Abstract: A disposable cartridge for use in a diagnostic assay system including a cartridge body defining a barrel port. A rotor is rotationally mounted to the cartridge body and comprises a plurality of assay chambers and a plurality of rotor ports each fluidly coupled to at least one of the plurality of assay chambers. A syringe is coupled to the cartridge body and operative to inject and withdraw assay fluids through the barrel port. The syringe includes a barrel defining an internal environment, a plunger positioned in the barrel and structured to move within a working area, and a disposable shaft structured to detachably mate at a first end with the plunger. The disposable shaft is isolated from the internal environment of the barrel.

Abstract: A disposable cartridge for mitigating cross-contamination of fluid sample reagents. The disposable cartridge includes a cartridge body defining a syringe barrel having an barrel port operative to inject and withdraw assay fluids in response to the displacement of a syringe plunger. Furthermore, the disposable cartridge includes a rotor defining a plurality of assay chambers in fluid communication with the barrel port through one of a plurality of rotor ports disposed about the periphery of the rotor. Finally, the disposable cartridge includes a flow control system between the barrel and rotor ports which prevents cross-contamination of fluid sample reagents from one assay chamber to another assay chamber.

Abstract: A method for preparing a sample by utilizing a shearing force in the presence of a size stabilizer to break apart the sample to obtain nucleic acid molecules in a usable size range. Once nucleic acid molecules are obtained, magnetic nanoparticles are used to concentrate and clean the nucleic acid molecules for further testing.

Abstract: A disposable cartridge comprises a cartridge body defining at least one syringe barrel having an barrel port configured to inject and aspirate assay fluids by displacement of a barrel plunger and at least one reaction chamber configured to receive and perform diagnostic testing on the assay fluids. The disposable cartridge also includes at least two rotors mounted for rotation to the cartridge body, each of the rotors defining a plurality of ports in fluid communication with at least one of the assay chambers of a respective one of the rotors. The rotors are selectively rotated such that a port of one rotor aligns with a port of the other rotor. At least one of the rotors is disposed in fluid communication with the syringe port of the syringe barrel such that assay fluids may flows from at least one of the assay chambers through the ports of the rotors by displacement of the barrel plunger.

Abstract: A method for preparing a sample by utilizing a shearing force in the presence of a size stabilizer to break apart the sample to obtain nucleic acid molecules in a usable size range. Once nucleic acid molecules are obtained, magnetic nanoparticles are used to concentrate and clean the nucleic acid molecules for further testing.

Abstract: A system and method for preparing a diagnostic fluid sample for use with a fluid assay system. The method comprises the steps of: amplifying the fluid sample to increase the number of cells subject to being tested; drawing a first volume of the fluid sample into a first syringe of a dual-barrel syringe and dispensing the first volume of the fluid sample through a media filter. The method further comprises the steps of placing the bacteria-laced filter into a lysis module; dispensing a first portion of a lysis buffer into the lysis module from the second syringe of the dual-barrel syringe; and dispensing a second portion of the lysis buffer through the media filter into a disposable cartridge of a fluid assay system.

Abstract: A disposable cartridge for mitigating cross-contamination of fluid sample reagents. The disposable cartridge includes a cartridge body defining a syringe barrel having an barrel port operative to inject and withdraw assay fluids in response to the displacement of a syringe plunger. Furthermore, the disposable cartridge includes a rotor defining a plurality of assay chambers in fluid communication with the barrel port through one of a plurality of rotor ports disposed about the periphery of the rotor. Finally, the disposable cartridge includes a flow control system between the barrel and rotor ports which prevents cross-contamination of fluid sample reagents from one assay chamber to another assay chamber.

Abstract: A diagnostic assay system for accelerating reagent reactions comprising a base portion receiving a disposable cartridge and a cover portion moveably mounted to the base such that the disposable cartridge may be installed and removed from the base portion. The disposable cartridge includes at least one assay chamber for receiving an assay fluid, and a cartridge body including a syringe barrel operative to move assay fluids into and out of the assay chambers. The diagnostic assay system also includes a heater proximal the at least one fluid assay-containing cavity, operational when the cover portion is in a closed position and configured to heat the assay fluid in one of the assay chambers to accelerate reagent reactions in the disposable cartridge.

Abstract: A disposable cartridge for mitigating cross-contamination of fluid sample reagents. The disposable cartridge includes a cartridge body defining a syringe barrel having an barrel port operative to inject and withdraw assay fluids in response to the displacement of a syringe plunger. Furthermore, the disposable cartridge includes a rotor defining a plurality of assay chambers in fluid communication with the barrel port through one of a plurality of rotor ports disposed about the periphery of the rotor. Finally, the disposable cartridge includes a flow control system between the barrel and rotor ports which prevents cross-contamination of fluid sample reagents from one assay chamber to another assay chamber.

Abstract: Methods and systems for determining a risk level of a neurodegenerative disease by analyzing expression levels of a plurality of RNA transcripts of a sample. The method uses an imager, a magnet, a light source, and a flow cell that includes a functionalized surface having a plurality of capture probes. Each of the plurality of capture probes is configured to bind molecules in the sample comprising one of the plurality of RNA transcripts. The method includes the following steps. Binding molecules in the sample to a magnetic particle. Directing the molecules to the functionalized surface using the magnet. Binding each specific molecule of the molecules to one of the plurality of capture probes configured to bind the RNA transcript of the specific molecule. Directing a light beam from the light source at bound molecules bound on each of the plurality of capture probes. Capturing light from the bound molecules.

