RE: FDA Final Rule

<< Previous Message | Next Message >>
From:"Jennings-Siena, Debbie" <ds.jennings-siena@baylordallas.edu>
To:"'Goodwin, Diana'" <DGoodwin@CHSNJ.org>, "'Histonet'" <HistoNet@pathology.swmed.edu>
Reply-To:
Date:Thu, 23 Sep 1999 10:22:02 -0500
Content-Type:text/plain; charset="iso-8859-1"

Hi Diana,
Sorry that you are still confused.  This has been a very confusing subject
and it has taken me quite awhile to half way understand.  It is the
manufacturer who decides what the classification of the antibody will be.
Most antibodies are classified as IHC reagents and not subject to the
disclaimer.  Most of the ASR's are antibodies against infectious disease and
prognostic markers, i.e. ER, PR, Ki-67 etc.  If you need anymore help,
please let me know.  Thanks
Debbie Jennings-Siena


	-----Original Message-----
	From:	Goodwin, Diana [SMTP:DGoodwin@CHSNJ.org]
	Sent:	Wednesday, September 22, 1999 8:53 AM
	To:	'Histonet'
	Subject:	FDA Final Rule

	Good Morning , Histonet.

	After reading Debbie Jennings-Sienna's article in the latest edition
of
	NSH in Action, I am still confused as to the classification of
	commercially available primary antibodies.  Are they or are they not
	considered to be ASR's?  Are we or are we not, as a clinical
laboratory,
	required to include a disclaimer on reports to clinicians of
patients on
	whom our lab has performed IHC testing using commercially available
	primary antibodies?

	Diana Goodwin,  HT
	Trenton,  NJ



<< Previous Message | Next Message >>