Abstract: Devices for detection of analytes in samples of various complexities are provided. The devices allow reflux of liquid into a sample-receiving member, providing for suitable analyte dilution and preventing leakage of cells or particulate material into the signal generation member. In one aspect, the devices are used to test analytes in biological samples such as blood, serum, plasma or other body fluids. In another aspect, the devices are used to test samples from tissues, such as organ tissues, tumor samples, or other body parts. In a further aspect, the devices are used to test microbial samples, food samples, or any other sample from which the analyte of interest can be captured into the reflux device.

Abstract: Methods to estimate safety and/or efficacy of therapeutic drugs, which include portable devices for anti-drug antibody (ADA) testing and databases containing anonymized data from humans and/or animal models, and related analyses, are provided. These methods and compositions can be used in various applications, including but not restricted to the following: uniform testing of patients for ADA; selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; scientific guidance for discovering and/or developing therapeutic drugs; postmarketing surveillance of therapeutic drugs.

Abstract: Portable devices for anti-drug antibodies (ADAs) testing are provided. These devices can be used in various applications, including but not restricted to the following: uniform testing of patients for ADAs; selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; scientific guidance for discovering therapeutic drugs; therapeutic drug development; postmarketing surveillance of therapeutic drugs.

Abstract: Portable devices for anti-drug antibody (ADA) testing, to estimate safety and/or efficacy of therapeutic agents are provided. These devices can be used to perform point of care risk assessment for various applications, including but not restricted to one or more of the following: selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; patient immune status prior and after vaccination; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; testing pre-existing antibodies as a risk factor; postmarketing surveillance of therapeutic drugs.

Abstract: Devices for detection of antibodies against therapeutic drugs (ADAs), in which chimeric proteins facilitate immobilization and exposure of target epitopes, are described. Results can be obtained in minutes, enabling point of care testing and/or patient self-testing, and risk assessment. The data can also be used for deriving scientific knowledge in the fields of oncology, autoimmune diseases (including but not restricted to diabetes, multiple sclerosis and rheumatoid arthritis), cardiovascular diseases, rare diseases, and other diseases for which treatment comprises administration of a therapeutic drug and/or gene therapy.

Abstract: Portable devices for anti-drug antibodies (ADAs) testing are provided. These devices can be used in various applications, including but not restricted to the following: uniform testing of patients for ADAs; selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; scientific guidance for discovering therapeutic drugs; therapeutic drug development; postmarketing surveillance of therapeutic drugs.

Abstract: Methods to estimate safety and/or efficacy of therapeutic drugs, which include portable devices for anti-drug antibody (ADA) testing and databases containing anonymized data from human and/or animal models and related analyses, are provided. These methods and compositions can be used in various applications, including but not restricted to the following: uniform testing of patients for ADA; selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; scientific guidance for discovering and/or developing therapeutic drugs; postmarketing surveillance of therapeutic drugs.