CAP does have guidelines, it's a paper that was published a few years back, its right on the CAP website. I have it if anyone needs it. I'm not sure they use it for their inspections but it covers how to validate an antibody. How many samples to run, what paperwork needs to be kept, etc.
Liz Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC Manager Premier Laboratory, LLC PO Box 18592 Boulder, Colorado 80308 office (303) 682-3949 fax (303) 682-9060 www.premierlab.com Ship to Address: 1567 Skyway Drive, Unit E Longmont, Colorado 80504 -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of thisis...@aol.com Sent: Wednesday, April 28, 2010 12:47 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Responses to IHC CAP Validation question The following is one respone I rec'd: 1. I asked CAP who told me that they do not currently have a guideline on validating but that they recommend what is in the following book: Quality Management In Anatomic Pathology, Promoting Patient Safety Through Systems Improvement and Error by Raouf E. Nakhleh, MD & Patrick Fitzgibbons, MD editors sold by CAP ! Chapter 8- Quality Management in IHC That is what we follow. I. Get a new antibody and optimize it with your positive control. II. Once optimized you need to run it on cases expected to be positive (how many?) "a suffient size ..." III. Must also be run on cases expected to be negative. (how many? IV. In a situation where you cannot expect a lot of cases or such a case has never been presented in your lab, then you must say just that. (ex. some of the hormones we just use a pituitary) _______________________________________________ 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