Systems and methods are disclosed for rapid PCR testing. Example embodiments may include a PCR testing module that includes a housing having a PCR machine disposed therein; a sample input station on the housing, wherein the sample input station is configured to receive a sample collection device (SCD) comprising a biological specimen sample provided by the patient; an SCD processing mechanism configured to transfer a lysed microportion of the biological specimen sample into a PCR sample tube attached to the SCD; at least one mechanism configured to separate the PCR sample tube from the SCD and transfer the PCR sample tube to the PCR machine; and a controller configured to (i) use the PCR machine to conduct a PCR test on contents of the PCR sample tube, and (ii) generate results of the PCR test.

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.

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.

An assembly includes a bracket, a magnetic elution slot, and a reagent pack loading station. The elution slot receives a multiple receptacle device having multiple receptacles interconnected by a connecting rib defining shoulders along either side of the receptacle device. The elution slot includes opposed walls attached to the bracket below a top surface of the bracket with the opposed walls disposed on either side of a slot formed in the bracket. The downwardly facing shoulders of the receptacle device are supported on the top surface of the bracket on opposed sides of the slot, and one or more magnets are attached to or embedded in one or both walls. The reagent pack loading station holds a multi-well reagent pack such that the wells of the reagent pack are accessible by a pipettor, and the reagent pack holding station includes spaced apart hold down features extending above the top surface of the bracket.

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.

An infectious disease screening system (1) for screening for infectious diseases, such as COVID-19 disease. The system comprises an ultrasonic transducer (49) for generating ultrasonic waves to lyse cells in a biological sample. The system (1) comprises a controller which controls the ultrasonic transducer (49) to oscillate at an optimum frequency for cell lysis, a PCR apparatus (16) which receives and amplifies the DNA from the sample; and a detection apparatus (70) which detects the presence of an infectious disease in the amplified DNA and provides an output which is indicative of whether or not the detection arrangement (70) detects the presence of an infectious disease in the amplified DNA.

The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

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.

A cap and a processing vial configured for interlocking engagement. The processing vial includes a locking collar surrounding an open upper end of the processing vial with lateral through holes formed through the locking collar. The vial also includes a latch hook located above each through hole. The cap includes a latch collar extending about a lower portion of the cap, where the latch collar is configured to snap in beneath the latch hooks of the processing vial when the lower portion of the cap is inserted into the open upper end of the processing vial to lock the cap to the processing vial.

A method for performing a nucleic acid amplification assay employs a thermally-conductive receptacle holder with one or more receptacle wells, each conforming to an outer surface of a lower portion of a vial. A through-hole extends from an inner surface of each well to an outer surface of the holder. A thermal element is positioned proximal to the holder for altering a temperature of the holder. A signal detection module is configured to generate an excitation signal directed through the through-hole of the well and detect an optical emission from a fluid contained in the vial supported by the well. At least one well supports a capped vial containing a reagent for a nucleic acid amplification assay and including an opaque cap sealing an open end of the vial. The lower portion of the vial is contained within a well, and the cap is situated above a top surface of the holder.