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 inserting and retaining a reagent within a disposable cartridge of a diagnostic assay system. The method includes the steps of: (i) drying a reagent in combination with a carrier, and (ii) inserting the carrier, with the dried reagent, into an open end of one of the assay chambers, wherein the carrier facilitates insertion of the pellet into a chamber without contact by an operator.

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 filtration column assembly is provided for use in combination with a disposable cartridge of a diagnostic assay system. The filtration column assembly includes a column matrix material configured to filter a fluid sample, a tubular column configured to sealably engage a filtration chamber of the disposable cartridge and a cap configured to be inserted into an end of the tubular column and define a passageway to direct the sample fluid from the second end of the tubular column into a collection cavity disposed adjacent the filtration chamber. The tubular column defines (i) a column cavity for receiving the column matrix material, (ii) a first end having an opening for receiving the fluid sample and configured to retain the column matrix material, and (iii) a second end, receiving the fluid directing cap, and having an opening to dispense a filtered fluid sample from the column cavity.

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: 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: 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 inserting and retaining a reagent within a disposable cartridge of a diagnostic assay system. The method includes the steps of: (i) drying a reagent in combination with a carrier, and (ii) inserting the carrier, with the dried reagent, into an open end of one of the assay chambers, wherein the carrier facilitates insertion of the pellet into a chamber without contact by an operator.

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 filtration column assembly is provided for use in combination with a disposable cartridge of a diagnostic assay system. The filtration column assembly includes a column matrix material configured to filter a fluid sample, a tubular column configured to sealably engage a filtration chamber of the disposable cartridge and a cap configured to be inserted into an end of the tubular column and define a passageway to direct the sample fluid from the second end of the tubular column into a collection cavity disposed adjacent the filtration chamber. The tubular column defines (i) a column cavity for receiving the column matrix material, (ii) a first end having an opening for receiving the fluid sample and configured to retain the column matrix material, and (iii) a second end, receiving the fluid directing cap, and having an opening to dispense a filtered fluid sample from the column cavity.

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: 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.