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Verification for Nonwaived Testing

  • Laboratories that do nonwaived testing must verify that they can obtain performance specifications comparable to those established by the manufacturer.
  • Generally this can be accomplished by doing split sample comparison studies with another laboratory to estimate any inaccuracy or bias, plus linearity studies to estimate imprecision and determine the reportable range.
  • The laboratory can do studies to determine its own reference ranges or the laboratory director can document that the manufacturer's ranges are appropriate.
  • For those laboratories doing nonwaived tests that have been modified or developed in-house, additional verification studies are required.