Membrane seal assemblies and single lid analysis cartridges and related methods

Abstract

A membrane seal assembly that seals one or more reagents within a sample cartridge that allows for a single lid cartridge design. Such a membrane seal assembly may include one or more layers, a bottommost layer that permanently seals with a sample cartridge having multiple chambers for one or more reagents, and a topmost layer that releasably seals a vent in the membrane seal assembly and is removable by an end user. This configuration allows the use of a single cover that can be integrally formed with the cartridge or is a separate component attached above the cartridge. The film seal assembly may include a peelable liner, or may be releasably attached to a bottom side of the single cover. Such a film assembly may include a plurality of layers including a polypropylene layer for permanent sealing to a rigid propylene cartridge and a polyester top layer for releasable and hermetic sealing with a gasket or cover.

Description

[0001] Cross - Reference to Related Applications

[0002] This PCT application claims priority to U.S. Provisional Application No. 63 / 377,470, filed Sep. 28, 2022, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present invention generally relates to the field of manufacturing biological devices, and more particularly to diagnostic test cartridges for analyzing fluid samples. BACKGROUND ART

[0004] In recent years, significant developments have been made in the field of biological detection devices that facilitate the manipulation of fluid samples within cartridges for biological detection of fluid samples by polymerase chain reaction (PCR). In this field, one notable development is the cartridge of Cepheid. For the configuration and operation of such cartridges, reference may be made to U.S. Patent No. 6,374,684, entitled "Fluid Control and Processing System," and U.S. Patent No. 8,048,386, entitled "Fluid Processing and Control," for a more in-depth understanding. While these cartridges represent significant advancements in the art, like any precision instrument, they have presented certain challenges in terms of manufacturing and user workflows. In particular, assembling multiple components in a precision pressurized instrument requires the assembly of many complex components, which imposes a significant cost burden and requires complex assembly techniques that can lead to potential defects and additional manufacturing challenges.

[0005] Traditional systems for manufacturing cartridges utilize a series of manufacturing processes and steps to ensure proper sealing of the chambers of a cartridge containing one or more reagents. Some such cartridges include steps such as ultrasonically welding a dual lid device to a cartridge body; and sealing reagents within the cartridge. The dual lid device includes a lower lid member ultrasonically welded over the cartridge and an upper lid member that closes over the lower lid member. After depositing one or more reagents into the chamber, an additional film seal may be used to seal the reagents within the cartridge. The top lid covers the bottom lid and the film seal, thereby securing the reagents within the chamber during storage and transportation to the end user. While the performance of the cartridges enabled by these techniques far exceeds that of traditional cartridges, current designs still present certain challenges in terms of the cost and complexity of manufacturing and assembly, which in turn introduce potential sources of defects and a significant cost burden.

[0006] Accordingly, there is a need for an improved design to avoid the complexity and associated potential drawbacks of the current dual-cap design and to reduce the cost burden associated with the cassette assembly. Further improvements are needed to maintain or further improve the sealing and performance reliability within the sample cassette. SUMMARY OF THE INVENTION

[0007] In one aspect, the present invention relates to a method of sealing a sample cartridge. The method may include the steps of: placing a film sealing assembly over a cartridge body of the sample cartridge, the sample cartridge having a plurality of chambers defined therein, the plurality of chambers including one or more reagent chambers and a sample chamber; permanently sealing the bottom surface of the film sealing assembly along the top edge of the cartridge body, wherein the film sealing assembly includes one or more vent openings defined therein for venting the one or more reagent chambers; and releasably and hermetically sealing the one or more vent openings by a top surface of the film sealing assembly to seal the one or more reagent chambers during storage and / or transportation to a user, wherein the sealing assembly is configured to facilitate release of the hermetic seal by an end user. The vent openings and inlets may be formed by laser cutting or any suitable means. As described herein, permanently sealing or permanent seals may also be referred to as "welding" or "welds", which may include heat sealing and / or adhesive sealing. It should be understood that any method described herein may include variations of one or more steps, or may include one or more intermediate or additional steps not described.

