Determining a patient's immunological response to diphtheria toxoid vaccination
Aiding in the evaluation of immunodeficiency
This assay does not provide diagnostic proof of lack of protection against diphtheria or the presence of absence of immunodeficiency. Results must be confirmed by clinical findings and other serological tests.
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.
Results of 0.01 IU/mL or more suggest a vaccine response.
A diphtheria toxoid booster should be considered for patients with antidiphtheria toxoid IgG values between 0.01 and less than 0.1 IU/mL.