immunostaining, method validation

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From:Vicki L McKaughan <>
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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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