RUO's in diagnostics... Was...RE: [Histonet] FITC C4d

Morken, Tim tim.morken <@t>
Wed Dec 6 14:34:01 CST 2006

Terri wrote "It is listed as a RUO which is no biggie, as long as you've
done your homework, documentation and have an ASR disclaimer on any
patient report."

This is not true.

ASR's and RUO's are not the same. ASR's are made ONLY by FDA-registered
companies and they can be used for diagnostic tests once the lab
validates them. RUO's are often made by non-FDA-registered companies and
cannot be used for diagnostic work (by law). The law actually says that
an RUO-only, non-FDA-registered company is not supposed to sell to
diagnostic labs if the lab intends to use the product for diagnostic
test (reported and charged tests). If it is used only for research and
is not reported or charged, then there is no problem. The lab is
required to use ONLY ASR or IVD labelled products for diagnostic tests
for which they report the results and charge for. RUO's by ANY company
are not to be used for diagnostic test.

The disclaimer is ONLY for ASR's. There is no disclaimer for RUO
antibodies because RUO's are not to be used for diagnostics, at least
they are not to be reported or charged. This is an FDA rule and they say
the CAP is wrong to say a diagnostic lab can use RUO's (CAP has a
section in the checklist that says an RUO can be used if the lab cannot
find the antibody as an ASR or IVD. FDA says this is not correct and no
use of RUO for diagnostics is legal). Of course these rules are flouted
daily by thousands of labs and FDA has made no effort to enforce this
them. Still, it is the law. Below is my correspondence with FDA about
this subject.

Tim Morken
Product Development
Lab Vision - Neomarkers
ThermoFisher Scientific

Here is my question to FDA and their answer. I asked in 2004 and
confirmed this in 2006. 

"Recently (Dec 2004,
tp.html) The College of American Pathologists (CAP), the accrediting
agency for diagnostic Anatomic Pathology labs, determined that RUO
antibody reagents are suitable for diagnostic work as long as the
laboratory using them makes a "reasonable" effort to find such
antibodies in IVD or ASR format, and undergoes validation of such

from: Anatomic Pathology checklist, Sept 2004, 

Item # ANP.12425             
"Antibodies, nucleic acid sequences, etc., labeled "Research Use Only"
(RUO) purchased from commercial sources may be used in home brew tests
only if the laboratory has made a reasonable effort to search for IVD or
ASR class reagents.  The results of that failed search should be
documented by the laboratory director.""

My question is:

Does the FDA approve of this reversal of the policy to not allow RUO's
for diagnostic use.

-----Original Message-----
From: Gutman, Steve [mailto:SIG <@t> CDRH.FDA.GOV]
Sent: Tuesday, April 05, 2005 8:14 AM
To: 'tpmorken <@t>'
Cc: St. Pierre, Don J.; Rodgers, Anthony (CDRH); Cardamone, Thomas E.;
Yost, Judith A (CMS)
Subject: FW: 03-393 aqr DSMICA Email Form Response

Dear Mr. Morken,

I was not familiar with this CAP change and will share this with CMS the
organization that grants deemed status to CAP.  While I do think this is
a pragmatic approach and probably well intentioned, I also think
unfortunately it is clearly at odds with the law.  Companies or
laboratories that follow this are potentially in jeopardy of compliance

If you have questions or concerns, please feel free to call me at

Steven Gutman, M.D.
Office of In Vitro Diagnostics 

-----Original Message-----
From: histonet-bounces <@t>
[mailto:histonet-bounces <@t>] On Behalf Of Terri
Sent: Wednesday, December 06, 2006 11:57 AM
To: Histonet (E-mail)
Subject: RE: [Histonet] FITC C4d

Ditto on Quidel's C4d performance, its great! It is listed as a RUO
which is no biggie, as long as you've done your homework, documentation
and have an ASR disclaimer on any patient report.  It still takes
interpretation and correlation with clinican results.  We used it when
looking at frozen section renal allografts with cell mediated rejection
at 1:20 and the goat anti mouse FITC at 1:10 Terri Braud

-----Original Message-----
From: histonet-bounces <@t>
[mailto:histonet-bounces <@t>]On Behalf Of Traci
Sent: Wednesday, December 06, 2006 2:24 PM
To: histonet <@t>
Subject: RE: [Histonet] FITC C4d


Quidel carries a C4d anibody ( not indirect labeled ) for FITC.  The
secondary is a Goat anti-mouse FITC.  The item number was A213 and this
worked well at a dilution of 1:40 made in normal goat serum on frozen
tissue.  The Quidel antibody is an ASR.

>From: "Richard Cartun" <Rcartun <@t>>
>To: "Donna Lawson" <dlawson <@t>>, 
><histonet <@t>>,"Mark Tarango" 
><mtarango <@t>>
>Subject: RE: [Histonet] FITC C4d
>Date: Wed, 06 Dec 2006 09:45:27 -0500
>I thought the disclaimer was for analyte-specific reagents (ASRs) only?
>Richard W. Cartun, Ph.D.
>Director, Immunopathology & Histology
>Assistant Director, Anatomic Pathology
>Hartford Hospital
>80 Seymour Street
>Hartford, CT  06102
>(860) 545-1596
>(860) 545-0174 Fax
> >>> "Tarango, Mark" <mtarango <@t>> 12/05/06 5:55 PM >>>
>I've tried and didn't find one.  It's all about the good faith effort, 
>if you ask me. . .
>You have that FDA disclaimer on the reports afterall, right?
>Mark Adam Tarango HT(ASCP)
>Histology/Immunohistochemistry Supervisor
>Nevada Cancer Institute
>One Breakthrough Way
>Las Vegas, NV  89135
>mtarango <@t>
>Direct Line (702) 822-5112
>Fax (702) 939-7663
>-----Original Message-----
>From: histonet-bounces <@t>
>[mailto:histonet-bounces <@t>] On Behalf Of Donna 
>Sent: Tuesday, December 05, 2006 12:03 PM
>To: histonet <@t>
>Subject: [Histonet] FITC C4d
>Is anyone out there using an indirect FITC labeled C4d antibody that is

>NOT an RUO? I can only find 2 and they both say for RUO not for 
>Clinical Diagnostics.
>Any Help will be greatly appreciated,
>Donna Lawson H.T. (ASCP) QIHC
>Histology Supervisor
>University of Kansas Hospital
>Histonet mailing list
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