Systems and methods related to sample transfer devices

Abstract

A sample transfer device is described. The sample transfer device includes: (1) a shell having a cap side and a tube side; (2) a cap disposed at or near an outer end of the cap side of the shell; (3) a channeled plunger communicatively coupled to the cap and forming a cap side seal; (4) a center plunger rod abutting and extending from the channel plunger towards the tube side; and (5) a gasket occupying a space defined between the inner wall of the shell and the central plunger rod and thereby forming a tube-side seal. When the cap-side seal is opened to form a fluid channel, and / or when the tube-side seal is opened to form a fluid communication, the sample transfer device is capable of dispensing a sample containing a target analyte present inside the shell.

Description

SYSTEMS AND METHODS RELATED TO SAMPLE TRANSFER DEVICESRELATED APPLICATION

[0001] This patent application claims priority to a provisional patent application number 62 / 923,637, which was filed on October 21, 2019, and which is incorporated herein by reference for all purposes.FIELD

[0002] The present arrangements and teachings relate to systems and methods for transferring fluid samples having a target analyte for further analysis, such that the transfer is carried out in a manner that is accurate and minimizes risk of contamination. In particular, the present arrangements and teachings relate to systems and methods used to transfer lysed samples containing a target analyte for further processing (e.g., biological samples that may include viruses such as severe acute respiratory syndrome SARS-CoV-2 (“COVID-19”) virus, harmful bacteria and chemical constituents of interest, and / or RNA, DNA, and / or protein for purposes of species identification) in a manner that does not require sample re-entry once a sample is inside a lysis tube. The present teachings and arrangements may also be used or adapted for use in transferring solutions and mixtures for any system where ease of use, precision, and lack of contaminations are prioritized.BACKGROUND

[0003] Testing samples containing one or more target analytes, and in particular, biosamples with one more target nucleic acids, has been a staple of biology laboratories for many decades. The advent of quantitative real-time PCR (qPCR) made the identification of and measurement of genetic targets accessible and practical for a greater number of analytical tests and applications.

[0004] Conventional systems and methods for obtaining samples containing target analyte and processing them downstream, however, often require a user to implement separate and multiple steps of sample collection, sample mixing, sample treatment, and / or sample transfer, which requires at least some sample re-entry by a user to provide access to the sample containing target analyte.

[0005] For example, a user may be required to contact a sample with laboratory equipment in separate steps of delivering a sample containing target analyte to a lysis tube for lysis, adding a buffer or diluent to the lysis tube, and transferring a lysed sample to a subsequent device for further testing and analysis. Such conventional methods and associated systems, however, risk contamination and inaccuracy at each step that requires contact with the sample containing target analyte. What is therefore needed are systems and methods that integrate sample lysis, lysate dilution, and sample-to-processing-device transfer, into an all-in-one form factor that and that provide ease-of-use user operation.SUMMARY

[0006] In one aspect, the systems of the present arrangements disclose a sample transfer device for transferring a sample containing a target analyte. The sample transfer device includes: (1) a shell having a cap side and a tube side, such that the cap side is opposite to the tube side, and the tube side is capable of attaching to a lysis tube having stored therein the sample containing target analyte, and wherein the shell has defined therein a narrow channel and a wide channel; (ii) a cap disposed at or near an outer end of the cap side of the shell, and wherein the cap is capable of being in an attached state or a detached state, such that in the attached state, the cap is attached to the cap side of shell, and covers a cap side opening of the shell and is capable of receiving an external force, and wherein the cap in the detached state, the cap is detached from the shell and the cap side opening is at least partially open to allow fluid inside the shell to flow out of the shell; (iii) a channeled plunger communicatively coupled to the cap, wherein the channeled plunger, when disposed within the narrow channel, defines a cap-side seal between the cap side and the tube side, and wherein upon receiving the external force at the cap, the external force is transferred to the channeled plunger, displacing the channeled plunger towards the tube side and displacing the channeled plunger from the narrow channel to be at least partially disposed inside the wide channel and thereby opening a cap-side fluid channel disposed within the channeled plunger to facilitate fluid communication from inside the shell to outside the shell; (iii) a center plunger rod abutting and extending from the channel plunger towards the tube side, such that upon the cap receiving the external force, the external force is transferred to the center plunger rod and the center plunger rod is displaced towards the tube side; (iv) a gasket occupying a space defined between an inner wall of the shell and the center plunger rod, wherein the gasket is affixed to the inner wall such that displacement of the center plunger rod, towards the tube side and to a location beyond the gasket, does not displace the gasket and the inner wall, and causes the center plunger rod to open up, at the tube side of the shell, a tube-side fluid connection for dispensing and receiving the fluid at the tube side of the shell, and when the center plunger rod remains disposed at the narrow channel, the gasket seals off the tube-side fluid connection at the tube side of the shell, defining a tube-side seal, and when the cap-side fluid channel and the tube-side fluid connection are open, a fluid dispensing flow path is defined inside the sample transfer device, which is capable of dispensing the fluid present inside the shell. In preferred embodiments of the present arrangements, afluid flow path includes a channel inside a channeled plunger seal, a channel inside a nozzle receiver, and a channel inside a fluid sealing tip.

[0007] Preferably, a lysis tube is attached to the tube side of the sample transfer device.

[0008] Preferably, the wide channel and the narrow channel are coextensive.

[0009] According to preferred embodiments of the present arrangements, in presence of the cap-side seal and tube-side seal, the shell has stored therein a diluent. The diluent may stored for use in downstream steps (e.g., diluting a lysate).

[0010] In one embodiment, the cap is a twist cap that is capable of receiving a twisting force, which is the external force. In another embodiment, the cap is or includes a button that is part of the cap and wherein a pressing force against the button applies a requisite amount of the external force. In certain embodiments, both a twist cap and a cap button are implemented to disrupt a tube side seal and / or a cap side seal.

[0011] The center plunger rod may include a shaft portion and a plugging portion, with the plugging portion having at least one dimension that is larger than that of the shaft portion, such that the gasket occupies the space between the inner wall of the shell and the plugging portion of the center plunger rod. Preferably, the plugging portion has a larger diameter than the shaft portion. In such configuration, when the center plunger rod opens a fluid communication, the center plunger rod may be released through a path defined by the fluid communication.

[0012] The center plunger rod may displace, under the external force, towards the lysis tube to travel past the gasket, the center plunger rod placed in a released state, opens up the tube-side seal allowing fluid communication between the shell and the lysis tube.

[0013] The plugging portion of the center plunger rod may be or include a hinged valve comprising a stable element and a plunger, wherein the stable element does not displace relative to the center plunger rod, wherein the plunger is attached to and rotatable relative to the center plunger rod such that during the displacement of the center plunger rod towards the tube side to a location beyond the gasket, the plunger rotates to open the hinged valve.

[0014] The sample transfer device may also include a barrel plunger disposed at or near the cap side of the shell, wherein the barrel plunger includes the narrow channel and the wide channel, and when the cap seal is not open, the narrow channel of the barrel plunger surrounds the channeled plunger.

[0015] The sample transfer device may also include processing-device-coupling components configured to define a fluid flow path from the cap side of the sample transfer device to a processingdevice for analyzing the sample containing the target analyte. The processing device may be a cartridge with an inlet port capable of receiving sample containing target analyte from the sample transfer device.

[0016] The processing-device-coupling components may include: (i) a nozzle receiver having defined therethrough a nozzle-receiver fluid channel in fluid communication with the cap side channel, being coupled to or engaged with the channeled plunger and being at least partially surrounded by the narrow channel of the barrel plunger; (ii) a nozzle engaged with the nozzle receiver; and (iii) a sealing tip secured to the nozzle and having defined therethrough the sealing tip channel, and further comprising a nozzle-receiver-engaging portion that engages with the nozzle receiver to define a nozzle fluid flow path that includes the nozzle-receiver fluid channel and the sealing-tip fluid channel.

