Abstract: A diagnostic test kit for detecting the presence or absence of nitrites within a test sample is provided. The test kit comprises an aromatic primary amine that is capable of reacting with a nitrite to form a diazonium ion. The test kit also comprises a lateral flow device that comprises a chromatographic medium and an absorbent material that receives the test sample after flowing through the chromatographic medium. The chromatographic medium defines a detection zone within which is contained a detection reagent (e.g., nucleophilic aromatic amine) that is capable of reacting with the diazonium ion to form an indicator (e.g., azo compound). The indicator exhibits a color that is different than the color of the detection reagent.

Abstract: A diagnostic test kit that employs a lateral flow assay device and a plurality of assay reagents for detecting a test analyte within a test sample is disclosed. The assay reagents include detection probes that are capable of producing a detection signal representing the presence or quantity of the test analyte in the test sample. To further enhance detection accuracy, calibration probes are also used that are capable of producing a calibration signal representing the presence or quantity of a calibration analyte. The calibration signal may be utilized to calibrate the detection signal.

Abstract: A diagnostic test system for detecting the presence or absence of an analyte within a test sample is provided. For instance, the system may include a swab and a detection unit. The detection unit includes a first component that is capable of receiving the swab, the first component defining an insertion chamber within which a fluid is capable of being retained. The detection unit also includes a second component that defines a detection chamber within which an assay for detecting the presence or absence of the analyte is capable of being contained. The first component is rotatable relative to the second component from an inactive position to an active position. In the inactive position, the fluid remains substantially contained within the insertion chamber. In the active position, the fluid may flow from the insertion chamber to the detection chamber and contact the assay.

Abstract: A diagnostic test system for detecting the presence or absence of an analyte within a test sample is provided. For instance, the system may include a swab and a detection unit. The detection unit includes a first component that is capable of receiving the swab, the first component defining an insertion chamber within which a fluid is capable of being retained. The detection unit also includes a second component that defines a detection chamber within which an assay for detecting the presence or absence of the analyte is capable of being contained. The first component is rotatable relative to the second component from an inactive position to an active position. In the inactive position, the fluid remains substantially contained within the insertion chamber. In the active position, the fluid may flow from the insertion chamber to the detection chamber and contact the assay.

Abstract: A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a self-calibrated magnetic binding assay format (e.g., sandwich, competitive, etc.) that includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating a calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional (e.g., directly or inversely) to the intensity of the detection signal calibrated by the intensity of the calibration signal. It has been discovered that the fluidics-based device of the present invention provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.

Abstract: A diagnostic test unit is provided. The test unit comprises a stem having a first end and a second end, the stem defining at least one flow channel extending between the first end and the second end. A swab is disposed at the first end of the stem, the swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte. The test unit also comprises a fluid chamber configured to contain a fluid, wherein the fluid chamber is in fluid communication with the swab via the flow channel. The test unit also comprises a rupturable seal that inhibits leakage of the fluid from the fluid chamber prior to use, and an assay for detecting the presence or absence of the analyte. The assay is in fluid communication with the swab, the flow channel, and the fluid chamber.

Abstract: A diagnostic test kit for detecting the presence or quantity of an enzyme or enzyme inhibitor is provided. The diagnostic kit utilizes reactive complexes to facilitate the detection of the enzyme or enzyme inhibitor. The reactive complexes include a substrate joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter and magnetic substance. In one embodiment, for example, a peptide, protein, or glycoprotein substrate is joined to a reporter (e.g., dyed latex particle) and magnetic particle. In this embodiment, the substrate provides a cleavage target for a proteolytic enzyme. Specifically, upon contacting the reactive complexes, the proteolytic enzyme cleaves the substrate and releases the reporter and/or magnetic particle. The signal exhibited by the released reporters may then be used to indicate the presence or quantity of an enzyme or enzyme inhibitor within the test sample.

Abstract: A device for capturing a substance, the device including a generally tubular body including a generally tubular inner surface defined by a first layer, the inner surface defining a pocket therewithin, the pocket having a distal end and a proximal end, the distal end being generally closed and the proximal end being generally open, the proximal end being configured to allow the insertion of a finger into the pocket through the proximal end, and a generally tubular outer surface generally disposed radially outwardly from the inner surface, wherein a portion of the outer surface is adapted to capture the substance.