CellMarque has a concise explanation of the IVD/ASR system at
http://www.cellmarque.com/2000/Pages/finalrule.html

Also, As I understand it, an RUO antibody can be used like an ASR if the
institution undertakes full validation (that includes proving the intended
target is labeled). There are some large institutions that develop their own
antibodies in a research setting and then validate them for in-house
diagnostic use.

Tim Morken
Lab Vision / Neomarkers
www.labvision.com
 

-----Original Message-----
From: Stapf, Ross [mailto:RossS@BaylorHealth.edu] 
Sent: Wednesday, January 28, 2004 9:55 AM
To: Horn, Hazel V; Mitchell, Jeannette M.; Histonet@pathology.swmed.edu
Subject: RE: [Histonet] FW: ASRs



I have found a few links regarding ASR's, RUO's and what has happened in the
USA with these rules. 


http://www.ashi-hla.org/usefullinksfiles/asr-freg.pdf
This one is the FDA ruling regarding ASR's.  Especially read Comment 16 on
page 8.

http://www.fda.gov/cdrh/comp/fr01598b.html
http://www.gklaw.com/powerpoint/IP/Analyte_Specific_Reagent_Regulations.
ppt

The last one is a PowerPoint presentation prepared by a PhD and an attorney
on the subject.  If you download it and then open it in PowerPoint viewing
the presenter's notes, it has a lot of information.

I admit that I'm still trying to figure it out.  I hope someone here knows
for certain.  As far as I can tell, the FDA does not want Pathologist's to
use RUO's in their diagnosis, but has not begun to enforce this and may not
have published final rules stating this.


Please feel free to read the above links and disagree.  I'm not an expert.
I'm trying to figure this out myself.

Ross M Stapf
Histopathology Manager
Baylor University Medical Center
3500 Gaston Ave.
Dallas, TX 75246
214-820-2465

214-820-4110 fax
RossS@baylorhealth.edu



-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Pat Zeitlow
Sent: Wednesday, January 28, 2004 9:30 AM
To: Horn, Hazel V; Mitchell, Jeannette M.; Histonet@pathology.swmed.edu
Subject: RE: [Histonet] FW: ASRs


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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