[Histonet] IHC validation

[Allan Wang]

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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