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Diphtheria Antitoxoid
Test Code4865
CPT Codes
86648
Preferred Specimen
1 mL serum
Minimum Volume
0.3 mL
Transport Container
Transport tube
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Grossly icteric
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Tues, thurs, sat
Report Available
2-4 days
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.
Clinical Significance
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.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |