This discussion takes place frequently and I also would like final
resolution.  The following statement is from CAP Advocacy (11/98) and
seems clear enough.  Please let me know if something more current
exists.

ASR FACT SHEET
"The FDA very clearly distinguishes ASRs from Immunohistochemistry (IHC)
reagents (final rule effective Aug. 17, 1998).  The FDA defines IHCs as
"in vitro diagnostic devices...intended to identify, by immunological
techniques, antigens in tissue or cytologic specimens."  Unlike ASRs,
IHCs are labeled by manufacturers with directions for use and
performance indications."

Based upon that, my interpretation and practice has been that
disclaimers are unnecessary on IHC antibodies in general.  It may be
that you could be using antibodies that are worked up with home brew
methods (do not come with instructions and performance indications) in
which case I would assume the disclaimer would be appropriate.  

I look forward to the responses from the group on this.
Pat Zeitlow
Boyce & Bynum Laboratories
-----Original Message-----
From: Horn, Hazel V [mailto:HornHV@archildrens.org] 
Sent: Tuesday, January 27, 2004 1:43 PM
To: 'Mitchell, Jeannette M.'; Histonet@pathology.swmed.edu
Subject: RE: [Histonet] FW: ASRs

The disclaimer is necessary if the antibody is labeled ASR by the
manufacturer.   If it is, you must use the disclaimer.    Almost all of
our
antibodies are IVD or ASR and we bill for those.  But, if we have a RUO
antibody (we have 2)  we  do not bill for those immunos.   It's not a
CAP
requirement,  it's a CLIA requirement for the statement and CAP is just
following through with their inspections to see if labs are complying.

Hazel Horn, HT/HTL (ASCP)
Histology Supervisor
Arkansas Children's Hospital

Phone - 501.364.4240
Fax - 501.364.3912 

-----Original Message-----
From: Mitchell, Jeannette M. [mailto:Jeannette.Mitchell@vtmednet.org] 
Sent: Tuesday, January 27, 2004 1:05 PM
To: Histonet@pathology.swmed.edu
Subject: [Histonet] FW: ASRs



> Can folks tell me what they are doing with regard to CAP Checklist 
> Dec. 2003 question  # ANP.12425 regarding ASRs (Analyte Specific 
> Reagents) ? We currently do not have any disclaimer in our patient 
> surgical reports because all our antibodies are commercially produced 
> (not "home brews"). In reading this recently revised requirement 
> however it sounds like we need to have this statement in all our 
> reports that have had IHC performed. Most of the antibodies we use 
> have package inserts saying for "Research Use Only".
> 
> I'd appreciate any feedback as to whether the CAP recommended 
> disclaimer is necessary with commercially bought antibodies (not in 
> kits). thanks Jude
> Jude Carpenter, BS, HTL(ASCP)
> Chief Technologist for Autopsy/Histology/Surgical Pathology
> 111 Colchester Ave.
> Burlington,  VT  05401
> jude.carpenter@vtmednet.org
> (802)847-5116
> fax: (802)847-3509
> 


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