Fw: Re: [Histonet] antibody validation Thanks, but need Non-"U" also

Tue Sep 15 11:16:42 CDT 2009

Hi Cynthia,

Thank you, this is exactly what I was looking for.  You are a rare
jewel.  Especially for the size of your facility.  I am impressed!  I wish I would have received more feed-back from small labs, but that's OK.  I have been doing some pro-active sleuthing of local labs.

After numerous conversations with my fellow histologists that do IHC, I am
finding out what I have long suspected and have experienced while doing
technical support and consulting.  The routine histology laboratory is
multitasking all of their regular histology duties with the addition of IHC
testing.  Pathologists do not want to lose the IHC revenue to a reference
laboratory, so they bring on-board simple IHC panels, and send out their
esoteric or prognostic markers to a well known reference laboratory.  Most
histologists have been asked to bring on board IHC, without the proper
educational background or tools.    The average histologist has
not had the opportunity to take continuing education classes, or even go on the
histonet.  This may be due to lack of continuing education funds, or lack
of interest; It is amazing that pathologists can go to their continuing
education meetings, but don't support their histologists.  Unfortunately,
these histologists do not understand the importance of standardization or
validation steps.  When something goes bump in the night, they are unaware
how to troubleshoot the problem.  This is unfortunate for the histologist,
the pathologist and most of all, the patient.  One more reason for
pathologists to support continuing education.  Hope to see you all at NSH!

Akemi Allison-Tacha BS, HT(ASCP)HTL
Histology Manager
APMG Laboratories
105A Cooper Court, Los Gatos, CA 95032
Contact: 800.848.2764
V/M: 408.884.2718
Fax: 408.884.2758
Cell: 408.335.9994
(W) E-Mail: aallison-tacha <@t> apmglab.com
(P) E-Mail: akemiat3377 <@t> yahoo.com

--- On Mon, 9/14/09, Cynthia Robinson <robinsoc <@t> mercyhealth.com> wrote:

From: Cynthia Robinson <robinsoc <@t> mercyhealth.com>
Subject: Re: [Histonet] antibody validation Thanks, but need Non-"U" also
To: "Akemi Allison-Tacha" <akemiat3377 <@t> yahoo.com>
Date: Monday, September 14, 2009, 11:08 AM

Hi,

I work at 250 bed facility.  For the initial protocol workup we use the manufacturer recommended protocol and run an IHC TMA control block with 25 different tissues and
 tumors.  Once the pathologist has looked and responded I search for 5-10 cases with expected positive results and then a selection of 5-10 normal or negative tissues and run the protocol. 

Hope this is what you were wanting.

Cindi

Cindi Robinson HT(ASCP)
Mercy Medical Center
Dunes Medical Laboratories
350 W Anchor Dr
Dakota Dunes SD 57049
phone-712-279-2768
robinsoc <@t> mercyhealth.com

>>> Akemi Allison-Tacha <akemiat3377 <@t> yahoo.com> 9/14/2009 12:53 PM >>>
Hi All,

I would like to thank those of you who have responded to the e-mail below regarding antibody validation.  The information I received was pretty much what I expected from university IHC labs.  I would like to know what
 smaller IHC labs are doing for validation and re-validation when changes are made to their protocols.

Thank you again for any and all responses,
Akemi

Akemi Allison-Tacha BS, HT(ASCP)HTL
Histology Manager
APMG Laboratories
105A Cooper Court, Los Gatos, CA 95032
Contact: 800.848.2764
V/M: 408.884.2718
Fax: 408.884.2758
Cell: 408.335.9994
(W) E-Mail: aallison-tacha <@t> apmglab.com 
(P) E-Mail: akemiat3377 <@t> yahoo.com 

--- On Fri, 9/11/09, Akemi Allison-Tacha <akemiat3377 <@t> yahoo.com> wrote:

From: Akemi Allison-Tacha <akemiat3377 <@t> yahoo.com>
Subject: [Histonet] antibody validation
To: "histonet" <histonet <@t> lists.utsouthwestern.edu>
Date: Friday, September 11, 2009, 8:20 AM

Good Morning and Happy Friday out there in Histo-Land!

I would like your assistance in an issue that I have just become aware of regarding antibody validation.  I have been requested to bring on-board approximately (7) new antibodies in the immediate future, and several antibodies later.

Although, many of you who know me realize I have worked in IHC R&D for a well known IHC company for many years, it has been a while since I have overseen a clinical IHC lab.  I would like your assistance and input on how you are validating new antibodies.   Not counting Her2-neu, it has been
 my understanding that it is recommended to test samples with varying antigen expression from 10-15 cases.  Furthermore, you should check for Sensitivity: expression range of Positive cases, low to high (10-15 cases).  Specificity: (+) vs expected (-) cases/tissues (10-15 cases) and Precision (Reproducibility): 

It has been my practice that any changes that are made to existing protocols, such as a new detection kit or antigen retrieval methodology, also requires re-validation.  

I am curious how you approach validation.  Also, do any of you just use a single known positive control for that antibody, and run it, and if it is positive, feel that it is satisfactory, and put it on-line for testing.

Thank you in advance for your input, and have a great weekend!

Akemi Allison-Tacha BS, HT(ASCP)HTL
Histology Manager
APMG Laboratories
105A Cooper Court, Los Gatos, CA 95032
Contact: 800.848.2764
V/M:
 408.884.2718
Fax: 408.884.2758
Cell: 408.335.9994
(W) E-Mail: aallison-tacha <@t> apmglab.com 
(P) E-Mail: akemiat3377 <@t> yahoo.com 

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