Tysabri® Antibody Test

Test Code

19215

CPT Codes
83516

Preferred Specimen

2 mL serum

Minimum Volume

0.5 mL

Instructions

Please label each specimen tube with two forms of patient identification. These forms of identification must also appear on the requisition form.

Collect whole blood in a red top tube (no-gel) or a serum separator tube, let it clot for at least 30 minutes at room temperature and centrifuge within 1 hour of collection. Transfer the serum to a plastic screw-cap vial for transport to the laboratory.

Transport Container

Plastic screw-cap vial

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
Refrigerated: 28 days
Frozen: 6 months

Methodology
Enzyme Linked Immunosorbent Assay (ELISA)

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

Setup Schedule

Set up: Fri; Report available: 7-10 days

Reference Range

See Laboratory Report

Clinical Significance

Antibodies against natalizumab (Tysabri) are found in 4.5% to 14.1% of natalizumab-treated multiple sclerosis patients.

Performing Laboratory
Athena Diagnostics
200 Forest Street 2nd Floor
Marlborough, MA 01752

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.