[Histonet] Antibody Validation CLIA

Greg Dobbin greg.dobbin at gmail.com
Fri Mar 16 12:25:05 CDT 2018

Hi Paula,
Let me first say I am Canadian and my lab is not governed by CLIA or CAP.
But for what it is worth, here are my thoughts...

When thinking about validating antibodies for IHC you must first consider
whether the antibody in question is Class-I (prognostic eg Breast markers,
CD117, etc) or Class-II. Class-I require a more robust validation protocol
then Class-II antibodies.

Next you need to consider why the validation is needed. Is it:

   1. a new Ab in your lab?
   2. a new vendor for an antibody?
   3. a new lot number of an existing antibody in your menu?
   4. a change in protocol of an existing antibody?

#'s 1 and 2 require a larger validation whereas #'s 3 and 4 should only
require a minimal check (unless of course there is a drastic change in the
protocol in #4).

As for absolute numbers of slides for each, unless CLIA provides this
information, you are left to work with your Director to find that balance
between cost (ie more slides = increased cost) with confidence (how many do
you need to see in order to feel confident that the stain is performing as

I hope this helps.

*Greg Dobbin*
1205 Pleasant Grove Rd
RR#2 York,
PE      C0A 1P0

*Everything in moderation...even moderation itself**!*

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