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Order Code QNADL Adalimumab Quantitative, Serum


Specimen Required


Only orderable as part of profile. For more information see ADALP / Adalimumab Quantitative with 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 concentration

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 with Antibody, Serum.

 

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Adalimumab QN, S

Specimen Type

Serum

Specimen 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 QUANTITATIVE:

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

Method Description

Adalimumab Quantitation:

The adalimumab enzyme-linked immunosorbent assay (ELISA) is designed to determine the quantity of free adalimumab (therapeutic antibody against tumor necrosis factor-alpha: [TNF]-alpha) in serum samples. In a first incubation step, the free adalimumab from the sample is bound to the specific monoclonal anti-adalimumab antibody coated on the plate. To remove all unbound substances, a washing step is carried out. In a further incubation step, peroxidase-labeled antibody is added. Tetramethylbenzidine (TMB) is used as a substrate for peroxidase. Finally, an acidic stop solution is added to terminate the reaction. The color changes from blue to yellow. The intensity of the yellow color is directly proportional to the concentration of free adalimumab in the sample. A dose response curve of the absorbance unit (optical density: OD) verses concentration is generated, using the values obtained from standard. The concentrations of free adalimumab in the samples are determined directly from this curve.(Package insert: Adalimumab Drug Level ELISA reagent. Immun Diagnostik; 10/2020)

Day(s) Performed

Monday, Wednesday, Friday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

80145