[Histonet] IHC validation

[Echague, Caren Ann - MGH]

Where do you purchase your Tisssue Micro arrays? I know they are quite expensive.
We are currently running validations and using only a handful of positive cases. Most of them don't have ten positive and negative cases but as long as you can get a statement from the medical director, this should be CAP compliant.
Cae Aguilar, HTL (ASCP)
Histology Supervisor
7079802801

-----Original Message-----
From: Allan Wang [mailto:allanw at biomax.us] 
Sent: Thursday, March 22, 2018 11:02 AM
Cc: histonet at lists.utsouthwestern.edu
Subject: Re: [Histonet] IHC validation

How are labs validating for rarer biomarkers like ALK, ROS1, or MMR loss?
Following the guideline of 10 positive cases may be difficult.
I've seen other companies with control slides just with a few engineered cell lines as positive and negative controls. Is that enough for validation alone?

We are creating TMAs for validation of ALK and MMR loss (MLH1, PMS2, MSH6,
MSH2) so I am interested in knowing how many cases are desired.

Allan

Allan Wang
Lab Manager
US Biomax

On Tue, Mar 20, 2018 at 1:54 PM, Terri Braud via Histonet < histonet at lists.utsouthwestern.edu> wrote:

> Just another note:  You can order unstained tissue microarrays with 
> the prerequisite number of cases, both positive and negative, and 
> stain your validation all on one slide.  I've done this for years and 
> for 3 different validations of entire IHC platform changes, ranging 
> from 40 to over 100 antibodies each time.  Saves time and money.
>
> Terri L. Braud, HT(ASCP)
> Anatomic Pathology Supervisor
> Laboratory
> Holy Redeemer Hospital
> 1648 Huntingdon Pike
> Meadowbrook, PA 19046
> ph: 215-938-3689
> fax: 215-938-3874
> Care, Comfort, and Heal
>
> Message: 2
> Date: Fri, 16 Mar 2018 06:54:30 -0700
> From: "Paula" <plucas at biopath.org>
> Subject: [Histonet] Antibody Validation CLIA
>
> Hello,
> We've been discussing about the quantity of slides to run as a 
> validation for IHC antibodies. We are governed by CLIA, and we would 
> like to know if there is a set number of slides to run for a 
> particular antibody we would like to bring in-house for Validation.  I think CAP requires 20 slides..?
> And so we are asking if there is  a requirement with CLIA to run a 
> certain number of slides, or is it up to us (the laboratory director) 
> to decide how many slides to run for Validation/Verification.
> Thank you in advance
> Paula
>
>
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