[Histonet] Antibody Validation

Tue Jun 15 10:49:28 CDT 2010

I agree with Rene. All lot to lot and new antibodies need to be checked for
consistency. This is part of your validation process. This even holds true
for pre-dilutes which are already tested by the manufacturer  for optimum
results.

Beatrice Sullivan, HT(A.S.C.P.) HTL , AAS, CLSP(N.C.A.)
AP Supervisor
Shore Memorial Hospital
609-653-3590

             Rene J Buesa                                                  
             <rjbuesa <@t> yahoo.co                                             
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             histonet-bounces@         Teri.Hallada <@t> midmichigan.org        
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                                                                   Subject 
                                       Re: [Histonet] Antibody Validation  
             06/15/2010 10:49                                              
             AM                                                            

Teri:
You are right about the validations you propose although I am not surprised
that your vendor does not think it is necessary. They are in the business
of selling and you are in the business of assuring the high quality of your
work to obtaining the most accurate work for patients' sake.
There is where the difference resides. Ignore your vendor and keep
validating your protocols.
René J.

--- On Tue, 6/15/10, Teri.Hallada <@t> midmichigan.org
<Teri.Hallada <@t> midmichigan.org> wrote:

From: Teri.Hallada <@t> midmichigan.org <Teri.Hallada <@t> midmichigan.org>
Subject: [Histonet] Antibody Validation
To: histonet <@t> pathology.swmed.edu
Date: Tuesday, June 15, 2010, 7:55 AM

I am being questioned by our vendor as to why we need to validate our
automated immunostainer and image analysis instrument. They would like
documentation pertaining to the requirement of validation and the number
of specimens utilized for validation.  I am requesting that each
antibody be validated on the instrument against a previously validated
instrument. Additionally, I am requesting that each new lot of antibody
be validated upon receipt against previously ran specimens. This would
also apply to the image analysis antibodies. (Her2 has been validated by
FISH.) The vendor has apparently polled users in the area and this is
not a standard protocol, therefore the request for documentation.

I think it is pretty clearly stated by CAP in the Quality Management In
Anatomic Pathology. Any other suggestions?

Teresa Hallada BS, MT/CT (ASCP)
Pathology Lead
MidMichigan Health - Gratiot
teri.hallada <@t> midmichigan.org
989.463.1101 ext 3423

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