Abstract: Assay modules, preferably assay cartridges, are described as are reader apparatuses which may be used to control aspects of module operation. The modules preferably comprise a detection chamber with integrated electrodes that may be used for carrying out electrode induced luminescence measurements. Methods are described for immobilizing assay reagents in a controlled fashion on these electrodes and other surfaces. Assay modules and cartridges are also described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones and the like. In certain preferred embodiments, these modules are adapted to receive and analyze a sample collected on an applicator stick.

Abstract: The present invention relates to a microfluidic based assay system, comprising a disposable assay cartridge and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using the cartridge and device of the invention, as well as kits for conducting assays.

Abstract: The present invention relates to a device and method for determining the presence of a specific compound in solution. The device includes a nanosensor having an electrically conducting pathway between at least a first and second contact. The device also includes a first receptor, suitable for binding a specific compound in the solution, attached to the nanosensor, and a second receptor also suitable for binding the specific compound while the specific compound is bound to the first receptor. The second receptor is attached to an enzyme added to the solution. When the solution having the second receptor is added to the device, and a second compound that is a substrate for the enzyme is subsequently added to the solution, a measured difference in an electrical property in the device before and after the application of the second compound is indicative of the presence of the specific compound in the solution.

Abstract: Provided is an analysis method in which increase in a background can be prevented in a simple manner without cost. The analysis method of the present invention is carried out using a sample analysis tool 10 including a development member 11 in which a developing solution supply portion 12, a sample supply portion 13, and a detection portion 14 in which a substance 17 that specifically binds to an analyte 16 in a sample is immobilized are provided in this order from upstream to downstream along the flow of a developing solution. A sample solution is supplied to the sample supply portion 13, and a developing solution is supplied to the developing solution supply portion 12 simultaneously with the supply of the sample solution or prior to the supply of the sample solution. By the development of the developing solution in the development member 11 in the presence of a labeled specifically binding substance 15, the sample solution is introduced to the detection portion 14.

Abstract: The invention is to devices and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature for forming a diluted sample for analysis. The devices and methods also include a dilution verification feature for verifying the degree of dilution of the diluted sample. The devices preferably are capable of being used in the point-of-care diagnostic field is provided.

Abstract: The present application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

Abstract: The present invention relates to a modular chemiresistive sensor. In particular, a modular chemiresistive sensor for hypergolic fuel and oxidizer leak detection, carbon dioxide monitoring and detection of disease biomarkers. The sensor preferably has two gold or platinum electrodes mounted on a silicon substrate where the electrodes are connected to a power source and are separated by a gap of 0.5 to 4.0 ?M. A polymer nanowire or carbon nanotube spans the gap between the electrodes and connects the electrodes electrically. The electrodes are further connected to a circuit board having a processor and data storage, where the processor can measure current and voltage values between the electrodes and compare the current and voltage values with current and voltage values stored in the data storage and assigned to particular concentrations of a pre-determined substance such as those listed above or a variety of other substances.

Abstract: A nanocomposite structure includes: a) a charged fibrous substrate including fibers having disposed on their surfaces a multilayer structure including a layer of a first polyelectrolyte and disposed thereon a layer of a second polyelectrolyte of opposite charge from the first, the second polyelectrolyte forming the outermost layer of the charged fibrous substrate; and b) charged nanorods having a charge opposite that of the charged fibrous substrate, including gold nanorods each having disposed on its surface one or more layers, the outermost of which is a third polyelectrolyte having a charge opposite that of the second polyelectrolyte, wherein the first and third polyelectrolytes may be the same or different; wherein the charged nanorods are disposed unaligned with respect to each other on the charged fibrous substrate.

Abstract: Methods are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.

Abstract: Devices for separating magnetically labeled moieties in a sample are provided. Aspects of the devices include a magnetic field source, a first magnetic field guide having a wedge-shaped portion with an apex edge, and a second magnetic field guide having a wedge-shaped portion with an apex edge. The apex edge of the first magnetic field guide is aligned substantially across from and parallel to the apex edge of the second magnetic field guide, and the device is configured to separate magnetically labeled moieties from non-magnetically labeled moieties in the sample. Also provided are methods of using the devices, as well as systems and kits configured for use with the devices and methods.

