This test should be regarded as 'Research Use Only'. This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics for this test have been validated by National Jewish Health. It has not been cleared or approved by the U.S. Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinival laboratory testing.
This test may not be covered by insurance and providers need to inform all patients of this prior to ordering.
For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commercial payers, prior authorization should be obtained.