Diphtheria Antibody, IgG
Also known as: DIP
Use
The Diphtheria Antibody test is used to evaluate a patient's ability to produce antibodies to a pure protein vaccine after vaccination. This aids in ruling out antibody deficiency by assessing immune response to diphtheria vaccination. It is particularly useful in patients with suspected immunodeficiency or inadequate vaccine response. Responder status is determined based on antibody concentrations in post-vaccination specimens compared to pre-vaccination levels, providing insights into the quality of the vaccine response by classifying patients as non-responders, weak responders, or good responders.
Special Instructions
Pre-vaccination and post-vaccination specimens should be collected, with the post-vaccination sample drawn 30 days after immunization. Ensure specimens are clearly marked as 'Pre-Vaccine' or 'Post-Vaccine'. If shipped separately, the 'Post' specimen must be received within 60 days of the 'Pre' specimen.
Limitations
This test has not been cleared or approved by the US Food and Drug Administration (FDA). It is performed in a CLIA certified laboratory for clinical purposes but may not be suitable for regulatory purposes. Results interpretation should consider that high pre-vaccination antibody levels (> 1.0 IU/mL) can complicate response assessment based solely on ratios, and a post-vaccination concentration above 2.5 IU/mL in such cases is usually deemed adequate.
New York Approved
Methodology
Immunoassay (Multiplex Protein Panel)
Biomarkers
LOINC Codes
- 13227-4
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1 mL
Minimum Volume
0.15 mL
Container
ARUP Standard Transport Tube
Collection Instructions
Separate serum from cells ASAP or within 2 hours of collection. Clearly mark specimens as 'Pre-Vaccine' or 'Post-Vaccine'.
Storage Instructions
Refrigerated.
Causes for Rejection
Plasma or other body fluids.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 48 hours |
| Refrigerated | 2 weeks |
| Frozen | 1 year (avoid repeated freeze/thaw cycles) |