CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
- When and how should validation assess analytic sensitivity, analytic specificity, accuracy (assay concordance), and precision (inter-run and inter-operator variability)?
- What is the minimum number of positive and negative cases that need to be tested to analytically validate an immunohistochemical assay for its intended use(s)?
- What parameters should be specified for the tissues used in the validation set?
- How do certain preanalytic variables influence analytic validation?
- What conditions require assay revalidation?
The expert panel drafted recommendations following a systematic review of about 100 publications covering nearly 1,500 citations in the context of their own expert judgments.
The final recommendations after consideration of the public comments, further discussion, and analysis will be presented at the CAP ’13 Course and published in the Archives of Pathology & Laboratory Medicine.
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