40 cases Validation ?s

From:Amos Brooks

    For those who were asking about the validation requirement on 40 cases
... I did botch up a bit. I said it was in CAP and it wasn't. It was in
NCCLS. The Dec.1999 Quality Assurance for Immunohistochemistry Approved
Guideline MM4-A Vol. 19 # 26 in Section 8.6 on pg. 39. It basically said
that 15-20 cases of each type (that which you would expect to stain and that
which you would not) should be stained and evaluated for validation. That
means 30-40 cases should be evaluated before setting a new antibody as a
routine test.
    I really don't think they would make a big fuss over that though in
light of the discussions on the requirement in the back of the book (pgs.
66-67). I think the main idea is that they want you to be absolutely sure
the stain is working before making it routine.
Amos Brooks

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