The U.S. Clinical Laboratory Improvement Amendments (CLIA) require laboratory users of nonwaived, unmodified, FDA-cleared or approved test system to perform the following before reporting patient test results:
- Demonstrate that the test system is capable of obtaining 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 ranges (normal values) are appropriate for the laboratory's patient population.
