Adalimumab Activity and Neutralizing Antibody

Test Details

This test measures the capacity of adalimumab to neutralize TNF-activity. Additionally, adalimumab neutralizing antibodies (NAb) are titered (reporting the highest dilution of patient sera in which NAb activity is detected).

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.


Test Notes

  • This test has conditional NY approval. Call Client Services at (800) 522-2787 for status updates.
  • Hotline: Refer to the Test Mix Addendum for interface build information.
  • This test measures the capacity of Adalimumba to neutralize TNF-activity. Additionally, adalimumab neutralizing antibodies (NAb) are titered (reporting the highest dilution of patient sera in which NAb activity is detected). Tests are not available separately.

Ordering Information

Test Name Adalimumab Activity and Neutralizing Antibody
Test Code 2011248
Mnemonic ADA NAB
CPT Code(s) 86352 x2
Methodology Cell Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative Chemiluminescent Immunoassay
Performed Mon, Wed, Thu, Sat
Reported 2–3 Days
Specimen Required
  • Patient Prep: Collect specimens before adalimumab treatment.
  • Collect: Serum separator tube.
  • Specimen Preparation: Separate serum 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.
  • Stability (collection to initiation of testing): After separation from cells: Ambient: 48 hours; Refrigerated: 4 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Interpretive Data

This test is used to evaluate secondary response failures to infliximab therapy.

See Compliance Statement B.

IF Adalimumab Activity is: Not Detected
AND Adalimumab Neutralizing Ab Titer is: Not Detected
THEN A higher dosage of adalimumab or shortening the dosing interval may be appropriate.

IF Adalimumab Activity is: Not Detected
AND Adalimumab Neutralizing Ab Titer is: 1:20 or greater
THEN A change to another anti-TNF-α drug may be appropriate.

IF Adalimumab Activity is: 0.65 ug/mL or greater
AND Adalimumab Neutralizing Ab Titer is: Not Detected
THEN A change to another type of therapy (not targeting TNF-α) may be appropriate.
IF Adalimumab Activity is: 0.65 ug/mL or greater
AND Adalimumab Neutralizing Ab Titer is: 1:20 or greater
THEN Repeat testing is suggested to rule out decreasing adalimumab activity and/or increasing adalimumab neutralizing antibodies.

Note: This test is performed pursuant to an agreement with Biomonitor.

DTA Details

DTA(s) for TDN: ADALIM
Component Num Component Mnemonic Component Chart Name Ord/Res Description Prompt Test Chartable Loinc Code
2011249 ADALIM Adalimumab Activity R   N Y  
2011250 ADA_NAB Adalimumab Neutralizing Antibody R   N Y  
2011251 EER ADA EER Adalimumab R   N Y