Abstract: Described herein is a fluid collection unit comprising: a receptacle for passively collecting a fluid sample; and a fluid flow path in fluid communication with the receptacle, the fluid flow path passing through the unit for directing the fluid sample from the receptacle to an opposing end of the unit.

Abstract: Described herein is a device for collecting plasma from a blood sample, the device comprising a body defining a flow channel extending between a proximal and a distal end, the flow channel comprising: a membrane region for supporting a separation membrane that filters red blood cells from the plasma; a plasma collection region for supporting an absorbent membrane that collects the plasma; and a chamber for separating the membrane region from the plasma collection region.

Abstract: Described herein is a fluid collection unit comprising: a receptacle for passively collecting a fluid sample; and a fluid flow path in fluid communication with the receptacle, the fluid flow path passing through the unit for directing the fluid sample from the receptacle to an opposing end of the unit.

Abstract: A hinged cap for engaging a housing of a diagnostic device comprises a central body; two arms extending from opposing sides of one end of said central body, said arms being substantially parallel; each of said arms comprising a cap hinge member for engaging a housing hinge member on said housing, wherein said cap hinge member and said housing hinge member define a hinge axis around which said cap is pivotable between an open and a closed position with respect to said housing.

Abstract: A solid support for detecting the presence of an analyte in a sample at or above a predetermined threshold comprises: a competitive analyte within said solid support, wherein said competitive analyte is coupled to a first member of a binding pair; a labelled conjugate within said solid support, downstream of said competitive analyte, wherein said analyte and said competitive analyte compete for binding to said conjugate; and a capture reagent immobilized within said solid support, downstream of said conjugate, wherein said capture reagent comprises a second member of the binding pair; wherein the affinity of the first and second members of the binding pair for one another and the distance between the conjugate and the capture reagent and/or the conjugate and the competitive analyte within the solid support are selected so as to increase the threshold of the solid support for the analyte.

Abstract: The present invention relates to analytical methods, platforms, and devices for the rapid and efficient immunochromatic determination of one or more components in fluid samples.

Abstract: The invention is directed to a novel enzymatic analytical membrane, a lateral flow enzymatic detection method, and analytical device incorporating same. The invention is useful for rapidly enzymatically determining the presence of one or more analytes in small volumes of sample. The invention provides an enzymatic analytical membrane for detecting the presence of one or more small-molecule analytes in a biological sample where the membrane comprises a receiving zone; a separation zone and a signal zone, at least one of the zones comprising one or more enzymes for converting the analytes into a form detectable by reaction with a chromogenic agent present in the signal zone and wherein the membrane horizontally receives sample at the receiving zone, and the sample continues via lateral flow through the receiving zone, separation zone and signal zone where a visible color change is formed indicating the presence of the analyte.

Abstract: The present invention relates to analytical methods, platforms, and devices for the rapid and efficient immunochromatic determination of one or more components in fluid samples.

Abstract: The present invention relates to analytical methods, platforms, and devices for the rapid and efficient immunochromatic determination of one or more components in fluid samples. The devices are especially useful for identifying analytes in small volumes of whole blood samples utilizing one membrane principally for separating particles such as red blood cells from plasma and a second membrane as the site for reactions to identify the analytes.

Abstract: The present invention relates to analytical methods, platforms, and devices for the rapid and efficient immunochromatic determination of one or more components in fluid samples. The devices are especially useful for identifying analytes in small volumes of whole blood samples utilizing one membrane principally for separating particles such as red blood cells from plasma and a second membrane as the site for reactions to identify the analytes.

Abstract: A hinged cap for engaging a housing of a diagnostic device comprises a central body; two arms extending from opposing sides of one end of said central body, said arms being substantially parallel; each of said arms comprising a cap hinge member for engaging a housing hinge member on said housing, wherein said cap hinge member and said housing hinge member define a hinge axis around which said cap is pivotable between an open and a closed position with respect to said housing.

