Re: [Histonet] Using Ventana with new antibody lots

From:Rene J Buesa

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
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



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