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.

Quantitative measure of etanercept. Promonitor®-ETN is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of free etanercept (ETN) in human serum samples. The amount of ETN, when considered in conjunction with anti-ETN antibodies (Promonitor®-anti-ETN Ref. 5120230000) and clinical findings, like disease activity, can contribute valuable information to the physician to assess the efficacy of therapies with ETN. It has been described that patients not responding to etanercept obtain lower etanercept concentrations compared with responding patients. Promonitor®-ETN is a sandwich ELISA to test up to 40 patients. The microwell strips are provided pre-coated with an anti-ETN human F(ab´)2 fragment. Diluted calibrators, controls and diluted patient samples are added to separate wells, allowing ETN present to bind to pre-immobilized anti-ETN antibodies. Unbound sample is washed away, and a second HRP-labeled anti-ETN monoclonal antibody is added to each well. A second incubation step allows the HRP-labeled anti-ETN antibody to bind to the ETN that has become attached to the microwells. After washing away the excess of unbound HRP-labeled anti-ETN 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 ETN calibration curve. A four parameter logistic (4PL) model is used to fit the curve. Positive and Negative Controls are used to monitor assay performance. ETN concentration is calculated by interpolating sample OD in the calibration curve. Warnings for each sample are optionally included; this setting can be configured here.

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.

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.

Quantitative measure of infliximab. Promonitor®-IFX is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of infliximab (IFX, Remicade®) in human serum samples. The amount of IFX, when considered in conjunction with anti-IFX antibodies (Promonitor®-anti-IFX Ref. 5070230000) and clinical findings, like disease activity, contributes valuable information to the physician to assess the efficacy of therapies with IFX, predict infusion-related reactions and loss of clinical response by the patient. The correlation between reduced serum IFX concentrations, anti-IFX antibody formation, and increased disease activity has been demonstrated in several clinical studies in a series of pathologies. Promonitor®-IFX is a capture ELISA where microwell strips are provided pre-coated with an anti-TNFa human F(ab´)₂ fragment bound to human recombinant TNFa. Diluted calibrators, controls and diluted patient samples are added to separate wells, allowing IFX present to bind to pre-immobilized TNFa. Unbound sample is washed away, and the specific HRP-labeled anti-IFX monoclonal antibody is added to each well. A second incubation step allows the anti-IFX antibody to bind to the IFX that has become attached to the microwells. After washing away the excess of unbound HRP-labeled anti-IFX 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 IFX in the patient sample. Optical densities (OD) of the calibrators are plotted to construct the IFX calibration curve. A four parameter logistic (4PL) model is used to fit the curve. Positive and Negative Controls are used to monitor assay performance. IFX concentration is calculated by interpolating sample OD in the calibration curve. Therapeutical interpretation of IFX results in a clinical setting is provided. Warnings for each sample are optionally included; this setting can be configured here.

Quantitative measure of anti-infliximab antibodies. Promonitor®-anti-IFX is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of anti-infliximab antibodies in human serum samples. The amount of anti-infliximab antibodies, when considered in conjunction with the infliximab (IFX, Remicade®) level (Promonitor®-IFX Ref. 5060230000) and clinical findings, like disease activity, contributes valuable information to the physician to assess the efficacy of therapies with IFX, predict infusion-related reactions and loss of clinical response by the patient. Due to its chimeric structure, IFX often raises an unwanted immune response in the treated patient, causing Anti-Drug Antibodies (ADA) to form. All Anti-IFX antibodies are neutralizing anti-idiotypic antibodies which can render the therapy completely useless. It is also known that the presence of high titers of anti-IFX antibodies may be related to severe complications like infusion-related reactions. The correlation between reduced serum IFX concentrations, ADA formation and increased disease activity has been demonstrated in several observational clinical studies in a series of pathologies. Promonitor®-anti-IFX is a bridging ELISA where microwell strips are provided pre-coated with IFX. The bridging ELISA takes advantage of the two arms of IgG subclasses 1, 2 and 3, to crosslink the IFX coated on the plate. Calibrators, controls and diluted patient samples are added to separate wells, allowing anti-IFX antibodies present to bind to pre-immobilized IFX. Unbound sample is washed away, and HRP-labeled IFX is added to each well. A second incubation allows the HRP-labeled IFX 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-IFX binding antibodies in the patient sample. Optical densities (OD) of the calibrators are plotted to construct the anti-IFX 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-IFX antibodies 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.

Quantitative measure of adalimumab. Promonitor®-ADL is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of adalimumab (ADL) in human serum samples. The amount of ADL, when considered in conjunction with anti-ADL antibodies (Promonitor®-anti-ADL Ref. 5090230000) and clinical findings, like disease activity, contributes valuable information to the physician to assess the efficacy of therapies with ADL and loss of clinical response by the patient. The correlation between reduced serum ADL concentrations, anti-IFX antibodies formation and increased disease activity has been demonstrated in several clinical studies in a series of pathologies. Promonitor®-ADL is a sandwich ELISA where microwell strips are provided pre-coated with an anti-ADL human F(ab´)₂ fragment. Diluted calibrators, controls and diluted patient samples are added to separate wells, allowing ADL present to bind to pre-immobilized anti-ADL antibodies. Unbound sample is washed away, and a second HRP-labeled anti-ADL monoclonal antibody is added to each well. A second incubation step allows the HRP-labeled anti-ADL antibody to bind to the ADL that has become attached to the microwells. After washing away the excess of unbound HRP-labeled anti-ADL 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 ADL calibration curve. A four parameter logistic (4PL) model is used to fit the curve. Positive and Negative Controls are used to monitor assay performance. ADL concentrations are calculated by interpolating sample OD in the calibration curve. Therapeutical interpretation of ADL results in a clinical setting is provided. Warnings for each sample are optionally included; this setting can be configured here.

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.

Quantitative measure of golimumab. Promonitor®-GLM is an enzyme-linked immunosorbent assay (ELISA) for the quantitative detection of golimumab (GLM) in human serum. It is used as an aid in monitoring patient´s clinical response to GLM therapy in conjunction with other clinical findings. The amount of GLM, anti-GLM antibodies (Promonitor®-ANTI-GLM Ref. 5210230000) 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 GLM. Promonitor®-GLM is a capture ELISA. The microwell strips are provided pre-coated with an anti-TNFa human monoclonal antibody bound to recombinant human TNFa. Pre-diluted Calibrators, Controls and diluted patient samples are added to separate wells, allowing GLM present to bind to pre-immobilized Anti-GLM antibodies. Unbound sample is washed away, and a second HRP-labeled anti-GLM monoclonal antibody is added to each well. A second incubation step allows the HRP-labeled anti-GLM antibody to bind to the GLM that has become attached to the microwells. After washing away the excess of unbound HRP-labeled anti-GLM 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 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. GLM concentration is calculated by interpolating sample OD in the calibration curve. Warnings for each sample are optionally included; this setting can be configured here.

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.