[Histonet] Validating new Benchmark instrument

[joelle weaver]

Fawn
Unfortunately you have to validate each with new instrumentation, platform, change, fixation/processing alteration etc. I do at least 10 cases for IVD and 20 or so for ASR. You may be able to do less than your normal validation process and amount of slides for a completely new AB, since you are just trying to show that your previously validated AB works the same as your new platform/instrument.  See what your medical director requires.
You will have the information from your previous validation studies, titers, cases, etc to help make it a little more streamlined. It should be easier since you are using the same vendor,  and probably the same clones and all that. You have some reports in the Ventana instruments that you might be able use to migrate over data. This might be more useful than using someone else's spreadsheet or data, especially if they don't use Ventana. 




Joelle Weaver MAOM, HTL (ASCP) QIHC
 
> From: Fawn.Bomar <@t> HalifaxRegional.com
> To: histonet <@t> lists.utsouthwestern.edu
> Date: Tue, 1 Oct 2013 17:06:53 +0000
> Subject: [Histonet] Validating new Benchmark instrument
> 
> Hi everyone,
> 
> 
> 
> I know that this subject has come up several times and I am sorry to bother everyone again but I was hoping to find some help.  We are upgrading our Benchmark Immuno machines to the Benchmark XT immuno machine at the end of October.  Does anyone have any suggestions on how to approach the validation process?  Do we need to validate every antibody that we use as well as the kits?  I know that there is also a gray area surrounding how many slides need to be run to consider the antibody validated, but what would be the suggested amount of slides to validate a new machine as I know this will be very costly.  Does anybody have a log/checklist/spreadsheet that they would be willing to share to help document this validation of the machine and each of the antibodies?
> 
> 
> 
> Thank you in advance for your help
> 
> 
> 
> Fawn Bomar
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