Diphtheria Antitoxoid, Endpoint Determination

Test Code
10682


CPT Codes
86317

Preferred Specimen
1 mL serum


Minimum Volume
0.3 mL


Transport Container
Transport tube


Transport Temperature
Room temperature


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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 2-3 days


Reference Range
≥0.10 IU/mL


Clinical Significance
Used to evaluate diphtheria immunization response. Antibody levels of > or = to 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-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042




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.