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HelpTest Code ADALX Adalimumab Quantitative with Reflex to Antibody, Serum
Additional Codes
EPIC Order Code: LAB4282
Ordering Guidance
If both quantitation and antibody testing are needed, regardless of the quantitation results, order ADALP / Adalimumab Quantitative with Antibody, Serum
Specimen Required
Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7)
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL Serum
Collection Instructions:
1. Draw blood immediately before the next dose of drug administration (trough specimen).
2. Centrifuge and aliquot serum into a plastic vial.
Useful For
Therapeutic drug monitoring of adalimumab
Evaluating patients for loss of response, partial response on initiation of therapy, autoimmune or hypersensitivity reactions, primary nonresponse, reintroduction after drug holiday, endoscopic/computed tomography enterography recurrence (in inflammatory bowel disease), acute infusion reactions and proactive monitoring including reflex testing for antibodies to adalimumab
This test does not differentiate between the originator and biosimilar products.
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.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
Adalimumab QN with Reflex to Ab, SSpecimen Type
SerumSpecimen Minimum Volume
Serum: 0.35 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 28 days |
| Frozen | 28 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
| Heat-treated specimen | Reject |
Reference Values
ADALIMUMAB QUANTITATIVE:
Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.
ADALIMUMAB ANTIBODY:
<14.0 AU/mL
Interpretation
Low trough concentrations may be associated with loss of response to adalimumab (ADL) due to possible development of an immune response to ADL. Testing for antibodies-to-adalimumab (ATA) is suggested in patients with trough concentrations less than 8.0 mcg/mL.
Adalimumab trough concentrations greater than or equal to 8.0 mcg/mL in patients with loss of response to therapy may suggest possible benefit of treatment with a different monoclonal antibody therapy.
Adalimumab concentrations greater than or equal to 35 mcg/mL suggest possible testing at a time point other than trough and should be evaluated within the clinical context of the patient.
Interpretation and patient management will be different according to disease state, clinical presentation (symptomatic versus appropriate response to therapy), several other laboratory tests and a combination of the drug concentration and/or presence of anti-drug-antibodies.
In the setting of loss of response to ADL therapy for adults with active inflammatory bowel disease (IBD), a clinical decision tool from the American Gastroenterology Association (5,8) 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 ADL (<8 mcg/mL) but no detectable ATA, the patient care team may choose to increase the dose of ADL in an attempt to increase the amount of the drug in circulation.
-If the patient has subtherapeutic ADL concentrations (<8 mcg/mL) in the presence of an ATA, the patient care team may switch the patient to another tumor necrosis factor inhibitor.
-For patients with increased trough concentrations of ADL (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 interleukin (IL)-12/IL-23 antibodies.
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 ADL 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 |
Antibody-to-adalimumab, AU/mL |
Comment |
|
<8 |
Negative |
Absence of detectable antibody-to-adalimumab (ATA). Low concentration of ADL may be attributable to other parameters related to ADL clearance. |
|
<8 |
Positive |
Presence of ATA detected, which correlates with low concentration of ADL.
ATA may be associated with increased clearance and lower circulating concentrations of ADL. |
|
8.1-15 |
Negative |
Absence of detectable ATA.
At this concentration of 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 ATA ≥ 500 AU/mL, up to 15 mcg/mL for ATA between 150-500 and up to 8 mcg/mL ADL for ATA between 50-150 AU/mL. |
|
Low or moderate positive (14-499) |
Presence of ATA detected. At this concentration of ADL, the detected titer of the ATA may be modestly underestimated.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATA ≥500 AU/mL, up to 15 mcg/mL for ATA between 150-500 and up to 8 mcg/mL ADL for ATA between 50-150 AU/mL. |
|
|
High positive |
Presence of ATA detected.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATA ≥500 AU/mL, up to 15 mcg/mL for ATA between 150-500 and up to 8 mcg/mL ADL for ATA between 50-150 AU/mL. |
|
|
>15 |
Negative |
At this concentration of 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 ATA ≥500 AU/mL, up to 15 mcg/mL for ATA between 150-500 and up to 8 mcg/mL ADL for ATA between 50-150 AU/mL. |
|
Low positive (14-149)
|
Presence of ATA detected. At this concentration of 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 ATA ≥500 AU/mL, up to 15 mcg/mL for ATA between 150-500 and up to 8 mcg/mL ADL for ATA between 50-150 AU/mL. |
|
|
Moderate positive (150-499 U/mL) |
Presence of ATA detected. At this concentration of 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 ATA ≥500 AU/mL, up to 15 mcg/mL for ATA between 150-500 and up to 8 mcg/mL ADL for ATA between 50-150 AU/mL. |
|
|
High positive (≥500) |
Presence of ATA detected.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATA ≥500 AU/mL, up to 15 mcg/mL for ATA between 150-500 and up to 8 mcg/mL ADL for ATA between 50-150 AU/mL. |
Day(s) Performed
Monday, Wednesday, Friday
Report Available
2 to 4 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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 Test Request (T728)
-Therapeutics Test Request (T831)