Test Details
Methodology
Electrochemiluminescence Immunoassay (ECLIA)
Result 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.
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.
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 Instructions
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.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 14 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x6 |
Storage Instructions
Refrigerate or freeze.
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 | |
| Order Code | 505510 | |||||
| Order Code Name | Natalizumab Drug + Antibody | |||||
| Order Loinc | ||||||
| Result Code | 505507 | |||||
| Result Code Name | Natalizumab Drug Level | |||||
| UofM | ug/mL | |||||
| Result LOINC | Pending | |||||
| Order Code | 505510 | |||||
| Order Code Name | Natalizumab Drug + Antibody | |||||
| Order Loinc | ||||||
| Result Code | 505508 | |||||
| Result Code Name | Anti-Natalizumab Antibody | |||||
| UofM | ng/mL | |||||
| Result LOINC | Pending |