[Histonet] Antibody Validation CLIA
LNormington at uwhealth.org
Fri Mar 16 12:16:31 CDT 2018
CAP suggests running 10 negative and 10 positive cases for non-prognostic markers.
CAP required running 20 negative and 20 positive cases for prognostic markers.
In the event the case volume is less than the suggested 10 and 10 cases for non-prognostic markers, the reason for that decision should be stated in the validation. Ultimately, the decision is up to your director.
Lacy Normington, HTL(ASCP)CM
Manager, Surgical Pathology Lab Services UW Health
600 Highland Avenue
Madison, WI 53792-2472
From: Paula via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Friday, March 16, 2018 8:55 AM
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Subject: [Histonet] Antibody Validation CLIA
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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
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