Abstract: A system includes a fluid transfer device and a lateral flow assay device. The fluid transfer device has an inlet fluidically coupleable to a bodily fluid source, an outlet fluidically coupleable to a sample reservoir, and a sequestration chamber configured to receive an initial volume of bodily fluid. The fluid transfer device can be transitioned between (1) a first state with the sequestration chamber in fluid communication with the inlet to receive the initial volume, (2) a second state with the outlet in fluid communication with the inlet to receive a subsequent flow of bodily fluid, and (3) a third state with the lateral flow assay device in fluid communication with the sequestration chamber to receive a portion of the initial volume of bodily fluid. The lateral flow assay device configured to provide an indication associated with a presence of a target analyte in the bodily fluid.

Abstract: A system includes a fluid transfer device and a lateral flow assay device. The fluid transfer device has an inlet fluidically coupleable to a bodily fluid source, an outlet fluidically coupleable to a sample reservoir, and a sequestration chamber configured to receive an initial volume of bodily fluid. The fluid transfer device can be transitioned between (1) a first state with the sequestration chamber in fluid communication with the inlet to receive the initial volume, (2) a second state with the outlet in fluid communication with the inlet to receive a subsequent flow of bodily fluid, and (3) a third state with the lateral flow assay device in fluid communication with the sequestration chamber to receive a portion of the initial volume of bodily fluid. The lateral flow assay device configured to provide an indication associated with a presence of a target analyte in the bodily fluid.

Abstract: A collection system configured to maintain the integrity of a bodily fluid sample has a proximal end portion, a distal end portion, and an inner surface defining a fluid flow path therethrough. The distal end portion is configured to be placed in fluid communication with a patient. The proximal end portion is configured to be placed in fluid communication with a fluid reservoir. The fluid flow path defined by the inner surface is associated with at least one flow characteristic configured to limit a stress within the flow of the bodily fluid between the distal end portion and the proximal end portion.

Abstract: Mass spectrometry techniques for determining the status of sepsis in an individual are provided. A biomarker profile resolved from a biological sample, taken from the individual, using a mass spectrometry technique is compared to a reference biomarker profile. A single such comparison classifies the individual as belonging to or not belonging to a reference population. The individual's biomarker profile and the reference biomarker profile comprise a plurality of ions each having a mass-to-charge ratio of about 100 Daltons to about 1000 Daltons. The plurality of ions can be detected by electrospray ionization mass spectrometry in positive mode. The comparison uses a decision rule, such as a classification tree, that determines the status of sepsis in the individual without requiring knowledge of the identity of the biomarkers in the biomarker profile from the individual and without requiring knowledge of the identity of the biomarkers in the reference biomarker profile.

Abstract: An assay transponder is disclosed. The assay transponder has an RF transceiver that allows the assay transponder to communicate wirelessly with another RF device. The transponder also has a sensor that interrogates an assay associated with the transponder. The assay exhibits a response to a sample environment in which the transponder is placed. The transponder communicates the results of the assay interrogation to the other RF device by modulating a signal indicative of the results onto an RF carrier signal and transmitting the signal via an antenna.

Abstract: The invention provides a device comprising one or more support materials capable of providing lateral flow. The one or more support materials contain an area for a receiving a biological sample containing a target analyte, an area having a movably contained detector ligand capable of forming a complex with the target analyte, a first capture area having a predetermined amount of an immobile capture reagent, where the immobile capture reagent is capable of specifically binding to the complex, a second capture area having the immobile capture reagent, and a lysing agent. Typically, the area for receiving the biological sample, the area having the movably contained detector ligand, the first capture area, and the second capture area are arranged in the one or more support materials such that a sample is capable of sequential lateral flow through these areas.