[0017] Preferably, the nozzle receiver and the channeled plunger slidably engage with the narrow channel of the barrel plunger such that the narrow channel guides displacement of the channeled plunger inside the narrow channel and towards the tube side. The nozzle receiver may further include nozzle-receiver-grabbing extensions as part of the barrel plunger and that are configured to place the nozzle receiver and the barrel plunger in a locked state such that the barrel plunger prevents slidable displacement of the nozzle receiver within the narrow channel of the barrel plunger.

[0018] The barrel plunger may also include an o-ring to facilitate its operation as a plunger. Preferably, the barrel plunger acts both as a plunger and a barrel. During displacement of a center channeled plunger or a nozzle receiver, the plunger may operate as a barrel, guiding displacement of the channeled plunger or the nozzle receive through slidable engagement therein. During delivery of force to drive fluid through cap side fluid channel, the barrel may act as a plunger, by reducing a volume in the sample transfer device and creating a pressure differential between the device and an attached processing device, thereby driving fluid transfer towards the processing device, r, the

[0019] According to certain embodiments of the present arrangements, during the detached state of the cap, the rubber sealing tip and the nozzle are configured to be aligned with an inlet port to the processing device such that the rubber sealing tip and the nozzle form a sealed connection between the sample transfer device and the processing device.

[0020] The sample transfer device may also include an alignment ring surrounding an outer surface of the cap side of the shell, such that the alignment ring facilitates alignment of the rubbersealing tip and the nozzle with the processing device, and the alignment ring is configured to engage with complementary features on the processing device to facilitate the alignment.

[0021] The sample transfer device is further configured to receive a pushing force, delivered to an outer surface of the shell, for pushing in the rubber sealing tip into the inlet port to achieve an engaged state of the sample transfer device with the processing device. In this engaged state, the rubber sealing tip is configured to seal the inlet port, the nozzle receiver and the barrel plunger are configured to be in the locked state, and the pushing force drives the barrel plunger away from the cap side to the tube side to facilitate reduction of volume inside the sample transfer device, as the reduction of volume creates a pressure differential between the processing device and the sample transfer device that is designed to transfer the sample containing the target analyte through the cap-side fluid connection and into the processing device. This preferably provides a force sufficient to dispense the diluted lysate to the processing device when the processing device is engaged to the fluid transfer device.

[0022] Further, the rubber sealing tip and the nozzle are capable of being in a detached state such that the rubber sealing tip is designed to occupy the inlet port and the nozzle is designed to cover the inlet port, and wherein in the detached state, the rubber sealing tip and the nozzle are designed not to be engaged to the sample transfer device.

[0023] In another aspect, the methods of the present teachings disclose a method of transferring a fluid mixture. The method include: (i) obtaining, inside a lysing tube, a lysate; (ii) obtaining a sample transfer device comprising a shell having a cap side and a tube side with a capside seal disposed between the cap side and the tube side and a tube-side seal at or near an end of the shell at the tube side, with diluent stored between the cap-side seal and the tube-side seal; (iii) coupling the lysing tube to the tube-side of the shell; (iv) applying an external force to the cap side to break the tube-side seal to form a tube-side fluid communication between the tube side and the lysis tube, thereby releasing the diluent into the lysis tube to form a diluted lysate; (iv) opening the cap-side seal to form a fluid communication between the tube side and the cap side. The above applying and opening steps form a fluid flow pathway that allows the diluted lysate to flow outside the shell. The method may also include dispensing the diluted lysate from the shell.

[0024] In certain embodiments of the present teachings, the opening and applying steps are carried out contemporaneously or near contemporaneously.

[0025] The method of transfer may further include delivering the diluted lysate from the lysis tube through the tube-side fluid connection by inverting the tube side relative to the cap side of the sample transfer device.

[0026] Delivering the diluted lysate from the lysis tube through the tube-side fluid connection may further include steps of: (i) aligning processing-device engaging features disposed on an outer end of the cap side with complementary features on a processing device for processing a target analyte; and (ii) applying a pushing force to the sample transfer device, thereby engaging the processingdevice-engaging features with the complementary features on the processing device. In certain embodiments of the present teachings, the aligning and applying steps are carried out contemporaneously .

[0027] Further, prior to the aligning step, the method may include detaching a cap disposed on the cap side of the shell.

[0028] The method may also include, after delivering the fluid sample to a processing device, (ii) disengaging the sample transfer device from the processing device, thereby releasing at least some of the processing-device-engaging features from the sample transfer device to produce a sealed processing device; and (ii) processing the lysate in the sealed processing device to determine presence and / or characteristics of the target analyte.

[0029] In certain embodiments of the present arrangements, prior to the obtaining lysate step, step, the method may include steps of: (i) obtaining an empty lysis tube coupled to a the sample transfer device at the tube side of the shell; (ii) separating the empty lysis tube from the tube-side of the shell; (iii) adding a sample containing target analyte and buffer to the empty lysis tube; (iv) recoupling the lysis tube containing the sample containing target analyte and buffer to the tube side of the shell; and (v) lysing the sample containing target analyte and buffer to form the lysate.

[0030] In another aspect, the methods of the present teachings disclose a method of assembling a sample transfer device. The method includes steps of: (i) inserting a gasket into a shell having a cap side and a tube side and the gasket being inserted through the tube side of the shell; (ii) disposing, at the cap aide, a channeled seal in a narrow channel defined inside the shell and the narrow channel is coextensive with a wide channel; (iii) dispensing diluent into the tube side of the shell; and (iv) positioning a center plunger rod through the gasket and securing the center plunger rod between the gasket and the channeled seal to form a tube side seal. Preferably, in the context of the dispensing step, the narrow channel and the wide channel are defined in a barrel plunger. Prior to the positioning the center plunger rod through the gasket, the method may further include a step of: adding a hinged valve to the center plunger rod to form a center plunger rod assembly such that the positioning the center plunger rod and the securing the center plunger rod includes positioning the center plunger rod assembly and securing the center plunger rod assembly.

[0031] The method of assembly may further include: (i) attaching an o-ring to the barrel plunger to form a barrel plunger assembly; and (ii) inserting the barrel plunger assembly into the shell.

[0032] The method of assembly may further include steps of: (i) fitting the channeled seal onto a nozzle receiver to form a channeled-seal-nozzle-receiver sub-assembly, (ii) inserting a rubber sealing tip into a disposable nozzle to form a nozzle-tip sub-assembly; (iii) attaching the nozzle-tip sub-assembly to the channeled-seal-nozzle-receiver sub-assembly to form a nozzle assembly; and (iv) placing the nozzle assembly into the barrel plunger.

[0033] The method of assembly may further include attaching a cap to the shell that covers the disposable nozzle and the rubber sealing tip on the nozzle assembly.BRIEF DESCRIPTIONS OF THE DRAWINGS

[0001] Figure 1A is a side view of a sample transfer device, according to one preferred embodiment of the present arrangements, attached to a lysis tube.

[0002] Figure IB is a side-sectional view of the sample transfer device and lysis tube of Figure 1A.

[0003] Figure 2 is a perspective view of a lysis tube, according to one preferred embodiment of the present arrangements, capable of being used with the sample transfer devices of the present arrangements.

[0004] Figure 3 is a perspective view of a shell, according to one preferred embodiment of the present arrangements, used in the sample transfer device of Figures 1A and IB.

