[Histonet] Re: ASR antibodies verses IVD antibodies

[Eric Hoy]

Dr. Richmond,

I frequently share your frustration with acronyms and abbreviations, but
these are two that I actually know.  ASR is Analyte Specific Reagent, a term
that is applied to many of the monoclonal antibodies that we use in the
clinical immunology lab, and also to antibodies used in Immunohistochemistry
(IHC).  This means that the manufacturer hasn't done the studies necessary
to get FDA (Finicky Dumb Aristocrats) clearance to sell it as an In Vitro
Diagnostic (IVD), and so each lab that wants to use it has to go through a
process of validation to show that the reagent does what we want it to do.

Another layer of bureaucracy added to our lives to "improve" the quality of
what we do.

Regards,
Eric Hoy (another aging lout)

===================================================
Eric S. Hoy, Ph.D., SI(ASCP)
Clinical Associate Professor
Department of Health Care Sciences
The University of Texas Southwestern Medical Center
Dallas, Texas
Email: eshoy <@t> flash.net
===================================================


On 10/24/13 9:22 AM, "Bob Richmond" <rsrichmond <@t> gmail.com> wrote:

> Jim Vickroy in US area code 217 asks for "ASR antibodies verses IVD
> antibodies" so here are some verses for the occasion. (Happy Friday Eve!)
> 
> What's an ASR?
> What's an IVD?
> (I do know FDA
> and sometimes CAP.)
> Endless abbreviations
> leave me with frustrations.
> Please, spell it out,
> for this aging lout!
> 
> ("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.")
> 
> Bob Richmond
> Samurai Pathologist
> Maryville TN
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