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HelpOrder Code ABADL Adalimumab Antibody, Serum
Specimen Required
Only orderable as part of a profile. For more information see ADALP / Adalimumab Quantitative Antibody, Serum.
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: 0.5 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial
Useful For
Therapeutic drug monitoring of adalimumab antibody levels
Testing Algorithm
When this test is ordered, adalimumab quantitation and testing for antibodies to adalimumab will always be performed.
Method Name
Only orderable as part of a profile. For more information see ADALP / Adalimumab Quantitative Antibody, Serum.
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
Adalimumab Ab, SSpecimen Type
SerumSpecimen Minimum Volume
0.35 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 28 days | |
| Frozen | 28 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Heat-treated | Reject |
| Gross icterus | OK |
Reference Values
Only orderable as part of profile. For more information see ADALP / Adalimumab Quantitative with Antibody, Serum.
ADALIMUMAB ANTIBODY:
<14.0 AU/mL
Method Description
Antibodies to Adalimumab:
An enzyme-linked immunosorbent assay (ELISA) is used to determine the presence of antibodies against TNF-alpha blocker adalimumab (Amjevita and Humira). During sample preparation, the antibodies-to-adalimumab (ATA) are separated from the therapeutic antibody adalimumab using an acid dissociation to acquire free ATA. By adding the peroxidase conjugate (POD-therapeutic antibody adalimumab) and the tracer (biotinylated therapeutic antibody adalimumab), the unlabeled therapeutic antibodies are replaced, and the labeled antibodies can form a complex with the ATA. This complex binds via biotin to the streptavidin-coated microtiter plate. It is detected via the peroxidase conjugate with the peroxidase converting the substrate, TMB, to a blue product. The enzymatic reaction is stopped by adding an acidic solution. The samples convert from blue to yellow. The color change is measured in a photometer at 450 nm. The interpretation is made using the cut-off control.(Package insert: Adalimumab Total ADA ELISA reagent. Immun Diagnostik; 02/2021)
Day(s) Performed
Monday, Wednesday, Friday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
83520