[0005] Figure 4 is a perspective view of a center plunger rod, according to one preferred embodiment of the present arrangements, used in the sample transfer device of Figures 1A and IB.

[0006] Figure 5 A is a perspective view of a hinged valve, according to one preferred embodiment of the present arrangements in a closed state and connected to a center plunger rod.

[0007] Figure 5B is a is a perspective view of the hinged valve of Figure 5A and in an open state.

[0008] Figure 6 is a perspective view of a channeled plunger, according to one preferred embodiment of the present arrangements, used in the sample transfer device of figures 1 A and IB.

[0009] Figure 7A is a side view of a barrel plunger, according to one preferred embodiment of the present arrangements, used in the sample transfer device of Figures 1A and IB.

[0010] Figure 7B is a side-section of the barrel plunger of Figure 7A.

[0011] Figure 8 is a perspective view of a nozzle receiver, according to one preferred embodiment of the present arrangements, used in the sample transfer assembly of figures 1A and IB.

[0012] Figure 9 is a perspective view of a disposable nozzle, according to one preferred embodiment of the present arrangements, used in the sample transfer assembly of figures 1A and IB.

[0013] Figure 10 is a perspective view of a rubber sealing tip, according to one preferred embodiment of the present arrangements, used in the sample transfer assembly of figures 1A and IB.

[0014] Figure 11 is a perspective view of a rubber sealing tip and disposable nozzle subassembly, according to one preferred embodiment of the present arrangements, used in the sample transfer assembly of figures 1A and IB.

[0015] Figure 12A is a side-sectional view of a sample transfer device, according to one preferred embodiment of the present arrangements, showing location of certain salient components associated with a cap-side seal and a tube-side seal.

[0016] Figure 12B is a side-sectional view of a sample transfer device, according to one preferred embodiment of the present arrangements, showing location of certain salient components when a tube-side fluid communication is open.

[0017] Figure 12C is a side-sectional view of a sample transfer device, according to one preferred embodiment of the present arrangements, showing location of certain salient components when a cap-side fluid communication is open.

[0018] Figure 13A is a side-sectional view of certain salient components in Figure 12A that are associated with a cap side seal, according to one preferred embodiment of the present arrangements.

[0019] Figure 13B is a si de- sectional view of certain components in Figure 12B that are associated with breaking a cap side seal to form a cap-side fluid channel.

[0020] Figure 13C is a side-sectional of certain components in Figure 12C that are associated with a cap side fluid channel.

[0021] Figure 14 is a side-sectional view of a sample transfer device, according to one preferred embodiment of the present arrangements, showing location of certain salient components associated with open fluid connection at a tube side of a sample transfer device and open fluid channel between a tube side and a cap side of the sample transfer device.

[0022] Figure 15A is a side view of a sample transfer device, according to one preferred embodiment of the present arrangements, prior to engagement with a sample processing device.

[0023] Figure 15B is a side view of the sample transfer device and sample processing device of claim 15A in an engaged configuration.

[0024] Figure 16 is a process flow diagram showing certain salient steps for a method, according to one preferred embodiment of the present arrangements, of transferring a fluid mixture. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0001] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present arrangements and teachings. It will be apparent, however, to one skilled in the art that the present teachings may be practiced without limitation to some or all of these specific details. In other instances, well-known method steps have not been described in detail in order to not unnecessarily obscure the present arrangements and teachings.

[0002] The systems and methods of the present arrangements and teachings relate to sample transfer devices and associated methods that are used to transfer samples (e.g., biological samples containing a target analyte) to testing devices for further analysis (e.g., determining presence or characteristics of a target analyte). In certain embodiments of the present arrangements, such testing is carried out in sample processing devices that are removable cartridges adapted for use by hand-held target-analyte detection devices, such as those disclosed in U.S. Patent No. 12,064,763B2 by Dehgan et al. In other embodiments of the present arrangements, however, the sample transfer devices of the present teachings are adapted for use with other sample processing devices. As used herein, such cartridges, or other sample processing devices adapted for other testing and analysis may be thought of as a closed structure or combination of structures for carrying out such processing reactions for determining presence of and / or characteristics of a target analyte.

[0003] Conventional teachings, however, require multiple sample-entry steps to load a sample for lysis and then transfer the sample to a processing device for subsequent testing and analysis. For example, conventional techniques require a user to collect a sample and lysis tube, transfer the sample into the lysis tube, enter the lysis tube to dilute the sample with lysis buffer, lyse the sample to release a target analyte to form a lysed sample, and then re-enter the tube to transfer the lysed sample to a testing device (e.g., cartridge) for testing and analysis. The systems and methods of the present arrangements and teachings, however, disclose a sample-transfer system that integrates sample lysis, lysate dilution, and sample-to-processing-device transfer, into an all-in-one form factor that provides ease-of-use user operation. Thus, an advantage over prior transfer systems is the implementation of an integrated design that eliminates sample re-entry after sample collection, thus reducing sample cross-contamination risk and improving user experience and reliability, particular for relatively untrained users in the field.

[0004] To this end, Figure 1A shows a side view of a sample-transfer device 100, according to one preferred embodiment of the present arrangements. Figure 1 shows a sample transfer device 102 attached to a lysis tube 104. A sample transfer device may be thought of as the transfer device attached to a tube (e.g., a sample transfer device 100) or the sample transfer device separately from a tube (e.g., sample transfer device 102 attached to lysis tube 104).

[0005] As shown in Figure 1A, sample transfer device 102 includes a cap button 106, a twist cap 108, an alignment ring 110, a barrel plunger 112, an o-ring 114, a center plunger rod 116, a shell 118 containing a diluent 120, and connecting features 124. Shell 118 has a cap side 122 and tube side 123, which may also be thought of as a lysis tube side. Lysis tube 104 includes a sample containing target analyte 126 contained therein. In other embodiments, however, lysis tube 104 may contain other or additional fluids, such as buffers or reagents.

[0006] Figure IB shows a cross-section of sample transfer device 100 of Figure 1A. Sample transfer device 102, lysis tube 104, cap button 106, twist cap 108, alignment ring 110, barrel plunger 112, o-ring 114, center plunger rod 116, shell 118, diluent 120, connecting features 124, cap side 122, tube side 123, and sample containing target analyte 126 are substantially similar to their counterparts in Figure 1A. Figure IB also shows certain components of transfer device 102 not visible in Figure 1A, i.e., a barrel plunger 112, a gasket 117, a rubber sealing tip 128, a disposable nozzle 130, a channeled plunger 132, a nozzle receiver 134, and a hinged valve 135 coupled to or part of a plugging portion of center plunger rod 116.

[0007] As shown in figures 1A and IB, shell 118 of sample transfer device 102 is divided into two regions or sides, a cap side 122 and a tube side 123, which are opposite to each other. In the embodiment of Figure IB, cap side 122 and tube side 123 are separated by channeled plunger 132 such that a region between channeled plunger 132 and cap 108 is cap side 122 of shell 118 and a region between channeled plunger 132 and lysis tube 104 is tube side 123 of shell 118.

[0008] Cap button 106 and twist cap 108 are each configured to receive an external force (e.g., supplied by a user) and transferring the external force to communicatively coupled components, such as plunger seal 132, rod 116, nozzle receiver 134, nozzle 130, and rubber sealing tip 108, to facilitate displacement of these components in sample transfer device 102.

[0009] Cap button 106 is capable of receiving a pressing force and twist cap 108 is capable of receiving a twisting force to transfer such force to the communicatively coupled components. In certain embodiments of the present arrangements, sample transfer device 102 only implements capbutton 106 or twist cap 108. In other embodiments of the present arrangements, both cap button 106 and twist cap 108 are implemented.

