Adalimumab Concentration and Anti-Adalimumab Antibody

CPT: 80299; 82397
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Test Details

Synonyms

  • Anti-TNF-alpha Drug
  • Humira

Use

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.

In the absence of anti-adalimumab antibodies, the adalimumab drug level typically reflects the total adalimumab concentration in serum. In the presence if anti-adalimumab 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 anti-adalimumab antibodies. In addition, the absence of anti-adalimumab antibodies does not guarantee positive response to treatment.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

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

Serum must be separated from cells within 45 minutes of venipuncture. 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.

Storage Instructions

Refrigerate or freeze

Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

7 days

Frozen

7 days

Causes for Rejection

Plasma specimen received

Clinical Information

Special Instructions

This test is pending NY state approval.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504575 Adalimumab+Ab 503866 Adalimumab Drug Level ug/mL 74117-3
504575 Adalimumab+Ab 503867 Anti-Adalimumab Antibody ng/mL 74116-5

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