[Histonet] IHC VALIDATION

[Fulton Regan]

Hi Dawn,


I would suggest having a look at this CAP guidance paper, below.  If I can be of any assistance, please feel free to contact me. 

1. Patrick, L. F. et al. Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center. Arch. Pathol. Lab. Med. 138, 1432–1443 (2014).


Regan

Regan Fulton, MD/PhD
PhenoPath
551 North 34th Street, Suite 100
Seattle, WA 98103
Phone 206-374-9000   


CEO, Array Science, LLC
475 Gate 5 Road, #102
Sausalito, CA 94965



> On Feb 27, 2018, at 8:34 AM, Olszewski, Dawn via Histonet <histonet at lists.utsouthwestern.edu> wrote:
> 
> Good morning Histo Peeps,
> 
> I was wondering if anyone would be willing to share their protocol on antibody validation for the IHC lab on FFPE tissues.  Do you know if there are specific regulations on validation or does each lab/hospital develop their own methods.  We are no longer under CAP for inspections,  but we are inspected by Joint Commission.
> 
> If you know of specific regulations could you please site them.  We seem to be in disagreement on how this should be done in our lab.
> Thanks for any and all advice in advance.
> 
> Sincerely,
> 
> Dawn Olszewski, HTL(ASCP)QIHC
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