Ordering Recommendation

Use to monitor adalimumab or adalimumab biosimilar therapy.

New York DOH Approval Status

Testing is not New York state approved. Specimens from New York clients will be sent out to a New York state-approved laboratory.

Specimen Required

Patient Preparation

Collect specimens before next scheduled dose of adalimumab or adalimumab biosimilar (trough specimen). Avoid exposure to biotin (vitamin B7) for 12 hours prior to specimen collection.

Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP. Transfer 1 mL serum to an ARUP standard transport tube. (Min 0.1 mL)
New York State Clients: 2 mL (Min: 1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Grossly hemolyzed, icteric, or lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 2 days; Refrigerated: 2 weeks; Frozen: 1 month (avoid repeated freeze/thaw cycles).
New York State Clients: Ambient: 1 week; Refrigerated: 1 week; Frozen: 308 days

Methodology

Quantitative Electrochemiluminescent Immunoassay (ECLIA) with Acid Dissociation

Performed

Sun-Sat

Reported

3-7 days

Reference Interval

Interpretive Data

Adalimumab Quantitation:

Limit of Quantitation = 0.4 ug/mL.

Results of 0.4 ug/mL or higher indicate the detection of adalimumab or an adalimumab biosimilar. Therapeutic level may vary depending on the disease being treated.

Antibodies to Adalimumab Quantitation:

Limit of Quantitation = 20 ng/mL

Results of 20 ng/mL or higher indicate the detection of antibodies against adalimumab or an adalimumab biosimilar. Interpret in the context of adalimumab or adalimumab biosimilar trough concentration to determine clinical significance and impact on treatment efficacy.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

80145; 82397

Components

Component Test Code* Component Chart Name LOINC
3017044 Adalimumab Quantitation 86894-3
3017045 Antibodies to Adalimumab Quantitation 86895-0
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Abrilada
  • Amjevita
  • Cyltezo
  • Hadlima
  • Hulio
  • Humira
  • Hymiroz
  • Idacio
  • Yusimry
Adalimumab and Antibodies to Adalimumab Quantitation