FW: Research Use Only
------ Forwarded Message
From: Patti Loykasek
Date: Thu, 05 Dec 2002 08:05:49 -0800
To: "Willis, Donna"
Subject: Re: Research Use Only
> Patsy and histonetters,
> How are other hospital based IHC departments handling the compliance issue
> of not performing and/or charging IHC that are on RUO antibodies. If we
> order a concentrated antibody from several of the overseas companies the
> products sheets say that the antibody is for Research Use Only. The FDA
> compliance won't let us use these antibodies in a clinical setting. I know
> that companies that don't manufacture their antibodies in the US don't have
> to worry about FDA but if they want to sell their products to US labs they
> need to change the wording in the products sheets.
> Donna Willis
> Histology Lab Manager
> Harris Methodist Fort Worth, Tx
Hi Donna. Here is how we handle the RUO antibodies - which are the vast
majority of antibodies. This classification does not prevent them from being
used & reported on cases, but you must have the the "home brew" disclaimer
that is required by FDA. There is a CAP statement covering this that we
include in our reports. According to the CLIA guidelines each lab must
establish and verify the accuracy & precision of all tests. To that end we
have an in house antibody validation program that we use for each antibody &
keep extensive records. This is covered by "Analyte Specific Reagents"
regulation Federal Register/ Vol 62, No. 225. Hope this helps.
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