[Histonet] Antibody Validation

Teri.Hallada <@t> midmichigan.org Teri.Hallada <@t> midmichigan.org
Tue Jun 15 06:55:28 CDT 2010


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

___________________________________
Please note that this email message and any attachments may contain privileged and confidential information that is protected against use or disclosure under federal and state law.  The information is intended only for the personal and confidential use of the intended recipient. If the reader of this message is not the intended recipient or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this information in error and that any review, dissemination, distribution, copying or action taken in reliance on the contents of this communication is strictly prohibited.  If you have received this email in error, please advise by immediate reply.  


More information about the Histonet mailing list