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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

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Secondary ID

64863

Useful For

Therapeutic drug monitoring of adalimumab concentration and antibody levels, if appropriate

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

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 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.

 

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

 

Optimal therapeutic concentrations of adalimumab may vary according to the disease.(12-14) For adults with active inflammatory bowel disease, a concentration of 7.5 mcg/mL or greater is considered therapeutic.(6)

 

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.

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)