Abstract: A biological fluid separation device adapted to receive a biological fluid sample having a first portion and a second portion is disclosed. The device includes a housing having a first chamber having a first chamber inlet for receiving the biological fluid sample therein and a first chamber outlet. The housing has a second chamber having a second chamber inlet and a second chamber outlet, and a separation member separating at least a portion of the first chamber outlet and the second chamber. The separation member is adapted to restrain the first portion of the biological fluid sample within the first chamber and to allow at least a portion of the second portion of the biological fluid sample to pass into the second chamber. An actuator, such as a vacuum source, draws the biological fluid sample into the first chamber and the second portion into the second chamber.

Abstract: A biological fluid separation device adapted to receive a biological fluid sample having a first portion and a second portion is disclosed. The device includes a housing having a first chamber having a first chamber inlet for receiving the biological fluid sample therein and a first chamber outlet. The housing has a second chamber having a second chamber inlet and a second chamber outlet, and a separation member separating at least a portion of the first chamber outlet and the second chamber. The separation member is adapted to restrain the first portion of the biological fluid sample within the first chamber and to allow at least a portion of the second portion of the biological fluid sample to pass into the second chamber. An actuator, such as a vacuum source, draws the biological fluid sample into the first chamber and the second portion into the second chamber.

Abstract: Methods and apparatus provide filtration for concentrating analytes, such as bacteria or exosomes, of a biological sample, such as blood or urine. The technology may employ membrane devices that implement one or more tangential flow filtration processes such as in stages. An example membrane device may typically include a membrane having sides and ends. The membrane may selectively permit constituent(s) of the sample to pass through while retaining other constituents at one side. An input chamber of the device may include an inlet near one end and an outlet near the other end, and that may permit a tangential flow of the sample along the first side surface, and a trans-membrane passing of constituent(s). An output chamber of the device may be configured at the second side surface to receive the passing constituents. Such devices may be provided in a kit to facilitate targeting of a desired biological analyte concentration.

Abstract: A blood separation device that allows high quality plasma to be generated using a single power source. The device includes a housing with an inlet port adapted to receive the blood sample, a first chamber having a first chamber flow channel in fluid communication with the inlet port, a second chamber having a second chamber flow channel, a separation member disposed between the first chamber and the second chamber. In some embodiments, the blood separation device detects or tests for the presence of a substance, such as an antigen or an antibody.

Abstract: Provided herein are compositions, methods, systems and/or kits for measuring microbial viability in a sample. Certain embodiments of the present disclosure are related to detection tests comprising compositions, methods, systems and/or kits for measuring an antimicrobial minimum inhibitory concentration and for measuring microbial susceptibility to the antimicrobial. Certain embodiments of the present disclosure are related to detection tests comprising compositions, methods, systems and/or kits for assessing microbial proliferation in a sample.

Abstract: Disclosed herein are diagnostic assays using surface enhanced Raman spectroscopy (SERS)-active particles, including liquid-based assays; magnetic capture assays; microparticle-nanoparticle satellite structures for signal amplification in an assay; composite SERS-active particles useful for enhanced detection of targets; and sample tubes and processes for using the same.

Abstract: Provided herein are methods, systems, and devices for detecting and/or identifying one or more specific microorganisms in a culture sample. Indicator particles, such as surface enhanced Raman spectroscopy (SERS)-active nanoparticles, each having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest, can form a complex with specific microorganisms in the culture sample. Further, agitating magnetic capture particles also having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest can be used to capture the microorganism-indicator particle complex and concentrate the complex in a localized area of an assay vessel for subsequent detection and identification. The complex can be dispersed, pelleted, and redispersed so that the culture sample can be retested a number of times during incubation so as to allow for real-time monitoring of the culture sample.

Abstract: A biological fluid separation device adapted to receive a biological fluid sample having a first portion and a second portion is disclosed. The device includes a housing having a first chamber having a first chamber inlet for receiving the biological fluid sample therein and a first chamber outlet. The housing has a second chamber having a second chamber inlet and a second chamber outlet, and a separation member separating at least a portion of the first chamber outlet and the second chamber. The separation member is adapted to restrain the first portion of the biological fluid sample within the first chamber and to allow at least a portion of the second portion of the biological fluid sample to pass into the second chamber. An actuator, such as a vacuum source, draws the biological fluid sample into the first chamber and the second portion into the second chamber.