[0008] In some embodiments, the permanent seal comprises, for example, sealing the bottom surface of the film seal assembly along the top edge of the cartridge surrounding one or more reagent chambers by heat sealing, induction sealing, adhesive sealing, or any suitable sealing means. In some embodiments, heat sealing may also utilize an adhesive. These methods may further comprise fixing a single lid member of the cartridge above the film seal assembly, wherein the single lid member is removable and / or movable between an open and a closed position, in which the single lid member is fixed above the film assembly. In some embodiments, the single lid member is integrally formed with the cartridge, which may further facilitate improving the workflow by improving the peelability of one or more layers of the film seal assembly. In other embodiments, the single lid member is a separate component from the cartridge and is releasably coupled to the cartridge. In either case, the single lid member may be releasably fixed above the cartridge by corresponding snap-fit features, latches, closure mechanisms, or any suitable coupling means.

[0009] In some embodiments, the film seal assembly comprises at least two separable layers, namely a top layer and a bottom layer. A sealing method using such an assembly may comprise providing a releasable hermetic seal by heat sealing and / or adhesive sealing the top layer to the bottom layer. The bottom layer may comprise one or more sub-layers. In some embodiments, when the cartridge is formed of rigid polypropylene, the bottom layer comprises at least one bottom-most sub-layer containing polypropylene for permanently sealing the cartridge. The bottom layer may further comprise a top-most layer of polyester for releasably sealing the separable top layer and / or providing heat resistance to the bottom layer. In some embodiments, the separable top layer is an adhesive liner formed of polyester. In some embodiments, the top layer comprises one or more protrusions that extend forward beyond the perimeter of the top of the cartridge to facilitate manual grasping by the user to remove the liner. In such embodiments, the single lid member releasably coupled above the cartridge may comprise a front tab that extends beyond the perimeter of the top of the cartridge to facilitate manual grasping by the user to remove the liner when opening the single lid member. In some embodiments, the film seal assembly comprises an adhesive layer (e.g., a double-sided adhesive strip) that may extend partially or fully across the top layer to fix the top layer to the lid member, such that when the lid member is opened, the top layer peels away from the film seal assembly.

[0010] In some embodiments, the film seal assembly includes a single layer, wherein the top surface of the single layer is releasably sealed to the lid of the sample cartridge, and the bottom layer is configured to be permanently sealed to the cartridge. The single layer may include one or more adhesives disposed thereon. In some embodiments, the single layer includes at least two inseparable sub-layers, wherein the bottom layer includes a first material for permanently heat-sealing the cartridge, and the top sub-layer includes a second material different from the first material, the second material being selected for releasably sealing the lid of the sample cartridge. In some embodiments, pressure is applied to the lid to releasably seal the top surface, such that a pressure-sensitive adhesive disposed on the top surface hermetically seals the lid to the top surface of the assembly. The top surface may be releasably sealed by heat-sealing.

[0011] In another aspect, the present invention relates to a film seal assembly for sealing above a cartridge of a sample cartridge having a plurality of chambers, the plurality of chambers including one or more reagent chambers for containing one or more reagents for analyzing a fluid sample injected into the sample cartridge. Such a film seal assembly may include: one or more layers disposed within a planar assembly, wherein each of the one or more layers is planar and shaped to cover the perimeter of the top edge of the cartridge. In some embodiments, the planar assembly includes a top surface and a bottom surface, wherein the bottom surface is configured to be permanently sealed along the top edge of the cartridge to cover the plurality of chambers defined therein, the film seal assembly having one or more vent openings at least partially extending therethrough for venting the one or more reagent chambers, and the top surface being configured to releasably and hermetically seal the one or more vent openings to hermetically seal the one or more reagent chambers for storage and / or transportation to an end user.

