0050210
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Diphtheria Antibody, IgG

DIP
Example Reports
Not Protected
Protective

Ordering Recommendation

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

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube. "Pre" and "post" vaccination specimens should be submitted together 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 the cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Methodology

Quantitative Multiplex Bead Assay

Performed

Sun-Sat

Reported

1-3 days

Reference Interval

Antibody concentration of  > 0.1 IU/mL is usually considered protective.

Interpretive Data

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.

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.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

86317

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Components

Component Test Code* Component Chart Name LOINC
0050210 Diphtheria Antibody, IgG 13227-4
* 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

  • Corynebacterium diphtheriae Antitoxin
  • Diphtheria Antitoxoid
  • Diptheria Vaccine Response
Diphtheria Antibody, IgG