Abstract: Improved methods for use in nucleic acid amplification, including multiplex amplification, where the amplification is carried out in two or more distinct phases are disclosed. The first phase amplification reaction preferably lacks one or more components required for exponential amplification. The lacking component is subsequently provided in a second, third or further phase(s) of amplification, resulting in a rapid exponential amplification reaction. The multiphase protocol results in faster and more sensitive detection and lower variability at low analyte concentrations. Compositions for carrying out the claimed methods are also disclosed.

Abstract: A conveyor assembly for transporting a carrier coupled to a receptacle to a processing station located within a housing of an instrument. The conveyor assembly includes a spur conveyor subassembly and a buffer conveyor subassembly for transporting the carrier from a host conveyor assembly to the spur conveyor subassembly. The spur conveyor subassembly includes (i) a rotatable diverter having at least one recess for receiving and moving the carrier between the buffer conveyor subassembly and the spur conveyor subassembly and (ii) a gripper configured to grasp the carrier and move it from the diverter to the processing position located within the housing of the instrument.

Abstract: Multiple receptacles containing a reaction mixture are transported to corresponding receptacle wells of a thermally-conductive receptacle holder in thermal communication with a support that is in thermal communication with a heat sink. The heat sink is pre-heated to a temperature above ambient temperature, and the temperature of the receptacle holder is cycled. Optical communication is established between each of the receptacle wells and an excitation signal source and an emission signal detector during cycling, and whether an emission signal is emitted from any of the receptacles is determined as an indication of the presence of a target nucleic acid.

Abstract: Disclosed are methods for amplifying a nucleic acid target region using an amplification oligomer comprising a target-binding segment and a heterologous displacer tag situated 5? to the target-binding segment. Initiation of an amplification reaction from the tagged amplification oligomer produces an amplicon comprising the displacer tag, such that once the complement of the displacer tag has been incorporated into a second amplicon, a displacer oligonucleotide having a sequence substantially corresponding to the displacer tag sequence is used to participate in subsequent rounds of amplification for displacement of an extension product primed from a site within the second amplicon 5? to the displacer priming site. Also disclosed are related kits and reaction mixtures comprising the displacer-tagged amplification oligomer and corresponding displacer oligonucleotide.

Abstract: A diagnostic system is configured to perform first and second, different nucleic acid amplification reactions. The system includes a bulk reagent container compartment configured to store first bulk reagent container containing a first bulk reagent for performing sample preparation processes with a first subset and a second subset of a plurality of samples and a second bulk reagent container containing a second bulk reagent for performing the first nucleic acid amplification reaction. The system includes a unit-dose reagent compartment storing a unit-dose reagent pack including unit-dose reagents for performing the second nucleic acid amplification reaction.

Abstract: Method and system for quantifying target nucleic acids using real-time amplification and internal calibration adjustment. The approach employs a single fixed data point in combination with a single adjustment calibrator amplified on the instrument that is to be calibrated for approximating a complete calibration curve.

Abstract: A method and apparatus for freezing a liquid droplet includes dispensing, by a liquid dispenser, a droplet of liquid into a fluid chamber containing a freezing liquid. The droplet of liquid is allowed to dwell in the freezing liquid for at least a predetermined dwell time so that the droplet of liquid freezes to a frozen droplet. The method and apparatus further includes injecting, by a gas injector, a stream of gas transversely to a surface of the freezing liquid at about where the frozen droplet is located along the surface of the freezing liquid contained in the fluid chamber so that the frozen droplet sinks in the freezing liquid.

Abstract: A reagent pack changer includes a reagent pack input device, a reagent pack storage compartment, a reagent pack storage carousel disposed within the storage compartment, and a rotary distributor. The input device includes a reagent pack input carousel rotatable about an axis of rotation, with reagent pack stations for holding reagent packs disposed around the axis of rotation of the carousel. The reagent pack storage carousel is rotatable about an axis of rotation with reagent pack stations for holding reagent packs disposed around the axis of rotation. The rotary distributor is configured to move a reagent pack between the reagent pack input carousel and the reagent pack storage carousel.

Abstract: A system includes a reagent pack input carousel, a carousel frame supporting the carousel, and a track on which the carousel frame is supported for movement of the carousel into and out of an instrument in drawer-like fashion. The carousel is rotatable about an axis of rotation and includes a plurality of reagent pack input stations arranged about the perimeter of the carousel. Each input station is adapted to carry a reagent pack, and the input stations are oriented at an angle with respect to a radial orientation relative to the axis of rotation. Each input station includes an alignment block located at a radially inner end of the station, and the block is received within a recess formed in an end of the reagent pack placed in the station to align and position of the reagent pack within the station.

Abstract: Disclosed are nucleic acid oligomers, including amplification oligomers, capture probes, and detection probes, for detection of Zika virus nucleic acid. Also disclosed are methods of specific nucleic acid amplification and detection using the disclosed oligomers, as well as corresponding reaction mixtures and kits.

