[Histonet] RE: ASR antibodies verses IVD antibodies

[Morken, Timothy]

Jim, Since companies are not allowed, by law, to tell you any method information about ASR's, it is the responsibility of the lab to do a comprehensive validation according to CLIA regulations. Treat it as if it were an antibody some researcher gave you and you need to figure out EVERYTHING to complete a validation:  specificity and sensitivity, reproducibility, etc. That all has to be documented.

Tim Morken
UCSF Pathology

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Vickroy, Jim
Sent: Wednesday, October 23, 2013 10:37 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] ASR antibodies verses IVD antibodies


In older CAP regulations ASR's had to be handled separately than IVD antibodies including a disclaimer acquired from the FDA.   I don't find that in the current CAP checklist.  Has this been eliminated and if so how are people handling validation of ASR antibodies?   Are they using the validation they use for new antibodies introduced to the lab?

Jim

James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor Memorial Medical Center
217-788-4046


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