RE: [Histonet] Re: Dr. Cartun can you answer a CAP question?

From:"Joe Nocito"

Howdy all,
Many moons ago when I was the supervisor of the IHC at the AFIP, I'm talking
mid-lat 1980's, we used to run polyclonals using PAP, our negative was a
normal rabbit serum, and we used to run our monoclonals ABC with a normal
mouse serum negative. At that time we were staining (by hand of course) 350
slides a day. Once when I was QCing the slides, all the polyclonals looked
fine, but I noticed that all the monoclonals, including the negative had
background staining. Come to find out after a little digging, the specimen
came from a person who had been bitten by a rat some time ago. My theory was
that mouse and rat are close and maybe the patient had mouse antibodies.
That was the only case I can remember that a negative was a good thing.

Joe Nocito, BS, HT(ASCP) QIHC
Histology Manager
Pathology Reference Lab
San Antonio, TX

-----Original Message-----
[]On Behalf Of Galbraith,
Sent: Thursday, July 29, 2004 9:47 AM
To: Richard Cartun;;
Subject: RE: [Histonet] Re: Dr. Cartun can you answer a CAP question?

Dr. Cartun:

I would be first in line to sign that petition.  We used to just run a
negative for each species (as you say in the harsest conditions utilized)
until the latest verbage change.  We had changed prior to our last
inspection but the inspector did indeed check to see if we were in
compliance regarding negative controls for each pretreatment.  As I noted
this did indeed considerably increase cost without any revenue gain since in
the worst case you could have a negative control for each test Ab used.
However, it does appear that CAP is rather serious about this and there have
even been rumblings about isotype specific neg's which would make the
situation even more complex.  We too have switched to non-avidin/biotin
detection systems and also rarely see any background staining.  Sometimes it
seems that the vigorous science of research carries into the cost conscious
clinical world perhaps more than necessary.  However, every time that I get
to thinking that neg's always seem to be rather meaningless, then once in a
RARE, RARE while we do detect a patient that does have some specific
staining on some of the extra negative slides that we run today, so perhaps
CAP does have a point.

Best wishes,

Joe Galbraith

-----Original Message-----
[]On Behalf Of Richard
Sent: Tuesday, July 27, 2004 5:43 PM
Subject: [Histonet] Re: Dr. Cartun can you answer a CAP question?

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


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
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"?


>>> 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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