[Histonet] IHC Validation

[Rene J Buesa]

Hi Michael:
This is what I think, for what it is worth:
1- if you and the reference lab are using different clones, that is not much of a validation,
 
2- additionally the validation using another lab poses additional problems: it is not only the instrument they are using, but how they use it, what is the whole protocol before using the instrument, and how the instrument is maintained. At the end of the day, you will compare your results with those of the other lab, but qualitatively only.
 
3- now, and this is much more important: if every time you are going to implement a new antibody you are going to go through this whole validation process it will be very expensive and, as you wrote, your pathologists are satisfied.
 
This is how I used to approach this issue: when I changed from manual to the DAKO auto stainer, the pathologists were the ones who decided if the results were comparable using the same controls I used manually and automated.
 
Each time they wanted a new antibody or clone to be added to our battery of Abs I tried several supposedly positive controls and the pathologists either accepted or required either increasing or decreasing the Abs dilution to get the intensity and reaction pattern they were looking for when comparing with the reference they read. They (and I) also compared the results with what the literature described as desirable.
 
My validations always rested on the acceptance or rejection from our pathologists. They are the ones who are going to use it and no matter who is going to "validate" your protocol, the bottom line resides with the likes or dislikes of the pathologists. You will never be able to over-rule their decision and they are the ones responsible for the whole lab results regarding CAP.
 
My advise: rely on your pathologists and never attempt to do a costly validation that is not going to be either appreciated or required. You can advise your pathologists but they are the "deciders"
René J.
 
 
--- On Fri, 5/4/12, Dessoye, Michael J <mjdessoye <@t> commonwealthhealth.net> wrote:


From: Dessoye, Michael J <mjdessoye <@t> commonwealthhealth.net>
Subject: [Histonet] IHC Validation
To: histonet <@t> lists.utsouthwestern.edu
Date: Friday, May 4, 2012, 8:50 AM


Hello all,

A year or so ago, we upgraded from a Benchmark XT to Benchmark Ultra.
For validation, we selected a variety of cases as usual and ran them on
both instruments before we retired the XT.  Now, when we add a brand new
antibody, we again select a variety of cases, and once we're happy with
them on the Ultra we send the same cases to a reference lab for
comparison.  

I'm now faced with changing clones for several antibodies.  I expected
to go through pretty much the same validation procedure, but it got me
thinking...the reference lab does not always use the same clone as some
of ours.  I suppose this really wouldn't be a 'true' validation in this
case.

Does anyone have any thoughts on this?  The pathologists are perfectly
happy with the staining of the new clone, but the only reference lab I
can use uses a different clone.  Any thoughts on how to perform a good
validation in this case?

Michael J. Dessoye, M.S. | Histology Supervisor | Wilkes-Barre General
Hospital | An Affiliate of Commonwealth Health |
mjdessoye <@t> commonwealthhealth.net | 575 N. River Street | Wilkes Barre,
PA 18764 | Tel: 570-552-1432 | Fax: 570-552-1526 
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