If you are a brand new lab, how do you validate IHC if you are no= t
yet receiving patient specimens? Can the validation be done on cont rol
tissues only?
Sincerely,
Tonia Richmond, AS, HT (ASCP)
Chief Operations Officer = / Laboratory
Grace Pathology
PH: (501) 765-7367
Email: = [1]tonia.= richm...@gracepathology.com
-----histonet-boun...@lists.utsouthwestern.edu wrote: -----
<= /FONT>
To: "thisis...@= aol.com" <thisis...@aol.com>,
"histonet@lists.utsouthwestern.edu" <
;histonet@lists.utsouthwestern.edu>
From: "McMahon, Loralee A" <Lo= ralee_mcma...@urmc.rochester.edu>
Sent by: histonet-boun...@lists.u= tsouthwestern.edu
Date: 04/28/2010 02:01PM
Subject: RE: [Histonet] Re= sponses to IHC CAP Validation question
Any inspection that I have under= gone we have used the 25 to 30
case rule. Except for the Er/Pr//Her-2= . We use closer to 50
cases. We also use a TMA to make our live= s easier. The TMA
contains known positives and known negatives.
I= n cases of t-cell or b-cell markers or cytokeratins. 25 to 30
cases i= s easy. But when you are validated for more hard to find
markers (SV-= 40) then fewer cases is acceptable. We always throw
in a slide that w= e know will not stain for sv-40 like a tonsil -
then you can say it has spe= cificity.
Any inspector that I have come across is usually understanding= of
this. But I am sure that there are exceptions to this.........esp
ecially if they are not familiar with immunohistochemistry.
Loralee McMahon, HTL (ASCP)
Immunohistochemistry Supervisor
Strong M= emorial Hospital
Department of Surgical Pathology
(585) 275-7210
______________________ 5F__= _______________
From: histonet-boun...@lis= ts.utsouthwestern.edu
[histonet-boun...@lists.utsouthwestern.edu] On Behalf= Of
thisis...@aol.com [thisis...@aol.com]
Sent: Wednesday, April 28, 201= 0 2:47 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] R= esponses to IHC CAP Validation question
The following is one respone= I rec'd:
1. I asked CAP who told me that they do not currentl= y have a
guideline on
validating but that they
recommend what is in t= he following book:
Quality Management In Anatomic Pathology, Promoting P= atient
Safety
Through Systems Improvement and Error
by Raouf E. Nakhl= eh, MD & Patrick Fitzgibbons, MD editors
sold by CAP !
Chapter 8-= Quality Management in IHC
That is what we follow.
I. Get a new antib= ody and optimize it with your positive control.
II. Once optimized you n= eed to run it on cases expected to be
positive
(how many?)
"a suffien= t size ..."
III. Must also be run on cases expected to be negative. (how= many?
IV. In a situation where you cannot expect a lot of cases or such a
case has
never been presented in your lab, then you must say just = that.
(ex. some of the hormones we just use a pituitary)
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Histonet mailing list
Histonet@lists.utsouthwestern.edu
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______________________ 5F__ ______________________
Histo= net mailing list
Histonet@lists.utsouthwestern.edu
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References
1. 3D"mailto:tonia.richm...@gracepathology.com";
2. 3D"http://lists.utsouthwestern.edu/mailman/listinfo/histonet";
3. 3D"http://=/
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