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26217 Adalimumab Quantitative with Reflex to Antibody, Serum (ADALX)

Adalimumab Quantitative with Reflex to Antibody, Serum (ADALX)
Test Code: ADALXSO
Synonyms/Keywords

​Humira

Test Components

​If the result is 8.0 mcg/mL or less, then adalimumab antibody test will be performed at an additional charge.

Useful For

Detection and quantification of antibodies directed against adalimumab in serum

Trough level quantitation for evaluation of patients with loss of response to adalimumab

Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Serum​Serum Separator Tube (SST)​Red Top Tube (RTT)​0.5 mL​0.35 mL
Specimen Stability Information
Specimen TypeTemperatureTime
​Serum ​​Refrigerated (preferred)​28 days
​Frozen​28 days
Rejection Criteria
Gross Hemolysis
​Gross Lipemia
Interference

Laboratory testing of patients for quantitation of adalimumab and assessment of immunogenicity (development of autoantibodies against adalimumab) can help optimize therapy when partial response or loss of response to therapy is observed. As a side note, tumor necrosis factor (TNF) measurement is not the analyte of choice for monitoring therapy with TNF inhibitors (such as adalimumab or infliximab), since it would not distinguish between free TNF and TNF bound to the monoclonal antibody, either in the extracellular or membrane-bound form of the cytokine.

Toxicity effects other than acute hypersensitivity infusion reactions have not been described nor correlated with adalimumab concentrations.

Optimal therapeutic concentrations of adalimumab may vary according to the disease (eg, Crohn disease verses ulcerative colitis verses rheumatoid arthritis). 

Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories​Tuesday, Friday​1 to 4 days​Enzyme-Linked Immunosorbent Assay (ELISA)
Reference Lab
Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories

ADALIMUMAB QUANTITIATIVE WITH REFLEX TO ANTIBODY

Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.

 

ADALIMUMAB ANTIBODY

<14.0 AU/mL 

Interpretation

Currently, adalimumab quantitation is one of the most commonly tested monoclonal antibodies in routine practice; this testing 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, but the testing may be ordered for anyone on adalimumab. Results from adalimumab and ATA testing play an important role in patient management. When measured at trough, for patients who have undetectable or low concentrations of adalimumab, but no detectable ATA, the physician may choose to increase the dose of adalimumab in an attempt to increase the amount of the drug in circulation. If the patient has low adalimumab in the presence of an ATA, in many cases the physician may switch the patient to another tumor necrosis factor (TNF) inhibitor. In contrast, for patients with increased trough concentrations of adalimumab, whether or not an ATA is present, 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, in the setting of IBD.

Adalimumab quantitation will be interpreted in 2 different ways. When measured at trough, individuals may be considered to have adequate trough levels when drug concentrations are above 8 mcg/mL, and faster clearance of the drug, which may warrant a dosing adjustment or additional action if adalimumab trough concentration is below or equal to 8 mcg/mL. Adalimumab quantitation may influence patient management decisions as to whether therapy should continue as is, dose escalation is necessary, or a switch to a new therapeutic regimen is needed.

Low trough concentrations may be correlated with loss of response to adalimumab. For adalimumab trough concentrations of 8.0 mcg/mL or less, testing for  ATA is suggested.

For adalimumab trough concentrations above 8.0 mcg/mL, the presence of ATA is unlikely; patients experiencing loss of response to adalimumab may benefit from an increased dose or more frequent dosing.

Adalimumab concentration results above 35 mcg/mL are suggestive of a blood draw at a time-point in treatment other than trough. 

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​80145​1
​83520​1​if needed
Synonyms/Keywords

​Humira

Test Components

​If the result is 8.0 mcg/mL or less, then adalimumab antibody test will be performed at an additional charge.

Ordering Applications
Ordering ApplicationDescription
​COM​Adalimumab, S
​Cerner​Adalimumab, S (ADALX)
​Centricity​Adalimumab, S (ADALX)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Serum​Serum Separator Tube (SST)​Red Top Tube (RTT)​0.5 mL​0.35 mL
Specimen Stability Information
Specimen TypeTemperatureTime
​Serum ​​Refrigerated (preferred)​28 days
​Frozen​28 days
Rejection Criteria
Gross Hemolysis
​Gross Lipemia
Interference

Laboratory testing of patients for quantitation of adalimumab and assessment of immunogenicity (development of autoantibodies against adalimumab) can help optimize therapy when partial response or loss of response to therapy is observed. As a side note, tumor necrosis factor (TNF) measurement is not the analyte of choice for monitoring therapy with TNF inhibitors (such as adalimumab or infliximab), since it would not distinguish between free TNF and TNF bound to the monoclonal antibody, either in the extracellular or membrane-bound form of the cytokine.

Toxicity effects other than acute hypersensitivity infusion reactions have not been described nor correlated with adalimumab concentrations.

Optimal therapeutic concentrations of adalimumab may vary according to the disease (eg, Crohn disease verses ulcerative colitis verses rheumatoid arthritis). 

Useful For

Detection and quantification of antibodies directed against adalimumab in serum

Trough level quantitation for evaluation of patients with loss of response to adalimumab

Test Components

​If the result is 8.0 mcg/mL or less, then adalimumab antibody test will be performed at an additional charge.

Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories

ADALIMUMAB QUANTITIATIVE WITH REFLEX TO ANTIBODY

Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.

 

ADALIMUMAB ANTIBODY

<14.0 AU/mL 

Interpretation

Currently, adalimumab quantitation is one of the most commonly tested monoclonal antibodies in routine practice; this testing 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, but the testing may be ordered for anyone on adalimumab. Results from adalimumab and ATA testing play an important role in patient management. When measured at trough, for patients who have undetectable or low concentrations of adalimumab, but no detectable ATA, the physician may choose to increase the dose of adalimumab in an attempt to increase the amount of the drug in circulation. If the patient has low adalimumab in the presence of an ATA, in many cases the physician may switch the patient to another tumor necrosis factor (TNF) inhibitor. In contrast, for patients with increased trough concentrations of adalimumab, whether or not an ATA is present, 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, in the setting of IBD.

Adalimumab quantitation will be interpreted in 2 different ways. When measured at trough, individuals may be considered to have adequate trough levels when drug concentrations are above 8 mcg/mL, and faster clearance of the drug, which may warrant a dosing adjustment or additional action if adalimumab trough concentration is below or equal to 8 mcg/mL. Adalimumab quantitation may influence patient management decisions as to whether therapy should continue as is, dose escalation is necessary, or a switch to a new therapeutic regimen is needed.

Low trough concentrations may be correlated with loss of response to adalimumab. For adalimumab trough concentrations of 8.0 mcg/mL or less, testing for  ATA is suggested.

For adalimumab trough concentrations above 8.0 mcg/mL, the presence of ATA is unlikely; patients experiencing loss of response to adalimumab may benefit from an increased dose or more frequent dosing.

Adalimumab concentration results above 35 mcg/mL are suggestive of a blood draw at a time-point in treatment other than trough. 

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories​Tuesday, Friday​1 to 4 days​Enzyme-Linked Immunosorbent Assay (ELISA)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​80145​1
​83520​1​if needed
For most current information refer to the Marshfield Laboratory online reference manual.