Abstract: Methods, compositions and kits for detecting the complement Factor B cleavage product Ba in a biological sample are described. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of or ruling out pre-eclampsia in a pregnant human subject.

Abstract: Devices for use in extracting an analyte of interest from a sample are described. In one embodiment, a device is comprised of a first plurality of chambers, where one or more chambers in the plurality of chambers has a deep end and a shallow end with a depth d1. A channel disposed between at least two adjacent chambers in the plurality of chambers has a depth greater than d1. The dimensions of the chamber and channel provide control of fluid movement in the device, particularly when introducing fluid into the device for its use and during use of the device.

Abstract: An analytical device for performing an assay to determine the presence or approximate quantity of at least one analyte in a liquid sample is described. The device is manufactured to include an integrated desiccant within at least a test strip of the device. Addition of an integrated desiccant within the device improves signal to noise ratio, eases the manufacturing process, and saves in cost of production of the device.

Abstract: A device for extraction or isolation of an analyte, such as a nucleic acid, a protein, or a cell, from a sample, and in particular from a biological sample, is described. Methods of using the device are also described. Further processes, such as amplification of the isolated analyte, may also be carried out within the device.

Abstract: A device for extraction or isolation of an analyte, such as a nucleic acid, a protein, or a cell, from a sample, and in particular from a biological sample is described. Methods of using the device are also described.

Abstract: An analytical device for performing an assay to determine the presence or approximate quantity of at least one analyte in a liquid sample is described. The device is manufactured to include an integrated desiccant within at least a test strip of the device. Addition of an integrated desiccant within the device improves signal to noise ratio, eases the manufacturing process, and saves in cost of production of the device.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: Methods, compositions and kits for detecting Group A streptococcus in a biological sample are described. More particularly, the present disclosure provides an immunoassay in which the specificity of detection of Group A streptococcus is enhanced by addition of N-acetyl-D-glucosamine. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of streptococcal infection in a human subject.

Abstract: Magnetic ink is used to mark defective parts or assemblies during manufacturing, thereby allowing the defective parts or assemblies to be detected in products following manufacturing, even if they are concealed or hidden in the final product. An example of such a defect-containing product is a laminated microfluidic device which contains a defective capillary.

Abstract: An analytical device for performing an assay to determine the presence or approximate quantity of at least one analyte in a liquid sample is described. The device is manufactured to include an integrated desiccant within at least a test strip of the device. Addition of an integrated desiccant within the device improves signal to noise ratio, eases the manufacturing process, and saves in cost of production of the device.

Abstract: A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: Provided herein are methods and devices for rapid testing of solid, semi-solid, or liquid specimens, such as stool, blood, urine, saliva, or swab specimens of the cervix, urethra, nostril, and throat, and for environmental testing.

Abstract: An apparatus for detection of an analyte of interest in a solid, semi-solid, or liquid biological sample, using a lateral flow assay test strip, is described. The apparatus minimizes sample handling and manipulation upon introduction of the sample into a sample-receiving chamber and transfer of the sample to a test chamber containing the assay strip.

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: The invention relates to devices for performing single step assays for the determination of the presence or absence of an analyte in a liquid sample, and methods of determining the presence or absence of such analytes using such devices. Devices disclosed comprise a labeled analyte-binding reagent reversibly-immobilized on a non-porous solid material, which solid material is in physical contact with a dry porous carrier bearing an immobilized analyte-binding reagent. Also provided are quantitative assay devices.

Abstract: The invention relates to devices for performing single step assays for the determination of the presence or absence of an analyte in a liquid sample, and methods of determining the presence or absence of such analytes using such devices. Devices disclosed comprise a labeled analyte-binding reagent reversibly-immobilized on a non-porous solid material, which solid material is in physical contact with a dry porous carrier bearing an immobilized analyte-binding reagent. Also provided are quantitative assay devices.