Evaluate the ability of a patient to produce antibody to pure protein vaccines (diphtheria and tetanus) and protein conjugated bacterial (H. influenzae) vaccines after vaccination to rule out antibody deficiency.
Quantitative Multiplex Bead Assay
Serum separator tube.
Transfer 1.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.45 mL) Acute and convalescent specimens must be labeled as such. Clearly mark specimens as "Pre-Vaccine" or "Post-Vaccine". Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens.
Plasma or other body fluids. Contaminated, hemolyzed, or severely lipemic specimens.
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
Diphtheria and tetanus:
Antibody concentration of > 0.1 IU/mL is usually considered protective for diphtheria or tetanus.
Haemophilus influenzae type B:
< 1.0 µg/mL = Antibody concentration not protective.
> 1.0 µg/mL = Antibody to H. influenzae type B detected. Suggestive of protection.
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, and 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.
Haemophilus influenza B:
1. If the post-vaccination concentration is < 3.0 µg/mL, the patient is considered to be a nonresponder.
2. If the post-vaccination concentration is 3.0 µg/mL, a patient with a ratio of 4 is a good responder, a ratio of 2-4 is weak responder, and a ratio of < 2 is considered a nonresponder.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Laboratory Developed Test (LDT)
|Component Test Code*||Component Chart Name||LOINC|
|0050210||Diphtheria Antibody, IgG||13227-4|
|0050535||Tetanus Antibody, IgG||53935-3|
|0050542||Haemophilus influenzae b Antibody, IgG||11256-5|
- Anti-tetanus toxoid
- C. tetani
- Clostridium tetani
- Corynebacterium diphtheriae Antitoxin
- Diphtheria Antitoxoid
- Tetanus Immune Response
- Tetanus toxoid antibodies
- Tetanus/Diphtheria Antibody Panel