[Histonet] Her2/Neu Valadation
Rene J Buesa
rjbuesa <@t> yahoo.com
Tue Nov 4 14:24:14 CST 2008
The question has the answer in itself. You have to do the comparisons in the amount recommended between results in your lab vs. in other labs. That is what a validation requires.
--- On Tue, 11/4/08, Amy Self <ASelf <@t> georgetownhospitalsystem.org> wrote:
From: Amy Self <ASelf <@t> georgetownhospitalsystem.org>
Subject: [Histonet] Her2/Neu Valadation
To: histonet <@t> lists.utsouthwestern.edu
Date: Tuesday, November 4, 2008, 11:09 AM
How are you handling/answering the following question from the CAP
Thanks in advance,
Georgetown Hospital System
ANP.22997 Phase I
N/A YES NO
If the laboratory assesses HER2 protein over-expression by
immunohistochemistry (IHC) or HER2 gene amplification by fluorescence in
situ hybridization (FISH), has the laboratory documented appropriate
validation for the assay(s)?
NOTE: Initial test validation must be performed on a minimum of 25
cases (recommended 25-100). Validation may be performed by comparing the
results of testing with a validated alternative method (i.e., IHC vs.
FISH) either in the same laboratory or another laboratory, or with the
same validated method performed in another laboratory; validation
testing must be done using the same set of cases in both labs.
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