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.