[Histonet] Antibody Validation CLIA

Normington Lacy LNormington at uwhealth.org
Fri Mar 16 12:16:31 CDT 2018

CAP suggests running 10 negative and 10 positive cases for non-prognostic markers.
CAP required running 20 negative and 20 positive cases for  prognostic markers.

In the event the case volume is less than the suggested 10 and 10 cases for non-prognostic markers, the reason for that decision should be stated in the validation.  Ultimately, the decision is up to your director.  

Lacy Normington, HTL(ASCP)CM
Manager, Surgical Pathology Lab Services UW Health
600 Highland Avenue
Madison, WI 53792-2472

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Subject: [Histonet] Antibody Validation CLIA

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We've been discussing about the quantity of slides to run as a validation for IHC antibodies. We are governed by CLIA, and we would like to know if there is a set number of slides to run for a particular antibody we would like to bring in-house for Validation.  I think CAP requires 20 slides..?
And so we are asking if there is  a requirement with CLIA to run a certain number of slides, or is it up to us (the laboratory director) to decide how many slides to run for Validation/Verification.

Thank you in advance


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