[Histonet] Changing from Ventana IView Detection Kit to Ventana Ultraview kit

[Elizabeth Chlipala]

Joe

I believe that is for initial validation, you can also place multiple tissues on a slide.  For new lot numbers of a previously validated protocol I would use only 3 tissues, strong positive, moderate to weak positive and then negative, these can all be placed on one slide.  I'm not in clinical but that's also the recommendations from the CAP paper on standardization in IHC.

Liz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, CO 80308-1592
(303) 682-3949 office
(303) 682-9060 fax
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Ship to address:

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-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Joe Nocito
Sent: Tuesday, September 25, 2012 4:35 PM
To: 'Vanessa Perez'; 'Vickroy, Jim'; histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] Changing from Ventana IView Detection Kit to Ventana Ultraview kit

We are having a lively discussion about having 10 known positives and 10
known negatives to validate new antibodies. Many years ago we set up 5 and 5
even before CAP thought of the idea. This year's checklist added the 10 and
10 part, but it is up to the medical director.
What is everyone else doing out there? We are using the Ventana UltraView
detection kits. Everyone who uses these kits know how  expensive they are.
Is 5 and 5 sufficient or should go by CAP recommendations?

Joe Nocito

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Vanessa
Perez
Sent: Tuesday, September 25, 2012 2:37 PM
To: Vickroy, Jim; histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] Changing from Ventana IView Detection Kit to Ventana
Ultraview kit

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.

Vanessa

-----Original Message-----
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
217-788-4046


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