Seems the actual amount of validation slides can vary with different Medical 
directors( Pathologist) or thats what Ive seen in places. They( The 
Pathologist) sign off on it. With that said ER/PR and Her2 have more vigorous 
criteria( very specific, such as the 25-50). Also, the 2011 AP133 guidline is 
suppose to go into more detail on this. I havnt seen that new recomendation 
yet. So If anyone has it, would love to see it posted here myself? 
 
Thanks
 
Kim


________________________________
From: "Morken, Timothy" <timothy.mor...@ucsfmedctr.org>
To: 'Amber McKenzie' <amber.mcken...@gastrodocs.net>; 
"histonet@lists.utsouthwestern.edu" <histonet@lists.utsouthwestern.edu>
Sent: Wednesday, November 16, 2011 2:08 PM
Subject: [Histonet] RE: Validation

Amber, is this new instrument the same kind as your old instrument and are you 
using the same reagents? Or is it a totally different platform with different 
reagents?

Putting in a new instrument of the same kind and using the same reagents just 
requires verifying the new instrument works. You have to convince whoever wants 
to know that it works the same as the older instrument so running a variety of 
antibodies and procedures on it will suffice to prove that. Doing 
reproducibility tests also proves the instrument works as intended - 5 to 10 
identical slides on one run, 5 to 10 identical slides on 5 to 10 runs. 

If it is a totally different platform with different reagents then you are in 
for revalidating each of your antibodies on the new system.

Tim Morken
Supervisor, Histology, IPOX
UCSF Medical Center
San Francisco, CA, USA

-----Original Message-----
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Amber McKenzie
Sent: Wednesday, November 16, 2011 10:21 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Validation


Just wondering what y'alls opinion is on validation:  I don't really understand 
why optimization isn't enough.  At that point, the pathologist has said what he 
wanted the stain to look like, so why do 3-10 positive slides on the new 
instrument to compare to previous slides from another instrument?  Thanks!

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