[Histonet] RUO's and diagnostic IHC

[Houston, Ronald]

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

Don't shoot the messenger.........

 

"-----Original Message-----
From: Gutman, Steve [mailto:steve.gutman <@t> 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
position on use of RUOs to support home brews.  In general, we think
this 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.

 

Thanks.

 

Steve

 

________________________________

From: Houston, Ronald [mailto:HoustonR <@t> 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. 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
laboratorians.

 

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

 

Sincerely

Ronnie Houston, MS, HT(ASCP)QIHC

Anatomic Pathology Manager

Columbus Children's Hospital

700 Children's Drive

Columbus, OH 43205

(614) 722 5465

houstonr <@t> chi.osu.edu <mailto:houstonr <@t> chi.osu.edu> "

 

 

Ronnie Houston, MS, HT(ASCP)QIHC

Anatomic Pathology Manager

Columbus Children's Hospital

700 Children's Drive

Columbus, OH 43205

(614) 722 5465

houstonr <@t> chi.osu.edu <mailto:houstonr <@t> chi.osu.edu> 

 

 



-----------------------------------------
Confidentiality Notice: This e-mail message, from Children's
Hospital, Columbus, Ohio, including any attachments, is for the
sole use of the intended recipient(s) and may contain confidential
and privileged information. The recipient is responsible to
maintain the confidentiality of this information and to use the
information only for authorized purposes pursuant to Children's
Hospital's confidentiality policies. If you are not the intended
recipient (or authorized to receive information for the intended
recipient), you are hereby notified that any review, use,
disclosure, distribution, copying, printing, or action taken in
reliance on the contents of this e-mail is strictly prohibited. If
you have received this communication in error, please notify us
immediately by reply e-mail and destroy all copies of the original
message. Thank you.