[Histonet] ANP.23018

[Morken, Timothy]

Lisa,  I take this to mean that when you have an antigen for which expression level is a critical part of the interpretive decision that your control should have a full range of expression levels. The most important part of that is ensuring you are not missing low expression levels, for instance in ER staining. Or cut-off expression levels in Her2.  Ideally you will have a protocol that delineates which antigens require that type of control  and which of your controls meet the requirement. Of course you need a good validation of the control that shows the desired expression levels under suitable staining conditions.


Tim Morken
Department of Pathology
UC San Francisco Medical Center

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Lisa Brenner
Sent: Wednesday, March 06, 2013 9:21 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] ANP.23018

Hello,
 
I was hoping someone could give me their interpretation of what they are looking for in this checklist question.
 
ANP.23018 Control materials at more than one expression (level) are run concurrently with patient specimens.
 
Note: Controls should verify test performance at relevant decision points. For many tests, a positive and negative control are sufficient. Controls need be run only on days when patient specimens are tested. For immunohistochemistry, the laboratory must follow the control requirements in the immunohistochemistry section of this checklist.
 
This question is under quality control. Kind of under validation and calibration all under digital image analysis.
 
I follow all the control requirements for immuno, special stains, and daily H&E QC. What are they looking for? Thanks in advance for your input.
 
Lisa
 
 
Lisa Brenner HTL
Histology Lab Holland Hospital
602 Michigan Ave.
Holland, MI 49423
(616)394-3184


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