Adalimumab, Serum




Test Mnemonic

ADALIM

CPT Codes

  • 83529 - QTY (1)
  • 80145 - QTY (1)

Performing Laboratory

Cleveland Clinic Laboratories

FDA Category

Laboratory Developed Test


Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
1 mLSerumSST (Gold) Refrigerated 

Alternate Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
1 mLSerumNo additive (Red) Refrigerated 

Minimum Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
0.5 mL     

Stability

Environmental Condition Description
Ambient7 Days
Refrigerated14 Days
Frozen60 Days

Days Performed

Mon, Thu

Turnaround Time

1 - 4 days

Methodology

Name Description
Enzyme-Linked Immunosorbent Assay (ELISA) 

Reference Range

Adalimumab Free Drug Level
Sex Age From Age To Type Range Range Unit
       Normal>=7.5ug/mL
Adalimumab Total Anti-Drug Antibody Level
Sex Age From Age To Type Range Range Unit
       Normal<10AU/mL

Special Info

Patients taking a biotin dose greater than 5 mg/day should refrain from taking biotin for at least 24 hours. Clinicians should consider biotin interference as a source of error, when clinically suspicious of the laboratory result.

Clinical Info

Trough free adalimumab level and total (free and bound) anti-drug antibody levels for patients undergoing therapy with adalimumab and -atto. Draw just prior to scheduled dose. In adults with active IBD treated with anti-TNF agents, the AGA suggests reactive therapeutic drug monitoring to guide treatment changes. Reference ranges and high/low indicator flags are provided as general guidelines only. The treating physician must determine appropriate target levels/dosing based on the specific clinical situation.

Clinical Limitation

Adalimumab drug levels greater than 10 ug/mL may result in falsely-decreased adalimumab anti-drug antibody levels.