Evaluate the ability of a patient to produce antibody to pure protein vaccine after vaccination to rule out antibody deficiency.
Quantitative Multiplex Bead Assay
Serum separator tube. "Pre" and "post" vaccination specimens should be submitted together for testing. "Post" specimen should be drawn 30 days after immunization.
Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.15 mL) Mark specimens clearly as "Pre-Vaccine" or "Post-Vaccine". If shipped separately, "Post" specimen must be received within 60 days of "Pre" specimen.
Plasma or other body fluids.
After separation from the cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
Antibody concentration of > 0.1 IU/mL is usually considered protective.
Responder status is determined according to the ratio of a one-month post-vaccination specimen to pre-vaccination concentration of diphtheria IgG antibody as follows:
1. If the post-vaccination concentration is less than 1.0 IU/mL, the patient is considered a nonresponder.
2. If the post-vaccination concentration is greater than or equal to 1.0 IU/mL, a patient with a ratio of less than 1.5 is a nonresponder, a ratio of 1.5 to less than 3.0, is a weak responder, and a ratio of 3.0 or greater, is a good responder.
3. If the pre-vaccination concentration is greater than 1.0 IU/mL, it may be difficult to assess the response based on a ratio alone. A post-vaccination concentration above 2.5 IU in this case is usually adequate.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
|Component Test Code*||Component Chart Name||LOINC|
|0050210||Diphtheria Antibody, IgG||13227-4|
- Corynebacterium diphtheriae Antitoxin
- Diphtheria Antitoxoid
- Diptheria Vaccine Response