[0012] In some embodiments, the thin film seal assembly has at least two separable layers, the at least two separable layers including a top layer and a bottom layer. The releasable seal may include a heat seal and / or an adhesive seal of the bottom layer. In some embodiments, the top layer comprises polyester and may be configured as a peelable adhesive liner. The bottom layer may include one or more inseparable sub-layers, and the one or more vent openings extend through the bottom layer. In some embodiments, the bottom layer may include at least one bottom terminal sub-layer, the at least one bottom terminal sub-layer including polypropylene for permanently heat sealing a cassette formed of rigid polypropylene. The bottom layer may further include a top terminal sub-layer, the top terminal sub-layer including polyester for releasably sealing the separable top layer. In some embodiments, the thin film assembly is defined as a single layer. The single layer may include one or more adhesives thereon to facilitate permanent sealing to the cassette and / or releasable sealing to a lid of the sample cassette. In some embodiments, the top surface is configured to be releasably sealed by an adhesive and / or a heat seal. The single layer may include at least two inseparable sub-layers, the at least two inseparable sub-layers including a bottom terminal sub-layer having a first material for permanently heat sealing the cassette and a top terminal sub-layer of a second material different from the first material, the second material being selected for releasably sealing to the lid. In some embodiments, the topmost layer comprises polyester and the bottommost layer comprises polypropylene.

[0013] In yet another aspect, the present invention relates to an improved sample cartridge design. The sample cartridge may include: a cartridge body having a plurality of chambers defined therein, wherein the plurality of chambers include a sample chamber for receiving a fluid sample and one or more reagent chambers for storing one or more reagents for performing an analytical assay on the fluid sample, the plurality of chambers opening along the top of the cartridge body; and a lid attached to and covering the top of the cartridge body and the plurality of chambers. Such a sample cartridge is well suited for use with the improved film sealing assembly described herein. Such a film sealing assembly may include an assembly having at least two separable layers, including: a bottom layer having a bottom surface configured to permanently seal over the cartridge body, the bottom layer having one or more vent openings defined therein; and a top peelable layer disposed over the bottom layer, the top peelable layer hermetically sealing the one or more vent openings in the bottom layer, the top peelable layer being removable by an end user. In some embodiments, the top layer includes a polyester liner and the bottom layer includes polypropylene. In some embodiments, the bottom layer has a plurality of inseparable sub-layers, the plurality of inseparable sub-layers including: a bottom-most sub-layer including polypropylene for permanently sealing to the cartridge body, and a top-most sub-layer including polyester for releasably and hermetically sealing to the polyester liner. It should be understood that the film sealing assembly may be applied to any suitable sample cartridge, including an integral, unitary cartridge having an integral lid, or a conventional cartridge having a separable lid, and the assembly process may be partially or fully automated. Suitable film sealing assemblies may also include assemblies having a single layer, such as any of those described herein.

[0014] In another aspect, the present invention relates to a method of using a sample cartridge sealed by a film sealing assembly having at least a separable top layer and a bottom layer. Such a method may include the steps of: opening the lid of the sample cartridge, thereby peeling off the top layer of the film sealing assembly to expose the bottom layer of the film assembly sealed at the top of the cartridge body, the film sealing assembly having one or more openings corresponding to sample chambers and one or more reagent chambers; injecting a biological sample into the sample chamber through an opening among the one or more openings; and closing the lid of the sample chamber to seal the sample container for subsequent testing. In some embodiments, the film sealing assembly may include additional auxiliary openings on the reagent chambers to allow a user to inject a dedicated reagent. In some embodiments, the film sealing assembly includes an adhesive layer disposed above the top layer to fix the top layer to the lid, such that when the lid is opened, the top layer peels off from the bottom layer of the film sealing assembly. In some embodiments, at least the top layer and the adhesive layer include forward projecting protrusions that extend forward from the periphery of the top of the cartridge body corresponding to forward projecting protrusions of the lid to facilitate peeling off the top layer when the lid is opened. In some embodiments, the lid is manually opened by a user. In some embodiments, the lid is opened in a robotic manner by an automated system. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figures 1A - 1B Shows an exemplary diagnostic test cartridge having an improved film sealing assembly according to some embodiments.

