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 <rjbu...@yahoo.co m> To Sent by: histo...@pathology.swmed.edu, histonet-bounces@ teri.hall...@midmichigan.org lists.utsouthwest cc ern.edu 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.hall...@midmichigan.org <teri.hall...@midmichigan.org> wrote: From: teri.hall...@midmichigan.org <teri.hall...@midmichigan.org> Subject: [Histonet] Antibody Validation To: histo...@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.hall...@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. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet