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Test 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, 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.


Secondary ID

620311

Useful For

Therapeutic drug monitoring of adalimumab

 

Quantifying adalimumab antibodies as part of a profile 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

 

This test does not differentiate between the originator and biosimilar products.

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

Serum

Specimen 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
Heat-treated Reject
Gross icterus OK

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
(≥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.

>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.

Method Description

Testing for antibodies-to-adalimumab is performed using a laboratory-developed immunoassay.(Unpublished Mayo method)

Day(s) Performed

Tuesday, Friday

Report Available

3 to 6 days

Specimen Retention Time

14 days

Performing 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