Assays and methods for verifying the validity of a urine sample submitted for Drugs of Abuse (DOA) testing. Embodiments include a SUD Diagnostic Panel that includes six assays: specific gravity index assay, long-duration counterfeit urine assay, short-duration counterfeit urine assay, oxidant history assay, pH assay, and creatinine assay. The SUD Diagnostic Panel detects twelve principle classes of adulteration. Detection of adulteration of one or more urine samples from a patient indicates an attempt to subvert test results and provides an objective indication in one instance and an object diagnosis in another instance of SUD.

The present disclosure relates to a device for detection of gaseous amines, originating from disease in the human urogenital system. The device comprising an inner surface 1 for facing the user and outer surface 3 for facing away from the user, wherein said device comprises a removable indicator 5 of gaseous amines. The removable indicator 5 is configured to be arranged in an indicator pocket 6. The device is made of a flexible material of a shape adapted to cover orifices of the human urogenital system but not the anus.

A microfluidic device comprises electrically conductive lower portions, transparent to an incident optical beam; first upper portions electrically conductive and configured to receive an electrical signal; shielding portions opaque to the incident optical beam and arranged between the first upper portions and the lower portions, the shielding portions having one or more through openings; one or more compartments containing a filler means and markers dispersed in filler means. Each compartment comprises at least one lower chamber and at least one upper chamber in fluid communication with each other via said one or more through openings. Each lower chamber extends between a respective through opening and the lower portions and each upper chamber extends between at least one respective through opening and the first upper portions. The markers are electrically charged and are configured to move between an upper chamber and one or more lower chambers in variable amounts according to the intensity of the electric signal applied to one or more upper portions and to emit an optical emission beam when illuminated in the lower chamber by the incident optical beam.

Devices and methods for calculating various coagulation characteristics associated with a patients liquid test sample. The presently disclosed and claimed inventive concept(s) relate to an improved device(s) and method(s) for conducting coagulation assays on a patients liquid test sample, including, without limitation, a patients whole blood sample.

A cartridge for sample preparation includes an inlet configured to receive a collected sample, a phase transfer assembly including a plurality of bead layers, and an outlet. The collected sample is configured to be transferred through the bead layers of the phase transfer assembly to extract a compound therefrom. The outlet is configured to transfer the extracted compound to a detector for analysis of the extracted compound.

Provided herein are systems and methods of assessing a concentration of iron in a body fluid sample, such as whole blood. Systems include a highly stable, fast reacting, and accurate sensing area of a sensor for contacting with a body fluid sample, wherein upon contact, the body fluid sample causes a color change to the sensor that correlates with the concentration of iron in the body fluid sample. The disclosed systems and methods generate one or more signal outputs of light intensity data, from which the concentration of iron in the body fluid sample is determined.

A heating device for testing a biological sample is disclosed. The heating device can include a heat source operable to generate heat. In addition, the heating device can include a controller in communication with the heat source and operable to control heat generation by the heat source to heat a biological sample at less than or equal to about 2 degrees C./s. Furthermore, a heating device for testing a biological sample is disclosed that can include a heat source operable to generate heat to heat a biological sample. The biological sample can be at least partially contained within a removable enclosure distinct from the heating device. Additionally, the heating device can include an enclosure interface associated with the heat source. The enclosure interface can be configured to interface with the enclosure such that heat is transferred from the heat source to the enclosure by conduction.

A multiplexed vertical flow serodiagnostic testing device for diseases such as Lyme disease includes one or more multi-piece cassettes that include vertical stacks of functionalized porous layers therein. A bottom piece of the cassette includes a sensing membrane with a plurality of spatially multiplexed immunoreaction spots or locations. Top pieces are used to deliver sample and/or buffer solutions along with antibody-conjugated nanoparticles for binding with the immunoreaction spots or locations. A colorimetric signal is generated by the nanoparticles captured on the sensing membrane containing disease-specific antigens. The sensing membrane is imaged by a cost-effective portable reader device. The images captured by the reader device are subject to image processing and analysis to generate positive (+) or negative (−) indication for the sample. A concentration of one or more biomarkers may also be generated. The testing device is rapid, simple, inexpensive, and allows for simultaneous measurement of multiple antibodies and/or antigens making it an ideal point-of-care platform for disease diagnosis.

Described systems and methods allow the detection and quantitative estimation of changes in the properties of a liquid sample comprising living biological cells, the changes caused by exposure to a target analyte such as a toxin, drug, pesticide, etc. A variable stimulus such as an oscillating magnetic field is applied to the sample, inducing variations in a position or shape of a constituent of the sample. Such variations produce measurable variations in electric and/or optical properties of a sensor, variations which allow a precise quantification of changes due to exposure to the target analyte.

The present invention provides a biomaterial assay strip as a strip-type platform for use in a point-of-care test device. The strip includes a porous matrix bearing micropores and composed of materials comprising a copolymer selected from the group comprising polysulfone, polyethersulfone, and polyarylsulfone in order to increase separation efficiency of the blood cells contained in a sample and to improve accuracy and reproducibility of measurements with a small amount of blood, wherein the matrix comprises an enzyme, a dye, and a hydrophilic polymer material therein, which all respond to a biomaterial and wherein the matrix develops a color as the biomaterial contained in the sample which is brought into contact with the upper layer of the matrix and then diffuses to the lower layer of the matrix, thereby assaying the biomaterial.