Abstract: Described herein is a system and method for determining the presence and/or amount of a target in a sample. In some embodiments, a microfluidic device, such as a strip having a microfluidic network thereon, is inserted into an instrument to perform an assay therein. The strip may be configured to receive the sample from a porous member via capillary action, with minimal or no compression of the porous member. The instrument may include a gas bladder actuation assembly, actuated by an eccentric cam, to compress and decompress a gas bladder on the microfluidic device, thereby enabling fluid movement thereon. The instrument may further comprise a magnet disposed in a fixed location, so as to capture any complexes formed between the target and magnetic particles disposed within the microfluidic device. The magnet may be aligned with an optical detection assembly configured to detect the target captured with the magnetic particles.

Abstract: Methods, devices, and reagents are described for performing ratiometric assays for hemoglobin A1c. The methods involve a direct ratio determination between Hb A1c and normalized total hemoglobin utilizing a saturating amount of hemoglobin so that Hb A1c binds proportionately to a substrate. In some applications, the assay utilizes a proximity label system for signal generation and/or labeled magnetic beads. The methods can be configured as homogeneous or heterogeneous assays.

Abstract: A method of performing a non-isothermal nucleic acid amplification reaction, the method comprising the steps of: (a) mixing a target sequence with one or more complementary single stranded primers in conditions which permit a hybridization event in which the primers hybridize to the target, which hybridization event, directly or indirectly, leads to the formation of a duplex structure comprising two nicking sites disposed at or near opposite ends of the duplex; and performing an amplification process by; (b) using a nicking enzyme to cause a nick at each of said nicking sites in the strands of the duplex; (c) using a polymerase to extend the nicked strands so as to form newly synthesized nucleic acid, which extension with the polymerase recreates nicking sites; (d) repeating steps (b) and (c) as desired so as to cause the production of multiple copies of the newly synthesized nucleic acid.

Abstract: Disclosed is a method of performing a non-isothermal nucleic acid amplification reaction, wherein the temperature at which the method is performed is non-isothermal and subject to a reduction of at least 2° C. during amplification process steps. The present invention provides an improved nucleic acid amplification technique having one or more advantages over existing techniques including, for example, decreased reaction time, increased yield, and decreased non-specific amplification products.

Abstract: A monitor comprises circuitry to receive a signal and process the signal to monitor at least one characteristic of a subject, and a flexible polymer casing forming a waterproof enclosure for the circuitry. The flexible polymer casing is infused with a conductive material at location to form infused electrode that extends from an exterior of the flexible polymer casing to an interior of the flexible polymer casing, and the infused electrode is coupled to the circuitry so as to allow the signal to pass from outside the flexible polymer casing to the circuitry. A polymer in a portion of the flexible polymer casing that is infused with the conductive material at the location is cross-linked with a polymer in a portion of the flexible polymer casing that is not infused with the conductive material.

Abstract: The present invention relates to a microfluidic based assay system, comprising a disposable assay cartridge and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using the cartridge and device of the invention, as well as kits for conducting assays.

Abstract: Disclosed is a method of performing a non-isothermal nucleic acid amplification reaction, the method comprising the steps of: (a) mixing a target sequence with one or more complementary single stranded primers in conditions which permit a hybridisation event in which the primers hybridise to the target, which hybridisation event, directly or indirectly, leads to the formation of a duplex structure comprising two nicking sites disposed at or near opposite ends of the duplex; and performing an amplification process by; (b) using a nicking enzyme to cause a nick at each of said nicking sites in the strands of the duplex; (c) using a polymerase to extend the nicked strands to as to form newly synthesised nucleic acid, which extension with the polymerase recreates nicking sites; (d) repeating steps (b) and (c) as desired so as to cause the production of multiple copies of the newly synthesised nucleic acid; characterised in that the temperature at which the method is performed is non-isothermal, and subject to shu

Abstract: The present invention relates to a microfluidic assay system and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using a disposable system and associated reading device, as well as kits for conducting assays.

Abstract: Disclosed are systems and methods for using one or more light sources and associated photodetectors to determine different physiological parameters of a subject based on the subject's activity state. A processor may, for example, be configured to determine, based at least in part on data received from an accelerometer at a first time, that a first physiological parameter of the subject is to be determined, to cause the light source(s) to operate in a first manner and process signals from the photodetector(s) to determine the first physiological parameter, to determine, based at least in part on data received from the accelerometer at a second time, that a second physiological parameter of the subject is to be determined, and to cause the light source(s) to operate in a second manner and process signals from the photodetector(s) to determine the second physiological parameter.

Abstract: The present invention relates to a microfluidic based assay system, comprising a disposable assay cartridge and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using the cartridge and device of the invention, as well as kits for conducting assays.

Abstract: Disclosed is a method of performing a non-isothermal nucleic acid amplification reaction, the method comprising the steps of: (a) mixing a target sequence with one or more complementary single stranded primers in conditions which permit a hybridisation event in which the primers hybridise to the target, which hybridisation event, directly or indirectly, leads to the formation of a duplex structure comprising two nicking sites disposed at or near opposite ends of the duplex; and performing an amplification process by; (b) causing a nick at each of said nicking sites in the strands of the duplex; (c) using a polymerase to extend the nicked strands so as to form newly synthesised nucleic acid, which extension with the polymerase recreates nicking sites; (d) repeating steps (b) and (c) as desired so as to cause the production of multiple copies of the newly synthesised nucleic acid; characterised in that the temperature at which the method is performed is non-isothermal, and subject to a reduction of at least 2°

Abstract: The present invention relates to a microfluidic assay system and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using a disposable system and associated reading device, as well as kits for conducting assays.

Abstract: A subtractive corrective assay device and methodology, whereby ail required binding and label detection reagents are initially located within the detection zone. Application of a magnetic field is used to selectively remove bound label from the detection zone by means of paramagnetic particles. The relationship between measured label concentration before and after the application of a magnetic field within the detection zone is used to accurately measure analyte concentration within the sample.

Abstract: A health-monitor patch comprising at least one physiological sensor and digital processor is configured to be adhered to the skin of a subject. A health-monitor patch may further include an accelerometer and may detect cardiac waveforms, activity performed by the subject, and a body orientation of the subject. A health-monitor patch may be disposable, in some embodiments, and used for outpatient monitoring. Aspects of noise cancellation and reel-to-reel manufacturing are also described.

Abstract: The present invention relates to a microfluidic based assay system, comprising a disposable assay cartridge and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using the cartridge and device of the invention, as well as kits for conducting assays.

Abstract: A health-monitor patch comprising at least one physiological sensor and digital processor is configured to be adhered to the skin of a subject. A health-monitor patch may further include an accelerometer and may detect cardiac waveforms, activity performed by the subject, and a body orientation of the subject. A health-monitor patch may be disposable, in some embodiments, and used fox outpatient monitoring. Aspects of noise cancellation and reel-to-reel manufacturing are also described.

Abstract: In one embodiment, a method for implementing two-way communication between at least first and second devices comprises steps of: (a1) during finite time periods following transmission of respective first messages from the first device to the second device, using the first device to listen for second messages transmitted from the second device to first device; and (a2) after each of the finite time periods following the transmission of the respective first messages from the first device to the second device, ceasing to use the first device to listen for second messages transmitted from the second device to the first device until after the first device transmits another first message to the second device.