-----Original Message-----
From: Ric Wiles 
Sent: Thursday, April 13, 2000 12:45 PM
To: Histonet
Subject: RE: Penfix and Dako's HecepTest



Hello,

I'm responding to the questions that have been recently raised regarding
HecepTest.  Yes, fixation guidelines and staining protocols are required
with HercepTest.  This was necessary in order to create a truly standardized
detection system and to gain FDA approval. 

The example given in a previous post on the Histonet of two blocks using two
different fixation times  "...one fixed for a week in formalin the other
fixed for an hour, are both still FDA approved because they were fixed in
formalin."  Actually, neither one are within the guidelines.  The package
insert states that specimen blocks should be fixed 18-24 hours in neutral
buffered formalin. Regarding clearing reagents:  The package insert also
indicates that xylene, toluene or xylene substitutes are appropriate for
use.  There are no restrictions on paraffin types but, of course, plastic
embedding medium should be avoided.  The Epitope Retrieval Solution that is
provided with the kit is specifically formulated for use with HercepTest.
No other retrieval solution should be substituted including DAKO's regular
Target Retrieval Solution. As has been indicated, the use of the approved
fixative and protocol is very important. Deviation from these can lead to
erroneous results.  If anyone has further questions, please call our
Technical Service Group at 800 424-0021.

Ric Wiles
Manager, DAKO Corp. Technical Service Group

-----Original Message-----
From: Reynolds, David A [mailto:dareynolds@anmc.org]
Sent: Wednesday, April 12, 2000 2:26 PM
To: cgarver@yorkhospital.edu; HistoNet@pathology.swmed.edu
Subject: RE: Penfix and Dako's HecepTest


Yes.  Also, I believe Dako's antigen (target) retrieval method must be used
as well.  

> -----Original Message-----
> From:	cgarver@yorkhospital.edu [SMTP:cgarver@yorkhospital.edu]
> Sent:	Tuesday, April 11, 2000 4:37 PM
> To:	HistoNet@pathology.swmed.edu
> Subject:	Re: Penfix
> 
> 
	(Edited)
> It has come to our attention through IMPATH labs that DAKO's Hercept Test
> was FDA approved using 10% NB Formalin or Bouins only.  
> 
> Has anyone else been made aware of this issue with DAKO's Hercept Test?
> 
> 
> On Tue, 11 Apr 2000, joyce judge wrote:
> 
> > Does anyone know of any alternatives to "PenFix"
> > Joyce Judge
> > Saints Memorial Medical Center
> >
> > __________________________________________________
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> 
>