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Test ID ADALP Adalimumab Quantitative with Antibody, Serum

Method Name

QNADL, ABADL: Enzyme-Linked Immunosorbent Assay (ELISA)

INTAD: Technical Interpretation


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 adalimumab antibody component, consider ADALX / Adalimumab Quantitative with Reflex to Antibody, Serum. ADALX testing begins with adalimumab quantitation and testing for adalimumab antibodies is only performed when the quantitation results are 8.0 mcg/mL or less.



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: 0.4 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.


Reporting Name

Adalimumab QN with Antibodies, S

Specimen Type

Serum

Specimen Stability Information

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

Report Available

3 to 6 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

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

 

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

 

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

Day(s) Performed

Monday, Wednesday, Friday

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

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

Specimen Minimum Volume

See Specimen Required

Reference Values

ADALIMUMAB QUANTITATIVE:

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

 

ADALIMUMAB ANTIBODY:

<14.0 AU/mL