A fluid container holder includes a body having a receptacle configured to receive a container. The body has a conductive outer surface for connection to an electrical ground or voltage source, and the holder is not formed solely of an electrically conductive metal. A fluid container handling assembly includes a drawer having a holder supporting a fluid container, and a frame supporting the holder. The frame is movable between a first position providing access to the holder and a second position positioning the holder within the instrument. The assembly also includes a first lock securing the holder to the frame when the frame is at the first frame position and unlocking the holder from the frame when the frame is at the second frame position. The assembly also includes a holder transporter configured to move the holder between a first holder position and a second holder position within the instrument.
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Claim 1: . A holder for supporting one or more containers of fluid, the holder comprising:
Claim 2: . The holder of, wherein the first electrically nonconductive portion of the bottom wall and the secondtheelectrically nonconductive portion of the at least one of the first and second side walls each comprise an electrically non-conductive plastic.
Claim 3: . The holder of, wherein the first electrically conductive metal coating of the bottom wall and the second electrically conductive metal coating of the at least one of the first and second side walls are both made of either aluminum or copper.
Claim 4: . The holder of, wherein the one or more receptacles include multiple receptacles.
Claim 5: . The holder of, wherein the first electrically nonconductive portion of the bottom wall includes an inner surface, and each receptacle of the one or more receptacles extends from one of the one or more openings on the top surface to the inner surface of the bottom wall opposite the outer surface.
Claim 6: . The holder of, wherein the second electrically conductive metal coating of the at least one of the first and second side walls covers about 20% to about 30% of a vertical height of the second electrically nonconductive portion of the at least one of the first and second side walls.
Claim 7: . The holder of, wherein the second electrically conductive metal coating of the at least one of the first and second side walls covers substantially the entirety of the second electrically nonconductive portion of the at least one of the first and second side walls.
Claim 8: . The holder of, wherein the second electrically conductive metal coating of the at least one of the first and second side walls has a thickness between about 0.5 mils and about 2.0 mils.
Claim 9: . The holder of, wherein the first electrically conductive metal coating of the bottom wall has a thickness between about 0.5 mils to about 2.0 mils.
Claim 10: . The holder of, wherein the first and second electrically nonconductive portions comprise the same material.
Claim 11: . The holder of, wherein the first and second electrically conductive metal coatings comprise the same metal.
Claim 12: . The holder of, wherein:
Claim 13: . The holder of, wherein the second electrically conductive metal coating of the at least one of the first and second side walls covers about 20% to about 30% of a vertical height of the second electrically nonconductive portion of the at least one of the first and second side walls.
Claim 14: . The holder of, wherein the second electrically conductive metal coating of the at least one of the first and second side walls covers substantially the entirety of the second electrically nonconductive portion of the at least one of the first and second side walls.
Claim 15: 15. The holder of clam 1, wherein each receptacle has a size and shape that matches a size and shape of a fluid filled container to be received in the receptacle.
Claim 16: 16. The holder of, further comprising one or more knobs extending from the bottom wall.
Claim 17: 17. The holder of, wherein the one or more knobs comprise a first knob aligned with each receptacle of the one or more receptacles.
Claim 18: 18. The holder of, wherein each first knob comprises a post portion extending from the bottom wall and a flange extending outwardly from a distal end of the post portion.
Claim 19: 19. The holder of, wherein the one or more knobs comprise a second knob aligned with each receptacle of the one or more receptacles.
Claim 20: 20. The holder of, further comprising a crevice formed in the first and second side walls and the bottom wall that separates each of the multiple receptacles.
Claim 21: 21. The holder of, further comprising:
Claim 22: 22. The holder of, wherein each channel is at least partially bounded by a spring arm.
Claim 23: 23. The holder of, further comprising:
Claim 24: 24. A compartment for storing fluids in an instrument, the compartment comprising:
Claim 25: 25. An instrument configured to analyze one or more samples, comprising:
Claim 26: 26. The instrument of, further comprising:
Claim 27: 27. The instrument of, wherein the one or more holders are positioned on, or proximate to, a surface of the instrument such that the electrically conductive outer surface of a first holder of the one or more holders is electrically grounded by a direct or indirect physical contact with the surface.
Claim 28: 28. The instrument of, wherein each holder of the one or more holders further includes a cover configured to retain the one or more containers in each holder while providing access to the one or more containers by the fluid transfer device, the cover including an electrically nonconductive portion that extends at least partially over the one or more containers.
