Abstract: Disclosed are nucleic acid oligomers, including amplification oligomers, detection probes, and capture probes, for detection of Plasmodium species nucleic acid in a sample. Also disclosed are methods of specific nucleic acid amplification and detection, including amplification and detection of target nucleic acid in real time, using the disclosed oligomers, as well as corresponding reaction mixtures and kits.

Abstract: A receptacle delivery system for an instrument includes a carriage, a puck rotatably supported by the carriage, a first electric motor, and a second electric motor. The puck comprises a plurality of spring-loaded fingers arranged around a vertical axis and configured to removably support a receptacle therebetween. The first electric motor is configured to move the carriage between a first location and a second location of the instrument. The second electric motor is configured to rotate the puck about the vertical axis.

Abstract: Delivering a receptacle to an instrument comprises supporting a receptacle in a carriage when the carriage is positioned at a first location of the instrument, activating a sensing system coupled to the carriage to confirm that the receptacle is supported by the carriage, moving the carriage, and the receptacle supported therein, to a second location of the instrument, applying a clamping force to the receptacle as the carriage moves from the first location to the second location, at the second location, extracting at least a portion of a fluid contained in the receptacle using a fluid extraction device of the instrument, moving the carriage, and the receptacle supported therein, from the second location to the first location, and releasing the clamping force from the receptacle as the carriage moves from the second location to the first location.

Abstract: A method of automated sample processing includes aspirating a portion of a first sample from a first sample containing receptacle. The method includes dispensing the first sample portion into a first processing receptacle. The method includes transporting a first carrier coupled to the first processing receptacle containing the first sample from a position inside the first instrument to a host conveyor assembly using a first intermediate conveyor assembly. The method includes transporting the first carrier from the host conveyor assembly to a first processing position within a second instrument using a second intermediate conveyor assembly. The method includes aspirating a portion of the first sample from the first processing containing receptacle. The method includes dispensing the portion of the first sample into a first assay receptacle. The method includes performing a first assay on the portion of the first sample in the first assay receptacle using the second instrument.

Abstract: A method of transporting a carrier coupled to a receptacle to a processing position within an instrument. The method includes a step of transporting the carrier coupled to the receptacle from a first carrier position outside the instrument to a second carrier position located on a spur conveyor, where the first carrier position is laterally offset from the second carrier position. The method includes a step of grasping the carrier coupled to the receptacle at the second carrier position with a gripper of the spur conveyor. The method includes a step of moving the gripper, while the gripper is grasping the carrier coupled to the receptacle, along a first linear path defined by the spur conveyor to transport the carrier coupled to the receptacle from the second carrier position to the processing position within the instrument.

Abstract: A cap for dispensing lytic agents into a sample well of a fluidic cartridge includes a deformable wall defining a chamber. A lower sleeve situated beneath the deformable wall defines a recess that is open to the chamber. A frangible membrane affixed to an end of the lower sleeve encloses the recess and the chamber. Lytic agents comprising non-magnetic beads and a magnetic element are contained within the chamber and the recess. A method for lysing cells contained in a sample includes providing sample to the sample well, inserting the cap into the well, applying a force to the deformable wall so the lytic agents rupture the frangible membrane and are released into the well, and subjecting the sample and the lytic agents to a magnetic field causing the magnetic element to agitate the non-magnetic beads to lyse cells contained within the sample.

Abstract: This disclosure concerns amplification primers, hybridization assay probes, compositions containing such primers and probes, and associated reagents, kits, and methods, that can be used to analyze samples for the presence of Influenza A virus, Influenza B virus, Respiratory Syncytial Virus A, and/or Respiratory Syncytial Virus B target nucleic acids.

Abstract: An instrument for applying thermal energy to a reaction chamber of a test platform includes first and second heaters disposed in a spaced-apart configuration to receive the reaction chamber in a position so that the first and second heaters contact different parts of the reaction chamber. Each heater is configured to apply thermal energy to the reaction chamber by conductive heat transfer through a part of the reaction chamber contacted by the respective heater. A first controller is configured to control thermal energy generated by the first heater, and a second controller is configured to control thermal energy generated by the second heater. The first and second controllers control thermal energy generated by the first and second heaters, respectively, independently of each other to achieve a common temperature profile for the first heater and the second heater.

Abstract: Provided are compositions, kits, and methods that can be used to selectively amplify a first target nucleic acid that is distinguishable from a second target nucleic acid, where the two target nucleic acids have both common and different sequence domains. Structured primers useful in the amplification method include 5? and 3? target-hybridizing sequences separated from each other by a joining region that does not hybridize to the target nucleic acid. Polymerase-based extension of the structured primer depends on specific hybridization of the 5? sequence of the primer, thereby facilitating hybridization and extension of the 3? sequence of the primer.

Abstract: A method of loading consumables into a sample processing instrument. In the method, a tray storing sample processing consumables is aligned with a support cavity defined by a support of the sample processing instrument. A flange is contacted with a portion of the support, where the flange extends outward from a wall of a cover coupled to the tray. The cover is decoupled from the tray by pressing a panel of the cover, and the tray is seated in the support cavity.

