Promonitor®-anti-RTX Ref. 514XX30000

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Quantitative measure of anti-etanercept antibodies.

Promonitor®-ANTI-RTX is an enzyme-linked immunosorbent assay (ELISA) for the quantitative or semi-quantitative determination of anti-rituximab antibodies (IgG) in human serum. It is used as an aid in monitoring patient´s clinical response to rituximab (RTX) therapy in conjunction with other clinical findings. It is known that any biological drug can be potentially immunogenic and induce the formation of Anti-Drug Antibodies (ADA), thereby potentially reducing treatment efficacy.

Promonitor®-anti-RTX is a bridging ELISA. The microwell strips are provided pre-coated with RTX. The bridging ELISA takes advantage of the two arms of IgG subclasses 1, 2 and 3, to crosslink the RTX coated on the plate. Calibrators, controls and diluted patient samples are added to separate wells, allowing anti-RTX antibodies present to bind to pre-immobilized RTX. Unbound sample is washed away, and HRP-labeled RTX is added to each well. A second incubation step allows the HRP-labeled RTX to bind to the antibodies that have become attached to the microwells. After washing away the excess of 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-RTX antibodies in the patient sample.

Optical densities (OD) of the calibrators are plotted to construct the RTX calibration curve. A four parameter logistic (4PL) model is used to fit the curve. Positive and Negative Controls are used to monitor assay performance. RTX concentration is calculated by interpolating sample OD in the calibration curve.

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.