Claim 29: 29. A method of detecting a fluid level in a container including a fluid, comprising:
Claim 30: 30. A method of extracting fluid from a container, comprising:
Claim 31: 31. The method of, wherein the method further comprises:
Claim 32: 32. The method of, wherein the bottom wall is connected to the electrical ground via an electrically conductive spring.
Complete technical specification and implementation details from the patent document.
The present applicationis a reissue of U.S. Pat. No. 11,345,946, whichclaims the benefit of priority under 35 U.S.C. § 119(e) based on U.S. Provisional Application Ser. No. 62/480,977 filed on Apr. 3, 2017, and U.S. Provisional Application Ser. No. 62/476,529 filed on Mar. 24, 2017. The entire content ofthe patent andeach of these applications is incorporated herein by reference thereto.
This disclosure is directed to systems for detection of a fluid level through capacitive techniques and for handling containers, and related methods of use.
Automated analytical procedures for analyzing a sample (e.g., a biological sample, chemical sample, etc.) typically require the use of consumable reagents in the form of fluid solutions and/or suspensions. In some cases, such consumables are stored in containers in an instrument that is configured to perform the analysis. During the analysis, these reagents may be accessed by a fluid transfer apparatus (e.g., a robotic pipettor) of the instrument through a penetrable seal, cover, or septum of the container. Over time, the reagents get consumed, and their levels in the containers decrease. Many techniques may be used to detect the level of the reagents in the containers. The current disclosure describes a capacitance based technique to detect the level of the reagent in the container.
Sometimes containers filled with fluid reagents are stored in and/or loaded into the instrument at different areas from where the fluid reagent is actually used by the instrument. The current disclosure describes various techniques for handling containers as the containers are loaded into and moved within the instrument.
In some embodiments, a holder for supporting one or more containers of fluid is disclosed. The holder may include a bottom wall having an electrically conductive outer surface for connection to an electrical ground or voltage source, a top surface defining one or more openings, and one or more receptacles. Each receptacle of the one or more receptacles may depend from an opening of the one or more openings towards the bottom wall. Each receptacle is configured to receive at least one container of the one or more containers. The holder may not be formed solely of an electrically conductive material.
Additionally or alternatively, embodiments of the system may include one or more of the following features: the electrically conductive outer surface may be provided by an electrically conductive material affixed to an electrically nonconductive surface of the bottom wall; the electrically conductive material may be coated on the electrically nonconductive surface of the bottom wall; the electrically conductive material may include one of aluminum and copper; the holder may further include first and second side walls, wherein the one or more receptacles may be between the first and second side walls; at least one of the first and second side walls may include an electrically conductive outer surface contiguous with the electrically conductive outer surface of the bottom wall; the electrically conductive outer surface of at least one of the first and second side walls may be provided by an electrically conductive material affixed to an electrically nonconductive surface; the holder may further include an RFID tag affixed to a non-conductive surface of the holder; the one or more receptacles may include multiple receptacles; each receptacle of the one or more receptacles may extend from one of the one or more openings on the top surface to an inner surface of the bottom wall opposite the outer surface.
In some embodiments, a holder for supporting one or more containers of fluid is disclosed. The holder may include a bottom wall, first and second side walls, a top surface defining one or more openings, and one or more receptacles between the first and second side walls. Each receptacle of the one or more receptacles (a) may be in communication with an opening of the one or more openings, (b) may extend from the opening towards the first surface of the bottom wall, and (c) may be configured to receive at least one container of the one or more containers. At least one of the bottom wall, the first side wall, and the second side wall may have an electrically conductive layer affixed to an outer surface thereof. The electrically conductive layer may be for connection to an electrical ground or voltage source.
Additionally or alternatively, embodiments of the system may include one or more of the following features: the electrically conductive layer may be affixed to at least one of the bottom wall, the first side wall, and the second side wall; the electrically conductive layer may be coated on at least one of the bottom wall, the first side wall, and the second side wall; the electrically conductive layer may include one of aluminum and copper; the first and second side walls may be electrically nonconductive and extend between the top surface and the bottom wall; the bottom wall and at least one of the first and second side walls may include the electrically conductive layer; the electrically conductive layer may extend from the bottom wall to the top surface of at least one of the first and second side walls; the one or more receptacles may include multiple receptacles; each receptacle of the one or more receptacles may extend from one of the one or more openings on the top surface to the first surface of the bottom wall, and a base of a container positioned in each receptacle contacts the first surface.
