Promonitor®-anti-GLM Ref. 521XX30000

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Quantitative measure of anti-golimumab antibodies.

Promonitor®-ANTI-GLM is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of anti-golimumab antibodies (IgG) in human serum. It is used as an aid in monitoring patient´s clinical response to golimumab (GLM) 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-GLM is a bridging ELISA. The microwell strips are provided pre-coated with GLM. The bridging ELISA takes advantage of the two arms of IgG subclasses 1, 2 and 3, to crosslink the GLM coated on the plate. Prediluted Calibrators, Controls and diluted patient samples are added to separate wells, allowing anti-GLM antibodies present to bind to pre-immobilized TNFa. Unbound sample is washed away, and HRP-labeled GLM is added to each well. A second incubation step allows the HRP-labeled GLM 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-GLM antibodies in the patient sample.

Optical densities (OD) of the calibrators are plotted to construct the anti-GLM 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-GLM antibodies 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.