[0016] FIG. 2A shows a conventional sample cartridge having a welded double-lid device and a film seal, provided to a user with the lid in the top cover open to receive a fluid sample; FIG. 2B shows an exploded view of the conventional sample cartridge, showing its main components including a double-lid device, a multi-chamber body, a reaction vessel, a valve assembly, and a base; Figure 2C -2D shows a detailed view of the double-lid device; FIG. 2E shows the state of the double-lid device before being placed on the top of the sample cartridge body for ultrasonic welding by a welding horn.

[0017] Figures 3A - 3C Shows an exemplary diagnostic test cartridge body having an integrally formed single lid according to some embodiments.

[0018] Figures 4A - 4B Respectively show the top views of multiple chambers of the test cartridge body before and after applying a film seal according to some embodiments Figure 3A in the test cartridge body.

[0019] Figures 5A - 5C Shows another embodiment having a separately manufactured single lid and attached to a conventional cartridge body according to some embodiments.

[0020] Figure 6Schematic diagram showing an improved film seal assembly according to some embodiments.

[0021] Figure 7A and 7B Front perspective view of a test cassette having an improved film seal assembly according to some embodiments, showing the states before and after peeling off the top gasket of the film seal assembly, respectively.

[0022] Figure 8A and 8B Showing according to some embodiments Figures 7A - 7B Front perspective view of the test cassette and film seal assembly shown, showing the states before and after peeling off the top gasket of the film seal assembly, respectively.

[0023] Figures 9A - 9B Showing a double-layer film seal assembly according to some embodiments.

[0024] Figure 10 Showing a single-layer film seal assembly according to some embodiments.

[0025] Figures 11A - 11B Showing a double-layer film seal assembly with protrusions and a molded cover according to some embodiments, and Figure 11C Showing an exemplary adhesive layer structure before assembly according to some embodiments.

[0026] Figure 12 Showing a method of assembling a diagnostic test cassette using an improved film seal assembly according to some embodiments.

[0027] Figure 13 Showing an alternative single-piece cassette design with an integrally formed lid according to some embodiments.

[0028] Figure 14 Showing an alternative single-piece cassette design with an integrally formed lid and a snap-fit structure according to some embodiments. Detailed Description

[0029] The present invention generally relates to improved sample cassettes and film seal assemblies, as well as related use, sealing, and assembly methods. In particular, the sample cassette and film seal assembly designs described herein are intended to improve current cassette designs and sealing methods, which rely on a double-lid design that has a high cost burden at the manufacturing and component levels and introduces potential sources of defects, as described in more detail below. The designs and methods described herein overcome these challenges by providing a seal assembly that can employ a more reliable heat-sealing method, and can utilize less costly raw materials (e.g., films, rather than injection-molded components), and further avoid the complexity of current designs and the drawbacks associated with current assembly techniques such as ultrasonic welding.

[0030] I. System Overview

[0031] In one aspect, the present invention relates to an improved thin film seal assembly that facilitates welding (i.e., direct permanent attachment to a cartridge) and a releasable airtight seal of one or more vent openings defined in the thin film seal assembly. This configuration allows the sample cartridge to maintain an airtight seal of one or more reagents within one or more chambers located within the sample cartridge during storage and / or shipment to an end user, after which the end user can release the airtight seal, inject a fluid sample into the sample chamber, and perform an analytical test on the sample. These improved thin film seal assemblies can include a bottom surface permanently attached to the top of the cartridge and a top surface that releasably and airtight seals one or more vent openings in the thin film assembly.

