there were discrepancies between techniques in the category of ILM. In 10 (56%) cases there was an overdiagnosis in DG and in 8 (44%) an overdiagnosis in MI. Only in two cases, the diagnostic discrepancy exceeded one degree of difference between lesions, and they were ASCUS or AGUS for DG and CIN 2 for MI. CONCLUSIONS:In this validation test in which routine cases during a two-week period have been used, observing the cases with both techniques on the same day, we have obtained a strong degree of concordance. The discordances obtained have not been considered relevant.