Adalimumab Concentration and Anti-Adalimumab Antibody (Serial Monitor)

CPT: 80299; 82397
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Test Details

Synonyms

  • Anti-TNF-α Drug
  • Humira®

Test Includes

Adalimumab concentration; antiadalimumab antibody level; serial monitoring

Use

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.

Methodology

Electrochemiluminescence immunoassay (ECLIA)

Reference Interval

• 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.

Additional Information

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.

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

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.

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

References

Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to antiadalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul; 66(7):921-926. 17301106
Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009 Nov; 137(5):1628-1640. 19664627

LOINC® Map

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
503890 Adalimumab+Ab (Serial Monitor) 503868 Adalimumab+Ab (Serial Monitor) N/A
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

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