RE: ASR reagents
The ASR statement needs to be in the report if the antibody is identified by
the supplier as ASR. Antibodies that come to mind to me are HSV and Ki-67.
Those are the 2 we do that are ASR. The antibodies labeled IVD do not
require the language and are/can be used for diagnostic testing. RUO
antibodies are just that, for research use only and not to be billed for
under FDA guidelines. The couple of antibodies we use that are RUO we do
not bill the patient for.
> -----Original Message-----
> From: Garza-Williams, Sara [SMTP:Garza-Williams.Sara@tchden.org]
> Sent: Thursday, March 21, 2002 1:09 PM
> To: 'email@example.com'
> Subject: ASR reagents
> With CAP inspection coming up. Can someone out in histonet world clarify
> the question under ANP.12425 - If immunohistochemical studies involving
> reagents labeled by the manufacturer as "analyte-specific reagents"
> part of the specimen evaluation, is the federally-required clarifying
> statement part the report?
> In your final surgical report would you include in the comment section:
> (Mandatory language) "This test was developed and its performance
> characteristics determined by (laboratory name). It has not been cleared
> approved by the U.S Food and Drug Administration." Or would you use: "The
> FDA has determined that such clearance or approval is not necessary. This
> test is used for clinical purposes. It should not be regarded as
> investigational or for research. This laboratory is certified under the
> Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to
> perform high complexity clinical laboratory testing."
> I guess I'm a bit confused regarding the requirements of CAP and the
> (company) selling the antibody for immunohistochemical staining. Most of
> product specification sheets that I have say "For in vitro diagnostic use"
> or "For research Only" "Not for use in diagnostic procedures"
> Would you include one of the above comments in the report, regardless?
> Necessary to do so?
> Ahh I'm confused.....................
> Sara A. Williams
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