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Test ID ADALX Adalimumab Quantitative with Reflex to Antibody, Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Useful For

Detection and quantification of antibodies directed against adalimumab in serum

 

Trough level quantitation for evaluation of patients with loss of response to adalimumab

Highlights

Adalimumab (tradename Humira, manufactured by AbbVie) is a fully human therapeutic monoclonal antibody targeting tumor necrosis factor alpha (TNF), a proinflammatory cytokine that is upregulated in several autoimmune inflammatory states.

 

Adalimumab is FDA-approved for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis; ankylosing spondylitis, pediatric and adult Crohn disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Adalimumab is a subcutaneous injection, usually self-administered every other week at a fixed dose of 40 mg in adults, although dosing can vary.

 

Testing for adalimumab concentration and presence of antiadalimumab antibodies is helpful to adjust therapeutic strategies for patients starting therapy (proactive monitoring), and to adjust dosing when partial response or loss of response to therapy is observed, manifested as recurrence of symptoms.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
ADLAB Adalimumab Ab, S No No

Testing Algorithm

If the result is 5.0 mcg/mL or less, then adalimumab antibody test will be performed at an additional charge.

Method Name

ADALX, ADLAB: Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Adalimumab QN with Reflex to Ab, S

Specimen Type

Serum

Specimen Minimum Volume

0.35 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days

Reference Values

ADALIMUMAB QUANTITIATIVE WITH REFLEX TO ANTIBODY

Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.

 

ADALIMUMAB ANTIBODY

<14.0 AU/mL

Day(s) and Time(s) Performed

Tuesday, Friday; 9 a.m.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

80145

83520 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ADALX Adalimumab QN with Reflex to Ab, S 86894-3

 

Result ID Test Result Name Result LOINC Value
ADALX Adalimumab QN with Reflex to Ab, S 86894-3

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.