Adalimumab and Anti-Adalimumab Antibody, DOSEASSURE ADL

Test Code
LAB00502


Alias/See Also
LAB00502
LabCorp TC: 503890
Anti-TNF-alpha drug
Humira


CPT Codes
80145, 82397

Includes
Adalimumab+Ab (Serial Monitor) Adalimumab Drug Level
Anti-Adalimumab Antibody


Preferred Specimen
2 mL Serum
(Marble, Gold, Red) 


Minimum Volume
1 mL


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 test on frozen samples, please submit separate frozen specimens for each test requested.


Transport Temperature
Frozen


Specimen Stability
Frozen: 308 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Plasma specimen received


Methodology
Electrochemiluminescence Immunoassay (ECLIA)

Report Available
6-10 days


Limitations
In the absence of antiadalimumab antibodies, the adalimumab drug level typically reflects the total adalimumab concentration in serum. In the presence of antiadalimumab antibodies, the adalimumab level typically reflects the antibody-unbound fraction of adalimumab concentration in serum.

This assay provides clinically valid antibody results at drug levels well above treatment targets (>30 ug/mL). Failure of adalimumab therapy may not always be due to the presence of antiadalimumab antibodies. In addition, the absence of antiadalimumab antibodies does not guarantee positive response to treatment.


Clinical Significance
Monitor antiadalimumab therapy for individuals with Crohn's disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides adalimumab drug concentration levels as well as the level of antiadalimumab antibodies.
 


Performing Laboratory
LabCorp




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.