Diphtheria Antitoxoid
Test Summary
Used to evaluate diphtheria immunization response. Antibody levels of ≥0.10 IU/mL are considered protective. For Pre and Post vaccination testing to assess normal immune response, please refer to test code 10680-Diphtheria Antitoxoid, Pre and Post Vaccination.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 mL serum
Minimum Volume
0.3 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 7 days
- Refrigerated: 14 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis, gross lipemia, gross icterus
Order Code
DIPTH
EPIC (Premier) Code
LAB4393
Includes
N/A
CPT Code
- 86648
Billing Code
- 670871
CPT Statement
Methodology
Immunoassay (IA)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
≥0.10 IU/mL
Interpretive Criteria
Antibody levels ≥0.10 are considered protective. After a primary series of three properly spaced diphtheria toxoid doses in adults or four doses in infants, a protective level of antitoxin (defined as ≥0.10 IU of antitoxin/mL) is reached in more than 95% of immunized persons.
Interpretive Criteria
| <0.10 | Nonprotective Antibody Level |
| ≥0.10 | Protective Antibody Level |
Antibody levels ≥0.10 are considered protective. After a primary series of three properly spaced diphtheria toxoid doses in adults or four doses in infants, a protective level of antitoxin (defined as ≥0.10 IU of antitoxin/mL) is reached in more than 95% of immunized persons.
Setup Schedule / Expected Turnaround Time
Daily; Report available: 1 - 2 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 mL serum
Minimum Volume
0.3 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 7 days
- Refrigerated: 14 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis, gross lipemia, gross icterus
Result Information
Methodology
Immunoassay (IA)
Testing Laboratory
N/A
Reference Range
≥0.10 IU/mL
Interpretive Criteria
Antibody levels ≥0.10 are considered protective. After a primary series of three properly spaced diphtheria toxoid doses in adults or four doses in infants, a protective level of antitoxin (defined as ≥0.10 IU of antitoxin/mL) is reached in more than 95% of immunized persons.
Interpretive Criteria
| <0.10 | Nonprotective Antibody Level |
| ≥0.10 | Protective Antibody Level |
Antibody levels ≥0.10 are considered protective. After a primary series of three properly spaced diphtheria toxoid doses in adults or four doses in infants, a protective level of antitoxin (defined as ≥0.10 IU of antitoxin/mL) is reached in more than 95% of immunized persons.
Setup Schedule / Expected Turnaround Time
Daily; Report available: 1 - 2 days