Abstract: Test devices are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.

Abstract: Accordingly, in some embodiments methods for detecting an analyte or analytes in one or more sample(s) are provided. The methods encompass providing a solid support with an addressable marker and an associated ligand, contacting the solid substrate to a sample, thereby forming a contacted solid support, associating the contacted solid support with a FET array and detecting the electrical properties of the FET array and thereby detecting an analyte or analytes in one or more samples. In other embodiments, the sample encompasses a second addressable marker.

Abstract: A system for determining usability of an analytical test strip includes a sample chamber to receive a fluid sample, a reagent in the sample chamber having a moisture-varying impedance, and two detection electrodes contacting the reagent. A test meter applies an AC waveform across the reagent via the detection electrodes while measuring an impedance of the reagent. A processor automatically determines whether the measured impedance of the reagent meets a dryness criterion. The meter includes a housing, a strip port connector, an impedance measurement circuit and the processor. A method for determining usability of a strip inserted in a hand held meter includes applying an AC waveform across a reagent of the strip and measuring a first electrical signal, and determining whether the strip meets the dryness criterion based on the first electrical signal. The test strip and ways of determining an analyte are also described.

Abstract: Lysing may include agitating a specimen in a chamber along with a medium that includes a particulate lysing material that has an affinity for a biological material. Lysing material may include beads or other material which may be coated that facilitates binding. The medium may include a fluid with a high salt or low pH level. The biological material may be eluted by lowering a concentration of salt or increasing a pH level. Lysing materials with two or more different affinities may be employed. Heating may be used. Lysing may be performed in a flow through apparatus.

Abstract: Provided herein are systems and methods for performing complex chemical, physical and biological assays. In particular, provided herein are systems and methods for performing microfluidic assays.

Abstract: The invention relates to a method for determining the presence of an analyte by means of a distribution of small magnetic particles. According to said method, the magnetizations of the small particles are oriented in relation to each other by means of an outer magnetic focusing field; once the focussing field has been terminated, the magnetizations of the small particles are rotated asynchronously to the magnetic field by means of an outer magnetic field of suitable field intensity and rotational frequency, which rotates about a longitudinal axis (z); the temporal course of the superpositioned transverse magnetization of the set of particles is detected; and the presence of the analyte is deduced from the detected temporal course. The invention also relates to a corresponding device (1).

Abstract: A system for providing pregnancy testing in conjunction with disease risk testing, comprising a testing device having an alignment target and having a plurality of immunoassay test strips, the plurality of immunoassay test strips each including a sample pad, a conjugate pad containing particles for conjugating with antibodies or antigens present in the biologic sample, and a membrane strip having a test line and a control line, wherein the test line and the control line are viewable, and a mobile device having a camera, a viewing screen, and a software application stored thereon, wherein the software application provides executable instructions to determine a risk value for each of at least one disease risk tested using the biologic sample, assess the risk value for each of the at least one disease risk tested, and present, if immediate medical action is required, a medical action indicator on the viewing screen.

Abstract: A system for providing immunoassay test results for multiple medical conditions, comprising a testing device having thereon an alignment target and having a plurality of immunoassay test strips, the plurality of immunoassay test strips each including a sample pad capable of receiving a biologic sample, a conjugate pad containing particles for conjugating with antibodies or antigens present in the biologic sample, and a membrane strip having a test line and a control line, wherein the test line and the control line are viewable, and a mobile device having a camera, a viewing screen, and a software application stored thereon, wherein the software application provides executable instructions to capture an image of the testing device, process an image to determine pixel count and line intensity of the test line of each of the plurality of immunoassay test strips, and present test results on the viewing screen.

Abstract: The invention is to devices and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature for forming a diluted sample for analysis. The devices and methods also include a dilution verification feature for verifying the degree of dilution of the diluted sample. The devices preferably are capable of being used in the point-of-care diagnostic field is provided.

Abstract: The present disclosure provides apparatuses and methods for analyzing the presence of a target analyte. The apparatuses and methods of the present disclosure can be operated in a multiplexed format to perform various assays of clinical significance.