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HelpTest Code Adal w/Rflx Adalimumab Quantitative with Reflex to Antibody, Serum
Specimen Required
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
Clinical System Name: Adalimumab Level with Reflex to Antibody
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.
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
Adalimumab QN with Reflex to 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 |
Reference Values
ADALIMUMAB QUANTITATIVE:
Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.
ADALIMUMAB ANTIBODY:
<14.0 AU/mL
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; KR9657, ver 10/2020)
Antibodies to Adalimumab:
This ELISA test serves for the determination 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 in order 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 should be 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; KR9651, ver 02/2021)
Day(s) Performed
Monday, Wednesday, Friday
TAT: 3 - 6 days
Report Available
2 to 4 daysPerforming 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. This test 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 |
Forms
If not ordering electronically, complete, print, and send one of the following with the specimen:
-Gastroenterology and Hepatology Client Test Request (T728)
-Therapeutics Test Request (T831)