[Histonet] new antibody validation

[Patrick Laurie]

Based off the statement:

*The scope of the validation is at the discretion of the laboratory
director and will vary with the antibody*

It seems that it gives the laboratory director the ability to give specific
qualifications for each antibody.  If a laboratory director says 2 positive
cases and 1 negative case is appropriate for validation (I can't believe
that there would be one), CAP wouldn't cite them if they had a specific
written and signed procedure for this.
We try to follow the recommendations by Goldstein et. al. 2007,
"Recommendations for improved standardization of immunohistochemistry" from
applied immunohistochemistry and molecular morphology.  Paraphrasing from
recommendation #9: 10 samples high levels of target antigen, 10 samples of
intermediate to low target antigen and 5 samples of no IHC evidence of
target antigen.
On Thu, Mar 1, 2012 at 8:46 AM, Sebree Linda A <LSebree <@t> uwhealth.org> wrote:

> We have been picking (or trying to) 10 positive cases that have negative
> tissue elements included.  Obviously for some hard-to-find positive
> cases we need to make due with what's available.
>
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Carol
> Bryant
> Sent: Thursday, March 01, 2012 9:56 AM
> To: histonet <@t> lists.utsouthwestern.edu
> Subject: [Histonet] new antibody validation
>
> ANP.22750
> The laboratory has documented validation of new antibodies, prior to use
> in patient diagnosis.
> In the CAP's note it states that a panel of 10 positive and 10 negative
> neoplasms would be sufficient for a well-characterized antibody.
>
> How extensive a panel of tissues are laboratories using to meet this
> checklist requirement?  Is it necessary to do 10 positive and 10
> negatives or can it be at the discretion of the laboratory director?
>
> Carol Bryant, CT (ASCP)
> Cytology/Histology Manager
> Lexington Clinic
> Phone (859) 258-4082
> Fax (859) 258-4081
> cbrya <@t> lexclin.com
>
>
>
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-- 
Patrick Laurie HT(ASCP)QIHC
CellNetix Pathology & Laboratories
1124 Columbia Street, Suite 200
Seattle, WA 98104
plaurie <@t> cellnetix.com