Validating a digital primary diagnosis workflow: a practical framework for laboratories

Whitlock S, Byrne C, Al Mansoori R

Digital Pathology Journal · Published 2 Jul 2026 · DOI: 10.00000/dpj.2026.0088

Abstract

Transition to digital primary diagnosis requires structured validation covering scanner performance, image management, display calibration, concordance testing and ongoing quality monitoring. This review consolidates published guidance into an operational framework, with worked examples of concordance study design, sample size considerations, discrepancy adjudication and documentation for accreditation assessment.

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Introduction

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Methods

Study design, data sources, inclusion criteria, statistical analysis and ethical approval are reported in full in the published version.

Results

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Discussion

Interpretation, limitations and implications for practice are presented in the published version.

References

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