[Histonet] new anitbody

[Richard Cartun]

You need to prove that the antibody labels its intended target and that there is no cross-reactivity with unrelated proteins.  The number of cases needed to do this will depend on the antibody's "track record" and its purpose.  For example, antibodies used to identify predictive targets (ER, PR, and HER2 in breast CA) will require more cases to complete your validation since patients are being treated based on the presence or absence of these targets.  Some IHC experts will tell you that you need to run 25, 50, or maybe even 100 cases (positive and negative) to validate an antibody.  I tell people that you need to run enough cases so that your pathologists feel comfortable interpretating that test.  After all, they are the ones that sign-off on these tests.  When bringing a new antibody on-board, read the antibody product data sheet and the pathology literature, and then sit down with your pathologist and create a "reasonable" validation plan.  In my opinion, far too much money is being wasted running unnecessary slides for validation purposes.

Richard

Richard W. Cartun, MS, PhD
Director, Histology & Immunopathology
Director, Biospecimen Collection Programs
Assistant Director, Anatomic Pathology
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 545-1596 Office
(860) 545-2204 Fax


>>> Amber McKenzie <amber.mckenzie <@t> gastrodocs.net> 1/3/2012 4:06 PM >>>
I know when you get a new instrument you have to validate every antibody against previous stained slides on the original instrument, but what actions must be taken for a new antibody?  Besides, putting the protocol in and running control slides.


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