[Histonet] IHC negative controls

Sebree Linda A LSebree <@t> uwhealth.org
Fri Oct 26 09:23:45 CDT 2012

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.


-----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

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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