Tysabri (Natalizumab) Immunogenicity
Use
This test is essential for detecting immunogenicity in patients treated with Tysabri (Natalizumab), which is crucial for assessing potential adverse immunological reactions. Natalizumab is a monoclonal antibody used to treat multiple sclerosis and Crohn's disease. Identifying immunogenicity allows healthcare providers to manage and adjust treatment plans effectively, ensuring patient safety and optimizing therapeutic efficacy. The presence of antibodies against Natalizumab can reduce the drug's efficacy and may lead to hypersensitivity reactions.
Special Instructions
The patient sample should be collected using a red top tube, and processing requires centrifugation and aliquoting of 1 mL serum into a plastic vial. It is recommended to send the specimen frozen to maintain sample integrity. This test is available for order in New York State.
Limitations
The test has limitations, including potential interference from highly lipemic, icteric, or hemolyzed samples, leading to inaccurate results. Also, the performance characteristics of this test have not been cleared or approved by the U.S. Food and Drug Administration, as it was developed and validated by Eurofins Viracor.
New York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 49598-6
- 49598-6
Result Turnaround Time
7-14 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1 mL
Minimum Volume
Not provided
Container
Plastic vial
Collection Instructions
Centrifuge and aliquot 1 mL of serum into a plastic vial. Send frozen.
Causes for Rejection
Hemolysis, Lipemia, Icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 14 days |
| Frozen | 14 days |