ER/PR, Her2 Regulatory Questions

<< Previous Message | Next Message >>
From:"Louri Caldwell" <> (by way of histonet)
Content-Type:text/plain; charset="us-ascii"

Hello everyone,

I have been asked to initiate immunoperoxidase procedures for ER/PR and Her2
on breast cancer cases and I want to be sure we follow all applicable
regulations.  I have read the CAP, FDA, and CLIA guidelines, but I want to
be sure I've done everything correctly.

Our current procedure is as follows:  We use Dako's ER & PR primary
antibodies with their LSAB2 kit for ER & PR, and the Herceptest kit for
Her2.  The lot of each antibody and kit is tracked as to date
ordered/received/opened/discarded, along with the initial reactivity of each
antibody/kit, and the cases tested using each lot.  Along with each case
tested, a control block is being used that has a range of known reactivity
to each antibody (from 0 to 3+) and a negative control section of the case
being tested.  In addition to these 2 controls, the Herceptest kit control
slide is run with the Her2.  The results of each stain as dictated by the
pathologist is also tracked.

Here are the questions I have:

  Are there any additional controls that need to be run or validation
procedures I need to go through in order to be compliant?

  Do I need to go through separate validation procedures if I use less
reagent than the Herceptest instructions dictate?  If so, to what extent?

  Are there any restrictions as to who can perform these procedures?

Any assistance would be greatly appreciated.  Wishing all a very safe and
happy holiday season.

Louri Caldwell
Get Your Private, Free Email at

<< Previous Message | Next Message >>