Method validation aims to establish or verify the baseline performance of any newly introduced instrument, equipment, or method in terms of accuracy, precision, analytic sensitivity, interference, and reportable range.
Validation testing should represent the antibody's intended use 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 × # of diseased patients with a negative test (divided by) total number of patients without the disease
Diagnostic % sensitivity = 100 × # of diseased patients with a positive test (divided by) total number of patients tested