Abstract: An instrument includes a first chassis and a second chassis that includes a cartridge support cradle configured to hold a cartridge with a sample chamber between the first and second chassis. An actuator coupled to one or both of the first and second chassis is configured to effect automated relative movement between the first and second chassis to vary a distance therebetween. A detector mounted within the upper chassis includes a plunger rod movable between first and second positions and a sensor for detecting when the plunger rod is in the second position. As the first and second chassis are moved relatively toward each other by the actuator, if the fluidic cartridge is situated on the cartridge support cradle, and a cap closes the sample chamber, the plunger rod will contact the cap and move from the first position to the second position.

Abstract: This disclosure provides oligomers, compositions, and kits for detecting and quantifying Hepatitis B virus (HBV), including different genotypes and variants thereof, and related methods and uses. In some embodiments, oligomers target the P and/or S open reading frames of HBV and are configured to provide substantially equivalent quantification of different genotypes and variants of HBV.

Abstract: Disclosed are compositions and methods for performing nucleic-acid-based assays to determine the presence or absence of a target nucleic acid in a biological sample. The disclosed methods include the use of one or more oligomers that specifically hybridize to a nucleolin nucleic acid to assess the cellularity of the biological sample. Also disclosed are related composition and methods for assessing the cellularity of a biological sample for use in a molecular diagnostic assay.

Abstract: An assembly includes first and second thermal modules. Each thermal module includes at least one thermal assembly comprising a thermal element in thermal contact with an associated thermal block. Each thermal block has an exposed contact surface, and each contact surface of the second thermal module is situated in aligned opposition with respect to an associated contact surface of the first thermal module. A thermal module actuator is configured to effect automated relative movement between the first thermal module and the second thermal module to vary a distance between the contact surface of each thermal assembly of the second thermal module and the associated contact surface of each thermal assembly of the first thermal module. An optical fiber is associated with a through hole extending through the thermal block of each thermal assembly of the first thermal module to transmit an optical signal through each thermal block of the first thermal module.

Abstract: A fluidic cartridge includes a cartridge body defining two or more fluidly connected wells, and at least one of the wells comprises an expansion well. A first coupling structure at least partially surrounds the expansion well, and a chamber expander is attached to the cartridge body. The chamber expander includes a base with a second coupling structure located on a bottom side of the base and configured to be operatively coupled to the first coupling structure to form a hermetic seal between the chamber expander and the cartridge body. An expansion chamber extends from the base to expand the capacity of the expansion well by at least the capacity of the expansion chamber. A mouth defines an opening into an interior space of the expansion chamber, and a cap is configured to be coupled to the mouth to close the opening.

Abstract: Disclosed are methods for diagnosing Bacterial Vaginosis in a subject comprising performing an assay for the detection of any one or more of Lactobacillus sp., Atopobium vaginae, and Gardnerella vaginalis in a subject sample. Also disclosed are compositions and methods for detecting Lactobacillus sp., Atopobium vaginae, and/or Gardnerella vaginalis nucleic acid in a sample.

Abstract: A fluid sample is dispensed into a sample chamber of a fluidic cartridge, the sample chamber containing non-magnetic beads, a magnetic element, and an internal control reagent contained within an internal control pellet including an internal control for validating an assay result and/or to validate the effectiveness of a cell lysis procedure. The magnetic element is exposed to a magnetic field, thereby causing movement of the magnetic element, which causes movement of the non-magnetic beads. Movement of the non-magnetic beads causes cells contained within the fluid sample to lyse and release nucleic acids. The internal control reagent dissolves in the presence of the fluid sample or movement of the non-magnetic beads disintegrates the internal control pellet, thereby releasing the internal control into the fluid sample. Movement of the magnetic element and the non-magnetic beads causes the internal control to be distributed within the fluid sample.

Abstract: A fluid sample is dispensed into a sample chamber of a fluidic cartridge, the sample chamber containing non-magnetic beads and a magnetic element. A portion of the non-magnetic beads and magnetic element have an internal control reagent containing an internal control deposited thereon for validating an assay result and/or to validate the effectiveness of a cell lysis procedure. The magnetic element is exposed to a magnetic field, thereby causing movement of the magnetic element, which causes movement of the non-magnetic beads. Movement of the non-magnetic beads causes cells contained within the fluid sample to lyse and release nucleic acids. The internal control reagent dissolves in the presence of the fluid sample, thereby releasing the internal control into the fluid sample, and the movement of the magnetic element and the non-magnetic beads causes the internal control to be distributed within the fluid sample.

Abstract: A lysis vessel for performing cell lysis includes a laterally extending member and a sleeve having a bottom end defining an open bottom end of the vessel. A first porous membrane is affixed to a top or bottom surface of the laterally extending member and covers a vent in the member. A second porous membrane is affixed to the bottom end of the sleeve and covers the open bottom end. The bottom surface of the laterally extending member, an inner surface of the sleeve, and the first and second porous membranes define a lysis chamber. A plurality of non-magnetic beads are contained within the lysis chamber, and at least one magnetic element is contained within the lysis chamber. The first and the second porous membranes are sized to retain the plurality of non-magnetic beads and the at least one magnetic element within the lysis chamber.