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Validation Criteria
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Validation Criteria
Concordance testing should be performed with a validated FISH assay and should be confirmed annually.
Assay procedures must be validated by the laboratory before offering the test clinically.
The new test should show 95% concordance with a validated reference assay.
It should be confirmed that only 5% or less of samples classified as either positive or negative disagree with that validated assay on an ongoing basis.
If the laboratory cannot satisfy this criterion, it should not perform HER2 testing and should send specimens to a reference laboratory.
Equivocal cases are not expected to be 95% concordant, rather they should be subjected to a confirmatory test.
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