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25071 Diphtheria Toxoid IgG (DIPGS)

Diphtheria Toxoid IgG (DIPGS)
Test Code: DIPGSO
Synonyms/Keywords
Anti-diphtheria toxoid, Corynebacterium diphtheria, Diphtheria Immune Response, Diphtheria toxoid antibodies
Useful For

Determining a patient's immunological response to diphtheria toxoid vaccination

Aiding in the evaluation of immunodeficiency

Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Serum​ Serum Separator Tube (SST) Red Top Tube (RTT) ​0.5 mL ​0.4 mL ​
Specimen Stability Information
Specimen Type Temperature Time
​Serum ​Refrigerated (preferred) 30 days
​ ​Frozen ​30 days
Rejection Criteria
​​Gross Hemolysis
​Gross Lipemia
​Gross Icterus
​Heat inactivated specimen
Interference

​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.

Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available Methodology/Instrumentation
​Mayo Clinic Laboratories Monday through Friday​ 1 to 4 days
Enzyme-Linked Immunosorbent Assay (ELISA)
Reference Lab
Mayo Clinic Laboratories
Test Information

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.   ​

Reference Range Information
Vaccinated: POSITIVE (>=0.01 IU/mL)
Unvaccinated: NEGATIVE (<0.01 IU/mL)
Reference values apply to all ages.
Interpretation

​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.

Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​86317 ​ ​ ​ ​
Classification

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.   ​

Synonyms/Keywords
Anti-diphtheria toxoid, Corynebacterium diphtheria, Diphtheria Immune Response, Diphtheria toxoid antibodies
Ordering Applications
Ordering Application Description
​COM ​Diphtheria Toxoid, IgG (DIPGS)
​Cerner​Diphtheria Toxoid IgG (DIPGS)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Serum​ Serum Separator Tube (SST) Red Top Tube (RTT) ​0.5 mL ​0.4 mL ​
Specimen Stability Information
Specimen Type Temperature Time
​Serum ​Refrigerated (preferred) 30 days
​ ​Frozen ​30 days
Rejection Criteria
​​Gross Hemolysis
​Gross Lipemia
​Gross Icterus
​Heat inactivated specimen
Interference

​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.

Useful For

Determining a patient's immunological response to diphtheria toxoid vaccination

Aiding in the evaluation of immunodeficiency

Reference Range Information
Vaccinated: POSITIVE (>=0.01 IU/mL)
Unvaccinated: NEGATIVE (<0.01 IU/mL)
Reference values apply to all ages.
Interpretation

​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.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available Methodology/Instrumentation
​Mayo Clinic Laboratories Monday through Friday​ 1 to 4 days
Enzyme-Linked Immunosorbent Assay (ELISA)
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​86317 ​ ​ ​ ​
Classification

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.   ​

For most current information refer to the Marshfield Laboratory online reference manual.