Validation of Remote Digital Frozen Sections for Cancer and Transplant Intraoperative Services

Abstract

Introduction:Whole-slide imaging (WSI) technology can be used for primary diagnosis and consultation, including intraoperative (IO) frozen section (FS). We aimed to implement and validate a digital system for the FS evaluation of cancer and transplant specimens following recommendations of the College of American Pathologists.Materials and Methods:FS cases were routinely scanned at ×20 employing the “Navigo” scanner system. IO diagnoses using glass versus digital slides after a 3-week washout period were recorded. Intraobserver concordance was evaluated using accuracy rate and kappa statistics. Feasibility of WSI diagnoses was assessed by the way of sensitivity, specificity, as well as positive and negative predictive values. Participants also completed a survey denoting scan time, time spent viewing cases, preference for glass versus WSI, image quality, interface experience, and any problems encountered.Results:Of the 125 cases submitted, 121 (436 slides) were successfully scanned including 93 oncological and 28 donor-organ FS biopsies. Four cases were excluded because of failed digitalization due to scanning problems or sample preparation artifacts. Full agreement between glass and digital-slide diagnosis was obtained in 90 of 93 (97%, κ = 0.96) oncology and in 24 of 28 (86%, κ = 0.91) transplant cases. There were two major and one minor discrepancy for cancer cases (sensitivity 100%, specificity 96%) and two major and two minor disagreements for transplant cases (sensitivity 96%, specificity 75%). Average scan and viewing/reporting time were 12 and 3 min for cancer cases, compared to 18 and 5 min for transplant cases. A high diagnostic comfort level among pathologists emerged from the survey.Conclusions:These data demonstrate that the “Navigo” digital WSI system can reliably support an IO FS service involving complicated cancer and transplant cases.

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“…On the other hand, immunohistochemical staining was standardized on a single antibody and platform as required in pembrolizumab registration study. [ 16 ] Concerning preanalytical issues, WSI has shown to be reliable for assessment of almost any type of slide, from frozen section to cytological samples[ 20 21 22 ] when proper evaluation is critical and may require the consultation of an expert. [ 23 ]…”

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“…Several retrospective validation studies have demonstrated acceptable accuracy rates (average accuracy rate - 96.7%; range 68%–100%) for TP diagnoses of FS [ Table 4 ]. [ 6 8 14 15 16 17 18 19 20 21 ] Hence, the utility of TP for primary FS diagnosis is growing as we move into an age of increasing sub-specialization and centralization of pathology services. In the year 2008, Tsuchihashi et al .…”

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“…Food and Drug Administration clearance for these devices is relatively new (2017), and widespread adoption of digital pathology technology is still in its early phases. There is an increasing amount of data on validation of WSI compared to microscope viewing of glass slides, for example a recent study showed good concordance of slide interpretation of frozen sections done with glass slides/microscope compared to WSI/digital pathology workstation[ 52 ] Similar excellent intraobserver concordance between glass slides and digital pathology has been shown for routine clinical workload in surgical pathology[ 53 ].…”