Ordering Recommendation

Evaluate response failure to adalimumab therapy. Determine and adjust dosage or identify the need for change to another anti-TNF-α inhibitor.

Mnemonic
ADA DL R
Methodology

Cell Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative Chemiluminescent Immunoassay

Performed

Mon,Wed,Thu,Sat

Reported

2-3 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation

Collect specimens before adalimumab treatment.

Collect

Serum Separator Tube (SST).

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Contaminated, hemolyzed, icteric, or lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 4 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Reference Interval
Available Separately Components Reference Interval
2013605 Adalimumab Activity w/Rflx to Antibody Not Detected
No ADA Rflx to Neutralizing Ab Confirmation Not Detected

Interpretive Data

This test measures the capacity of adalimumab to neutralize TNF activity. If adalimumab is not detected, testing for neutralizing antibodies (NAb) will be performed. Adalimumab NAb titer is obtained by identifying the minimal serum dilution at which blocking of adalimumab activity is no longer observed.

This test is used to evaluate secondary response failures to adalimumab therapy. Secondary response failure is defined as loss of clinical response after initial improvement of clinical signs and symptoms. Therapeutic decision should rest on both the clinical response and the knowledge of the fate of the drug including the emergence of immunogenicity in individual patients.

Circulating adalimumab levels have been shown to vary considerably between patients. These differences relate to route and frequency of administration and patient-related features such as age, gender, weight, drug metabolism, and concomitant medications such as methotrexate and other immunosuppressants.


* AGA recommended target trough concentration for reactive monitoring of patients with active IBD on maintenance therapy is 7.5 ug/mL or greater for adalimumab (Feuerstein JD et al, Gastroenterology 2017; 153:827-834). The AGA makes no recommendation regarding the use of routine, proactive therapeutic drug monitoring in adults with quiescent IBD treated with anti-TNF agents.


Clinical Interpretation of Adalimumab and Antibody Testing Results in the Context of Treatment Failure
Adalimumab Activity
Adalimumab Neutralizing Antibody Titer
Interpretation
Not Detected Not Detected Sub-therapeutic dose. A higher dosage of adalimumab or shortening the dosing interval may be appropriate.
Not Detected Detected Likely immune-mediated treatment failure. A change to another anti-TNF drug may be appropriate.
Detected - Below Target* N/A Sub-therapeutic dose. A higher dosage of adalimumab or shortening the dosing interval may be appropriate.
Detected - Above Target* N/A A change to another type of therapy (not targeting TNF) may be appropriate, if the patient is not responding adequately to adalimumab therapy.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

This test is performed pursuant to an agreement with Svar Life Sciences. If Adalimumab drug level is not detected, then Adalimumab Neutralizing Ab Titer will be added. Additional charges apply.

Hotline History
N/A
CPT Codes

80145; if reflexed, add 82397

Components
Component Test Code* Component Chart Name LOINC
2013606 Adalimumab Activity w/Rflx to Ab
2013607 EER Adalimumab Activity w/Rflx to Ab
* 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
  • Humira
Adalimumab Activity with Reflex to Antibody