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Test ID ADALP Adalimumab Quantitative with Antibody, Serum


Ordering Guidance


If there is a known justification for performing both quantitation and antibody levels, this is the correct test to order. If there is not a known reason to perform the antibody levels component, consider ADALX / Adalimumab Quantitative with Reflex to Antibody, Serum. ADALX testing begins with adalimumab quantitation and only performs testing for antibodies when the quantitation results are 8.0 mcg/mL or less.



Specimen Required


Patient Preparation: For 12 hours before specimen collection, it is recommended that the patient not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1.0 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial


Forms

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

Useful For

Therapeutic drug monitoring of adalimumab concentration and antibody levels

Profile Information

Test ID Reporting Name Available Separately Always Performed
QNADL Adalimumab QN, S Yes, (ADALX) Yes
ABADL Adalimumab Ab, S No Yes
INTAD Adalimumab Interpretation No Yes

Testing Algorithm

When this test is ordered, adalimumab quantitation and testing for antibodies to adalimumab will always be performed.

Method Name

Enzyme Linked Immunosorbent Assay (ELISA)

Reporting Name

Adalimumab QN with Antibodies, S

Specimen Type

Serum

Specimen Minimum Volume

0.7 mL

Specimen Stability Information

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

Reference Values

ADALIMUMAB QUANTITATIVE:

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

 

ADALIMUMAB ANTIBODY:

<14.0 AU/mL

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ADALP Adalimumab QN with Antibodies, S 99781-7

 

Result ID Test Result Name Result LOINC Value
QNADL Adalimumab QN, S 86894-3
ABADL Adalimumab Ab, S 90779-0
INTAD Adalimumab Interpretation 77202-0