Validation in immunohistochemistry is a well-established and regulated process when it pertains to assays. However, little guidance currently exists on how to best validate automated instrumentation, including validation of a completely new platform or validation of a new instrument of the same make and model. Here, we share insights gained from our laboratory’s recent instrument validations, identifying key challenges such as variability in stain intensity related to tissue location on slides and the prevalence of “cold zones” affecting stain interpretation. Through these scenarios, we emphasize the importance of a robust validation plan that incorporates diverse assay-tissue combinations, strategic tissue placement, and the evaluation of larger tissue sections. In addition, we advocate for vendors to enhance their instrument testing protocols to proactively identify subtle performance issues. We propose a framework for more effective validation strategies, including emerging quantitative technologies in this field.
Fernandez-Pol et al. (Thu,) studied this question.