In some embodiments, a frame for supporting one or more containers of fluid is disclosed. The frame may include one or more holders. Each holder of the one or more holders may include a top surface defining one or more openings, a bottom wall having an electrically conductive outer surface for connection to an electrical ground or voltage source, one or more receptacles, wherein each receptacle of the one or more receptacles may depend from an opening of the one or more openings towards the bottom wall, and one or more containers containing a fluid. Each container of the one or more containers may be (a) positioned in a receptacle of the one or more receptacles, and (b) may be configured to receive a probe tip of a fluid transfer device adapted for capacitive fluid level sensing.
Additionally or alternatively, embodiments of the system may include one or more of the following features: the electrically conductive outer surface may be affixed to an electrically nonconductive surface of the bottom wall; the electrically conductive outer surface may be coated on the electrically nonconductive surface of the bottom wall; the electrically conductive outer surface may include one of aluminum and copper; each holder may further include first and second side walls extending between the top surface and the bottom wall, wherein the one or more receptacles may be between the first and second side walls; at least one of the first and second side walls may include an electrically conductive outer surface contiguous with the electrically conductive outer surface of the bottom wall; the electrically conductive outer surface of at least one of the first and second side walls may be affixed to an electrically nonconductive surface; the electrically conductive outer surface of at least one of the first and second side walls is coated on the electrically nonconductive surface; the bottom wall, the first side wall, and the second side wall may be part of a single component made of an electrically nonconductive material; frame may further include a cover configured to retain a container in a receptacle; the cover may include an electrically nonconductive portion that extends over at least a portion of a top surface of the container; at least one of the one or more containers may include an electrically conductive seal that the probe tip of fluid transfer device passes through when the probe tip of fluid transfer device enters the container; the one or more holders may be positioned on, or proximate to, a surface of the frame such that the electrically conductive outer surface of a first holder of the one or more holders is electrically grounded by a direct or indirect physical contact with the surface; the frame may further include an electrically conductive spring positioned between the electrically conductive outer surface of the first holder and the surface of the frame to establish the physical contact; the one or more holders may include multiple holders, and the one or more receptacles may include multiple receptacles; the frame may further include one or more indicators configured to indicate a status of the one or more containers; the one or more holders may be removably positioned on the frame.
In some embodiments, an instrument configured to analyze one or more samples is disclosed. The instrument may include one or more holders for supporting one or more containers of fluid. Each holder may include a top surface defining one or more openings, first and second side walls, and a bottom wall having an electrically conductive outer surface configured to be connected to an electrical ground. The holder may also include one or more receptacles between the first and second side walls. Each receptacle of the one or more receptacles may depend from an opening of the one or more openings towards the bottom wall, and each receptacle may also be configured to receive at least one container of the one or more containers, and a probe tip of the fluid transfer device adapted for capacitive fluid level sensing. The one or more containers may be accessible by the probe tip of the fluid transfer device.
Additionally or alternatively, embodiments of the system may include one or more of the following features: the electrically conductive outer surface may be affixed to an electrically nonconductive surface of the bottom wall; the electrically conductive outer surface may be coated on an electrically nonconductive surface of the bottom wall; the electrically conductive outer surface may include one of aluminum and copper; at least one of the first and second side walls may include an electrically conductive outer surface contiguous with the electrically conductive outer surface of the bottom wall; the electrically conductive surface of the at least one of the first and second side walls may be affixed to an electrically nonconductive surface; the electrically conductive outer surface of the at least one of the first and second walls may be coated on the electrically nonconductive surface; the instrument may further include an electrically conductive brush configured to contact at least one of the bottom wall and the at least one of the first and second side walls to electrically ground the electrically conductive outer surface of at least one of the bottom wall and the at least one of the first and second side walls; the instrument may further include a transporter configured to move at least one holder of the one or more holders from a first location to a second location in the instrument, wherein the second location includes the electrically conductive brush; the one or more holders may be positioned on, or proximate to, a surface of the instrument such that the electrically conductive outer surface of a first holder of the one or more holders is electrically grounded by a direct or indirect physical contact with the surface; the instrument may further include a spring positioned between the electrically conductive outer surface of the first holder and the surface of the instrument to establish the physical contact; each holder includes at least one container of the one or more containers may be positioned in at least one of the one or more receptacles; each holder may further include a cover configured to retain the one or more containers in the holder while providing access to the one or more containers by the probe tip of the fluid transfer device, the cover may include an electrically nonconductive portion that extends at least partially over the one or more containers; the one or more holders may include multiple holders removably positioned on the instrument, and the one or more receptacles may include multiple receptacles.
