[Histonet] RUO's and diagnostic IHC

From:"Houston, Ronald"

Here is a reply I received yesterday from Dr Steve Gutman, Director, In
=0AVitro Diagnostics, FDA, regarding the current status of using RUOs in
=0Athe clinical lab. He did add the disclaimer that these were his views=0Dand did not represent official FDA policy; and you thought it was
=0Aconfusing before!!!!!

Don't shoot the messenger....=2E....


"-----Original Message-----
From: Gutman, Steve [mailto:steve.gutman@fda.hhs.gov] 
Sent: Monday, January 29, 2007 2:52 PM
To: Houston, Ronald
Subject: RE: RUO's and ASR reagents in diagnostics - FDA disclaimer


I have had informal discussions with CAP but FDA has not taken a formal
=0Aposition on use of RUOs to support home brews.  In general, we think=0Dthis is a dreadful choice and clearly a tactic of last resort.  There
are no regulatory requirements for RUO devices.  So the laboratory takes
full responsibility for ensuring quality of production of the RUO
material being made over time.  This seems to me to put laboratories at
considerable liability risk since the general controls applied to ASRs
don't work here.  


As we try to review our regulatory policy in this area, it is certainly
one we should and will try to clarify.





From: Houston, Ronald [mailto:HoustonR@chi.osu.edu] 
Sent: Monday, January 29, 2007 10:23 AM
To: Gutman, Steve
Subject: RUO's and ASR reagents in diagnostics - FDA disclaimer
Importance: High

Dr Gutman,


There is tremendous confusion in laboratory circles regarding the FDA
disclaimer for ASR antibodies and whether or not this same disclaimer
can be used for RUO antibodies, particularly in light of CAP's change in
interpretation of the guidelines for IHC testing:


"Antibodies, nucleic acid sequences, etc., labeled "Research Use Only"
(RUO) purchased from commercial sources may be used in home brew test
only if the laboratory has made a reasonable effort to search for IVD or
ASR class reagents=2E The results of that failed search should be
documented by the laboratory director.

The laboratory must establish or verify the performance characteristics
of tests using Class I ASR's and RUO's in accordance with the Method
Performance Specifications section of the Laboratory General checklist."


Exactly what is the current stance of the FDA, and have any discussions
taken place between the FDA and CAP regarding their interpretation? Can
results of RUO testing be dictated into a diagnostic report and can the
test be billed?


Obviously, antibody manufacturers mandate that their RUO antibodies
cannot be used for diagnostic purposes, but they are as confused as the


Thank you for taking the time to clarify this very confusing situation.



Ronnie Houston, MS, HT(ASCP)QIHC
=0DAnatomic Pathology Manager

Columbus Children's Hospital
700 Children's Drive

Columbus, OH 43205

(614) 722 5465

houstonr@chi.osu.edu  "



Ronnie Houston, MS, HT(ASCP)QIHC

Anatomic Pathology Manager

Columbus Children's Hospital

700 Children's Drive

Columbus, OH 43205
=0D(614) 722 5465




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