Issues in using whole slide imaging for diagnostic pathology: “routine” stains, immunohistochemistry and predictive markers

Abstract

The traditional microscope, together with the “routine” hematoxylin and eosin (H & E) stain, remains the “gold standard” for diagnosis of cancer and other diseases; remarkably, it and the majority of associated biological stains are more than 150 years old. Immunohistochemistry has added to the repertoire of “stains” available. Because of the need for specific identification and even measurement of “biomarkers,” immunohistochemistry has increased the demand for consistency of performance and interpretation of staining results. Rapid advances in the capabilities of digital imaging hardware and software now offer a realistic route to improved reproducibility, accuracy and quantification by utilizing whole slide digital images for diagnosis, education and research. There also are potential efficiencies in work flow and the promise of powerful new analytical methods; however, there also are challenges with respect to validation of the quality and fidelity of digital images, including the standard H & E stain, so that diagnostic performance by pathologists is not compromised when they rely on whole slide images instead of traditional stained tissues on glass slides.

Key words::

• biological stains
• Biological Stain Commission
• companion diagnostics
• diagnosis
• digital images
• digital pathology
• Food and Drug Administration
• formalin fixation
• immunohistochemistry
• paraffin embedding
• predictive markers
• primary diagnosis
• regulatory issues
• reproducibility
• validation
• whole slide imaging

Declaration of interest: The author reports no conflicts of interest. The author alone is responsible for the content and writing of the paper.