[Histonet] ASR antibodies verses IVD antibodies

[Vickroy, Jim]

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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