Diphtheria Antitoxoid

Message

This test was developed and its performance characteristics have been determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

SRHC Clients:

1 yellow top tube or 1 red top tube
Transport to SRHC laboratory same day as collected

Test Code

LAB7185

Quest Code

4865

Alias/See Also

EPIC: LAB7185
Diphtheria Antitoxoid Antibody by EIA

CPT Codes
86648

Preferred Specimen

1 mL serum

Minimum Volume

0.3 mL

Transport Container

Transport tube

Transport Temperature

Refrigerated, stable 7 days

Specimen Stability

Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Grossly lipemic • Grossly icteric

Methodology
Immunoassay (IA)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Setup: Daily; Report available: 1-2 days

Reference Range

≥0.10 IU/mL

Interpretive Criteria

<0.10	Nonprotective Antibody Level
≥0.10	Protective Antibody Level

Antibody levels ≥0.10 are considered protective. After a primary series of three properly spaced diphtheria toxoid doses in adults or four doses in infants, a protective level of antitoxin (defined as ≥0.10 IU of antitoxin/mL) is reached in more than 95% of immunized persons.

Clinical Significance

Used to evaluate diphtheria immunization response. Antibody levels of ≥0.10 IU/mL are considered protective. For Pre and Post vaccination testing to assess normal immune response, please refer to test code 10680-Diphtheria Antitoxoid, Pre and Post Vaccination.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Dr
Chantilly, VA 20153

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.