[Histonet] IHC negative controls

[Kuhnla, Melissa]

Very good point Linda.  The only testing we currently report as an FDA
approved test are our breast markers.  It may be easy enough to maintain
the negative in that scenario.  For other scenarios, we are considering
dropping the negative as long as we perform and document an extensive
validation.  It still may be well worth it.  What do you think?

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Sebree
Linda A
Sent: Friday, October 26, 2012 10:24 AM
To: 'Glen Dawson'; histonet
Subject: RE: [Histonet] IHC negative controls

Hey Glen,

Don't know the answer to your specific question but on a related issue,
our lab has decided to maintain running negative controls due to the
fact that the manufacturer's data sheets for our IHC detection kits and
a majority of our antibodies require using +/- controls. The company in
question has told us they do not intend to change their guidelines as
its part of the FDA approval for their products. Performing IHC staining
not in compliance with the manufacturers' guidelines is against CLIA
reg's.  

Something to consider.

Linda

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Glen
Dawson
Sent: Friday, October 26, 2012 8:45 AM
To: histonet
Subject: [Histonet] IHC negative controls


All,
 
Can anyone tell me if JHACO & CLIA are deferring to CAP's judgement that
a negative control is not needed when utilizing a polymer detection?
 
I assume that this is the case, but I'd like to be sure.
 
Thank-you in advance,
 
Glen Dawson  BS, HT(ASCP), QIHC
Histology Technical Specialist
Janesville, WI
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