I recently asked CAP for specific details of how antibody validation should
be handled since there are many different opinions out there, from lab to
lab, tech to tech, and CAP and CLIA. Especially with CLIA enforcing more
regs on the anatomic pathology lab. In the past, we in AP did not feel like
many of these regs fit in our department, most seemed to be more geared to
the clinical laboratory. After experiencing a CLIA visit, I can tell you we
have changed our thinking. Dr. Patrick Fitzgibbons responded to my
question. There is a book that CAP publishes that every laboratory should
have called, "QUALITY MANAGEMENT IN ANATOMIC PATHOLOGY". Chapter 8 deals
specifically with IHC and Antibody validation. It details to what extent
they should be tested prior to patient testing. Who would know better what
is expected in this area?
Gwen Deville, Histology Supv.
Delta Pathology, Mid-Louisiana
Box 30113, 211 Fourth Street
Alexandria, LA 71301
Work: (318)473-3943 / (318) 473-3180
Pager: (318) 427-5444
Email: gdeville@deltapathology.com
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-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Tuesday, September 09, 2008 7:25 AM
To: histonet@lists.utsouthwestern.edu; Sharon.Davis-Devine
Subject: Re: [Histonet] Using Ventana with new antibody lots
This applies to ALL new lots or antibodies, not just for Ventana.
1- when I received a new lot, I tested it WITHOUT a patient section (just
with a + control) before using it with patients. The results were documented
in the Abs log.
2- the other question refers to the introduction of a new Ab, something you
had not used before. In that case you have to run it with a series of
potentially + controls, at different dilution rates to determine the working
concentration and the suitability for the purpose it is intended for. It is
like a validation test and should be documented also. The pathologist has to
sign the validation and concentration tests.
René J.
--- On Mon, 9/8/08, Sharon.Davis-Devine
wrote:
From: Sharon.Davis-Devine
Subject: [Histonet] Using Ventana with new antibody lots
To: histonet@lists.utsouthwestern.edu
Date: Monday, September 8, 2008, 5:15 PM
Ok, Histonetters I have another question for you.
According the CAP checklist question:
ANP.22750 Phase II
Has the laboratory documented evaluation of new antibody lots and new
antibodies, prior to use in patient diagnosis?
NOTE: For newly introduced antibodies, staining conditions should be
evaluated in cases expected to be positive and negative for the antigen
of interest. Ideally, a series of sufficient size should be run to give
the laboratory an idea of the sensitivity and specificity of the test.
How are you folks handling this question when using Ventana?
Thanks a bunch.
Sharon Davis-Devine, CT (ASCP)
Cytology Supervisor
Carle Clinic
602 West University
Urbana, Illinois 61801
Phone: 217-383-3572
Email: sharon.davis-devine@carle.com
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