Systems and methods for conducting designated reactions utilizing a base instrument and a removable cartridge. The removable cartridge includes a fluidic network that receives and fluidically directs a biological sample to conduct the designated reactions. The removable cartridge also includes a flow-control valve that is operably coupled to the fluidic network and is movable relative to the fluidic network to control flow of the biological sample therethrough. The removable cartridge is configured to separably engage a base instrument. The base instrument includes a valve actuator that engages the flow-control valve of the removable cartridge. A detection assembly held by at least one of the removable cartridge or the base instrument may be used to detect the designated reactions.

Methods and containers are provided for identifying a species, illustratively a bacterial species. Illustrative methods comprise amplifying various genes in the nucleic acid from the bacterial species in a single reaction mixture using pairs of outer first-stage primers designed to hybridize to generally conserved regions of the respective genes to generate a plurality of first-stage amplicons, dividing the reaction mixture into a plurality of second-stage reactions, each using a unique pair of second-stage primers, each pair of second-stage primers specific for a target bacterial species or subset of bacterial species, detecting which of the second-stage reactions amplified, and identifying the bacterial species based on second-stage amplification. Methods for determining antibiotic resistance are also provided, such methods also using first-stage primers for amplifying genes known to affect antibiotic resistance a plurality of the second-stage reactions wherein each pair of second-stage primers specific for a specific gene for conferring antibiotic resistance.

A system and method for processing and detecting nucleic acids from a set of biological samples, comprising: a molecular diagnostic module configured to receive nucleic acids bound to magnetic beads, isolate nucleic acids, and analyze nucleic acids, comprising a cartridge receiving module, a heating/cooling subsystem and a magnet configured to facilitate isolation of nucleic acids, a valve actuation subsystem including an actuation substrate, and a set of pins interacting with the actuation substrate, and a spring plate configured to bias at least one pin in a configurations, the valve actuation subsystem configured to control fluid flow through a microfluidic cartridge for processing nucleic acids, and an optical subsystem for analysis of nucleic acids; and a fluid handling system configured to deliver samples and reagents to components of the system to facilitate molecular diagnostic protocols.

Devices, containers, and methods are provided for performing biological analysis in a closed environment. Illustrative biological analyses include nucleic acid amplification and detection and immuno-PCR.

A flow cell with a predetermined breaking barrier in a duct region of the flow cell. The flow cell has a cut-out in a substrate of the flow cell, which forms a portion of the duct region and has an opening in a surface of the substrate. The opening is hermetically sealed by a barrier film fused and/or glued to the surface and forming the predetermined breaking barrier. A layer is provided to be arranged over the barrier film. The layer can be stretched into the cut-out on breaking of the barrier film and formation of an access to a duct region section bounded by the barrier film and the layer.

There is provided a sample processing cartridge comprising a. a sample entry location; b. a closed sample processing chamber; c. a sample analysis location comprising a sample analysis well; d. a first channel fluidly connecting the sample entry location and the sample processing chamber; e. a second channel connecting the sample analysis location and the sample processing chamber, the second channel comprising a closed or closable second channel valve; wherein the sample processing chamber comprises a second channel port providing fluid connection between the second channel and the sample processing chamber, the second channel port being positioned in a sample accumulating region of the sample processing chamber. There is also provided a sample processing system comprising the cartridge, and methods of use of the cartridge and processing system in a sample processing assay.

A nano-fluidic device includes: a first substrate that has a nanoscale groove on one surface; and a second substrate that is integrally provided with the first substrate by bonding one surface of the second substrate to the one surface of the first substrate and forms a nanochannel with the groove of the first substrate, in which either the first substrate or the second substrate includes at least a thin portion in a part of a position overlapping the nanochannel in plan view, and the thin portion is deformed by pressing to open and close the nanochannel.

A circuit with electrical interconnect for external electronic connection and sensor(s) on a die are combined with a laminated manifold to deliver a liquid reagent over an active surface of the sensor(s). The laminated manifold includes fluidic channel(s), an interface between the die and the fluidic channel(s) being sealed. Also disclosed is a method, the method including assembling a laminated manifold including fluidic channel(s), attaching sensor(s) on a die to a circuit, the circuit including an electrical interconnect, and attaching a planarization layer to the circuit, the planarization layer including a cut out for the die. The method further includes placing sealing adhesive at sides of the die, attaching the laminated manifold to the circuit, and sealing an interface between the die and fluidic channel(s).

A microfluidic valve includes a carrier layer and a flexible membrane layer arranged on a surface of the carrier layer. The surface of the carrier layer has a valve chamber in the form of a spherical cap and a membrane formed by the flexible membrane layer covers at least the valve chamber. A plurality of microfluidic channels opening into the valve chamber are formed in the surface of the carrier layer. Moreover, an inflow channel and an outflow channel are connected to one another by a microfluidic connection channel. The connection channel and the valve chamber are positioned relative to each other in such a way that in the closed state of the membrane, a fluid can flow from the inflow channel via the connection channel into the outflow channel to bridge the valve chamber, while the at least one supply channel is closed by the membrane.

The device comprises a nib (12) having a working surface (16) exposed or exposable for acquiring a biological sample and a porous structure to absorb the sample thus acquired. A reservoir (28) provides fluid under pressure to the nib via a valve (29), conveying and dispensing the sample into a reaction chamber (14), where it reconstitutes a dried-down reagent (43) to perform an analytic reaction on the sample, for example, an isothermal amplification of nucleic acid released from the sample by a membrane-disrupting agent pre-functionalised in the porous nib. The nib may be initially mounted (A) in the outlet of the reservoir or (B) in the inlet to the reaction chamber, in either case with its working surface (16) initially exposed to acquire the sample before the components of the device are assembled for performing the analytical procedure.