In some embodiments, a method of detecting a fluid level in a container including a fluid is disclosed. The method may include positioning the container in a receptacle of a holder such that a bottom surface of the container is disposed on, or is positioned proximate to, a first surface of the holder, wherein a second surface of the holder opposite the first surface includes an electrically conductive layer that is electrically grounded. The method may also include inserting a probe tip of the fluid transfer device having a probe tip configured for capacitive fluid level sensing into the container to detect a level of the fluid in the container.
Additionally or alternatively, embodiments of the system may include one or more of the following features: the electrically conductive layer may be attached to an electrically nonconductive surface of the holder; the electrically conductive layer may be coated on an electrically nonconductive surface of the holder; the holder may include a top surface spaced apart from the first surface such that the receptacle extends from the top surface towards the first surface, and the holder may further include a side wall having an electrically conductive side surface extending from the electrically conductive layer of the second surface towards the top surface; the method may further include electrically grounding the electrically conductive layer of the second surface by contacting the electrically conductive side surface to an electrical ground via an electrically conductive brush; contacting the electrically conductive side surface to an electrical ground may include moving the holder from a first location to a second location to engage the electrically conductive side surface with the electrically conductive brush; the electrically conductive layer of the second surface may be connected to an electrical ground via an electrically conductive metal spring; a top surface of the container opposite the bottom surface of the container may include an electrically conductive seal, wherein inserting the probe tip of the fluid transfer device may include inserting the probe tip into the container through the electrically conductive seal; the method may further include retracting the probe tip of the fluid transfer device from the container; retracting the probe tip of the fluid transfer device from the container may include restraining the container in the receptacle using a cover that extends over at least a portion of the container, wherein the cover includes an electrically nonconductive surface facing the electrically conductive seal.
In some embodiments, a method of extracting fluid from a container is disclosed. The method may include positioning the container in a receptacle of a holder. The receptacle may extend from a top surface of the holder towards a bottom wall of the holder, the bottom wall including an electrically conductive bottom surface that is connected to an electrical ground. The method may also include inserting a probe tip of the fluid transfer device having a probe tip configured for capacitive fluid level sensing into the container, detecting a level of the fluid in the container using the probe tip, and extracting fluid from the container using the probe tip of the fluid transfer device.
Additionally or alternatively, embodiments of the system may include one or more of the following features: the electrically conductive bottom surface may be affixed to an electrically nonconductive surface of the holder; the electrically conductive bottom surface may be coated on the electrically nonconductive surface of the holder; the holder may include a side wall that extends from the bottom wall to the top surface, the side wall may include an electrically conductive side surface that is contiguous with the electrically conductive bottom surface of the bottom wall; the method may further include electrically grounding the electrically conductive surfaces of the holder by contacting the bottom surface or the side surface to an electrical ground or voltage source via an electrically conductive brush; contacting the side surface to an electrical ground may include moving the holder from a first location to a second location to contact the side surface with the electrically conductive brush; the bottom surface may be connected to electrical ground via an electrically conductive spring; a top surface of the container opposite the bottom wall may include an electrically conductive seal, and wherein inserting the fluid transfer device may include inserting the probe tip into the container through the electrically conductive seal; the method may further include retracting the fluid transfer device from the container, and restraining the container in the receptacle using a cover that extends over at least a portion of the container.
In some embodiments, an assembly for handling a fluid container within an instrument includes a drawer having a holder, a frame, and a first lock. The holder is configured to support at least one fluid container. The frame is configured to support the holder, and is movable between (a) a first frame position providing access to the holder and (b) a second frame position positioning the holder within the instrument at a first holder position. The first lock secures the holder to the frame when the frame is at the first frame position and unlocks the holder from the frame when the frame is at the second frame position. The assembly also includes a holder transporter configured to move the holder between (a) the first holder position and (b) a second holder position within the instrument, wherein at least a portion of a path that the holder travels between the first holder position and the second holder position comprises a vertical component.
