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Test Code 0254510 Adalimumab Quantitative with Reflex to Antibody, Serum

Additional Codes

 

Mayo Test ID
ADALX

 


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

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
Serum Refrigerated (preferred) 28 days
  Frozen  28 days

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

NA

Other

NA

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

Interpretation

Currently, adalimumab quantitation is one of the most commonly tested monoclonal antibodies in routine practice; this testing is generally performed in conjunction with immunogenicity assessment for antibodies to adalimumab (ATA). Most often, this testing is ordered for patients with inflammatory bowel disease (IBD) who are on adalimumab therapy and who are experiencing loss of response, but the testing may be ordered for anyone on adalimumab. Results from adalimumab and ATA testing play an important role in patient management. When measured at trough, for patients who have undetectable or low concentrations of adalimumab, but no detectable ATA, the physician may choose to increase the dose of adalimumab in an attempt to increase the amount of the drug in circulation. If the patient has low adalimumab in the presence of an ATA, in many cases the physician may switch the patient to another tumor necrosis factor (TNF) inhibitor. In contrast, for patients with increased trough concentrations of adalimumab, whether or not an ATA is present, it may be necessary to switch the patient to a therapy with a different mechanism of action, such as the anti-alpha4-beta-7-integrin antibody vedolizumab or the IL12/IL23 antibody ustekinumab, in the setting of IBD.

 

Adalimumab quantitation will be interpreted in 2 different ways. When measured at trough, individuals may be considered to have adequate trough levels when drug concentrations are above 5 mcg/mL, and faster clearance of the drug, which may warrant a dosing adjustment or additional action if adalimumab trough concentration is below or equal to 5 mcg/mL. Adalimumab quantitation may influence patient management decisions as to whether therapy should continue as is, dose escalation is necessary, or a switch to a new therapeutic regimen is needed.

 

Low trough concentrations may be correlated with loss of response to adalimumab. For adalimumab trough concentrations of 5.0 mcg/mL or less, testing for antibodies to ATA is suggested.

 

For adalimumab trough concentrations above 5.0 mcg/mL, the presence of ATA is unlikely; patients experiencing loss of response to adalimumab may benefit from an increased dose or more frequent dosing.

 

Adalimumab concentration results above 35 mcg/mL are suggestive of a blood draw at a time-point in treatment other than trough.

Day(s) and Time(s) Performed

Tuesday, Friday; 9 a.m.

Analytic Time

1 day

Specimen Retention Time

14 days

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

80299

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 74117-3

Forms

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