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The page below is a sample from the LabCE course Breast Cancer Predictive Markers. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Validation Purpose

The goal of method validation is to establish or verify the baseline performance of any newly introduced instrument, equipment, or method as to its accuracy, precision, analytic sensitivity, interference, and reportable range.
Validation testing should represent the intended use of the antibody within that laboratory's patient population. Sensitivity, specificity, and precision should be established before clinical use. Precision can be established by repeated staining of the same positive/negative controls.
Acceptable specificity and sensitivity are determined by consultation with the Medical Director and comparison with published clinical data.
Diagnostic % specificity = 100 X the number of diseased patients with a negative test (divided by) the total number of patients without the disease
Diagnostic % sensitivity = 100 X the number of diseased patients with a positive test (divided by) the total number of patients tested