Natalizumab and Anti-Natalizumab Antibody, DoseASSURE™ NTZ

TEST: 505510
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CPT: 80299; 82397
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Synonyms

  • Anti-alpha4-integrin inhibitor
  • biologic therapeutic drug monitoring (TDM)
  • biological monitoring
  • immunogenicity testing
  • Tysabri drug and antibody testing

Expected Turnaround Time

10 - 14 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements

Specimen

Serum

Volume

2 mL

Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)

Container

Red-top tube or gel-barrier tube

Collection

Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Storage Instructions

Refrigerate or freeze.

Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x6

Test Details

Use

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.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
505510 Natalizumab Drug + Antibody 505507 Natalizumab Drug Level ug/mL Pending
505510 Natalizumab Drug + Antibody 505508 Anti-Natalizumab Antibody ng/mL Pending

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