Re: immunostaining, method validation

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From:amos brooks <>
To:Vicki L McKaughan <>
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    When we switched our automation not long ago we did the validation too. It was a pain in the a...nkle, but the up shot was that the procedures we developed were
greatly improved. We didn't use samples being tested (except with optimizing Herceptest), we did checkerboard titrations of each antibody at various staining times using
our control tissue. This made more sense since they are known positives and you have the old controls to compare them to.
    This is time consuming, but if taken on a antibody by antibody basis, it will be done before long. Then you will have an excellent set of slides to demonstrate that
your procedures are the best possible. Not to mention, you will inevitably find some tests that you can titer out further and thereby save some money. (maybe they'll give
you a raise ... haha).
Amos Brooks

Vicki L McKaughan wrote:

> We recently purchased a Ventana Nexes Immunostainer.  I have been told by our lab QA
> Director that I must do method validation/comparison studies for all the antibodies that we do.  She wants me to do 5 cases per antibody both with the Ventana and our
> old method which was basically manual.  If anyone else has encountered this I would like some suggestions on how to go about this study.
> It could prove to be very time comsuming and
> costly.  Does anyone know specifically if CLIA
> requires this for Histology?  Thanks for your help.
> Vicki McKaughan, HT (ASCP)
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