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HelpTest 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
Secondary ID
620311Useful 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)
Specimen 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
Interpretation
Adalimumab quantitation is generally performed in conjunction with immunogenicity assessment for antibodies to adalimumab (ATA). Most often, this testing is ordered for patients with inflammatory bowel disease (IBD) who are on adalimumab therapy and who are experiencing loss of response (reactive monitoring),(5) but the testing may be ordered for anyone on adalimumab-even when treatment is going well (proactive monitoring).(6-8)
Results from adalimumab and ATA testing play an important role in patient management. In the setting of loss of response to adalimumab therapy for adults with active IBD, a clinical decision tool from the American Gastroenterology Association(9,10) suggests the following scenarios for a blood draw that occurred at trough, immediately before the next injection dose:
-For patients who have undetectable or low concentrations of adalimumab (<8 mcg/mL) but no detectable ATA, the patient care team may choose to increase the dose of adalimumab in an attempt to increase the amount of the drug in circulation.
-If the patient has subtherapeutic adalimumab concentrations (<8 mcg/mL) in the presence of an ATA, the patient care team may switch the patient to another TNF inhibitor.
-For patients with increased trough concentrations of adalimumab (therapeutic or greater), whether an ATA is present or not, it may be necessary to switch the patient to a therapy with a different mechanism of action such as the anti-alpha4-beta-7-integrin antibody vedolizumab or the IL12/IL23 antibody ustekinumab.
-Low trough concentrations may be correlated with loss of response to adalimumab.
Adalimumab concentration results above 35 mcg/mL are suggestive of a blood draw at a time-point in treatment other than trough.
Test interpretation relies on clinical presentation and may differ from the statements above, which were designed for adults with IBD experiencing loss of response. For individuals on adalimumab therapy for other conditions such as rheumatoid arthritis, or pediatric patient populations or proactive monitoring, drug concentration therapeutic targets and patient management decision may be individualized. When both the drug quantitation and anti-drug-antibodies are ordered, an interpretive guide is offered below.
|
Adalimumab quantitation, mcg/mL |
ATA, AU/mL |
Comment |
|
<8 |
Negative |
Absence of detectable antibody-to-adalimumab (ATA). Low concentration of adalimumab (ADL) may be attributable to other parameters related to adalimumab clearance. |
|
<8 |
Positive |
Presence of antibody-to-adalimumab (ATA) detected, which correlates with low concentration of adalimumab (ADL). ATAs may be associated with increased clearance and lower circulating concentrations of ADL. |
|
8.1-15 |
Negative |
Absence of detectable antibody-to-adalimumab (ATA).
At this concentration of adalimumab (ADL), a low-titer (50-150 AU/mL) or moderate titer (150-500 AU/mL) ATA cannot be excluded. However, the presence of a high-titer ATA (≥500 U/mL) is unlikely.
If there is clinical suspicion for a low-titer ATA, suggest submission of a new sample obtained at trough.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
Low or moderate positive (14-499) |
Presence of antibody-to-adalimumab (ATA) detected. At this concentration of adalimumab (ADL), the detected titer of the ATA may be modestly underestimated.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
High positive |
Presence of antibody-to-adalimumab (ATA) detected.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥ 500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
>15 |
Negative |
At this concentration of adalimumab (ADL), a low (50-150 AU/mL) or moderate titer (150-500 AU/mL) ATA cannot be excluded. The presence of a high-titer ATA (≥500 U/mL) is unlikely, but also cannot be completely excluded.
If there is clinical suspicion for an ATA, suggest submission of a new sample obtained at trough, preferably during the maintenance phase of therapy.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
Low positive (14-149) Â |
Presence of antibody-to-adalimumab (ATA) detected. At this concentration of adalimumab (ADL), the detected titer of the ATA is likely underestimated.
Suggest submission of a new sample obtained at trough, preferably during the maintenance phase of therapy.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
Moderate positive (150-499 U/mL) |
Presence of antibody-to-adalimumab (ATA) detected. At this concentration of adalimumab (ADL), the detected titer of the ATA may be underestimated.
Suggest submission of a new sample obtained at trough, preferably during the maintenance phase of therapy.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
High positive |
Presence of antibody-to-adalimumab (ATA) detected.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 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
Report Available
2 to 4 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
83520
LOINC Code Information
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| ABADL | Adalimumab Ab, S | 90779-0 |