In some embodiments, the holder includes a first knob, and the frame comprises a base panel defining a first opening. The first knob of the holder extends through the opening when the holder is supported by the frame. The first lock can include an arm movable relative to the opening between (a) a first arm position at which the arm engages a portion of the first knob extending through the opening, thereby securing the holder to the frame, and (b) a second arm position at which the arm is disengaged from the portion of the first knob extending through the opening, thereby unlocking the holder from the frame. The holder can also include a second knob, and the base panel of the frame can further define a second opening. The second knob of the holder extends through the second opening when the holder is supported by the frame. The first lock, at the first arm position, engages a portion of the second knob extending through the second opening and, at the second arm position, is disengaged from the portion of the second knob extending through the second opening, thereby unlocking the holder from the frame.
In some embodiments, the arm comprises a first hook configured to engage the portion of the first knob extending through the first opening, and a second hook configured to engage the portion of the second knob extending through the second opening. The first knob and the second knob can each comprise a flange extending from a distal end of the respective first knob and second knob. The first hook and the second hook, at the first arm position, can be positioned between the respective flange and the base panel of the frame, thereby inhibiting vertical movement of the holder relative to the frame. In some embodiments, the arm rotates about an axis defined by a pivot pin coupled to the frame. The arm can be biased to the first arm position or to the second arm position. The drawer further includes a spring that biases the arm.
In some embodiments, the holder defines at least one slot, and the frame comprises at least one holder engagement member configured to be received in the at least one slot when the holder is supported by the frame. The at least one holder engagement member can be a protrusion extending from a panel.
In some embodiments, the drawer further comprises a stationary support, and the frame is movable relative to the stationary support. The drawer also includes a second lock configured to inhibit movement of the frame relative to the stationary support when the frame is at the second frame position and the holder is unlocked from the frame. The second lock can include one of a hook and a catch coupled to the moveable frame, and the other of the hook and the catch coupled to the stationary support. The hook cooperatively engages the catch when the frame is at the second frame position.
In some embodiments, the holder transporter includes a holder support configured to cooperatively engage the holder at the first holder position when the frame is at the second frame position. The holder support can include a pin, and the holder can include a channel configured to receive the pin when the moveable frame is at the second frame position, thereby generating an interference fit between the pin and the holder. The holder can also include a spring arm defining, at least in part, the channel. The holder can also include a flange, and the holder support can include a surface supporting the flange when the frame is at the second frame position. The holder support can also include a top portion spaced apart from the surface and inhibiting upward movement of the at least one fluid container supported by the holder when the frame is at the second frame position. The top portion may define an opening exposing at least a portion of the at least one fluid container supported by the holder when the moveable frame is at the second frame position.
In some embodiments, the holder transporter includes an actuator, and a movable transporter arm coupling the actuator to the holder support. The actuator rotates the movable transporter arm such that the holder support moves the holder along an arcuate path between the first holder position and the second holder position. The actuator can be an electric motor. The transporter can also include a second movable transporter arm coupled to the holder support.
In some embodiments, the instrument is an analytical instrument. The analytical instrument can include a first module configured to perform first analyses on samples, and a second module configured to perform second analyses different from the first analyses. The first holder position is within the first module, and the second holder position is within the second module. The first analyses can include performing first nucleic acid amplification reactions requiring thermal cycling, and the second analyses can include performing second nucleic acid amplification reactions requiring isothermal conditions. The first nucleic acid amplification reactions can include PCR reactions, and the second nucleic acid amplification reactions can include TMA reactions, NASBA reactions, and/or SDA reactions.
In some embodiments, a transporter moves a holder within an instrument. The holder is configured to support a container. The transporter can include a holder support configured to releasably couple with the holder, and an actuator coupled to the holder support and configured to move the holder support. The holder support is movable between (a) a first position at which the holder support is configured to receive the holder and (b) a second position. At least a portion of a path that the holder support travels between the first position and the second position comprises a vertical component.
In some embodiments, the holder support includes a pin configured to be received in a channel defined by the holder, thereby generating an interference fit between the pin and the holder. In some embodiments, the holder support includes a surface configured to support a portion of the holder, and a top portion spaced apart from the surface configured to inhibit upward movement of a fluid container supported by the holder when the holder is coupled to the holder support. The top portion may define an opening exposing at least a portion of the fluid container supported by the holder.
In some embodiments, the actuator comprises an electric motor.
In some embodiments, the transporter also includes a movable arm coupling the actuator to the holder support. The actuator can rotate the movable arm such that the holder support moves along an arcuate path.
