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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.