[Histonet] new antibody validation

[Carol Bryant]

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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