The transporter can be part of an analytical instrument. The analytical instrument can include a first module configured to perform first analyses on samples, and a second module configured to perform second analyses different from the first analyses. The first position is within the first module, and the second position is within the second module, in some embodiments.
In some embodiments, wherein the first analyses comprise performing first nucleic acid amplification reactions requiring thermal cycling, and the second analyses comprise performing second nucleic acid amplification reactions requiring isothermal conditions. The first nucleic acid amplification reactions can include performing PCR reactions, and the second nucleic acid amplification reactions can include performing TMA reactions, NASBA reactions, and/or SDA reactions.
In some embodiments, a method of handling a fluid container used by an instrument includes (a) moving a frame supporting a holder from (i) a first frame position providing access to the holder to (ii) a second frame position positioning the holder within the instrument, the holder supporting at least one fluid container; (b) unlocking the holder from the frame; and (c) moving, after step (b), the holder from the frame to another position along a path comprising a vertical component.
In some embodiments, step (b) includes moving a locking arm from (i) a first lock position at which the locking arm engages a portion of a first knob of the holder to (ii) a second lock position at which the arm is disengaged from the portion of the first knob of the holder. The locking arm can engage a portion of a second knob of the holder at the first lock position, and the locking arm can be disengaged from the portion of the second knob of the holder at the second lock position.
In some embodiments, step (b) can occur after or concurrently with step (a).
In some embodiments, the method also includes (d) engaging the holder with a holder support of the holder transporter when the frame is at the second frame position. Step (d) can occur after or concurrently with step (a).
In some embodiments, step (c) includes rotating an arm coupled to the holder support using an actuator, thereby moving the holder support along an arcuate path.
In some embodiments, the frame is positioned within a first module of an analytical instrument configured to perform first analyses on samples, and the other position the holder is moved to along the path is in a second module of the analytical instrument configured to perform second analyses on samples different than the first analyses. The first analyses can include performing first nucleic acid amplification reactions requiring thermal cycling, and the second analyses can include performing second nucleic acid amplification reactions requiring isothermal conditions for the duration of the second nucleic acid amplification reactions. The first nucleic acid amplification reactions can include PCR reactions, and the second nucleic acid amplification reactions can include TMA reactions, NASBA reactions, or SDA reactions.
In some embodiments, after step (c), the method further includes (e) inserting a probe tip of a first fluid transfer device into the fluid container at the other position in the second module of the analytical instrument; (f) aspirating at least a portion of fluid in the fluid container using the first fluid transfer device; and (g) withdrawing the probe tip of the first fluid transfer device from the fluid container.
In some embodiments, the method further includes (h) inserting a probe tip of a second fluid transfer device into the fluid container supported by the frame when the frame is at the second frame position; (i) aspirating at least a portion of fluid in the fluid container using the second fluid transfer device; and (j) withdrawing the probe tip of the second fluid transfer device from the fluid container. In some embodiments, steps (h), (i), and (j) occur before step (c).
In some embodiments, the method includes (k) moving the holder from the other position in the second module of the analytical instrument to the frame in the first module. The method can also include (l) moving the frame supporting the holder from (i) the second frame position to (ii) the first frame position; and (m) locking the holder to the frame. In some embodiments, step (m) occurs before or concurrently with step (l).
In some embodiments, the method further includes manually removing the fluid container from the holder while the frame is at the first frame position and the holder is locked to the frame.
Further features and advantages of the embodiments, as well as the structure and operational of various embodiments, are described in detail below with reference to the accompanying drawings. It is noted that the invention is not limited to the specific embodiments described herein. Such embodiments are presented herein for illustrative purposes only. Additional embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein.
The features and advantages of the embodiments will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout.
Reference will now be made in detail to examples of the present disclosure, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. Although embodiments of the current disclosure are described with reference to its application in an instrument that performs molecular genetics related analysis, this is only exemplary. As a person skilled in the art would recognize, embodiments of the current disclosure may be applied to any application.
Unless defined otherwise, all terms of art, notations and other scientific terms/terminology used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this disclosure belongs. All patents, applications, published applications and other publications (literature) referred to herein are incorporated by reference in their entirety. If a definition set forth in this section is contrary to or otherwise inconsistent with a definition set forth in the literature incorporated herein by reference, the definition set forth in this section prevails over the definition that is incorporated by reference.