Abstract: A biological fluid separation device adapted to receive a biological fluid sample having a first portion and a second portion is disclosed. The device includes a housing having a first chamber having a first chamber inlet for receiving the biological fluid sample therein and a first chamber outlet. The housing has a second chamber having a second chamber inlet and a second chamber outlet, and a separation member separating at least a portion of the first chamber outlet and the second chamber. The separation member is adapted to restrain the first portion of the biological fluid sample within the first chamber and to allow at least a portion of the second portion of the biological fluid sample to pass into the second chamber. An actuator, such as a vacuum source, draws the biological fluid sample into the first chamber and the second portion into the second chamber.

Abstract: Provided herein are methods, systems, and devices for detecting and/or identifying one or more specific microorganisms in a culture sample. Indicator particles, such as surface enhanced Raman spectroscopy (SERS)-active nanoparticles, each having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest, can form a complex with specific microorganisms in the culture sample. Further, agitating magnetic capture particles also having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest can be used to capture the microorganism-indicator particle complex and concentrate the complex in a localized area of an assay vessel for subsequent detection and identification. The complex can be dispersed, pelleted, and redispersed so that the culture sample can be retested a number of times during incubation so as to allow for real-time monitoring of the culture sample.

Abstract: Disclosed herein are diagnostic assays using surface enhanced Raman spectroscopy (SERS)-active particles, including liquid-based assays; magnetic capture assays; microparticle-nanoparticle satellite structures for signal amplification in an assay; composite SERS-active particles useful for enhanced detection of targets; and sample tubes and processes for using the same.

Abstract: Provided herein are methods, systems, and devices for detecting and/or identifying one or more specific microorganisms in a culture sample. Indicator particles, such as surface enhanced Raman spectroscopy (SERS)-active nanoparticles, each having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest, can form a complex with specific microorganisms in the culture sample. Further, agitating magnetic capture particles also having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest can be used to capture the microorganism-indicator particle complex and concentrate the complex in a localized area of an assay vessel for subsequent detection and identification. The complex can be dispersed, pelleted, and redispersed so that the culture sample can be retested a number of times during incubation so as to allow for real-time monitoring of the culture sample.

Abstract: Disclosed herein are diagnostic assays using surface enhanced Raman spectroscopy (SERS)-active particles, including liquid-based assays; magnetic capture assays; microparticle-nanoparticle satellite structures for signal amplification in an assay; composite SERS-active particles useful for enhanced detection of targets; and sample tubes and processes for using the same.

Abstract: A biological fluid separation device adapted to receive a biological fluid sample having a first portion and a second portion is disclosed. The device includes a housing having a first chamber having a first chamber inlet for receiving the biological fluid sample therein and a first chamber outlet. The housing has a second chamber having a second chamber inlet and a second chamber outlet, and a separation member separating at least a portion of the first chamber outlet and the second chamber. The separation member is adapted to restrain the first portion of the biological fluid sample within the first chamber and to allow at least a portion of the second portion of the biological fluid sample to pass into the second chamber. An actuator, such as a vacuum source, draws the biological fluid sample into the first chamber and the second portion into the second chamber.

Abstract: Methods and compositions for the detection of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity in blood samples are described. Some embodiments disclosed herein provide methods for detecting G6PD activity in undiluted or minimally diluted blood samples, including obtaining a blood sample, and detecting G6PD activity present in the undiluted or minimally diluted blood sample by epifluorescence. Also provided are methods for detecting G6PD activity and detecting a bloodborne microorganism as two parts of a single test.

Abstract: Provided herein are methods, systems, and devices for detecting and/or identifying one or more specific microorganisms in a culture sample. Indicator particles, such as surface enhanced Raman spectroscopy (SERS)-active nanoparticles, each having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest, can form a complex with specific microorganisms in the culture sample. Further, agitating magnetic capture particles also having associated therewith one or more specific binding members having an affinity for the one or more microorganisms of interest can be used to capture the microorganism-indicator particle complex and concentrate the complex in a localized area of an assay vessel for subsequent detection and identification. The complex can be dispersed, pelleted, and redispersed so that the culture sample can be retested a number of times during incubation so as to allow for real-time monitoring of the culture sample.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. A sensing element is attached to the distal end of an optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the optical conduit and sensing element may be housed within a cannulated bevel.

Abstract: Coated nanoparticles comprising a core surrounded by a shell that increases the reflectance of the nanoparticle, wherein the coated nanoparticle does not include a Raman-active molecule, are provided. Test devices and immunoassay methods utilizing the coated nanoparticles are provided.

Abstract: Disclosed herein are diagnostic assays using surface enhanced Raman spectroscopy (SERS)-active particles, including liquid-based assays; magnetic capture assays; microparticle-nanoparticle satellite structures for signal amplification in an assay; composite SERS-active particles useful for enhanced detection of targets; and sample tubes and processes for using the same.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. A sensing element is attached to the distal end of an optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the optical conduit and sensing element may be housed within a cannulated bevel.