Hi Dana:

This is a question that the CAP needs to re-visit because what "they"
are asking us to do is simply not practical in today's laboratory
environment.  As far as I am concerned, the use of a negative control is
grossly overstated.  Best case scenario in my lab is we run one negative
control and it gets treated with the harshest pretreatment used for that
particular case.  However, we frequently have cases (mostly consults
from other hospitals) where a negative control is not run because there
just aren't enough unstained slides available or we are staining an H&E
or stained cytology slides.  In these situations I look for internal
"negative controls" (i.e., cells that should be negative).  Since we
switched to non-avidin/biotin detection several years ago I hardly ever
see "non-specific" staining.  I would hope that most CAP inspectors
would understand the situation and not site you; I never do.

Maybe we should start a petition to get the CAP to re-examine this
question?

Richard

Richard Cartun, Ph.D.
Director, Immunopathology
Hartford Hospital
Hartford, CT  06102 

p.s. I hope you don't mind, but I sent my response to Histonet as well
since this has been a topic of interest recently.

>>> Dana Settembre  07/27/04 03:03PM >>>
Dr. Cartun,
Can I ask you how you handle your negative controls in reference to
CAP
requirements?
Our inspection is in September and our official revised CAP checklist
asks and states the following:
 
Are negative controls used for each antibody species? 
NOTE: A negative control for each primary antibody species must be
used.  Alternativly, buffer controls can be used
if multiple antibodies for each species are included.  The controls
used should also control for pre-treatment conditions.

I would greatly appreciate it if you would take the time to respond.

Dana Settembre
University Hospital - UMDNJ, Newark, NJ

 
>>> Richard Cartun  7/27/2004 11:23:45 AM >>>
Hi Dana:

Are you sure that BioCare's AMACR isn't "IVD"?

RIchard

>>> Dana Settembre  07/27/04 07:25AM >>>
Sorry,  Using Biocare Medical's AMACR which is Research Use Only.
Dana Settembre
University Hospital - UMDNJ
Newark, NJ

>>> Richard Cartun  7/23/2004 5:14:14 PM >>>
Is anyone using an antibody to "alpha-methylacyl-CoA racemase" (P504S)
that is labeled "IVD" or "ASR"?  Thank you!

Richard Cartun

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