Background: Frozen section (FS) diagnosis is one of the promising applications of digital pathology (DP). However, the implementation of an appropriate and economically viable DP solution for FS in routine practice is challenging. The objective of this study was to establish the non-inferiority of whole-slide imaging (WSI) versus optical microscopy (OM) for FS diagnosis using a low cost and portable DP system. Materials and Methods: A validation study to investigate the technical performance and diagnostic accuracy of WSI versus OM for FS diagnosis was performed using 60 FS cases[120 slides i.e, 60 hematoxylin and eosin (H & E) and 60 toluidine blue (TOLB)]. The diagnostic concordance, inter- and intra-observer agreement for FS diagnosis by WSI versus OM were recorded. Results: The first time successful scanning rate was 89.1% (107/120). Mean scanning time per slide for H and E and TOLB slide was 1:47 min (range; 0:22–3: 21 min) and 1:46 min (range; 0:21–3: 20 min), respectively. Mean storage space per slide for H and E and TOLB slide was 0.83 GB (range: 0.12–1.73 GB) and 0.71 GB (range: 0.11–1.66 GB), respectively. Considering major discrepancies, the overall diagnostic concordance for OM and WSI, when compared with the reference standard, was 95.42% and 95.83%, respectively. There was almost perfect intra as well as inter-observer agreement ( k ≥ 0.8) among 4 pathologists between WSI and OM for FS diagnosis. Mean turnaround time (TAT) of 14:58 min was observed using WSI for FS diagnosis, which was within the College of American Pathologists recommended range for FS reporting. The image quality was average to best quality in most of the cases. Conclusion: WSI was noninferior to OM for FS diagnosis across various specimen types. This portable WSI system can be safely adopted for routine FS diagnosis and provides an economically viable alternative to high-end scanners.

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