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Verification of Performance Specifications for Nonwaived Testing

The U.S. Clinical Laboratory Improvement Amendments (CLIA) require laboratory users of nonwaived, unmodified, FDA-cleared or approved test system to do the following before reporting patient test results:
  • Demonstrate that they can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics:
    • Accuracy
    • Precision
    • Reportable range of test results for the test system
  • Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population.