[Histonet] IHC Validation on new instrument

Troutman, Kenneth A kenneth.a.troutman <@t> Vanderbilt.Edu
Wed May 19 13:06:27 CDT 2010


Hi Laurie,

I have a Benchmark Ultra and a Benchmark XT from Ventana and they follow the basic steps, similar protocols and I needed to revalidate everything.  They are sufficiently different (in my experience) that it warranted a complete revalidation.  A part of the reasoning for this was some of the bulk reagents were different (a consideration that may lead you to not completely revalidate).  For me, there were a few protocols that were quite different from one to the other.  I would go to the trouble up front, that way there is no question later.

Good luck!

Ashley Troutman BS, HT(ASCP) QIHC
Vanderbilt University Histopathology
1301 Medical Center Drive TVC 4532
Nashville, TN  37232
615-343-9134

Message: 4
Date: Wed, 19 May 2010 07:59:30 -0700
From: "Laurie Colbert" <laurie.colbert <@t> huntingtonhospital.com>
Subject: [Histonet] IHC Validation on new instrument
To: <histonet <@t> lists.utsouthwestern.edu>
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        <57BE698966D5C54EAE8612E8941D768308BCAF81 <@t> EXCHANGE3.huntingtonhospital.com>

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What do others do when validating a new model of a piece of equipment -
same manufacturer, same basic staining process, but an updated version
of the equipment?



I've been told the protocols should be the same and that we only need to
run three controls with three different but similar protocols to
determine what looks best.  Do you all think that is thorough enough, or
would you run actual patient cases and compare old and new equipment?  I
don't see where the CAP checklist refers to new equipment - just new
antibodies and new antibody lots.



Laurie Colbert


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