[Histonet] Changing from Ventana IView Detection Kit to Ventana
vperez <@t> pathreflab.com
Tue Sep 25 14:36:51 CDT 2012
As far as lot to lot validation that's all we do. Use same control and compare both.
Now validating a new detection kit is a whole different story. Here I just made a checklist of all the antibodies we do and had the doc sign off on each stain with the new kit.
If you want you can do a slide of each with same control one with the iview and one with the ultraview.
All depends on how your doc wants to validate it.
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Vickroy, Jim
Sent: Tuesday, September 25, 2012 1:58 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Changing from Ventana IView Detection Kit to Ventana Ultraview kit
We are trying to decide how to validate our stains when we switch from Ventana's IView kit to their Ultraview Kit.
I have reviewed the CAP question on this and find the following wording:
The performance of new lots of antibody and detection system reagents are compared with old lots before or concurrently with being placed into service.
Note: Parallel staining is required to control for variables such as disparity in the lots of detection reagents or instrument function. New lots of primary and detection reagents must be
compared to the previous lot using an appropriate panel of control tissues. This comparison must be made on slides cut from the same control block.
Evidence: Written procedure and records of verification of new reagent lots.
For new lots of antibodies we have been running the new lot and comparing with the previous lot by reviewing the control slide from the old lot to the new lot.
Is this sufficient? Wording that bothers me is "appropriate panel of tissues"
Thanks for your input.
James Vickroy BS, HT(ASCP)
Surgical and Autopsy Pathology Technical Supervisor Memorial Medical Center
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