[Histonet] Her2/Neu Valadation

[Rene J Buesa]

Amy:
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 <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

Dear Histonetters,

 

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

 

Thanks in advance,

Amy

 

Georgetown Hospital System

843-527-7179

 

 

**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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