[0010] Cap button 106 and / or twist cap 108 is also configured to be a protective cap for processing-device-engaging components disposed beneath them in the device, such as rubber sealing tip 128, nozzle 130, and nozzle receiver 134. To this end, cap button 106 and twist cap 108 are disposed at an outer end of cap side 122 and preferably are attached to diluent shell 118 at an outer end of cap side 122.

[0011] Alignment ring 110 surrounds an outer surface of cap side 122 of shell 118. Preferably, alignment ring 110 facilitates alignment of rubber sealing tip 128 and / or nozzle 130 with a processing device, such that alignment ring 110 is configured to engage with complementary features on the processing device to facilitate such alignment, which thereby facilitates transfer of sample from sample transfer device 102 for downstream processing by a processing device, i.e., to determine presence or characteristics of a target analyte in a sample.

[0012] Certain components, including o-ring 114, rubber sealing tip 128, disposable nozzle 130, gasket rubber sealing tip 128, gasket 117, are preferably comprised of rubber or other compressible material.

[0013] Figure 2 shows a lysis tube 204, according to preferred embodiments of the present arrangements, with a sample containing target analyte 226 and, which is substantially similar to their counterpart in figures 1A and IB, i.e., lysis tube 104 and sample containing target analyte 126. Figure 2 also includes a gripping portion 237, as well as grooved ridged 238, which may be thought of as connecting features to a tube side of a shell (e.g., shell 118 of Figures 1A and IB). Lysis tube 204 is preferably adapted to carry out lysis reactions (e.g., temperature treatment) therein.

[0014] Figure 3 shows a shell 318 having a cap side 322 on one side and a tube side 323 on an opposite side, tube-engaging features 352 on tube side 223, and gripping surface 354 on an outer surface of cap side 322. In certain embodiments of the present arrangements, shell 318 has defined therein a narrow channel and a wide channel, which as explained below, are implemented to establish a cap-side seal and to open a cap-side fluid channel.

[0015] Shell 318 acts as shell for handling the sample transfer device and placing components of the device therein or thereon.

[0016] Shell 310 may also be configured to contain diluent within tube side 323. Preferably, diluent is water or a buffer capable of diluting a sample containing target analyte for treatment by a processing device.

[0017] Figure 4 shows a center plunger rod 416, according to one preferred embodiment the present arrangements. Rod 416 is substantially similar to its counterpart in figures 1A and IB, i.e., center plunger rod 116. Rod 416 includes a channeled-plunger-contacting end 440, a shaft portion 442, a plugging portion 444, and a striking portion 446. According to one preferred embodiment of the present arrangements, center plunger rod 416 abuts and extends from a channel plunger towards a tube side of a diluent shell, such that when a cap receives an external force (e.g., twisting force from twist cap 1106 of Figure 1A), the external force is transferred to center plunger rod 416, and center plunger rod 416 is displaced towards a tube side of a shell (e.g., shell 118 of Figure 1A).

[0018] In preferred embodiment of the present arrangements, plugging portion 444 operates with a gasket (e.g., gasket 117 of Figure IB), to occupy a space defined between an inner wall of a shell and center plunger rod 416, such that the gasket is affixed to the inner wall of the shell to create a tube-side seal. A tube-side seal seals off a location between a tube side of a shell and a lysis tube attached to the shell.

[0019] Preferably, during operation of the sample transfer device, displacement of the center plunger rod, towards the tube side of a shell, to a location beyond the gasket, does not displace the gasket and the inner wall, and causes the center plunger rod to open up a tube-side fluid connection at the tube side of said shell. In turn, this may allow the shell to dispense and receive fluid at the tube side of said shell. But when center plunger rod 416 does not displace to a location beyond the gasket, the gasket seals off the tube-side fluid connection at the tube side of said shell, defining a tube-side seal.

[0020] Striking end 446 may be used to rupture a seal cover (e.g., foil, paper, or the like) covering a lysis tube (e.g., lysis tube foil seal 236 of Figure 2) during displacement of center plunger rod 416.

[0021] In certain embodiments of the present arrangements, plugging portion 444 includes a hinged valve that is capable of opening or closing to define a fluid communication from the tube side of the shell to a region outside the device or to an attached lysis tube. To this end, Figure 5A shows a hinged valve 545, according to one preferred embodiment of the present arrangements, in a closed state. Hinged valve 545 includes a center plunger rod 516 and a striking end 546, which are substantially similar to their counterparts in Figure 4. Hinged valve 545 also includes a plunger 547, a hinge 548, and a stable element 549. As shown in v 5A, hinged valve 545 is in a closed configuration. During this closed state, hinged valve 545 operates with a gasket (e.g., gasket 117 of v IB), to form a tube-side seal between an inner surface of a shell.

[0022] Stable element 549 is stabilized on center plunger rod 516, and plunger 547 is attached to and rotatable relative to center plunger rod 516 on hinge 548 such that during displacement of center plunger rod 516 towards a tube side to a location beyond a gasket, the plunger rotates to open a tubeside fluid connection. Such rotation is facilitated by friction against a gasket during displacement of the rod.

[0023] Figure 5B shows the hinged valve of Figure 5A in an open configuration. To this end, Figure 5B shows a center plunger rod 516’ a striking end 546’, a plunger 547’, a hinge 548’, and a stable element 549’, which are substantially similar to their counterparts in Figure 5A. Preferably, an open configuration of hinged valve 545’ opens a fluid communication between a tube side of a diluent shell and a lysis tube.

[0024] Figure 6 shows a channeled plunger 632, according to one preferred embodiment of the present arrangements. Channeled plunger 632 is substantially similar to its counterpart in Figure IB. In certain embodiments of the present arrangements, channeled plunger 632 is a channeled plunger seal that forms a cap side seal in a narrow cavity disposed in a shell.

[0025] Channeled plunger 632 includes a channel 664 defined therethrough, a nozzlereceiver-engaging portion 665, a channel 666, and a rod-abutting surface 667. Channel 664 and channel 666 are preferably connected or the same channel. Channel 666 may be thought of as a connecting channel that connect to subsequent channels in a flowpath (e.g., a channel defined through a nozzle receiver). Thus, channel 666 preferably connects on one end to horizonal channel 664 inside channeled plunger 632 and connects on another end to a corresponding channel in a nozzle receiver. To facilitate this, channeled plunger 632 may be adapted to connect to a nozzle receiver at nozzlereceiver-engaging portion 665.

[0026] Channeled plunger 632 also includes a rod-abutting surface that contacts a center plunger rod during displacement of the rod.

[0027] Preferably, channeled plunger 632 is communicatively coupled to a cap (e.g., cap 108 of figures 1A and IB) such that the channeled plunger, when disposed within a narrow channel of a shell, defines a cap-side seal between the cap side and the tube side of the shell, and when the cap receives the external force, the external force is transferred to the channeled plunger, displacing the channeled plunger towards the tube side of the shell and displacing the channeled plunger from the narrow channel to be at least partially disposed inside a wide channel, thereby opening a cap-side fluid channel disposed within the channeled plunger to facilitate fluid communication from inside the shell to outside said shell. Preferably, the cap-side fluid channel incudes a horizontal channel inside thechanneled plunger that is open after said displacing the channeled plunger from the narrow channel to be at least partially disposed inside the wide channel. In such embodiments of the present arrangements, a narrow channel disposed in the shell blocks a horizontal channel in the channeled plunger to produce a tube-side seal, and a wide channel inside the shell opens to a horizontal channel inside the channeled plunger to produce a cap-side fluid channel.

