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Assignees
Member
CepheidCepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Cepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Publication Number
US-11927600-B2
Publication Date
2024-03-12
Expiration Date
Abstract
A fluidic bridge device for transport of a fluid sample between a first sample processing device and a second sample processing device. The fluidic bridge may include one or more fluid channels extending between fluid-tight couplings attachable to transfer ports of the first and second sample processing device. In one aspect the first device is a sample preparation device and the second device is an assay device. The fluidic bridge can include at least two fluid conduits, at least one for transport of the prepared sample, and at least one other to facilitate displacement of air to allow flow of the prepared sample through the other fluid conduit. The fluid channels can include one or more of an amplification chamber, a processing chamber, a gas-permeable vent, a bubble trap, a filter, and an external port. Methods of preparing and transporting a fluid sample between devices are provided herein.
Core Innovation
A fluidic bridge device for transport of a fluid sample between a first sample processing device and a second sample processing device is provided, wherein the fluidic bridge may include one or more fluid channels extending between fluid-tight couplings attachable to transfer ports of the first and second sample processing device. The fluidic bridge can include at least two fluid conduits, at least one for transport of the prepared sample, and at least one other to facilitate displacement of air to allow flow of the prepared sample through the other fluid conduit, and the fluid channels can include one or more of an amplification chamber, a processing chamber, a gas-permeable vent, a bubble trap, a filter, and an external port.
The invention addresses that conventional systems employing sequential processing arrangements are not versatile or easily adaptable to different protocols or processing and analysis systems, and that a single device may not provide the functionality needed to perform all the processing steps so that a user may need to utilize different devices. The present invention provides an apparatus, system and method for manipulating fluid samples to facilitate transport of a fluid sample prepared, at least in part, by a first sample processing device to a second sample processing device for further processing or analysis, including an elongate bridge having one or more fluid flow conduits extending between fluid-tight couplings on opposing ends to fluidly couple the first and second processing devices.
Claims Coverage
Independent claims identified: three. Main inventive features from those independent claims are extracted below.
Disposable cartridge comprising a plurality of chambers with a moveable valve body
A plurality of chambers contained within a housing, the chambers being fluidically interconnected by a moveable valve body comprising one or more fluid processing regions, wherein at least one of the fluid processing regions is configured for sample preparation.
Elongated fluidic bridge extending from the cartridge with fluid-tight couplings and one or more fluid channels
A fluidic bridge elongated along a length greater than a width, extending from the housing of the cartridge and having fluid-tight couplings on both opposing ends and one or more fluid channels extending in a lengthwise direction between the first and second ends adapted for transport of fluid into or out of the cartridge.
Fluidic bridge length sufficient to extend outside a cartridge receiver to allow transport to a separate device
The elongated fluidic bridge is of a sufficient length to extend outside a cartridge receiver device configured to receive the disposable cartridge for processing a sample to allow transport of the processed sample to another separate and independent device, wherein the fluidic bridge is configured for transporting a discrete amount of fluid sample obtained for biological analysis between the first and second device.
Module with cartridge receiver including cartridge interface unit, pressure interface unit, and sample preparation controller
A cartridge receiver adapted to receive and removably couple with the sample processing cartridge and interface with a separate and independent assay processing device, wherein the cartridge receiver includes a cartridge interface unit configured for moving the valve body, a pressure interface unit for applying pressure to move fluid among processing chambers, and a sample preparation controller configured to electronically communicate with the assay processing device and control the cartridge interface unit and pressure interface unit to process the unprepared sample into a prepared sample.
Module comprising a fluidic bridge coupleable with the sample processing cartridge and extending outside the cartridge receiver
A fluidic bridge that is elongated along a length greater than a width and coupleable with the sample processing cartridge, the fluidic bridge being of sufficient length to extend outside the cartridge receiver and having one or more fluid channels extending in a lengthwise direction between the first and second ends through which the sample processing cartridge and assay processing device are fluidly coupled to facilitate transport of the prepared sample to the assay processing device.
System comprising first and second separate sample processing devices and a fluidic bridge coupleable therebetween
A system comprising a first sample processing device configured for processing a fluid sample, a second sample processing device separate and independent from the first sample processing device configured for further processing of the fluid sample, and a fluidic bridge coupleable with each of the first and second sample processing device so as to facilitate transport of a fluid sample between the first and second sample processing device when coupled therebetween, wherein the fluidic bridge is elongated and extends a sufficient length such that it extends outside the first sample processing device.
The independent claims pool inventive features around (1) a disposable cartridge with a plurality of chambers interconnected by a moveable valve body for sample preparation, (2) an elongated fluidic bridge with fluid-tight couplings and one or more lengthwise channels that is sufficiently long to extend outside a cartridge receiver to transport discrete fluid samples between separate devices, (3) a module combining a cartridge receiver with interface units and a controller plus a bridge, and (4) a system comprising separate first and second sample processing devices coupled by the elongated fluidic bridge.
Stated Advantages
Allows intracellular material from a relatively large volume of fluid sample to be separated from the sample and concentrated into a much smaller volume of reaction fluid, permitting extraordinary concentration factors.
Improved versatility of analysis by facilitating transport of a prepared sample from a first sample processing device to a selected second sample processing device so various differing types of devices can be used.
Expedites the sample preparation process and allows for high volumes of samples to be prepared.
More consistent, predictable flow of fluid sample through the bridge where the cross-sectional area does not substantially vary across the length of the fluid channel.
Documented Applications
Transporting a prepared fluid sample from a sample preparation device to an assay or processing device for further processing or analysis, including detection of a target within the fluid sample.
Nucleic acid amplification testing (NAAT) including Polymerase Chain Reaction (PCR) assays for detecting a nucleic acid target.
Sample processing steps including filtering, concentrating, trapping debris, fragmenting DNA or RNA (e.g., by sonication), bisulfite treatment, reverse transcription, and final amplification with optical, chemical and/or electrical detection.
Use of the fluidic bridge with various sample analysis procedures including hybridization, optical interrogation, iso-electric focusing, antibody binding and detection (e.g., ELISA), sequencing, chromatography, and lateral flow chromatography.
Incorporation of processing features in the bridge such as an amplification chamber, filter, gas-permeable vent, bubble trap, micro-well array, isoelectric focusing region, optical detection window, or external port for aliquoting or adding reagents.
Systems in which a prepared sample is aliquoted between multiple subsequent sample preparation or analysis devices, including analysis for nucleic acid and protein and determining protein glycosylation.
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