Re: [Histonet] Her2/Neu Valadation

From:Rene J Buesa

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.
René J.

--- On Tue, 11/4/08, Amy Self  wrote:

From: Amy Self 
Subject: [Histonet] Her2/Neu Valadation
Date: Tuesday, November 4, 2008, 11:09 AM

Dear Histonetters,


How are you handling/answering the following question from the CAP


Thanks in advance,



Georgetown Hospital System




**NEW**                   09/27/2007


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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Thank you.
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