[0028] Figure 7A shows a barrel plunger 712, according to one preferred embodiment of the present arrangements, and Figure 7B shows a cross-section of barrel plunger 712. Barrel plunger 712 includes a narrow channel 778, a wide channel 780, an o-ring-receiving region 779, and gripping elements 776. In preferred embodiments of the present arrangements, a narrow channel and wide channel are disposed within a shell. In those embodiments that include barrel plunger 712, narrow channel 778 and wide channel 780 may disposed within barrel plunger 712, which is thereby disposed in a shell. When implemented in such manner, narrow channel 778 is disposed on an end of barrel plunger 712 that faces a cap side of a shell, and wide channel 780 is disposed on an end of barrel plunger 712 that faces a tube side of a shell.

[0029] Barrel plunger 778 is configured such that a channeled plunger (e.g., channeled plunger 132 of Figure IB) and / or a nozzle receiver (e.g., nozzle receiver 134 of Figure 1A) are slidably engaged with narrow channel 778.

[0030] Barrel plunger 712 is also configured to be capable of gripping a nozzle receiver (e.g., nozzle receiver 134 of Figure 1A) using gripping elements 776 (also thought of as “nozzle-receivergrabbing extensions”). Such nozzle-receiver gripping features are implemented to allow barrel plunger 712 and an associated nozzle receiver to achieve a locked state such that said barrel plunger prevents slidable displacement of the nozzle receiver within said narrow channel of said barrel.

[0031] In such locked configuration, barrel plunger 712 is capable of receiving a pushing force, delivered to an outer surface of a shell, for pushing in a rubber sealing tip into said inlet port to achieve an engaged state of the sample transfer device with said processing device. In achieving this engaged state, the pushing force drives the barrel plunger away from the cap side to the tube side to facilitate reduction of volume inside said sample transfer device, such that said reduction of volume creates a pressure differential between the processing device and said sample transfer device that is designed to transfer said sample containing said target analyte through said cap-side fluid connection and into said processing device. In other words, in such a locked state, barrel plunger 712 is capable of acting as a plunger that is movable against an inner surface of a shell to reduce a volume in the sample transfer device.

[0032] Figure 8 shows a nozzle receiver 834, according to one preferred embodiment of the present arrangements. Nozzle receiver 834 includes a channeled-plunger-engaging element 868, a barrel-plunger-locking region 869, a nozzle-engaging element 871, and a nozzle-receiver fluid channel 872 disposed therethrough.

[0033] Channeled-plunger-engaging element 868 attached nozzle receiver 834 to a channeled plunger.

[0034] Nozzle-receiver fluid channel 872 connects a channeled-plunger fluid channel to a rubber-sealing-tip channel.

[0035] Nozzle-engaging element 871 secures a nozzle on the nozzle receiver.

[0036] Barrel -plunger securing region 869 is capable of engaging with gripping elements on a barrel plunger (e.g., gripping elements 776 of barrel plunger 712 in Figure 7).

[0037] Figure 9 shows a disposable nozzle 930, according to one preferred embodiment of the present arrangements. Nozzle 930 includes a rubber-sealing-tip-receiving aperture 960, processingdevice-engaging features 962a and 962b, and a top surface 961.

[0038] Rubber-sealing-tip-receiving aperture 960 is capable of securing a rubber sealing tip to the disposable nozzle.

[0039] Processing-device-engaging features 962a and 962b are features capable of engaging with complementary features on a processing device to align and stabilize nozzle 930 prior to connection to a processing device for transfer of fluid from the sample transfer device.

[0040] Force applied at or near surface 961 when nozzle 930 is coupled to a processing device assembly may facilitate compression of gasket 930 and / or a rubber sealing tip disposed therein.

[0041] Figure 10 shows a rubber sealing tip 1028, according to one preferred embodiment of the present arrangements. Rubber sealing tip 1028 includes a nozzle-receiver-attaching element 1054, a nozzle-engaging region 1056, a rubber-sealing-tip channel 1058, and lips 1059, which preferably define an exit point for sample exiting the sample transfer devices of the present arrangements.

[0042] Nozzle-receiver-attaching element 1054 connects a nozzle receiver to rubber sealing tip 1058 to define a fluid flow path between a nozzle-receiver-channel (e.g., nozzle-receiver fluid channel 872 of Figure 8) and rubber-sealing-tip channel 1058.

[0043] Lips 1059 are configured to contact and be inserted into an inlet port of a sample processing device to transfer fluid from the sample transfer device to a processing device for furtherprocessing. Lips 1059 may be thought of as an outlet port that engages with a complementary inlet port on a processing device.

[0044] Lips 1059 are also configured to remain in the inlet port after dispensing and subsequent disengagement of the sample transfer device from a processing device. In such matter, lips 1059 seal the processing device in preparation for downstream reactions in the device. Such sealing may be facilitated by application of compressive forces to lips 1059 during such processing reactions.

[0045] Figure 11 shows a rubber sealing tip 1128 engaged to a nozzle 1130. Preferably, after dispensing sample from a sample transfer device, to a processing device, the combined sealing tip and nozzle assembly remains coupled to the processing device to seal and protect the processing device during subsequent processing.

[0046] Figure 12A shows a sample transfer device, according to one preferred embodiment of the present arrangements, in the presence of a cap side seal and tube side seal. The location shown in the box surrounding a channeled plunger 1132 is shown in more detail in Figure 13 A with respect to a cap-side seal.

[0047] The sample transfer device of Figure 12A includes a cap button 1206, a twist cap 1208, a rubber sealing tip 1228, a disposable nozzle 1230, a nozzle receiver 1234, a barrel plunger 1212, a channeled plunger 1232, an o-ring 1214, a center plunger rod 1216 having a striking end 1242 and a hinged valve 1245 disposed on one end of the center plunger rod, which are substantially similar to their counterparts in figures 1 A and IB. As shown in Figure 12A, cap button 1206 is in a non-pressed state and twist cap 1208 is in a non-twisted state such that an external force has not been applied to a cap side of device 1202. In such configuration, a tube side seal is defined at a location where hinged valve 1245 presses against gasket 1217, and a cap side seal is defined at a location where channeled plunger 1232 is disposed within a narrow channel of barrel plunger 1212.

[0048] Preferably, plunger 1232 and nozzle receiver 1212 are slidably engaged with barrel plunger 1232 such that said narrow channel guides displacement of said channeled plunger inside said narrow channel and towards said tube side.

[0049] Figure 13 A shows a magnified view of the components within the boxed area in Figure 12A. Channeled plunger 1332 is shown surrounded by barrel plunger 1312 in narrow channel 1378 of the barrel plunger and attached on one end with nozzle receiver 1334 and on another and abutting center plunger rod 1316. In this configuration, channel openings on each side of channeled plunger 1332 are blocked by walls of narrow channel 1378, defining a cap-side seal, according to one preferredembodiment of the present arrangements. Though channel 1366 is shown on a tube side of the sample transfer device, narrow channel 1378 blocks a fluid flowpath thereto.

[0050] Figure 12B shows the sample transfer device of Figure 12A after application of a twisting force to twist cap 1208 sufficient to open a tube side fluid connection. To this end, Figure 12B includes a cap button 1206’, a twist cap 1208’, a rubber sealing tip 1228’, a disposable nozzle 1230’, a nozzle receiver 1234’, a barrel plunger 1212’, a channeled plunger 1232’, an o-ring 1214’, a center plunger rod 1216 having a striking end 1242’ and a hinged valve 1245’ disposed on one end of the center plunger rod, and which are substantially similar to their counterparts in Figure 12A. The location shown in the box surrounding channeled plunger 1232’ is shown in more detail in Figure 13B with respect to a cap side seal.