Abstract: A sample processing station includes two or more container holders on a platform that is rotatable about a central axis of rotation. Each holder is configured to rotate about a secondary axis of rotation. The station includes a capping/decapping mechanism to cap or decap a container held in one of the container holders and an elevator with a chuck guide that contact the container holder as the chuck is lowered by the elevator to positon the chuck with respect to the cap of the container held in the holder and to hold jaws of the container holder in a closed position. In embodiment, the chuck guide includes a yoke with opposed arms and spindles located near distal ends of the arms that engage beveled shoulders of the container holder.

Abstract: Method and associated system for reading machine-readable labels on a plurality of sample receptacles held by a sample rack. In the method, a machine-readable label associated each of the plurality of sample receptacles is read with a first label reader when the rack is at a first location. The sample rack is then moved from the first location to a second location, where a rack identifier on the sample rack is sensed with a sensor separate from the first label reader. Finally, the rack identifier is associated with the machine-readable labels of the plurality of sample receptacles.

Abstract: A container includes a base with a top wall, a vessel depending from a top wall aperture in the top wall, a fluid retainer projecting above the top wall and surrounding the top wall aperture, and a skirt surrounding the vessel and including opposed grooves for gripping the container. A lid is disposed on a top end of the base and includes a cover wall with a lid aperture generally aligned with the top wall aperture of the base. A septum is disposed between the top wall of the base and the cover wall with a portion of the septum disposed between the lid aperture and the top wall aperture. Fluid retainer/return structure is configured to prevent fluid deposited on the septum from dripping off the container and to allow at least a portion of the fluid deposited on the septum to run off the septum and into the vessel.

Abstract: An apparatus for performing nucleic acid amplification reactions includes a thermally-conductive receptacle holder with front and back surfaces. The front surface includes a row of receptacle wells, and an outer surface of each well has a frustoconical shape, an inner surface of each well receives a receptacle, and each well has a through-hole extending between the inner and outer surfaces thereof. One or more thermal elements in contact with the back surface of the holder alter a temperature(s) of the holder. The apparatus includes multiple optical fibers, and each optical fiber provides optical communication between one of the wells and an excitation signal source and/or an emission signal detector. A first end of each optical fiber is disposed outside, within, or extends through the through-hole of a corresponding well, and a second end of each optical fiber is in optical communication with the excitation signal source and/or the emission signal detector.

Abstract: A receptacle cap includes a probe recess configured to receive a probe inserted therein to thereby frictionally secure the receptacle cap to the probe, and a closed lower end of the receptacle is insertable into an open end of a reaction receptacle to close the reaction receptacle. The receptacle cap and the reaction receptacle include interlocking features for securing the receptacle cap to the reaction receptacle.

Abstract: Method and system for quantifying target nucleic acids using real-time amplification and internal calibration adjustment. The approach employs a single fixed data point in combination with a single adjustment calibrator amplified on the instrument that is to be calibrated for approximating a complete calibration curve.

Abstract: A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest includes a base and first and second covers and is configured to support one or more receptacles each supporting one or more substances within interior spaces of the lyophilization nest. The interior spaces may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through the first and second covers. Each of the one or more vent holes have a corresponding sealing element configured to selectively form an air-tight seal within the vent holes, such that a controlled environment may be maintained within the interior spaces when the ambient conditions surrounding the lyophilization nest are not lyophilization conditions. The one or more sealing elements may be operable while the lyophilization nest is positioned within a sealed lyophilizer by depressing the sealing elements into corresponding vent holes to form the air-tight seal.

Abstract: A system includes a reagent pack input carousel, a carousel frame supporting the carousel, and a track on which the carousel frame is supported for movement of the carousel into and out of an instrument in drawer-like fashion. The carousel is rotatable about an axis of rotation and includes a plurality of reagent pack input stations arranged about the perimeter of the carousel. Each input station is adapted to carry a reagent pack, and the input stations are oriented at an angle with respect to a radial orientation relative to the axis of rotation. Each input station includes an alignment block located at a radially inner end of the station, and the block is received within a recess formed in an end of the reagent pack placed in the station to align and position of the reagent pack within the station.

Abstract: A nucleic acid diagnostic system includes a unit-dose reagent compartment storing at least one unit-dose pack, one or more unit-dose pack loading stations for holding a unit-dose pack at a location that permits a substance transfer device to dispense a reconstitution reagent into each well of the pack, a unit-dose pack distributor configured to transfer a unit-dose pack from the unit-dose reagent compartment to one of the unit-dose pack loading stations, and an electrostatic generator disposed within the housing of the unit-dose reagent compartment and/or adjacent the one or more unit-dose pack loading stations. The electrostatic generator imparts an electrostatic charge to each of the wells of the unit-dose pack and/or to a lyophilized reagent pellet within each well so that the electrostatic charge positions and holds each lyophilized reagent pellet at a bottom of each respective well of the unit-dose pack.

Abstract: A receptacle holder for supporting at least one fluid-containing receptacle includes a body and an RFID transponder. The body includes an electrically conductive portion defining a first recess configured to receive at least a first fluid-containing receptacle, and an electrically non-conductive portion attached to the electrically conductive portion. The RFID transponder is disposed on the electrically non-conductive portion of the body, and stores information about the receptacle holder. The receptacle holder can also include the first fluid-containing receptacle received within the first recess.