[0032] Such thin film assemblies can have different configurations, including single layer designs and multi-layer designs with or without a peelable liner, as further described in detail below. These thin film assemblies further improve other sample cartridge components by eliminating the need for a double lid design. The thin film seal assembly effectively replaces the function of the bottom lid, such that the double lid design can be replaced with a simplified single lid piece that can be manufactured as a separate component or integrally molded with the cartridge. This is advantageous because it reduces the cost burden of the components and further avoids the need for ultrasonic welding, which can damage various components within the sample cartridge and is a potential source of defects. A major advantage of this design is the flexibility to use a thin film seal instead of an ultrasonic welded lid when changing the geometry of the cartridge chamber. Advantageously, changing the geometry of the cartridge chamber does not require changing the lid and lid mold to match the cartridge, as the design and use of the thin film seal do not depend on the geometry.

[0033] In some embodiments, the thin film seal assembly is a dual film seal assembly, such as a bottom locking / welding layer and a top removable liner layer that airtight seals the assembly over the cartridge. A dual film seal system capable of continuous peeling is identified by using a pressure and laser cutting system. In some embodiments, the top liner film includes forward extending protrusions that can be fixed to the front protrusions of the single lid piece to allow the user to perform a single cartridge opening step workflow.

[0034] II. Thin Film Seal Assembly and Single Lid Cartridge

[0035] Figure 1AAn exemplary film seal assembly 130 is shown, which implements an improved sample cartridge design 100 having a cartridge body 110 integrally formed with a single lid member 120. The sample cartridge further includes a base 101, which can be formed separately and attached to the cartridge body or integrally formed with the cartridge body. In this embodiment, the film seal assembly 130 has a double-layer design, which includes a top layer 131 and a bottom layer 132. The bottom layer 132 is permanently sealed (e.g., welded) to the top edge of the cartridge body 110, for example, by adhesion and / or heat sealing. The bottom layer includes one or more vent holes that vent the chambers to allow a fluid sample to flow through the chambers during the use of a sample processing module that receives the sample cartridge and performs analysis and detection of the sample. The shape, vent holes, and inlet / outlet of the sample chamber can be made by laser cutting or by any suitable means. The top layer 131 is releasably attached to the bottom layer 132 to hermetically seal the vent holes in the bottom layer. In this embodiment, the top layer 131 is a peelable layer that can be removed by the end user, as shown, to allow venting of the chambers and access to the sample chamber to inject a fluid sample (lower right). Then the integrally formed single lid member 120 is closed, and the sample cartridge 100 is injected into a sample processing / analysis and detection module (not shown) for processing and analysis and detection. In this embodiment, the lid member and the top of the cartridge body include corresponding snap-fit features, i.e., resilient protrusions 122 on each side of the lid member 120 that snap-fit into corresponding profiles 112 defined along the sides of the top of the cartridge body. It should be understood that these structures can be reversed or have various other sizes, shapes, and positions.

