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Adalimumab Concentration and Anti-Adalimumab Antibody (Serial Monitor)
- Anti-TNF-α Drug
Adalimumab concentration; antiadalimumab antibody level; serial monitoring
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.
Electrochemiluminescence immunoassay (ECLIA)
• Adalimumab drug level:
− Quantitation limit: <0.6 μg/mL
− Results ≥0.6 μg/mL indicate detection of adalimumab.
In the presence of antiadalimumab antibody, the adalimumab drug level reflects the antibody-unbound fraction of adalimumab concentration in serum.
• Antiadalimumab antibody:
− Quantitation limit: <25 ng/mL
− Results ≥25 ng/mL indicate detection of adalimumab antibody.
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 μg/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.
1 mL (Note: This volume does not allow for repeat testing.)
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.
Refrigerate or freeze.
Causes for Rejection
Plasma specimen received
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|503890||Adalimumab+Ab (Serial Monitor)||503866||Adalimumab Drug Level||ug/mL||74117-3|
|503890||Adalimumab+Ab (Serial Monitor)||503867||Anti-Adalimumab Antibody||ng/mL||74116-5|
|Reflex Table for Anti-Adalimumab Antibody|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||000000||Serial Monitoring||000000||Serial Monitoring||N/A|