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Test Code ADAQN / ADALX-M Adalimumab Quantitative with Reflex to Antibody, Serum

Additional Codes

Software Test Code
SoftID                                                  ADAQN                                                                   
EPIC LAB20494
Mayo Laboratories ADALX


Specimen Required


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


Secondary ID

64863

Highlights

Adalimumab (brand name Humira) is a fully human therapeutic monoclonal antibody targeting tumor necrosis factor alpha, a proinflammatory cytokine that is upregulated in several autoimmune inflammatory states.

 

Adalimumab is FDA-approved for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis; ankylosing spondylitis, pediatric and adult Crohn disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Adalimumab is a subcutaneous injection, usually self-administered every other week at a fixed dose of 40 mg in adults, although dosing can vary.

 

Testing for adalimumab concentration and presence of anti-adalimumab antibodies is helpful to adjust therapeutic strategies for patients starting therapy (proactive monitoring), and to adjust dosing or treatment strategy when partial response or loss of response to therapy is observed, manifested as recurrence of symptoms.

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.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Adalimumab QN with Reflex to Ab, S

Specimen Type

Serum

Specimen 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

Clinical Information

Adalimumab, sold under the brand name Humira, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, chronic psoriasis, amongst others. Adalimumab is a tumor necrosis factor (TNF)-inhibiting, antiinflammatory, biologic medication. It binds to TNF-alpha, which normally binds to TNF-alpha receptors, leading to the inflammatory response of autoimmune diseases. By binding to TNF-alpha, adalimumab reduces inflammatory response. Because TNF-alpha is also part of the immune system that protects the body from infection, treatment with adalimumab may increase the risk of infections. Treatment with adalimumab is effective in reducing disease activity, offers significant benefits in quality of life, and may have the potential to change the progression of the disease when given early. However, over 30% of patients fail to respond to anti-TNF-alpha therapy, and approximately 60% of patients who responded initially lose the response over time and require either drug dose-escalation or switch to an alternative therapy in order to maintain response.(1)

 

Reasons for primary loss of response are not well understood but may include disease processes mediated by proinflammatory molecules other than TNF. Secondary loss of response, on the other hand, is associated with low serum albumin, high body-mass index, the degree of systemic inflammation and development of an immune response to therapy, or immunogenicity.(2,3) Antidrug antibody formation may increase drug clearance in treated patients or neutralize the drug effect, thereby potentially contributing to the loss of response. Antidrug antibodies could also cause adverse events such as serum sickness and hypersensitivity reactions.(4) Currently, adalimumab quantitation is commonly performed in conjunction with immunogenicity assessment for antibodies to adalimumab (ATA). Most often, this testing is ordered in patients on therapy who are experiencing partial or complete loss of response.

 

TNF inhibitor therapies are expensive and adverse events include greater risk for infections, such as reactivation of latent tuberculosis or hepatitis B, infusion or injection site reactions, cutaneous reactions, and reports of hepatoxicity, demyelinating disease, and higher incidence of mortality and hospitalization in heart failure patients have been documented.

Reference Values

ADALIMUMAB QUANTITATIVE

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

ADALIMUMAB ANTIBODY

<14.0 AU/mL

Cautions

Tumor necrosis factor (TNF) measurement is not the analyte of choice for monitoring therapy with TNF inhibitors (such as adalimumab or infliximab), since TNF testing 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 high adalimumab concentrations.

 

Optimal therapeutic concentrations of adalimumab may vary according to the disease.(11-13) For adults with active inflammatory bowel disease, a concentration of 7.5 mcg/mL or greater is considered therapeutic.(5)

 

For patients taking biotin supplements, it is recommended to wait at least 12 hours after the last ingestion of biotin to collect a blood sample for this test.

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; KR9657, ver 10/2020)

 

Antibodies to Adalimumab:

This ELISA test serves for the determination of antibodies against TNF-alpha blocker adalimumab (Humira). During sample preparation, the antibodies-to-adalimumab (ATA) are separated from the therapeutic antibody adalimumab using an acid dissociation in order 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 should be 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; KR9651, ver 02/2021)

Day(s) Performed

Monday, Wednesday, Friday

Report Available

2 to 4 days
NorDx Test Catalog Note:

Analytic time for send out tests is the time it will take to perform testing once it has arrived at the performing reference lab. Please add 1 to 2 days from time of collection to allow for receipt at NorDx central lab and shipment of specimen, add another day if specimen is collected on the day before a weekend or holiday.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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 Client Test Request (T728)

-Therapeutics Test Request (T831)