[Histonet] RE Antibody validation

[Rena Fail]

Teri

New lots of Antibodies recieved by a lab should be validated by  that laboratory.  Thus proving the new lots produce similar results sa the old under the same set of circumstances. Processing,  Retrevial methods, thickness of sections, techniques etc used in your laboratory contribute to the outcome.       
Having the Ab validated by the vendor does not verify that it works in your laboratory with your procedures.
Rena Fail


----- Original Message ----
From: "Teri.Hallada <@t> midmichigan.org" <Teri.Hallada <@t> midmichigan.org>
To: histonet <@t> pathology.swmed.edu
Sent: Tue, June 15, 2010 7:55:28 AM
Subject: [Histonet] Antibody Validation

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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