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From:THOMPSON.YVONNE_M@BAY-PINES.VA.GOV (by way of histonet)
To:histonet <histonet@magicnet.net>
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Dear Histonetters,
Would appreciate input on the use of expired immuno reagents/antibodies.
I am under the impression that some of us may aliquot and freeze
antibodies thereby extending their "life" beyond the expiration date
and some may use properly stored antibodies after expiration...both
practices and perhaps other combinations are then always quality assured by
running appropriate controls that validate results.

I've researched 21CFR809 and 21CFR864 as these were the codes that were
applied to the recent FDA ruling on Analyte Specific Reagents (ASRs). I
can find nothing that addresses this specific subject. I called the
FDA and their position is that there is no data to support the use of ASRs
beyond the expiration date and therefore they are not to be used.

So...what do my friends in Histoland think and do regarding this practice.
Inquiring pathologist and histologists minds want to know :-)
Thank you.
Yvonne Thompson, VA Medical Center, Bay Pines, FL.

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