[Histonet] RE: Validation
Timothy.Morken <@t> ucsfmedctr.org
Wed Nov 16 13:08:31 CST 2011
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.
Supervisor, Histology, IPOX
UCSF Medical Center
San Francisco, CA, USA
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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