Adalimumab Concentration and Anti-Adalimumab Antibody

Test Code
901513


CPT Codes
80299, 82397<br /> Restricted Client Code

Preferred Specimen
2 mL serum, received spun


Minimum Volume
1 mL (note: This volume does not allow for repeat testing)


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.

Additional Info
All positive antibody results are verified by confirmatory test.
<100 ng/mL Low antibody titer, no significant impact on free drug level
101 - 300 ng/mL Intermediate antibody titer, variable impact on free drug level
>301 ng/mL High antibody titer, significant impact on free drug level


Transport Container
Plastic screw-cap vial


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 7 days
Refrigerated: 7 days
Frozen: 308 days


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


Methodology
Electrochemiluminescence (ECLIA)

Setup Schedule
Set up: Mon, Wed; Report available: 3-7 days


Reference Range
See Laboratory Report


Clinical Significance
Monitor anti-adalimumab 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 anti-adalimumab antibodies.




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.