[Histonet] RE: Antibody validation

Wed Sep 26 08:36:12 CDT 2012

There is no one right answer for the number of cases needed to validate an antibody for diagnostic immunohistochemistry.  That decision must be made by the laboratory's medical director, not an outside organization.  Many of the primary antibodies available today have proven "track records" and we certainly do not need to "re-invent the wheel" here.

What I find helpful is a "Prospective Validation" where I continue to add cases to our original antibody validation file (Excel spreadsheet) that prove that the antibody is doing what it should be doing and that there is no analytical drift.

Richard

Richard W. Cartun, MS, PhD
Director, Histology & Immunopathology
Director, Biospecimen Collection Programs
Assistant Director, Anatomic Pathology
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 545-1596
(860) 545-2204 Fax

>>> "Sebree Linda A" <LSebree <@t> uwhealth.org> 9/26/2012 8:43 AM >>>
Joe,

We are abiding by the CAP 10/10 guidelines when at all possible and then
we compare our results with another method or same method but other lab,
i.e. reference or another clinical lab willing to trade slides with us.
The comparison part is where we are having issues as we, not me
personally, don't want to pay a reference lab for the comparison work so
we rely on others in our "Histonet family" willing to run our slides.
And of course, we're squeezing as many cases on a single slide as
possible.  

As to your question about 5/5 or more, CAP leaves it up to each lab as
to whether its feasible and possible to obtain their recommended quota.

Interesting thread as my days are spent in the middle of this exercise.

Linda Sebree 

-----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 5:35 PM
To: 'Vanessa Perez'; 'Vickroy, Jim'; histonet <@t> lists.utsouthwestern.edu 
Subject: RE: [Histonet] Changing from Ventana IView Detection Kit
toVentana 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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