[0036] Figure 1B Another film seal assembly 130 is shown, which is used to seal the top of an improved sample cartridge design 100' having a cartridge body 110' with an integrally formed lid member 120. Similar to the previous embodiment, the film seal assembly 130 includes a top layer 131 and a bottom layer 132, but this embodiment further includes adhesive layer 136 protrusions that fix the top layer 131 to the underside of the lid member to facilitate peeling of the top layer when manually opening the lid member. In some embodiments, the adhesive protrusion layer includes a double-sided adhesive layer with adhesive on both sides (e.g., pressure contact adhesive). See Figure 11C the exemplary configurations in. As shown, the top layer 131 includes a forward protruding protrusion that further extends beyond the perimeter of the top of the cartridge member and is located below the front protrusion of the lid member when closed, so that the user manually opens the lid member by pressing upward along the front protrusion of the lid member, and this manual action also engages the forward protruding protrusion and peels the top layer of the film seal assembly. In this embodiment, the cartridge body includes the same as above in Figure 1Athe same or similar components detailed in, except that the cassette design has a slightly different shape and engagement structure, as further detailed below in Figure 14 In this embodiment, the cover and top of the cassette include corresponding engagement structures, which include contoured cut-outs in the cover that snap into a single resilient protrusion disposed along the front of the cassette. It should be understood that the thin film seal assembly can be used with any cassette described herein (e.g., a unitary or unibody cassette) or even a conventional cassette. In this embodiment, the underlying layer is a lock seal film heat-sealed to the cassette, the lock seal film including vent holes and sample chamber cut-outs that can be formed by laser cutting or any suitable means, and plunger cut perforations located at the center. The top film is a peelable film that is sealed to the top of the underlying layer and includes plunger cut perforations located at the center. The top film can be sealed to the underlying layer by heat sealing, induction, adhesive sealing, or any suitable means. The additional adhesive layer 136 can be defined in any suitable shape and does not need to cover the entire top layer. In this embodiment, it is formed by laser cutting into an elongated tab shape and has a central opening or slot for the plunger to pass through. In some embodiments, the adhesive layer is defined as Figure 11C shown, as an adhesive layer 138 between two release liner layers 139, which is then laser cut into the desired shape (e.g., a tab shape with a central slot). One liner is peeled off, and the adhesive layer is applied to the top layer of the thin film seal assembly, and then the other liner is peeled off to expose the adhesive layer, and the cover is closed to start the adhesion, thereby fixing the top layer of the thin film assembly to the cover, so that when the user opens the cover, the top cover will peel off from the underlying layer. Compared to embodiments that do not have this adhesive layer and require the user to peel off an additional liner, this configuration further simplifies the workflow. It should be understood that some or all of these component aspects can be performed by an automated system.

[0037] Advantageously, this design eliminates the need for the bottom cover of the dual-cover design, and thus the dual-cover has been replaced by a single cover that closes the top of the thin film seal assembly (or the top of the underlying layer after removal of the peelable top layer). Therefore, since the design of the cover has been significantly simplified, the single cover can be included as an integrally molded part of the cassette. This design is advantageous because it not only reduces the cost burden of the assembly, but also eliminates the need to ultrasonically weld the cover to the cassette to achieve a seal, and mainly relies on the thin film assembly to seal the reagent therein.

[0038] By referring to the conventional cassette design that relies on a traditional double - lid device, the above - described uses and advantages of the improved thin - film sealing assembly and the cassette design with a single lid member can be further understood, as shown in FIGS. 2A - 2B. In this conventional design, the sample cassette 200 includes a separate double - lid device 220 that is ultrasonically sealed to the top of the cassette body 200 that houses reagents and fluid samples. The double - lid device 220 includes a bottom - lid portion 221b sealed to the cassette body and an open top - lid portion 221a, as Figure 2C shown, to allow a user to deposit a fluid sample in the cassette. When the sample cassette 200 is provided to the user, its reagents have already been placed in selected chambers and are sealed within the cassette by a thin film (not shown) sealed to the top of the bottom lid 221a. Except for the integrally formed lid member and the thin - film sealing assembly, other components of the sample cassette body described herein (e.g., chambers, valve body, reaction tube, base, etc.) can be the same as this conventional cassette design, so that the cassette can be improved without requiring any modification to the module operation.