Abstract: Polypeptides corresponding to stable, circulating degradation products of troponin I (TnI) are described. The fragments comprise a sequence of the N-terminus of native cardiac TnI with 95-115 amino acid and additionally include fragments lacking about the 20-30 N-terminal amino acids. Utilities of these fragments and antibodies thereto include sensitive detection of myocardial infarction and purification of antibodies sensitive to the detection of troponin I degradation products.

Abstract: The invention provides assay methods and kits that in general measure the level of a first analyte in a sample reduced by the level of a second analyte present in the same sample. In one embodiment, where levels of a first analyte from a first source is desirably determined and first analyte in the sample released from a second source is accompanied by proportional co-release of a second analyte, the assay identifies the level of first analyte released only from the first source. For analytes within bodily fluids, the assay can differentiate between elevated levels of analyte specific to the particular physiological or pathological state and elevated levels not specific to the particular state, providing single tests with diagnostic utility.

Abstract: A chromatographic assay device for the analysis of an analyte in a liquid sample has a proximal sample application zone and a distal test zone. The test zone contains a first ligand capable of binding with the analyte to form an analyte-ligand complex. The device also includes a spatially distinct reservoir containing a labeled reagent capable of binding to the analyte-ligand complex; an absorbent sink which is positioned to be capable of drawing the contents of the spatially distinct reservoir through the test zone; and structures for contacting the spatially distinct reservoir with the chromatographic medium so that the labeled reagent migrates from the reservoir to the absorbent sink, and thereby through the test zone to determine the presence or absence of the analyte. The device is used in a method for detecting analyte.

Abstract: This invention relates to single-chain polypeptides and their genetic sequences comprising human cardiac troponin I and troponin C. The single-chain polypeptide may be expressed recombinantly, and a linker peptide may be interposed between the troponin sequences. A linker peptide of about 6 to about 30 amino acids is preferred. The single-chain polypeptide has utility as a control or calibrator for troponin assays, for the purification of troponin subunits and as an antigen for the preparation of antibodies.

Abstract: The invention provides assay methods and kits that in general measure the level of a first analyte in a sample reduced by the level of a second analyte present in the same sample. In one embodiment, where levels of a first analyte from a first source is desirably determined and first analyte in the sample released from a second source is accompanied by proportional co-release of a second analyte, the assay identifies the level of first analyte released only from the first source. For analytes within bodily fluids, the assay can differentiate between elevated levels of analyte specific to the particular physiological or pathological state and elevated levels not specific to the particular state, providing single tests with diagnostic utility.

Abstract: A chromatographic assay device for the analysis of an analyte in a liquid sample has a proximal sample application zone and a distal test zone. The test zone contains a first ligand capable of binding with the analyte to form an analyte-ligand complex. The device also includes a spatially distinct reservoir containing a labeled reagent capable of binding to the analyte-ligand complex; an absorbent sink which is positioned to be capable of drawing the contents of the spatially distinct reservoir through the test zone; and structures for contacting the spatially distinct reservoir with the chromatographic medium so that the labeled reagent migrates from the reservoir to the absorbent sink, and thereby through the test zone to determine the presence or absence of the analyte. The device is used in a method for detecting analyte.

Abstract: An analytical test device is described for the immunochromatographic determination of the presence of one or more analytes in fluid samples. The device is configured such that the sample is allowed to enter the detection zone simultaneously from many different directions, eliminating stagnation of the flow of the sample. By selection of the porous substrate, the device also allows for the separation of red blood cells from plasma, providing a rapid test for one or more analytes in a sample of whole blood. The device of the present invention may measure more than one analyte simultaneously from a single sample, either by having multiple immunochromatographic pathways fed by a single sample, or multiple analytes detected in the same pathway by way of multiple capture antibodies.

Abstract: The invention provides assay methods and kits that in general measure the level of a first analyte in a sample reduced by the level of a second analyte present in the same sample. In one embodiment, where levels of a first analyte from a first source is desirably determined and first analyte in the sample released from a second source is accompanied by proportional co-release of a second analyte, the assay identifies the level of first analyte released only from the first source. For analytes within bodily fluids, the assay can differentiate between elevated levels of analyte specific to the particular physiological or pathological state and elevated levels not specific to the particular state, providing single tests with diagnostic utility.