[0051] As shown in Figure 12B, application of an external twisting force to a twist cap transfers such force to channeled plunger 1232’ (described in more detail with reference to Figure 14B) and center plunger rod 1216’, displacing the channeled plunger towards the tube side. Likewise, other components coupled to channeled plunger 1232’, such as sealing tip 1228’, nozzle 1230’, and nozzle receiver 1212’, are similarly displaced towards a tube side of the device.

[0052] A terminating end of center plunger rod 1216’ is also shown displaced outside the shell with hinged valve 1245’ in an open state, defining a tube side fluid channel.

[0053] Figure 13B shows a magnified view of the components within the boxed area in Figure 12B. As shown in Figure 13B, a portion of channeled plunger 1332 is displaced into wide channel 1380 of barrel plunger 1312’, but displacement has not advanced sufficiently to open a cap-side fluid channel.

[0054] Figure 12C shows the sample transfer device of Figure 12B after application of a pressing force to cap button 1206”. Figure 12C includes cap button 1206’, a twist cap 1208”, a rubber sealing tip 1228”, a disposable nozzle 1230”, a nozzle receiver 1234”, a barrel plunger 1212”, a channeled plunger 1232”, an o-ring 1214”, a center plunger rod 1216” having a striking end 1242” and a hinged valve 1245” disposed on one end of the center plunger rod, and which are substantially similar to their counterparts in Figures 12A and 12B. Due to application of an external pressing force on cap button 1206”, channeled plunger 1232”, sealing tip 1228”, nozzle 1230”, and nozzle receiver 1212”, are further displaced towards a tube side of the device further establishing a tube side fluid communication.

[0055] Though not shown in Figure 12C, displacement of center plunger rod 1216” towards a tube side of the transfer assembly may be sufficient enough to release rod 1216” from engagementwith channeled plunger 1232” such that rod 1216” is capable of being released, e.g., into a lysis tube attached to a tube end of a sample transfer device.

[0056] Figure 13C shows a magnified view of the components within the box of Figure 12C. To this end, Figure 13C shows that after cap 1206’ ’ receives a pressing force, the forces it transmitted to channeled plunger 1332” such that the channeled plunger is displaced sufficiently into wide channel 1380” such that a cap-side fluid channel is opened. Specifically, the cap-side fluid channel is associated with channel 1364 disposed within channeled plunger 1332”. Channel 1364 may be considered the same as, or fluidly connected to, channel 1366” such that opening of fluid channel 1364 defined a fluid flowpath through channel 1366”.

[0057] Figure 14 shows sample transfer device assembly 1400, according to one preferred embodiment of the present arrangements, in the presence of a cap-side fluid channel and a tube-side fluid communication. Figure 14 includes a cap button 1406, a twist cap 1408, a cap side 1422, a tube side 1423, and o-ring 1414, a center plunger rod 1416 dropped in fluid 1426, a rubber sealing tip 1428 with a rubber-sealing-tip fluid channel 1458 disposed therethrough, a nozzle receiver 1434 with a nozzle-receiver fluid channel 1472 disposed therethrough, a barrel plunger 1412 having a narrow channel 1478, a wide channel 1480, and nozzle-receiver-grabbing extensions 1476 gripping nozzle receiver 1434, gripping a region of nozzle receiver 1434 (e.g., barreled-plunger-locking region 869 of Figure 8).

[0058] As shown in Figure 14, a tube-side fluid communication has been established between the tube side and the cap side of the shell such that diluent has dropped into an attached lysis tube forming diluted lysate, leaving tube side 1423 relatively empty of fluid.

[0059] Further, a cap-side fluid channel has been established at channels 1464 and 1466 of channeled plunger 1432, which may be considered the same fluid channel in channeled plunger 1432. In certain embodiments of the present arrangements, channels 11464 and 1466 define horizontal and vertical portions of a t-channel.

[0060] In such configuration, a flow path is open at a tube side and at a cap side of a shell such that a fluid flow path is defined by a tube-side fluid communication, channels 1464 and 1466 of channeled plunger 1432, nozzle receiver fluid channel 1472, and rubber sealing tip fluid channel 1458, which is capable of engaging with and having fluid dispensed therethrough to a processing device.

[0061] Figure 14 also shows barrel plunger 1412 and nozzle receiver 1434 in a locked configuration. Such locked configuration is facilitated by barrel plunger gripping elements 1476 engaging complementar portions on nozzle receiver 1434.

[0062] Figure 15A shows a transfer assembly 1500, according to one preferred embodiment of the present arrangements, prior to engagement with a processing device. Transfer assembly 1500 incudes a transfer assembly device 1502 attached to a lysis tube 1504, with an alignment ring disposed around a cap side end of the device. Figure 15A also shows a gasket 1530 with a rubber sealing tip 1528 disposed therethrough. The tip and gasket subassembly are configured to engage with cartridge 1574, which includes an aligning feature 1576 that operates with alignment ring 1510 to facilitate alignment of tup 1528 and nozzle 1530 with an inlet port associated with cartridge 1574.

[0063] Figure 15B shows the same components from Figure 15A in an engaged state. Specifically, alignment ring 1510’ is shown engaged with aligning feature 1576 to guide alignment of sample transfer device 1502’, which has tube 1504’ disposed on the other end of the device. In such manner, assembly 1500 is engaged to cartridge 1574’.

[0064] In another aspect, the teachings of the present arrangements disclose a method for transferring a sample for further processing. To this end, Figure 16 is a process flow diagram showing certain salient steps involved in a method for transferring a sample. Preferably, the method is adapted to transfer a sample containing target analyte for processing by a processing device, such as a cartridge, to determine presence and / or characteristics of the target analyte.

[0065] The method begins with a step 1602, which includes obtaining, inside a lysing tube, a lysate. In certain embodiments of the present arrangements, however, prior to this obtaining step, a lysis tube is stored connected to a sample transfer device (e.g., sample transfer device 102 of Figure IB) with a diluent stored in a chamber defined by a cap side seal and a tube side seal.

[0066] The user may then remove the sample transfer device to access the lysis tube to introduce a sample and lysis buffer, reattach the sample transfer device to act as a cap to seal the lysis tube, and then lyse the sample (e.g., by heat treatment). In such matter, a lysing tube containing lysate may be obtained.

[0067] Next, a step 1604 includes obtaining a sample transfer device that has a shell having a cap side and a tube side with a cap-side seal disposed between the cap side and the tube side and a tube-side seal at or near an end of the shell at the tube side, and with a diluent stored between the capside seal and the tube-side seal.

[0068] Next, a step 1606 includes coupling the lysing tube to the tube side of the shell.

[0069] Next, a step 1610 includes applying an external pressing force to the cap side to break the tube-side seal to form a fluid channel between the tube side and the lysis tube, thereby releasing the diluent into the lysis tube to form a diluted lysate. The external pressing force is preferably appliedto a twist button as a twisting force or to a cap button as a pressing force. In certain embodiments of the present arrangements, both a twisting force and a pressing force are applied. For example, a twisting force may be delivered to partially break or disrupt or remove a tube side seal (i.e., a tubeside seal) by driving a rod having a striking end through a foil seal covering the lysis tube, in addition to breaking a tube side seal, or the pressing force may open a hinged valve associated with the rod to facilitate robustness of delivery of force. Then, a pressing force may be applied that will further disrupt a tube-side seal and further open a fluid communication between the tube side of the sample transfer device and the lysis tube attached to the sample transfer device.

