MabTrack ADA infliximab

MabTrack ADA infliximab ELISA is used to detect antibodies against the TNF inhibitor infliximab in human plasma and serum, essential for customizing treatment schedules in patients. Monitoring infliximab and its antibodies helps adjust dosages based on individual response, crucial for diseases like rheumatoid arthritis and intestinal disorders. This method aids in optimizing therapeutic outcomes by matching drug levels with patient-specific disease activity.

Article number	M2960
Product group	Biologics
Technique	ELISA
Synonyms	Remicade, Remsima, Inflectra, Zessly, Flixabi

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Product information

General information

MabTrack ADA infliximab ELISA is an enzyme-linked immunoassay (ELISA) for the rapid, reliable, and specific semi-quantitative assessment of antibodies against infliximab in human plasma and serum samples. Together with measuring infliximab drug levels, this assay is crucial for tailoring treatment plans to individual patients. Low levels of the drug often suggest the presence of antibodies against infliximab, which occurs in approximately 8% to 43% of rheumatoid arthritis patients receiving this treatment. These antibodies, targeting the variable domain of infliximab, can impair the effectiveness of the TNF inhibitor and reduce its plasma concentration.

By meticulously monitoring both drug levels and antibody formation along with disease activity, physicians can accurately gauge drug efficacy in a patient and develop personalized treatment strategies. Infliximab, a therapeutic antibody, targets tumor necrosis factor (TNF) and is commonly used to treat patients with rheumatic arthritis, intestinal disorders, skin diseases, and cancer. TNF is a key player in inflammation, potentially causing pain, swelling, and stiffness in rheumatoid arthritis, as well as ulcers in intestinal bowel disease. Blocking TNF can alleviate some of these symptoms, thereby enhancing patient quality of life. The concentrations of TNF inhibitors in plasma and serum vary significantly among patients and are closely linked to their clinical symptoms.

Infliximab is often referred to by its brand names, such as Remicade, Inflectra, Renflexis, and Ixifi,

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Test principles

The MabTrack ADA infliximab ELISA is a “sandwich-type” of enzyme immunoassay. In the microtiter plates, infliximab is captured to
polystyrene microtiter wells. Free anti-infliximab antibodies, present in the patient sample and in the levels 1-2 and positive and negative controls bind to infliximab on the microtiter plate. Non-bound material is then removed by washing. Subsequently, horseradish

peroxidase-labelled infliximab is added. HRP-labelled infliximab binds to the infliximab/ anti-infliximab complex present on the surface of
the microtiter well. After removal of non-bound HRP conjugate by washing, substrate solution is added to the wells. A coloured product is formed in proportion to the amount of anti-infliximab present in the sample and controls. After the reaction has been terminated by the addition of a stop solution, absorbance is measured in a microtiter plate reader. From the absorbance of samples and those of the levels, the samples can be qualified negative (-), (weak) positive (+), strong positive (++) for anti-infliximab antibodies.

Storage and stability

Should be stored at 2–8°C

Package contents

– The flat-bottom microtiter plate consists of 6 strips of 8 wells ready for use. All the wells are coated with infliximab. The microtiter plate is vacuum sealed in a plastic pouch containing desiccant. The kit provides the flexibility to use the microtiter plate on 3 separate occasions. Determine the number of strips required to test the desired number of samples plus 4 wells needed for running the controls. Remove strips that will not be used from the microtiter plate-frame and re-pack them in the plastic pouch containing the desiccant.

– Vials of level 1, level 2, positive control, negative control and HRP-conjugate once opened need to be discarded after use.

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Infliximab pre-coated microtiter plate	6 x 8 Wells	–	M2961	ready-to-use
Level 1	3 x 0,50 mL	clear caps	M296201	ready-to-use
Level 2	3 x 0,50 mL	clear caps	M296202	ready-to-use
Control+	3 x 0,50 mL	clear caps	M296203	ready-to-use
Control –	3 x 0,50 mL	clear caps	M295204	ready-to-use
Infliximab HRP-conjugate	3 x 3,5 mL	brown bottle	M2967	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. Leaking or damaged vials must not be used. Reagents (unopened or opened) should not be used beyond the expiration date, which is printed on the label of the vial. The reagent cannot be assumed to be free from infectious agents. Care must be taken in the use and disposal of each container and its contents. Waste-disposal, after completion of the test, should be performed according to your laboratory regulations.

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Test sample handling

1. Trough samples must be used to measure the concentration of anti-infliximab, thus samples must be taken within 24 hours BEFORE the drug is injected to make sure that the indicated expected levels reflect the trough level of the patient.

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

3. Separate plasma or serum from the blood cells within 4 hours after collection and perform the analyses immediately. If testing of the samples is delayed, they can be stored at 2-8 °C for 24 hours. If samples are not analysed within 24 hours, the samples must be stored frozen, they can be stored at ≤ -18 °C for 2 months.

4. Aliquot samples to avoid freeze-thaw cycles.

5. Prior to the assay, frozen samples must be thawed at room temperature. Do not use 37 °C or 56 °C water baths for thawing.

6. Mix the samples just before preparing the dilutions.

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