Promonitor®-RTX Ref. 513XX30000

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Quantitative measure of rituximab.

Promonitor®-RTX is an enzyme-linked immunosorbent assay (ELISA) for the quantitative or semi-quantitative determination of rituximab (RTX) in human serum. It is used as an aid in monitoring patient´s clinical response to RTX therapy in conjunction with other clinical findings. The amount of RTX, anti-RTX antibodies (Promonitor®-ANTI-RTX Ref. 5140230000) and clinical findings, like disease activity, can contribute valuable information to the physician to make a more accurate evaluation of the response to the treatment with RTX.

Promonitor®-RTX is a sandwich ELISA. The microwell strips are provided pre-coated with an anti-RTX human F(ab´)2 fragment. Diluted calibrators, controls and diluted patient samples are added to separate wells, allowing RTX present to bind to pre-immobilized anti-RTX antibodies. Unbound sample is washed away, and a second HRP-labeled anti-RTX monoclonal antibody is added to each well. A second incubation step allows the HRP-labeled anti-RTX antibody to bind to the RTX that has become attached to the microwells. After washing away the excess of unbound HRP-labeled anti-RTX antibody, 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 drug 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.

See also Related assays


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