[0070] Next, a step 1612 is carried out almost simultaneously, with respect to the abovedescribed delivering step. The step includes breaking the cap-side seal to form a fluid communication between the tube side and the cap side. Preferably, the same force or forces applied to the sample transfer device will remove the cap side seal and open a cap side fluid channel between the tube side of the sample transfer device and the cap side of the sample transfer device. This may include displacing a sealing component (e.g., a channeled plunger) a distance inside the sample transfer device sufficient to open, or provide access to, channels disposed on the sealing component.

[0071] Next, a step 1614 includes delivering the diluted lysate from the lysis tube through the tube-side fluid connection by raising the lysis tube relative to the sample transfer device. Preferably, this simply requires inverting the lysis tube connected to the sample transfer device so that the lysis tube is above the sample transfer device, such that gravity drops the diluted lysate into the tube side of the device.

[0072] In certain embodiments of the present teachings, because a cap side fluid channel has opened, the diluted lysate may flow through the channel along a flow path to exit the device. However, in preferred embodiments of the present arrangements, the sample transfer device is configured such that an additional force is necessary to drive the lysate through the cap side channel, even though the channel may otherwise may be thought of as “open.” For example, certain preferred embodiments of the present sample transfer device implement a fluid flow path in a series of connected channels through a channeled plunger, a nozzle receiver, and a rubber tip that engages with a processing device to deliver the diluted lysate for further processing by the processing device such that additional force may be required to delivery fluid therethrough.

[0073] The processing device may also require force to generate movement of the diluted lysate from an inlet port that receives the diluted lysate from the sample transfer devices of the present arrangements to deliver the lysate to reaction wells through narrow channels in the processing device.Such configurations may require additional force to drive the diluted lysate through the sample transfer device and processing device.

[0074] Accordingly, after a step 1616, which includes detaching a cap disposed on the cap side of the shell, which exposes certain processing-device-engaging features (e.g., nozzle, rubber sealing tip, nozzle receiver) for engagement to a processing device, a subsequent aligning step is implemented. This aligning step 1618 may include aligning processing-device engaging features disposed on an outer end of the cap side with complementary features on a processing device for processing a target analyte. Such alignment may be facilitated by an alignment ring disposed on an outer surface of the processing device, such that the alignment ring engaged with features associated with the processing device to facilitate alignment in step 1616. Such alignment may include aligning a rubber seal tip with a processing device’s inlet port.

[0075] Next, a step 1620 includes applying a pushing force to the sample transfer device, thereby engaging the processing-device-engaging features with the complementary features on the processing device. In other words, the sample transfer device is aligned with a processing device in step 1618 and it is engaged with the processing device in step 1620.

[0076] Next, a step 1622 includes, almost simultaneously with respect to applying the pushing force, driving delivery of the diluted lysate through the cap-side seal by providing a force sufficient to dispense the diluted lysate to the processing device such that the processing device is engaged to the fluid transfer device.

[0077] In one embodiment of the present teachings, a sample transfer device is adapted to include a barrel plunger that, during steps 1620 and / or 1622, displaces to remove a volume inside the sample transfer device, creating a pressure differential between the sample transfer device and the processing device that drives delivery of the lysate to the process device.

[0078] Next, a step 1624 includes disengaging the sample transfer device from the processing device, thereby releasing at least some of the processing-device-engaging features from the sample transfer device to produce a sealed processing device, which includes at least some of the processingdevice-engaging features from the sample transfer device with the processing device. In other words, after delivery of the lysate to the processing device, the processing device is ready to implement processing reactions having received a lysate containing a target analyte from a lysing tube in a manner that avoided sample reentry.

[0079] Although illustrative embodiments of the present arrangements and teachings have been shown and described, other modifications, changes, and substitutions are intended. Accordingly, it isappropriate that the appended claims be construed broadly and in a manner consistent with the scope of the disclosure, as set forth in the following claims.

Claims

CLAIMSWhat is claimed is:

1. A sample transfer device for transferring a sample containing a target analyte, said sample transfer device comprising: a shell having a cap side and a tube side, wherein said cap side is opposite to said tube side, and said tube side is capable of attaching to a lysis tube having stored therein said sample containing said target analyte, and wherein said shell has defined therein a narrow channel and a wide channel; a cap disposed at or near an outer end of said cap side of said shell, and wherein said cap is capable of being in an attached state or a detached state, and wherein in said attached state, said cap is attached to said cap side of shell, and covers a cap side opening of said shell and is capable of receiving an external force, and wherein said cap in said detached state, said cap is detached from said shell and cap side opening is at least partially open to allow fluid inside said shell to flow out of said shell; a channeled plunger communicatively coupled to said cap, wherein said channeled plunger, when disposed within said narrow channel, defines a cap-side seal between said cap side and said tube side, and wherein upon receiving said external force at said cap, said external force is transferred to said channeled plunger, displacing said channeled plunger towards said tube side and displacing said channeled plunger from said narrow channel to be at least partially disposed inside said wide channel and thereby opening a cap-side fluid channel disposed within said channeled plunger to facilitate fluid communication from inside said shell to outside said shell, a center plunger rod abutting and extending from said channel plunger towards said tube side, such that upon said cap receiving said external force, said external force is transferred to said center plunger rod and said center plunger rod is displaced towards said tube side; a gasket occupying a space defined between an inner wall of said shell and said center plunger rod, wherein said gasket is affixed to said inner wall such that displacement of said center plunger rod, towards said tube side and to a location beyond said gasket, does not displace said gasket and said inner wall, and causes said center plunger rod to open up, at said tube side of said shell, a tube-side fluid connection for dispensing and receiving said fluid at said tube side of said shell, and when said center plunger rod remains disposed at said narrow channel, said gasket seals off said tube-side fluid connection at said tube side of said shell, defining a cap-side seal.and wherein when said cap-side fluid channel and said tube-side fluid connection are open a fluid dispensing flow path is defined inside said transfer device and that is capable of dispensing said fluid present inside said shell.

2. The sample transfer device of claim 1, further comprising a lysis tube that is attached to said tube-side of said sample transfer device.

3. The sample transfer device of claim 1, wherein in presence of said cap-side seal and tubeside seal, said shell has stored therein a diluent.

4. The sample transfer device of claim 1, wherein said cap is a twist cap that is capable of receiving a twisting force, which is said external force.

5. The sample transfer device of claim 1, further comprising a button that is part of said cap and wherein a pressing force against said button applies a requisite amount of said external force.

6. The sample transfer device of claim 1, wherein said center plunger rod includes a shaft portion and a plugging portion, wherein said plugging portion has at least one dimension that is larger than that of said shaft portion, and wherein said gasket occupies said space between said inner wall of said shell and said plugging portion of said center plunger rod.

7. The sample transfer device of claim 1, wherein said plugging portion has a larger diameter than said shaft portion.

8. The sample transfer device of claim 6, wherein when said center plunger rod displaces, under said external force, towards said lysis tube and travels past said gasket, said center plunger rod placed in a released state, opens up said tube-side seal allowing fluid communication between said shell and said lysis tube.

9. The sample transfer device of claim 6, wherein said plugging portion of said center plunger rod is or includes a hinged valve comprising a stable element and a plunger, wherein said stable element does not displace relative to said center plunger rod, wherein said plunger is attached to and rotatable relative to said center plunger rod such that during said displacement of said center plunger rod towards said tube side to a location beyond said gasket, said plunger rotates to open said hinged valve.

10. The sample transfer device of claim 1, wherein said wide channel is coextensive with said narrow channel.

11. The sample transfer device of claim 10, further comprising a barrel plunger disposed at or near said cap side of said shell, wherein said barrel plunger includes said narrow channel and saidwide channel, and when said cap seal is not open, narrow channel of said barrel plunger surrounds said channeled plunger.

