Abstract: A laminated test strip device for detecting the presence of a plurality of target analytes in a biological sample is disclosed. The laminated test strip device is formed of a plurality of laminated layers of material that control sample flow and sample metering. Methods of producing and using the laminated test strip device are also disclosed.

Abstract: Devices, assemblies, and kits are disclosed for separating and/or metering a plasma sample from a patient's liquid test sample. Also disclosed are methods of producing and using same.

Abstract: Disclosed herein are methods for rapid detection of suspension of a blood sample from a subject and methods for improving the processing time of a point of care blood analysis. Specifically, the disclosed methods provide a rapid detection of hemoglobin concentration, more specifically glycated hemoglobin A1c, and determination of sugar concentration in the blood sample from the subject. Further disclosed herein are methods for rapidly diagnosing diabetes in a subject.

Abstract: A tangent flow hemolysis blood testing assembly, device and method are described herein.

Abstract: Analytical assay reaction cartridges are disclosed that include a reagent tray containing a liquid reagent disposed therein and a flexible cover removably attached thereto. The flexible cover has a portion that extends beyond the reagent tray and that forms a tab portion extends through an opening in a lid member of the cartridge in order to facilitate removal of at least a portion of the cover and release of the liquid reagent. Also disclosed are analytical assay reaction kits that include the cartridges and diagnostic instruments for use with the analytical assay reaction cartridges/kits, as well as methods of making and using the cartridges/kits.

Abstract: A tangent flow hemolysis blood testing assembly, device and method are described herein. The presently disclosed and claimed inventive concept(s) relate to a device(s), kit(s), and method(s) for injecting a patient's liquid test sample into a reaction vessel. More specifically, the presently disclosed and claimed inventive concept(s) relate to an improved liquid test sample injection device that comprises a plug that forms an airtight seal that facilitates the active injection of a liquid test sample into a reaction vessel, and kits and methods of use related thereto.

Abstract: An assay cartridge enabling improved measurement sensitivity of a target component (Troponin I or T) in the presence of high amount of albumin in a test sample. The assay cartridge includes a cartridge body including a sample inlet adapted to receive a patient sample and a reaction chamber coupled to the sample inlet, magnetic particles contained in the reaction chamber comprising a first antibody with a specific affinity towards the target component, electrodes provided at a location configured to be in contact with a rehydrated test sample containing the magnetic particles in the reaction chamber, and a sensor surface of the reaction chamber comprising a second antibody with a specific affinity towards the target component. Methods of quantifying a target component (e.g., a Troponin component) in immunoassay testing are provided, as are assay devices adapted to quantify a target component (e.g., Troponin I or T).

Abstract: Devices and methods for the hook effect detection associated with analytes of interest in the conductance of one or more diagnostic assays, including, without limitation, immunoassays.

Abstract: Lateral flow assay devices and kits for use in the detection of creatinine and in the detection of hemolysis in a biological fluid sample are disclosed. Methods of making and using the lateral flow assay devices and kits are also disclosed.

Abstract: Microfluidic devices, method for making and using same are disclosed. The microfluidic device can be made by applying a reagent in liquid form into a sample treatment site within a substrate base. The substrate base has hydrophilic properties bordering a flow channel, and has an application site, the sample treatment site and an analytical site. The flow channel is sized and configured so as to draw a sample applied into the application site to the analytical site through the sample treatment site by capillary action. The reagent is freeze-dried within the sample treatment site.

Abstract: Devices and methods for the hook effect detection associated with analytes of interest in the conductance of one or more diagnostic assays, including, without limitation, immunoassays.

Abstract: 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.

Abstract: Analytical assay reaction cartridges, kits containing same, and methods of production and use thereof are disclosed. These cartridges include a magnetic assembly that surrounds at least a portion of a sample read window on the cartridge. The cartridge also includes an analytical reagent positioned therewithin, wherein the analytical reagent comprises magnetic beads coated with at least one anti-red blood cell antibody.

Abstract: Devices, kits, and methods related to embodiments of an improved liquid test sample injection device comprising a sample mixture that comprises at least one sample flag compound for detecting the presence or non-presence of a patient's liquid test sample upon being interrogated by a pre-determined wavelength of light.

Abstract: A microfluidic device has a first substrate, a resilient diaphragm, an actuator, and a second substrate. The first substrate has an opening extending therethrough. The resilient diaphragm is secured to a second side and surrounds the opening. The actuator is secured to a first side and surrounds the opening. The first substrate, the resilient diaphragm, and the actuator cooperate to form a gas-tight chamber. The second substrate has a channel formed therein having a first end and a second end. The second substrate is secured to the first substrate. A volume of gas disposed in the gas-tight chamber pressurizes the gas-tight chamber and expands the resilient diaphragm such that the resilient diaphragm is disposed in the channel between the first end and the second end. The resilient diaphragm retracts from the channel to open the channel from the first end and the second when the gas-tight chamber is depressurized.

Abstract: Devices, kits, and methods separating and metering a plasma sample from a patient's liquid test sample.

Abstract: A microfluidic device has a first substrate, a resilient diaphragm, an actuator, and a second substrate. The first substrate has an opening extending therethrough. The resilient diaphragm is secured to a second side and surrounds the opening. The actuator is secured to a first side and surrounds the opening. The first substrate, the resilient diaphragm, and the actuator cooperate to form a gas-tight chamber. The second substrate has a channel formed therein having a first end and a second end. The second substrate is secured to the first substrate. A volume of gas disposed in the gas-tight chamber pressurizes the gas-tight chamber and expands the resilient diaphragm such that the resilient diaphragm is disposed in the channel between the first end and the second end. The resilient diaphragm retracts from the channel to open the channel from the first end and the second when the gas-tight chamber is depressurized.

Abstract: A reagent strip is described. The reagent strip includes a substrate and at least one reagent pad positioned on the substrate. The substrate has a storage unit storing an authentication code. The authentication code has a lot value and a secondary value related to the lot value by a predetermined function assigned to the lot value.

Abstract: Devices, assemblies, and kits are disclosed for separating and/or metering a plasma sample from a patient's liquid test sample. Also disclosed are methods of producing and using same.

Abstract: Analytical assay reaction cartridges are disclosed that include a reagent tray containing a liquid reagent disposed therein and a flexible cover removably attached thereto. The flexible cover has a portion that extends beyond the reagent tray and that forms a tab portion extends through an opening in a lid member of the cartridge in order to facilitate removal of at least a portion of the cover and release of the liquid reagent. Also disclosed are analytical assay reaction kits that include the cartridges and diagnostic instruments for use with the analytical assay reaction cartridges/kits, as well as methods of making and using the cartridges/kits.