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Test Code LAB10041 Adalimumab Quantitative with Reflex to Antibody, Serum


Ordering Guidance


If both quantitation and antibody testing are needed, regardless of the quantitation results, order ADALP / Adalimumab Quantitative with Antibody, Serum



Specimen Required


Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7)

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL Serum

Collection Instructions:

1. Draw blood immediately before the next dose of drug administration (trough specimen).

2. Centrifuge and aliquot serum into a plastic vial.

 


Secondary ID

64863

Useful For

Therapeutic drug monitoring of adalimumab

 

Evaluating patients for loss of response, partial response on initiation of therapy, autoimmune or hypersensitivity reactions, primary nonresponse, reintroduction after drug holiday, endoscopic/computed tomography enterography recurrence (in inflammatory bowel disease), acute infusion reactions and proactive monitoring including reflex testing for antibodies to adalimumab

 

This test does not differentiate between the originator and biosimilar products.

 

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
ADLAB Adalimumab Ab, S No No

Testing Algorithm

If the result is 8.0 mcg/mL or less, then adalimumab antibody test will be performed at an additional charge.

 

For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Adalimumab QN with Reflex to Ab, S

Specimen Type

Serum

Specimen Minimum Volume

Serum: 0.35 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 28 days
  Frozen  28 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Heat-treated specimen Reject

Reference Values

ADALIMUMAB QUANTITATIVE:

Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.

 

ADALIMUMAB ANTIBODY:

<14.0 AU/mL

Cautions

Tumor necrosis factor (TNF) measurement is not the analyte of choice for monitoring therapy with TNF inhibitors (such as adalimumab [ADL] or infliximab), since TNF testing would not distinguish between free TNF and TNF bound to the monoclonal antibody, either in the extracellular or membrane-bound form of the cytokine.

 

While the immunogenicity rates between reference product and biosimilars are similar, there could be epitope differences in the anti-drug-antibodies for each formulation.

 

Toxicity effects other than acute hypersensitivity infusion reactions have not been described nor correlated with high ADL concentrations.

 

For patients taking biotin supplements, it is recommended to wait at least 12 hours after the last ingestion of biotin to collect a blood sample for this test.

 

The presence of ADL in patients’ serum is a recognized interference in most adalimumab antibodies (ATA) methods. The ATA assay includes an acid dissociation step, which partially mitigates this interference. The best timeframe for a blood draw for therapeutic drug monitoring is at trough, immediately before the next dose of the medication.

 

This test is designed to quantify adalimumab regardless of formulation. It is suitable for testing both the reference product and all US Food and Drug Administration and European Medicines Agency-approved biosimilars. The test does not differentiate between the originator and biosimilar products.

Day(s) Performed

Monday, Wednesday, Friday

Report Available

2 to 4 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. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80145

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 86894-3

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send one of the following with the specimen:

-Gastroenterology and Hepatology Test Request (T728)

-Therapeutics Test Request (T831)