Just a few thoughts on the whole antibody validation format. I won't claim
to have figured the complete meaning behind all the regulations, but here
goes. I think it is incumbent upon each lab to validate the antibodies they
are using in their lab on their specimens with their reagents. I do mean
more than just a titer and pretreatment work-up. The antibody sensitivity,
specificity, accuracy and precision must be addressed. This will entail
collecting journal articles, staining a set of expected positive & expected
negative cases. Then you must analyze what this data means for this
antibody. This is fairly easy with some antibodies, and difficult with
others. We then have a lay out that we "plot" this information into, and
expound on these topics of the antibody. I do realize this is a lot of work,
and not done overnight.
Just some things to think about. Thanks


Patti Loykasek
PhenoPath Laboratories
Seattle, EA


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