MabTrack ADA adalimumab

Article number	M2950
Product group	Biologics
Technique	ELISA
Synonyms	Humira® Hyrimoz® TNF blocker

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General information

The MabTrack ADA adalimumab ELISA is an enzyme-linked immunosorbent assay (ELISA) for the rapid, reproducible, and specific semi-quantitative determination of antibodies against adalimumab in human plasma and serum samples. The MabTrack ADA adalimumab, along with the measurement of adalimumab drug levels, is important for customizing treatment regimes to individual patients. Low drug levels are often an indication of antibody formation against adalimumab. In about 25% to 30% of patients with rheumatoid arthritis treated with adalimumab, antibodies against the idiotypic determinant of adalimumab are formed. This can impair the function of the TNF blocker and lead to a decrease in plasma levels of the TNF blocker.

By closely monitoring drug levels and antibody formation in combination with disease activity, it is possible for physicians to determine the drug levels in individual patients and plan patient-specific treatment regimes. The therapeutic antibody adalimumab targets tumor necrosis factor (TNF) and is frequently used in patients with rheumatoid arthritis, intestinal diseases, skin conditions, or cancer. TNF plays a crucial role in inflammation, causing pain, swollen joints, and stiffness in patients with rheumatoid arthritis, as well as ulcers in patients with intestinal disease. Thus, inhibiting TNF is thought to alleviate some of these symptoms and thereby improve the quality of life for these patients. The plasma and serum levels of TNF blockers vary significantly among patients and correlate clearly with the clinical symptoms of the patients.

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Test principles

The MabTrack ADA adalimumab ELISA is a “sandwich” type enzyme immunoassay. In the microtiter plates, adalimumab is bound to polystyrene microtiter wells. Free anti-adalimumab antibodies present in the patient sample, in Level 1-2, and in the positive and negative controls bind to the adalimumab on the microtiter plate. Unbound material is then removed by washing. Subsequently, horseradish peroxidase-labeled adalimumab is added. The HRP-labeled adalimumab binds to the adalimumab/anti-adalimumab complex present on the surface of the microtiter well. After removal of unbound HRP conjugate by washing, a substrate solution is added to the wells. A colored product forms, the intensity of which is proportional to the amount of anti-adalimumab antibodies present in the sample or controls. After stopping the reaction by adding a stop solution, the extinction is measured in a microtiter plate reader. Based on the extinction of the samples and those of the levels, the samples can be classified as negative (−), (weakly) positive (+), or strongly positive (++) for anti-adalimumab antibodies.

Storage and stability

Should be stored at 2–8°C

Package contents

The flat-bottom microtiter plate consists of six strips with eight ready-to-use wells. All wells are coated with adalimumab. The microtiter plate is vacuum-sealed in a plastic bag containing a desiccant. The kit offers the flexibility to use the microtiter plate on three different occasions. Determine the number of strips required to test the desired number of samples, plus four wells needed for the controls. The unused strips are removed from the frame of the microtiter plate and repackaged in the plastic bag with the desiccant.

The vials with Level 1, Level 2, the positive and negative control, and the HRP conjugate must be disposed of after use once they have been opened.

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Adalimumab pre-coated microtiter plate	6 x 8 Wells	–	M2951	ready-to-use
Level 1	3 x 0,50 mL	transparent caps	M295201	ready-to-use
Level 2	3 x 0,50 mL	transparent caps	M295202	ready-to-use
Control+	3 x 0,50 mL	transparent caps	M295203	ready-to-use
Control –	3 x 0,50 mL	transparent caps	M295204	ready-to-use
Adalimumab HRP-conjugate	3 x 3,5 mL	brown bottle	M2957	ready-to-use
Wash buffer stock solution	1 x 50 mL	white bottle	M1805	Dilute 1:20 with distilled water
HPE dilution buffer	1 x 50 mL	white bottle	M2940	ready-to-use
TMB substrate solution	1 x 12,5 mL	brown bottle	M1821	ready-to-use
Stop solution 0,18 M H2SO4	1 x 13,0 mL	white bottle	M1823	ready-to-use
Plate seals	10 x

Precautions

For in vitro diagnostic use only. Reagents should be stored at 2–8°C. Leaky or damaged vials must not be used. Reagents (whether unopened or opened) should only be used up to the expiration date printed on the label. It cannot be ruled out that the reagents may contain infectious agents. Appropriate precautions should be taken when handling and disposing of the containers and their contents. After completion of the test, waste should be disposed of in accordance with local regulations.

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Test sample handling

1. For measuring the concentration of anti-adalimumab antibodies, samples must be taken during trough levels. Therefore, samples must be collected within 24 hours BEFORE the injection of the drug. Samples taken at other times may contain drug levels that can interfere with the test.

2. Only serum and EDTA plasma may be used in the assay.

3. lasma or serum must be separated from blood cells within four hours of collection, and the analyses must be carried out immediately. If testing of the samples is delayed, they can be stored for 24 hours at 2-8°C. If the samples are not analyzed within 24 hours, they must be stored frozen; they can be stored for two months at ≤ -18°C.

4. Aliquot samples to avoid freeze-thaw cycles.

5. Frozen samples must be thawed at room temperature before the assay. Do not use a 37°C or 56°C water bath for thawing.

6. Mix the samples just before preparing the dilutions.

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