[Histonet] RE: IHC Validation

[Algeo, Lacie A]

I have used the CAP published 'Quality Management in Anatomic Pathology' and it has been very helpful with this:

"For a well-characterized antibody  with a limited spectrum of antigenic targets, like chromogranin, or prostate specific antigen, the validation can be limited.  A panel of 10 positive and 10 negative neoplasms would be sufficient in this setting.  For an antibody that is not well characterized and/or has a wide range of reported activity, a more extensive validation is necessary.  The number of tissues tested should in this circumstance be large enough to determine whether the staining profile matches that previously described. "

We use cases known to be positive or negative for a given antibody or we request tumor types that are known to be positive or negative.  We do 10 of each.  If an antibody has a wide range of positivities (i.e. % positive like c-Myc or FOXP1), we try to have a range of different positivities for review.

Hope this helps,
Lacie

Lacie Algeo, HTL (ASCP) MBCM
Histology Supervisor
Providence Sacred Heart Medical Center Laboratory
101 W 8th Avenue
L-2
Spokane, WA 99204
509-474-4418
FAX 509-474-2052
lacie.algeo <@t> providence.org<mailto:lacie.algeo <@t> providence.org>


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