Test Directory

Test Code
NATAB
Test Name
Natalizumab Antibodies
CPT Codes
80299, 82397
Expected Turnaround Time
10 - 14 days
Clinical Utility

This test provides natalizumab drug and anti-natalizumab antibody concentrations for pharmacokinetic and immunogenic assessment to optimize treatment. This test may be helpful in any patient on natalizumab therapy for multiple sclerosis, Crohn's disease or other conditions.

In the presence of anti-natalizumab antibodies, the natalizumab level reflects the free antibody-unbound drug level.

This anti-natalizumab antibody assay is drug tolerant.

Specimen and Container Info

Specimen Type: Serum

Collection Container: Gold Top, Serum Separator

Alternate Collection Container: Red Top, Plain

Desired Specimen Volume: 2 mL

Collection Instructions
  1. Collect a gold top, serum separator tube via venipuncture.
Processing and Submission Instructions
  1. Allow the specimen to clot for at least 30-60 minutes.
  2. Separate serum from cells within 2 hours of collection.
  3. Transfer 2 mL of serum to a LabCorp PP transkpak frozen purple tube.
  4. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Patient Preparation

Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.

Transport Instructions

Transport to the laboratory frozen. 

Stability Requirements

Room Temperature

 14 days

Refrigerated

14 days

Frozen

14 days

Freeze/Thaw Cycles

Stable x6

Methodology
Electrochemiluminescence Immunoassay
Reference Intervals

 See patient report.

Limitations

High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.

Alternate Names
  • Natalizumab and Anti-Natalizumab Antibody, DoseASSURE™ NTZ
  • Anti-alpha4-integrin inhibitor
  • Biologic therapeutic drug monitoring (TDM)
  • Biological monitoring
  • Immunogenicity testing
  • Tysabri drug and antibody testing
Reference Lab
Labcorp Of America Holdings
Testing Schedule
Varies