Laura,

I currently use RUO's and charge for them.  The pathologists here at the
Medical College of Wisconsin are aggressive in seeking out the newest
antibodies out there to better treat the patient.  All my RUO's are put
through an extensive work-up and I can honestly say that they produce
results that are comparable to any of my other antibodies.  Since this is a
business, I must be able to bill for RUO's for the all important bottom line
to be met.  To do these antibodies at no charge would not be good.  I have
been trying to compile a list of RUO's, IVD's, ASR's, etc... to give to all
of my clients with a letter explaining that they have been officially
notified on the status of each of my antibodies.  Accordingly, the policy
they choose to follow will be their own but the technical portion must and
will be billed on my end.  Interesting thread.

Glen Dawson  BS, HT & QIHC (ASCP)
Lead IHC Technologist
Milwaukee, WI

-----Original Message-----
From: bliven.laura@marshfieldclinic.org
[mailto:bliven.laura@marshfieldclinic.org]
Sent: Wednesday, March 19, 2003 7:30 AM
To: histonet@pathology.swmed.edu
Subject: Research Use Only Antibodies



Mornin'

I understand how to handle IVD and ASR labeled antibodies, my questions
concern Research Use Only (RUO) labeled antibodies.

1.  Can we use RUO labeled antibodies in a clinical setting?  In a search of
the archives, I have a yes and no answer.  

2.  One response mentioned that you can use RUO, but only with the
disclaimer.  If so, do you also mention that certain antibodies in the panel
are for RUO, because it would not make sense to use the same disclaimer for
RUO and ASR antibodies.

3.  Three responses stated that you could not charge for RUO antibodies - is
this so?  (Of course we do QA and QC with all antibodies, no matter how they
come labeled.)

4.  Where can I get a direct answer for these questions and not a few pages
of reading with the answer depending upon how each person interprets the
regulation.

After all these years, one would think I would know these answers, but I
still don't - sorry and thanks for any feedback.

Laura