This test should be regarded as 'Research Use Only'. This test has not been cleared or approved by the U.S. Food and Drug Administration. It 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.
Test is forwarded from Mayo to National Jewish Reference Laboratories. Performance characteristics have been determined by National Jewish Clinical Reference Laboratories, Denver, CO. Results should be interpreted in conjunction with clinical findings.