[Histonet] IHC validation

[Joe Myers]

Kristy:
When validating an IHC procedure, regulatory guidelines like CLIA are not concerned so much with the types of specimens upon which the procedure will be applied as they are with how appropriately a given procedure detects different levels of protein expression, which, in turn, usually correlates to the  ‘degree of disease’.   In practical terms, this means that your lab’s efforts to validate should involve the staining of different tissues of the same type (i.e. skin), where the expression level ranges from ‘low‘ to ‘high’.  There are certainly a great deal more issues involved in procedure validation, but this is my attempt to answer your initial question.
Joe Myers, M.S., CT/QIHC(ASCP)

***************************

Message: 2
Date: Wed, 6 May 2020 05:43:22 -0700
From: Kristy Castillo <k.castillo at azdermgroup.com>
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] IHC validation

Would like to know when validating for IHC for a dermatology lab and just
for CLIA (no CAP), do you just need to show a shave, punch and excision lighting up?  Thanks!