Re: immunostaining, method validation

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From:Tim Morken <>
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This is a standard procedure when changing technology for doing a test. You 
need to show that the new method is equivalent to the old method. Ideally 
you should do it for each antibody you use, but it need not be done all at 
once, for instance, if you use some antibodies  infrequently you can do the 
validation when they are ordered.

Another (faster) way to do it is to do a statistical sampling of your 
antibodies and perform the validation on representative samples of 
antibodies, for instance you may do 10 percent of the rabbit antibodies and 
10 percent of ther mouse antibodies, or a percentage of sets of tumor 
markers, infedctious agents, membrane markers etc. This random testing would 
show that any antibody used works the same on the machine as in the manual 

Some of your med tech people could probably help you set this up since they 
have to do statistical sampling of their machines every day and know how it 

You should talk to you lab manager about the statistical method as it is 
used in all production areas to test products.

Tim Morken, B.A., EMT(MSA), HTL(ASCP)
Infectious Disease Pathology
Centers for Disease Control
1600 Clifton Rd.
Atlanta, GA 30333


Phone: (404) 639-3964
FAX:  (404)639-3043

----Original Message Follows----
From: Vicki L McKaughan <>
Subject: immunostaining, method validation
Date: Fri, 18 Feb 2000 12:16:54 -0800

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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