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HelpTest 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
Secondary ID
620310Useful 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)
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 QUANTITATIVE:
Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.
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)
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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.
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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) Â |
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 (≥500) |
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 (≥500) |
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
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
Report Available
2 to 4 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
80145
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| QNADL | Adalimumab QN, S | 86894-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| QNADL | Adalimumab QN, S | 86894-3 |