[Histonet] RE: Validation

[Kim Donadio]

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.Morken <@t> ucsfmedctr.org>
To: 'Amber McKenzie' <amber.mckenzie <@t> gastrodocs.net>; "histonet <@t> lists.utsouthwestern.edu" <histonet <@t> 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-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Amber McKenzie
Sent: Wednesday, November 16, 2011 10:21 AM
To: histonet <@t> 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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