Abstract: A method for optimizing the heat transfer when performing target amplification of an assay fluid, comprising the steps of: (i) moving assay fluid through at least one channel disposed along an underside surface of a disposable cartridge of a diagnostic assay test device such that the fluid collects in a amplification region of the channel; (ii) heating the amplification region of the assay channel to heat the assay fluid; (iii) interposing a conformal material between the underside surface of a disposable cartridge and the RF heater, and (iv) applying a contact pressure between the underside surface of a disposable cartridge and the RF heater.

Abstract: A method for preparing a sample by utilizing a shearing force in the presence of a size stabilizer to break apart the sample to obtain nucleic acid molecules in a usable size range. Once nucleic acid molecules are obtained, magnetic nanoparticles are used to concentrate and clean the nucleic acid molecules for further testing.

Abstract: A method for detecting a nucleic acid molecule in a biological sample includes amplifying a nucleic acid molecule to generate an amplicon having a single 5?-tail and coupling the 5?-tail to one of a plurality of capture probes on a surface of a sensor. The amplicon is converted to a single strand molecule and a target-specific catalyst cluster is bound to the single strand molecule. The catalyst cluster is subjected to metallization in order to detect the target nucleic acid.

Abstract: A disposable cartridge for mitigating cross-contamination of fluid sample reagents. The disposable cartridge includes a cartridge body defining a syringe barrel having an barrel port operative to inject and withdraw assay fluids in response to the displacement of a syringe plunger. Furthermore, the disposable cartridge includes a rotor defining a plurality of assay chambers in fluid communication with the barrel port through one of a plurality of rotor ports disposed about the periphery of the rotor. Finally, the disposable cartridge includes a flow control system between the barrel and rotor ports which prevents cross-contamination of fluid sample reagents from one assay chamber to another assay chamber.

Abstract: A diagnostic assay system for accelerating reagent reactions comprising a base portion receiving a disposable cartridge and a cover portion moveably mounted to the base such that the disposable cartridge may be installed and removed from the base portion. The disposable cartridge includes at least one assay chamber for receiving an assay fluid, and a cartridge body including a syringe barrel operative to move assay fluids into and out of the assay chambers. The diagnostic assay system also includes a heater proximal the at least one fluid assay-containing cavity, operational when the cover portion is in a closed position and configured to heat the assay fluid in one of the assay chambers to accelerate reagent reactions in the disposable cartridge.

Abstract: A system for detection of a target molecule includes an imager, a flow cell having a functionalized surface, a light source, and a magnet. The functionalized surface is configured to bind a target molecule attracted to the functionalized surface via the magnet. The target molecule is configured to bind a nanoparticle and the light source is configured to direct a light beam toward the bound nanoparticle. Light from the nanoparticle is captured by the imager and analyzed to detect the presence of the target molecule.

Abstract: Systems and method for analyzing molecules in a sample. The system includes an imager, a flow cell, a magnet, and a processor. The flow cell includes a functionalized surface comprising a capture probe configured to bind molecules comprising a first RNA transcript. The magnet is positioned opposite the functionalized surface. The magnet is configured to direct the molecules comprising the first RNA transcript to the functionalized surface to bind to the capture probe. The light source configured to direct a light beam at the bound molecules comprising the first RNA transcript. The imager is configured to capture light from the bound molecules comprising the first RNA transcript. A processor configured to determine a quantity of the molecules in the sample comprising the first RNA transcript. The process is further configured to determine an expression level of the first RNA transcript in the sample based on the quantity of the molecules.

Abstract: A disposable cartridge for preparing a nucleic acid sample including a stationary cartridge body and a cylindrical rotor rotationally mounted to the cartridge body. The cartridge body includes: (i) a cylindrical surface defining a fixed port and (ii) a syringe barrel defining a bore in fluid communication with the fixed port. When the disposable cartridge is disposed in combination with an assay system, syringe barrel is configured to receive a moveable plunger, i.e., to stroke the plunger into and out of the barrel. The rotor is seated within a cavity of the cartridge body such that a mating surface thereof slideably engages a cylindrical surface of the cavity. The rotor comprises a plurality of chambers fluidly connecting to a plurality of ports along the mating surface at different radial positions such that at least one of the chambers is fluidly connected to one of the ports by a connecting channel.

Abstract: A disposable cartridge comprises a cartridge body defining at least one syringe barrel having an barrel port configured to inject and aspirate assay fluids by displacement of a barrel plunger and at least one reaction chamber configured to receive and perform diagnostic testing on the assay fluids. The disposable cartridge also includes at least two rotors mounted for rotation to the cartridge body, each of the rotors defining a plurality of ports in fluid communication with at least one of the assay chambers of a respective one of the rotors. The rotors are selectively rotated such that a port of one rotor aligns with a port of the other rotor. At least one of the rotors is disposed in fluid communication with the syringe port of the syringe barrel such that assay fluids may flows from at least one of the assay chambers through the ports of the rotors by displacement of the barrel plunger.

Abstract: A blood collection assembly to facilitate the assay of a blood sample, comprising: (i) an absorptive media configured to collect and release the blood sample, (ii) a cartridge defining a cavity and a blood-sampling end configured to hold the absorptive media against a dermal membrane containing the blood sample; (iii) a lancet disposed within the cavity and having a lance at one end thereof; and (iv) a plunger configured to extend and retract the lancet through the absorptive media to lance the dermal membrane and collect the blood sample within the absorptive media. The cartridge containing the blood-filled, absorptive media is configured to be placed into a blood assay device for extraction of the blood sample from the absorptive media.