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Test Code ADALX Adalimumab Quantitative with Reflex to Antibody, Serum

Reporting Name

Adalimumab QN with Reflex to Ab, S

Useful For

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

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

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.


Reject Due To

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

Specimen Minimum Volume

0.35 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

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

Secondary ID

64863

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.

Report Available

2 to 4 days

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)