-Light microscopy (LM) is considered the reference standard for diagnosis in pathology. Whole slide imaging (WSI) generates digital images of cellular and tissue samples and offers multiple advantages compared with LM. Currently, WSI is not widely used for primary diagnosis. The lack of evidence regarding concordance between diagnoses rendered by WSI and LM is a significant barrier to both regulatory approval and uptake.
-To examine the published literature on the concordance of pathologic diagnoses rendered by WSI compared with those rendered by LM.
-We conducted a systematic review of studies assessing the concordance of pathologic diagnoses rendered by WSI and LM. Studies were identified following a systematic search of Medline (Medline Industries, Mundelein, Illinois), Medline in progress (Medline Industries), EMBASE (Elsevier, Amsterdam, the Netherlands), and the Cochrane Library (Wiley, London, England), between 1999 and March 2015.
-Thirty-eight studies were included in the review. The mean diagnostic concordance of WSI and LM, weighted by the number of cases per study, was 92.4%. The weighted mean κ coefficient between WSI and LM was 0.75, signifying substantial agreement. Of the 30 studies quoting percentage concordance, 18 (60%) showed a concordance of 90% or greater, of which 10 (33%) showed a concordance of 95% or greater. This review found evidence to support a high level of diagnostic concordance. However, there were few studies, many were small, and they varied in quality, suggesting that further validation studies are still needed.