References in the specification to “one embodiment,” “an embodiment,” a “further embodiment,” “an example embodiment,” “some aspects,” “a further aspect,” “aspects,” “for example,” “exemplary,” “some embodiments,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, such feature, structure, or characteristic is also a description in connection with other embodiments whether or not explicitly described. Further, as used herein, “a” or “an” means “at least one” or “one or more.”
In the discussion that follows, relative terms such as “about,” “substantially,” “approximately,” etc. are used to indicate a possible variation of ±10% in a stated numeric value. Further, the description below may use relative spatial and/or orientation terms in describing the position and/or orientation of a component, apparatus, location, feature, or a portion thereof. Unless specifically stated, or otherwise dictated by the context of the description, such terms, including, without limitation, top, bottom, above, below, under, on top of, upper, lower, left of, right of, inside, outside, inner, outer, proximal, distal, in front of, behind, next to, adjacent, between, horizontal, vertical, diagonal, longitudinal, transverse, etc., are used for convenience in referring to such component, apparatus, location, feature, or a portion thereof in the drawings and are not intended to be limiting.
As used herein, a “sample” refers to any material to be analyzed, regardless of the source. The material can be in its native form or any stage of processing (e.g., the material can be chemically altered or it can be one or more components of a sample that have been separated and/or purified from one or more other components of the sample). A sample can be obtained from any source, including, but not limited to, an animal, environmental, food, industrial or water source. Animal samples include, but are not limited to, peripheral blood, plasma, serum, bone marrow, urine, bile, mucus, phlegm, saliva, cerebrospinal fluid, stool, biopsy tissue including lymph nodes, respiratory tissue or exudates, gastrointestinal tissue, cervical swab samples, semen or other body or cellular fluids, tissues, or secretions. Samples can be diluted or contained within a receptacle containing diluents, transport media, preservative solution, or other fluids. As such, the term “sample” is intended to encompass samples contained within a diluent, transport media, and/or preservative or other fluid intended to hold a sample.
As used herein, a “diagnostic instrument” refers to any instrument capable of performing an assay on a sample and rendering a result. For example, a diagnostic instrument includes any instrument capable performing an assay on a sample to determine the presence or amount of an analyte in the sample. Any instrument capable of performing a hybridization assay, a molecular assay including a nucleic-acid-based amplification reaction, a sequencing assay, an immunoassay, or chemical assay on a sample is included in this definition of a diagnostic instrument. Exemplary diagnostic instruments capable performing an assay on a sample to determine the presence of an analyte in the sample include the Tigris®, Panther®, and Panther Fusion® systems sold by Hologic, Inc., Marlborough, Mass., as well as any of the diagnostic instruments disclosed in U.S. Patent Application Publication No. 2016/0060680, published Mar. 3, 2016.
illustrates an exemplary analysis or diagnostic instrument or systemused to describe embodiments of the current disclosure. Diagnostic systemillustrated inis a Panther Fusion system (from Hologic, Inc.) configured to perform molecular testing of multiple samples. However, this systemis only exemplary, and embodiments of the current disclosure may be used in any application and with any (or no) instrument. Diagnostic systemmay be configured to perform any type of analysis of a sample. In some embodiments, the diagnostic system may be configured to perform a plurality of different analyses (e.g., molecular assays) on a plurality of samples. In some embodiments, diagnostic systemmay be configured to perform different target nucleic acid amplification reactions on different samples. For example, a plurality of samples may be loaded on, or in, diagnostic system, and systemmay perform a first analysis (e.g., a first target nucleic acid amplification reaction) on a first subset of a plurality of samples, and perform a different analysis (e.g., a second target nucleic acid amplification reaction) on a second subset of the plurality of samples.
In some embodiments, diagnostic systemmay have a modular structure and may be comprised of multiple modules operatively coupled together. For example, systemmay comprise a first moduleand a second moduleoperatively coupled together. Both first moduleand second modulemay be configured to perform one or more steps of the first analysis and/or the second analysis. In some embodiments, first and second modules,may be separate modules selectively coupled together. That is, first modulecan be selectively and operatively coupled to one second module, and first modulecan be selectively decoupled from this second moduleand coupled to a different second module. First and second modules,may be coupled together by any method. For example, fasteners (for example, bolts or screws), clamps, belts, straps, or any combination of fastening/attachment devices may be used to couple these modules together. In some embodiments, diagnostic systemmay be an integral, self-contained structure (that is, first modulecannot be coupled to and decoupled from second module).
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March 31, 2026
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