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Verification of Performance Specifications for Nonwaived Testing

On April 24, 2003, the Clinical Laboratory Improvement Amendments (CLIA) Final Rules went into effect.

As of that date, each laboratory that introduces a nonwaived, unmodified, FDA-cleared or approved test system must do the following before reporting patient test results:

  • Demonstrate that it 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.