12. The sample transfer device of claim 10, further comprising processing-device-coupling components configured to define a fluid flow path from said cap side of said sample transfer device to a processing device for analyzing said sample containing said target analyte.

13. The sample transfer device of claim 10, wherein said processing-device-coupling components include: a nozzle receiver having defined therethrough a nozzle-receiver fluid channel in fluid communication with said cap side channel, being coupled to or engaged with said channeled plunger and being at least partially surrounded by said narrow channel of said barrel plunger; a nozzle engaged with said nozzle receiver; and a sealing tip secured to said nozzle and having defined therethrough said sealing tip channel, and further comprising a nozzle-receiver-engaging portion that engages with said nozzle receiver to define a nozzle fluid flow path that includes said nozzle-receiver fluid channel and said sealing-tip fluid channel.

14. The sample transfer device of claim 13, wherein said nozzle receiver and said channeled plunger slidably engage with said narrow channel of said barrel plunger such that said narrow channel guides displacement of said channeled plunger inside said narrow channel and towards said tube side.

15. The sample transfer device of claim 14, further comprising nozzle-receiver-grabbing extensions as part of said barrel plunger and that are configured to place said nozzle receiver and said barrel plunger in a locked state such that said barrel plunger prevents slidable displacement of said nozzle receiver within said narrow channel of said barrel.

16. The sample transfer device of claim 15, further comprising an o-ring surrounding said barrel plunger and that contacts an inner surface of said shell.

17. The sample transfer device of claim 16, wherein during said detached state of said cap, said rubber sealing tip and said nozzle are configured to be aligned with an inlet port to said processing device such that said rubber sealing tip and said nozzle form a sealed connection between said sample transfer device and said processing device.

18. The sample transfer device of claim 17, further comprising an alignment ring surrounding an outer surface of said cap side of said shell, wherein said alignment ring facilitates alignment of said rubber sealing tip and said nozzle with said processing device, such that said alignment ring isconfigured to engage with complementary features on said processing device to facilitate said alignment.

19. The sample transfer device of claim 18, wherein said sample transfer device is capable of receiving a pushing force, delivered to an outer surface of said shell, for pushing in said rubber sealing tip into said inlet port to achieve an engaged state of said sample transfer device with said processing device.

20. The sample transfer device of claim 19, wherein in said engaged state of said sample transfer device with said processing device, said rubber sealing tip is configured to seal said inlet port, said nozzle receiver and said barrel plunger are configured to be in said locked state, and said pushing force drives said barrel plunger away from said cap side to said tube side to facilitate reduction of volume inside said sample transfer device, wherein said reduction of volume creates a pressure differential between said processing device and said sample transfer device that is designed to transfer said sample containing said target analyte through said cap-side fluid connection and into said processing device.

21. The sample transfer device of claim 22, wherein said rubber sealing tip and said nozzle are capable of being in a detached state such that said rubber sealing tip is designed to occupy said inlet port and said nozzle is designed to cover said inlet port, and wherein in said detached state, said rubber sealing tip and said nozzle are designed not to be engaged to said sample transfer device.

22. A method of transferring a fluid mixture, said method comprising: obtaining, inside a lysing tube, a lysate; obtaining a sample transfer device comprising a shell having a cap side and a tube side with a capside seal disposed between said cap side and said tube side and a tube-side seal at or near an end of said shell at said tube side, and having diluent stored between said cap-side seal and said tube-side seal; coupling said lysing tube to said tube-side of said shell; applying an external force to said cap side to break said tube-side seal to form a tube-side fluid communication between said tube side and said lysis tube, thereby releasing said diluent into said lysis tube to form a diluted lysate; opening said cap-side seal to form a fluid communication between said tube side and said cap side; and wherein said applying and said opening form a fluid flow pathway that allows said diluted lysate to flow outside said shell.

23. The method of transferring a fluid mixture of claim 22, further comprising dispensing said diluted lysate from said shell.

24. The method of transferring a fluid mixture of claim 22, wherein said opening and said applying are carried out contemporaneously.

25. The method of transferring a fluid mixture of claim 22, further comprising delivering said diluted lysate from said lysis tube through said tube-side fluid connection by inverting said tube side relative to said cap side of said sample transfer device.

26. The method of transferring a fluid mixture of claim 25, wherein said delivering said diluted lysate from said lysis tube through said tube-side fluid connection further includes: aligning processing-device engaging features disposed on an outer end of said cap side with complementary features on a processing device for processing a target analyte; and applying a pushing force to said sample transfer device, thereby engaging said processing-deviceengaging features with said complementary features on said processing device.

27. The method of transferring a fluid mixture of claim 26, wherein said aligning and said applying are carried out contemporaneously.

28. The method of transferring a fluid mixture of claim 27, further comprising, prior to said aligning, detaching a cap disposed on said cap side of said shell.

29. The method of transferring a fluid mixture of claim 28, wherein said driving said delivery of said diluted lysate through said cap-side seal provides a force sufficient to dispense said diluted lysate to said processing device, wherein said processing device is engaged to said fluid transfer device.

30. The method of transferring a fluid mixture of claim 29, further comprising: disengaging said sample transfer device from said processing device, thereby releasing at least some of said processing-device-engaging features from said sample transfer device to produce a sealed processing device; and processing said lysate in said sealed processing device to determine presence and / or characteristics of said target analyte.

31. The method of transferring a fluid mixture of claim 22, wherein prior to said obtaining, inside a lysis tube, said lysate, said method includes: obtaining an empty lysis tube coupled to a said sample transfer device at said tube side of said shell; separating said empty lysis tube from said tube-side of said shell; adding a sample containing target analyte and buffer to said empty lysis tube;re-coupling said lysis tube containing said sample containing target analyte and buffer to said tube side of said shell; and lysing said sample containing target analyte and buffer to form said lysate.

32. A method of assembling a sample transfer device, said method comprising: inserting a gasket into a shell having a cap side and a tube side and said gasket being inserted through said tube side of said shell; disposing, at said cap aide, a channeled seal in a narrow channel defined inside said shell and said narrow channel is coextensive with a wide channel; dispensing diluent into said tube side of said shell; and positioning a center plunger rod through said gasket and securing said center plunger rod between said gasket and said channeled seal to form a tube side seal.

33. The method of assembling a sample processing device of claim 32, wherein in said dispensing, said narrow channel and said wide channel are defined in a barrel plunger.

34. The method of assembling a sample processing device of claim 33, further comprising: attaching an o-ring to said barrel plunger to form a barrel plunger assembly; inserting said barrel plunger assembly into said shell.

35. The method of assembling a sample processing device of claim 34, further comprising, prior to said inserting said barrel plunger assembly: fitting said channeled seal onto a nozzle receiver to form a channeled-seal-nozzle-receiver subassembly, inserting a rubber sealing tip into a disposable nozzle to form a nozzle-tip sub-assembly; attaching said nozzle-tip sub-assembly to said channeled-seal-nozzle-receiver sub-assembly to form a nozzle assembly; and placing said nozzle assembly into said barrel plunger.

36. The method of assembling a sample processing device of claim 35, further comprising attaching a cap to said shell that covers said disposable nozzle and said rubber sealing tip on said nozzle assembly.

37. The method of assembly a sample processing device of claim 32, wherein prior to said positioning said center plunger rod through said gasket, adding a hinged valve to said center plunger rod to form a center plunger rod assembly, and wherein said positioning said center plunger rod and said securing said center plunger rod includes positioning said center plunger rod assembly and securing said center plunger rod assembly.

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