Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update.

Jeffrey D GoldsmithMegan L TroxellSinchita Roy-ChowdhuriCarol F ColasaccoMary Elizabeth EdgertonPatrick L FitzgibbonsRegan FultonThomas HaasPatricia L KandalaftTanja KalicaninChristina LacchettiPatti LoykasekNicole E ThomasPaul E SwansonAndrew M Bellizzi

Published in: Archives of pathology & laboratory medicine (2024)

While many of the original guideline statements remain similar, new recommendations address analytic validation of assays with distinct scoring systems, such as programmed death receptor-1 and analytic verification of US Food and Drug Administration approved/cleared assays; more specific guidance is offered for validating immunohistochemistry performed on cytology specimens.

Keyphrases

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risk assessment
climate change
single cell
binding protein