Abstract: Detection devices, systems, and methods for detecting an analyte in a fluid sample are provided. The detection devices, systems, and methods can include colorimetric detection to rapidly determine the presence and/or quantity of the analyte obtained from a surface that is contaminated or suspected of being contaminated with the analyte. In one aspect, the detection device includes a sample reservoir in fluid communication with a fluid flow path. The fluid flow path includes a control well downstream of the sample reservoir, a valve assembly downstream of the control well, a reagent well downstream of the valve assembly, and a test well downstream of the reagent well. In one aspect, the reagent well includes a dried reducing agent configured to generate a gas in the presence of a detection dye and the analyte in the fluid sample.

Abstract: A filtration cell (10) for a biological sample including an upper chamber for receiving the biological sample to be filtered, a lower chamber in fluid communication with the upper chamber, and a filtration membrane (14) positioned between the upper chamber and the lower chamber is disclosed. A surface of the filtration membrane has a contact angle >90°. The flow of the biological sample through the upper chamber may be tangential to the filtration membrane and a filtrate passing through the filtration membrane may be collected in the lower chamber. Also, a method of filtering a biological sample including passing the biological sample through an upper chamber of a filtration cell as described above and collecting a filtrate in the lower chamber is disclosed.

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: 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: Tissue dissociators configured to disrupt a biological tissue sample are provided. Aspects of the tissue dissociators according to certain embodiments include a blade holder having a blade and a sample holder that includes a tissue actuator having a distal end pliable stopper where the tissue actuator is configured to be displaced along a longitudinal axis with the sample holder. Also provided are methods of dissociating a biological tissue sample with the tissue dissociators, as well as kits including the tissue dissociators.

Abstract: A filtration cell (10) for a biological sample having an outer housing (12) defining a first chamber and an inner housing (14) defining a second chamber is disclosed. The inner housing is disposed within the first chamber and rotatable with respect to the outer housing and at least a portion of the inner housing includes a filtration membrane (52). Upon rotation of the inner housing, a first portion of the biological sample passes from the first chamber into the second chamber and a second portion of the biological sample is restrained in the first chamber. Alternatively, the filtration cell may also include a rotation element disposed in the inner housing. Upon rotation of the rotation element with respect to the inner housing, a first portion of the biological sample to passes from the second chamber into the first chamber and a second portion of the biological sample is restrained in the second chamber.

Abstract: Tissue dissociators configured to disrupt a biological tissue sample are provided. Aspects of the tissue dissociators according to certain embodiments include a blade holder having a blade and a sample holder that includes a tissue actuator having a distal end pliable stopper where the tissue actuator is configured to be displaced along a longitudinal axis with the sample holder. Also provided are methods of dissociating a biological tissue sample with the tissue dissociators, as well as kits including the tissue dissociators.

Abstract: A filtration cell (10) for a biological sample including an upper chamber for receiving the biological sample to be filtered, a lower chamber in fluid communication with the upper chamber, and a filtration membrane (14) positioned between the upper chamber and the lower chamber is disclosed. A surface of the filtration membrane has a contact angle >90°. The flow of the biological sample through the upper chamber may be tangential to the filtration membrane and a filtrate passing through the filtration membrane may be collected in the lower chamber. Also, a method of filtering a biological sample including passing the biological sample through an upper chamber of a filtration cell as described above and collecting a filtrate in the lower chamber is disclosed.

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 filtration cell (10) for a biological sample having an outer housing (12) defining a first chamber and an inner housing (14) defining a second chamber is disclosed. The inner housing is disposed within the first chamber and rotatable with respect to the outer housing and at least a portion of the inner housing includes a filtration membrane (52). Upon rotation of the inner housing, a first portion of the biological sample passes from the first chamber into the second chamber and a second portion of the biological sample is restrained in the first chamber. Alternatively, the filtration cell may also include a rotation element disposed in the inner housing. Upon rotation of the rotation element with respect to the inner housing, a first portion of the biological sample to passes from the second chamber into the first chamber and a second portion of the biological sample is restrained in the second chamber.

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 includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

Abstract: A device includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

Abstract: A device includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

Abstract: A system and method for a patch-like, self-contained substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir, wherein the device can be attached to a skin surface via an adhesive contact surface and a push button activation assembly can then be used to remove an interlock, allowing a disk, or Belleville spring assembly to apply an essentially even and constant pressure to the contents of the fluid reservoir, allow the release of the patient needles into the skin surface, and establish a fluid communication path between the patient needles and the pressurized fluid reservoir contents. The push button activation assembly further allows the release of one or more improved safety mechanisms after use.

Abstract: An optical connector device is disclosed for optically connecting a biosensor wearable on the body of a patient to a reader outside of the body of the patient. The device comprises a base disk to be worn on the body of a patient. The base disk has a needle attached thereto and the needle houses a first fiber defining a first optical conduit. The distal end of the needle is insertable into the body of the patient, and a portion of the proximal end of the needle remains outside of the body of the patient when the device is worn. The device also comprises a connector housing a second fiber defining a second optical conduit.

Abstract: A device includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

Abstract: Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

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.