I think this is a very interesting question, especially I am interested 
to hear the opinions of the US people. Because in Germany we have no FDA 
or FDA-approved Test, you can use whatever you want. Although I have to 
say that the German Cancer Society recommended to use the polyclonal 
antibody from DAKO (but not the kit). However, this society never stated 
why. So we use the DAKO antibody (but not the kit anymore s. later) 
and are currently testing whether there are differences to other 
antibodies from other companies. 

In addition, we had problems trying the herceptest, because with the 
prediluted antibody we got no positive internal control as expected (the 
normal breast should be weak positive). This is probably due to our 
"special lab" conditions. 
The Dako people said that I have to adapt the pre-treatment procedure to 
our lab conditions, however it was not possible to get some free 
prediluted antibody for this sort of testing nor was it possible to get 
to know the concentration of the antibody solution in the kit. At this 
high costs (60 DM, about 30 US$ per slide) we said, no thank you ... 
so we just use the regular polyclonal antibody and make our own dilution. 


Dr. Heike Grabsch,
Dept of Pathology
University of Duesseldorf
Germany


Andrea Kelly wrote:
> 
> Can anyone explain the difference between the FDA approved Dako Herceptest
> and the other antibodies used for HER2/neu on automatic [immuno]stainers?
> Does it really matter whether the detection system is FDA approved or not?
> Thank you.