Abstract: The present disclosure relates to methods for predicting time-to-delivery in pregnant women. The methods include predicting that a pregnant woman will deliver within a predetermined time frame if PAMG-1 is determined to be present at a level above a predetermined detection threshold in a vaginal fluid sample obtained from the pregnant woman. Also provided are methods for determining a patient's risk of preterm labor and/or spontaneous rupture of the chorioamniotic membrane.

Abstract: A method for pretreatment of a sample of whole blood in a discrete fluid analyzing instrument comprises automated means for handling and analyzing the sample and means for performing a pretreatment step on the sample or a sub-sample of the sample. The means for pretreatment are used for immobilizing at least one substance or analyte from the sample or sub-sample wherein the substance or analyte is reversibly immobilized. Usually, the apparatus further comprises means for eluting the substance or analyte from the capture means prior to analysis.

Abstract: The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.

Abstract: We describe assay modules (e.g., assay plates, cartridges, multi-well assay plates, reaction vessels, etc.), processes for their preparation, and method of their use for conducting assays. Reagents may be present in free form or supported on solid phases including the surfaces of compartments (e.g., chambers, channels, flow cells, wells, etc.) in the assay modules or the surface of colloids, beads, or other particulate supports. In particular, dry reagents can be incorporated into the compartments of these assay modules and reconstituted prior to their use in accordance with the assay methods. A desiccant material may be used to maintain and stabilize these reagents in a dry state.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, to provide flow control information, to function as an internal control and/or to provide internal calibration information for the test device. The present invention also relates to methods for using the lateral flow devices to provide flow control information, to function as an internal control and/or to provide internal calibration information for the test device.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: The present invention relates to a method for detection of binding or interaction events between a binding agent and its corresponding analyte (such as an antibody and an antigen) in which a signal is detected which is substantially more amplified and thus easier to detect than in prior art systems. The method comprises simultaneous but separate addition of a first enhancement reagent having affinity for said analyte and a second enhancement reagent having affinity for the first enhancement reagent wherein the first enhancement reagent binds to the analyte and the second enhancement reagent binds to the first enhancement reagent, and, wherein the first and second enhancement reagents have more than one binding site so that they are able to bind to each other to thereby amplify a detectable signal from the binding event.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: This invention relates to a system and methods including their manufacturing technologies for enhanced sensing capability of one or more bioagents covering from HIV, Pathogens, virus, to cells detection. More particularly, this invention is related to HIV and pathogen diagnosis system and methods which may increase its sensitivity and may reduce the diagnosis time. Furthermore, the diagnosis system and method may be applicable to all early stage patients with various age groups, where early and accuracy in diagnosis, are required.

Abstract: A system and method for monitoring viscosity changes of a fluid stored in a volume are provided. The system includes a flexible chamber configured to receive and hold the fluid, a motion generator configured to induce a wave motion within the fluid, at least one sensor affixed at least in part to a portion of the flexible chamber and configured to measure at least a strain on a portion of the flexible chamber and generate an associated strain output. The strain output is effectuated by the wave motion of the fluid within the flexible chamber and correlates to a viscosity value of the fluid. A computer or controller is configured to receive the strain output from the sensor at a given time, compare the viscosity value associated with the strain output to a reference viscosity value, and determine whether to adjust the wave motion generated by the motion generator.

Abstract: Compositions, methods, and devices for the detection of multiple analytes with a single signal are provided.

Abstract: Disclosed are nanostructured gold films which may be produced by solution-phase depositions of gold ions onto a variety of surfaces. The resulting plasmonic gold films are used for enhanced spectroscopic-based immunoassays in multiplexed microarray format with detection mechanisms based on either surface-enhanced Raman scattering or near-infrared fluorescence enhancement. The preparation of the films and subsequent modifications of the gold film surfaces afford increased sensitivity for various microarrays. The films are discontinuous, forming gold “islands.” Sensitivity, size, shape, and density of the nanoscopic gold islands comprising the discontinuous nanostructured gold film are controlled to enhance the intensity of Raman scattering and fluorescence in the near-infrared, allowing for improved measurements in clinical diagnostic or biomedical research applications.

Abstract: Devices and methods for the detection of antigens are disclosed. Devices and methods for detecting food-borne pathogens are disclosed.

Abstract: Devices and methods incorporate mucolytic agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters one or more lysis agents and/or mucolytic agents. The mucolytic agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the mucolytic agent is localized between the sample application zone and the conjugate zone. In embodiments with a sample compressor, one or more mucolytic agents may be pre-loaded and dried on the sample compressor, the sample collector, in various locations on the test strip, or in the running buffer.

Abstract: Sandwich separation is based on forming a sandwich complex with a magnetic bead, buoyant bead, and a target. Once a sandwich formation is created, the sandwich can be separated using its dual physical properties, namely magnetism and buoyancy. Sandwich separation is highly specific, allows for removal of the beads that do not have any attached target, and reduces the number of background beads. Sandwich separation can also be used to allow for target detection in raw specimen. Also, improvement of detection capability is accomplished by performing AMBR measurements on a solid interface, where the rotational period speeds up and allows for dramatically reduced time-to-result.

Abstract: The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.

Abstract: Devices and methods incorporate mucolytic agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters one or more lysis agents and/or mucolytic agents. The mucolytic agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the mucolytic agent is localized between the sample application zone and the conjugate zone. In embodiments with a sample compressor, one or more mucolytic agents may be pre-loaded and dried on the sample compressor, the sample collector, in various locations on the test strip, or in the running buffer.

Abstract: A label-free method for the spatio-temporal mapping of protein secretions from individual cells in real time by using a chip for localized surface plasmon resonance (LSPR) imaging. The chip is a glass coverslip compatible for use in a standard microscope having at least one array of functionalized plasmonic nanostructures patterned onto it. After placing a cell on the chip, the secretions from the cell are spatially and temporally mapped using LSPR imaging. Transmitted light imaging and/or fluorescence imaging may be done simultaneously with the LSPR imaging.

Abstract: A rapid diagnostic test device uses driven flow technology to significantly expedite the testing time of a sample. The rapid diagnostic test device can be used to analyze liquids, such as some body fluids, by using labeled molecular affinity binding, such as immunochromatography. The test device can detect an analyte, such as an antibody or antigen, which may indicate a particular condition, the presence of a particular drug, or the like. The device includes an inner member that receives the body fluid. Dripping holes in the inner member, or a sloped surface, creates a stream force of the body fluid against the sample pad of the test strip. A portion of the stream force of the body fluid is directed upward toward the conjugate pad to push the antibody/body fluid sample onto the membrane of the test strip.

Abstract: A bio-related substance assay tube 2 comprises a target substance capture bead 3 serving as a first microparticle, compensation bead 4 serving as a second microparticle on which a given amount of a bio-related substance has been immobilized, and a negative control bead 5 serving as a third microparticle for use as a negative control. A mount unit 12 comprises a nozzle communicating with a pump, and the bio-related substance assay tube 2 is mounted in the mount unit 12 to ensure communication with this nozzle. An analyte is introduced into the bio-related substance assay tube 2, followed by labeling the bio-related substance bound to each microparticle to cause light emission. Based on light emission from each microparticle, a calibration curve is prepared or the emission intensity of the first microparticle is compensated to quantify the bio-related substance.