[Histonet] Antibody Validation - long response

Tue Jun 15 11:01:16 CDT 2010

Bottom line it's not the vendors responsibility to validate their equipment or antibodies in your lab. Some vendors may help you do this, but ultimately the lab needs to validate the equipment and IHC in their lab.  The vendors normally calibrate the equipment prior to shipment and once they set the instrument up in your lab, they should be able to provide you with the documentation that states that they calibrated the instrument.  Your instruments need to be calibrated prior to being validated. 

As far as your scanner goes some vendors can provide validation, but it's at a cost and that cost is not cheap depending upon what you actually want validated.  If you are using the scanner and associated algorithms for analysis then you need to validate that separately.  There are several steps required to validate a scanner - 1.  you validate the scanner 2.  if you are using a database to store your images then that also may need to be validated and 3.  if you are using algorithms that provide you with data then those algorithms need to be validated.   

For example prior to running a validation protocol on a tissue processor its needs to be calibrated for temperature.  All of your major equipment needs to be on a calibration schedule.  We calibrate all of our instruments once a year and validation is completed only once unless we change the instrument location or how we use the instrument. Pipettors are calibrated every 6 months.  All instruments are validated it may just be a one pager for the basic lab equipment but instruments like the tissue processor, slide staining, IHC stainer and scanner require written protocols some of these are 80 pages in length and go into great detail.  

The same goes for your antibodies.  Antibodies are validated initially with 25 tissue samples (10 strongly positive tissues, 10 moderate to weakly positive tissues and 5 tissues that have no reactivity) This type of validation is required for routine antibodies, prognostic markers such as Her-2, ER and PR require additional tissue samples.  New lots require 3 tissue samples one strongly positive on moderate to weakly positive and one negative.  If you change the antibody source or detection system or retrieval it needs to be validated again - This information comes from the paper Standarization of Immunohistochemistry from CAP its available on line - I have a copy if you need it.  There are also new guidelines for ER/PR and a new article on validation of ER/PR in the June issue of Archives of pathology from CAP.

Liz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, Colorado 80308
office (303) 682-3949 
fax (303) 682-9060
www.premierlab.com

Ship to Address:
1567 Skyway Drive, Unit E
Longmont, Colorado 80504

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Tuesday, June 15, 2010 8:50 AM
To: histonet <@t> pathology.swmed.edu; Teri.Hallada <@t> midmichigan.org
Subject: Re: [Histonet] Antibody Validation

Teri:
You are right about the validations you propose although I am not surprised that your vendor does not think it is necessary. They are in the business of selling and you are in the business of assuring the high quality of your work to obtaining the most accurate work for patients' sake.
There is where the difference resides. Ignore your vendor and keep validating your protocols.
René J.

--- On Tue, 6/15/10, Teri.Hallada <@t> midmichigan.org <Teri.Hallada <@t> midmichigan.org> wrote:

From: Teri.Hallada <@t> midmichigan.org <Teri.Hallada <@t> midmichigan.org>
Subject: [Histonet] Antibody Validation
To: histonet <@t> pathology.swmed.edu
Date: Tuesday, June 15, 2010, 7:55 AM

I am being questioned by our vendor as to why we need to validate our
automated immunostainer and image analysis instrument. They would like
documentation pertaining to the requirement of validation and the number
of specimens utilized for validation.  I am requesting that each
antibody be validated on the instrument against a previously validated
instrument. Additionally, I am requesting that each new lot of antibody
be validated upon receipt against previously ran specimens. This would
also apply to the image analysis antibodies. (Her2 has been validated by
FISH.) The vendor has apparently polled users in the area and this is
not a standard protocol, therefore the request for documentation. 

I think it is pretty clearly stated by CAP in the Quality Management In
Anatomic Pathology. Any other suggestions?

Teresa Hallada BS, MT/CT (ASCP)
Pathology Lead
MidMichigan Health - Gratiot
teri.hallada <@t> midmichigan.org
989.463.1101 ext 3423

___________________________________
Please note that this email message and any attachments may contain privileged and confidential information that is protected against use or disclosure under federal and state law.  The information is intended only for the personal and confidential use of the intended recipient. If the reader of this message is not the intended recipient or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this information in error and that any review, dissemination, distribution, copying or action taken in reliance on the contents of this communication is strictly prohibited.  If you have received this email in error, please advise by immediate reply.  
_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet

_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet