[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.
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


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.


 The information contained in this message may be privileged, confidential and
protected from disclosure. If the reader of this message is not the intended
recipient, or an employee or agent responsible for delivering this message to
the intended recipient, you are hereby notified that any dissemination,
distribution or copying of this communication is strictly prohibited. If you
have received this communication in error, please notify us immediately by
replying to this message and deleting it from your computer.
Thank you.
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu


More information about the Histonet mailing list