[Histonet] ANP.23018

[Elizabeth Chlipala]

Lisa

First of all I want to state that I'm in a research lab and not a clinical lab.

I believe that they are looking that the control tissues for IHC stains that are being used for image analysis (ER/PR, HER2, Ki-67, etc.) contain multiple tissue samples with different staining intensities, such as negative, 1+, 2+ and 3+ expression levels.  What expression levels you use I believe CAP leaves up to you but I would think one tissue that is 1+ and one tissue that is 3+ would work.   Others in the clinical setting may comment on this in more detail.   Vendors will supply cell block controls with varying expression levels with these kits but ideally you should be using laboratory positive controls (tissue processed in your lab) and these should consist of multiple tissues so when stained they will demonstrate different expression levels.

It's also important in the IHC protocol development and validation process that tissue of varying staining intensities be used also.

Liz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Laboratory Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, CO 80308
Work (303) 682-3949
Fax (303) 682-9060
Cell (303) 881-0763
liz <@t> premierlab.com
www.premierlab.com

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-----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 10:21 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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