Promonitor®-anti-ADL Ref. 509XX30000

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Quantitative measure of anti-adalimumab antibodies.

Promonitor®-anti-ADL is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of anti-adalimumab antibodies in human serum samples. The amount of Anti-Drug Antibodies (ADA), when considered in conjunction with the adalimumab (ADL) level (Promonitor®-ADL Ref. 5080230000) and clinical findings, like disease activity, contributes valuable information to the physician to assess the efficacy of therapies with ADL and predict loss of clinical response by the patient. ADL often raises an unwanted anti-idiotypic immune response in the treated patient, causing ADA to form. All anti-ADL antibodies are neutralizing anti-idiotypic antibodies which can render ADL completely useless. The correlation between reduced serum ADL concentrations, ADA formation and increased disease activity has been demonstrated in several clinical studies in a series of pathologies.

Promonitor®-anti-ADL is a bridging ELISA where microwell strips are provided pre-coated with ADL. The bridging ELISA takes advantage of the two arms of IgG subclasses 1, 2 and 3, to crosslink the ADL coated on the plate. Calibrators, controls and diluted patient samples are added to separate wells, allowing anti-ADL antibodies present to bind to pre-immobilized ADL. Unbound sample is washed away, and HRP-labeled ADL is added to each well. A second incubation allows the HRP-labeled ADL to bind to the antibodies that have become attached to the microwells. After washing away unbound HRP conjugate, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops in a spectrophotometer. The signal obtained is proportional to the amount of anti-ADL binding antibodies in the patient sample.

Optical densities (OD) of the calibrators are plotted to construct the anti-ADL antibodies calibration curve. A four parameter logistic (4PL) model is used to fit the curve. Positive and Negative Controls are used to monitor assay performance. Anti-ADL antibody titer is calculated by interpolating sample OD in the calibration curve. Interpretation of results in a clinical setting is provided. Warnings for each sample are optionally included; this setting can be configured here.

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Promonitor® is a trademark of Proteomika, S.L.