Promonitor®-anti-ETN Ref. 512XX30000

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Quantitative measure of anti-etanercept antibodies.

Promonitor®-anti-ETN is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of anti-etanercept antibodies in human serum samples. The amount of Anti-Drug Antibodies (ADA), when considered in conjunction with drug levels (Promonitor®-ETN Ref. 5110230000) and clinical findings, like disease activity, can contribute valuable information to the physician to assess the efficacy of therapies with etanercept (ETN).

It is known that any biological drug can be potentially immunogenic and induce the formation of ADA, thereby potentially reducing treatment efficacy. In the case of other anti-TNF treatments like infliximab and adalimumab, it has been extensively demonstrated that low drug levels and ADA formation strongly correlate with a loss of clinical response in several pathologies like rheumatoid arthritis, spondyloarthritis, Crohn´s disease and psoriasis. It has also been described that patients not responding to etanercept obtain lower etanercept concentrations compared with responding patients.

Promonitor®-anti-ETN is a bridging ELISA to test up to 40 patients. The microwell strips are provided pre-coated with ETN. The bridging ELISA takes advantage of the two arms of IgG subclasses 1, 2 and 3, to crosslink the ETN coated on the plate. Calibrators, controls and diluted patient samples are added to separate wells, allowing anti-ETN antibodies present to bind to pre-immobilized ETN. Unbound sample is washed away, and HRP-labeled ETN is added to each well. A second incubation step allows the HRP-labeled ETN 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-ETN antibodies in the patient sample. 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.