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.
In the United States, diphtheria toxoid is administered to children as part of the combined diphtheria-pertussis-tetanus vaccine. Anti-diphtheria toxoid antibodies form in response to vaccination using diphtheria toxoid protein.