[Histonet] RE: Validation

[Walter Benton]

Optimizing is getting the stain to look a certain way based on retrieval, incubations times etc.... validation is the process of running cases that are known positives of varying levels(degrees of positivity) and running them with normal cases to ensure the antibody is staining as intended based upon the optimized protocol that you have established. If for some reason the cases display background or do not stain the positive and negative cases as predicted based upon your optimization the antibody should not be validated as being ready for clinical use, it should be re-worked. Hope this helps.

Walter Benton HT(ASCP)QIHC
Histology Supervisor
Chesapeake Urology Associates
806 Landmark Drive, Suite 126
(All Deliveries to Suite 127)
Glen Burnie, MD 21061
443-471-5850 (Direct)
410-768-5961 (Lab)
410-768-5965 (Fax)
wbenton <@t> cua.md
________________________________________
From: histonet-bounces <@t> lists.utsouthwestern.edu [histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Amber McKenzie [amber.mckenzie <@t> gastrodocs.net]
Sent: Wednesday, November 16, 2011 1:20 PM
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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