Ordering Recommendation

Evaluate the ability of a patient to produce antibody to pure protein vaccines after vaccination to rule out antibody deficiency.

Mnemonic
D/T
Methodology

Quantitative Multiplex Bead Assay

Performed

Sun-Sat

Reported

1-2 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Serum separator tube. "Pre" and "post" vaccination specimens should be submitted for testing. "Post" specimen should be drawn 30 days after immunization.

Specimen Preparation

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.

Storage/Transport Temperature

Refrigerated

Unacceptable Conditions

Plasma or other body fluids.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Reference Interval

Antibody concentrations of  > 0.1 IU/mL are usually considered protective for diphtheria or tetanus.

Interpretive Data

Responder status is determined according to the ratio of a one-month post-vaccination sample to pre-vaccination concentration of IgG antibodies as follows:

Diphtheria and tetanus:
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 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.

Note
Hotline History
N/A
CPT Codes

86317 x2

Components
Component Test Code* Component Chart Name LOINC
0050210 Diphtheria Antibody, IgG 13227-4
0050535 Tetanus Antibody, IgG 53935-3
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • C. tetani
  • Clostridium tetani
  • Corynebacterium diphtheriae Antitoxin
  • Diphtheria Antitoxoid
  • Immune Response
  • nti-tetanus toxoid
  • Tetanus Immune Response
  • Tetanus toxoid antibodies
  • Tetanus/Diphtheria Antibody Panel
  • Tetanus/Diptheria Vaccine Response
  • Vaccine Response
Diphtheria & Tetanus Antibodies, IgG