[0039] FIG. 2B shows an exploded view of a conventional cassette design using a double - lid device. The shown cassette is based on Cartridge (Cepheid, Inc., Sunnyvale, Calif.). Cartridge 200 includes a cartridge body having a plurality of chambers 208 for containing various reagents and / or buffers. These chambers are disposed around a central syringe barrel 209 which is in fluid communication with a valve syringe tube 211 extending through the syringe barrel 209 to a valve body 210. The valve body 210 is interfaced within the cartridge body and is supported on a cartridge base 212. The cartridge typically includes one or more channels or cavities which may contain filter material (e.g., a glass filter column) capable of binding and eluting nucleic acids. In various embodiments, the cartridge further includes one or more temperature control channels or chambers which, in some embodiments, may act as thermal cycling chambers. An operable module's "plunger" (not shown) is used to draw fluid into the syringe barrel 209 and rotation of the valve body / syringe tube provides selective fluid communication between the various reagent chambers and channels and reaction chambers. Thus, by rotation of the valve body and plunger, the various reagent chambers, reaction chambers, matrix materials and channels are selectively fluidly connected and movement of the reagents (e.g., loading or unloading of chambers) is operated by the "syringe" action of the plunger. An attached reaction vessel 216 ("PCR tube") provides an optical window for real-time detection of, for example, amplification products, base identity in sequencing operations, by operation of modules within the system described herein. It should be understood that such reaction vessels may include a variety of different chambers, conduits or micro-well arrays for detecting target analytes. The sample cartridge may be equipped with means for preparing a biological fluid sample prior to delivery to the reaction vessel. Any chemical reagents required for viral or cell lysis, or means for binding or detecting target analytes (e.g., reagent beads) may be contained in one or more chambers of the sample cartridge and may thus be used for sample preparation.

[0040] The exemplary use of such a sample cartridge with a reaction vessel for analyzing a biological fluid sample is described in commonly assigned U.S. Patent No. 6,818,185, entitled "Cartridge for Conducting a Chemical Reaction," filed on May 30, 2000, the entire contents of which are incorporated herein by reference for all purposes. Examples of the sample cartridge and related instrument modules are shown and described in U.S. Patent No. 6,374,684, entitled "Fluid Control and Processing System," filed on August 25, 2000, and U.S. Patent No. 8,048,386, entitled "Fluid Processing and Control," filed on February 25, 2002, the entire contents of which are incorporated herein by reference in their entirety for all purposes. Various aspects of the sample cartridge can be further understood by reference to U.S. Patent No. 6,374,684, which more particularly describes certain aspects of the sample cartridge. Such a sample cartridge can include a fluid control mechanism, such as a rotary fluid control valve body, which is connected to the chambers of the sample cartridge. Rotation of the rotary fluid control valve body allows fluid communication between the chambers and the valve body in order to control the flow of a biological fluid sample stored in the cartridge into different chambers, where various reagents can be provided according to a specific protocol to prepare the biological fluid sample for analysis as needed. To operate the rotary valve body, the cartridge processing module includes a motor, such as a stepper motor that is typically coupled to a drive system that engages the structure of the valve body to control the movement of the valve body in coordination with the movement of a syringe, thereby causing the movement of the fluid sample according to the desired sample preparation protocol. U.S. Patent No. 6,374,684 demonstrates the fluid metering and dispensing functions of the rotary valve body according to a specific sample preparation protocol. It should be understood that the cap concept herein can be applied to a single-piece cartridge ("unibody"), such as any of those described in U.S. Application No. 18 / 184,326, filed on March 15, 2023, the entire contents of which are incorporated herein by reference for all purposes. It should also be understood that the cap concept of the present disclosure can also be applied to traditional cartridges.

[0041] Figure 2C-A detailed view of the traditional double-cover device 220 in 2D, which includes a top cover 221a and a bottom cover 221b. The chamber of the fluid container device disclosed herein may contain one or more reagents for various purposes. These reagents can exist in various forms. Non-limiting exemplary forms of reagents may include solutions, dry powders, or lyophilized beads. These reagents can be used for different purposes, including but not limited to chemical and / or enzymatic reactions, sample preparation, and / or detection. Non-limiting exemplary purposes may include lysis of cells or microorganisms, purification or separation of target analytes (e.g., specific cell populations, nucleic acids, or proteins), digestion or modification of nucleic acids or proteins, amplification of nucleic acids, and / or detection of target analytes. More details of the cover device can be found in U.S. Patent No. 10,273,062, the entire content of which is incorporated herein by reference.

[0042] Figure 2C A top view showing the underside of the bottom cover and the underside of the top cover portion. The underside of the bottom cover includes a plurality of conduits 222 protruding upward from the top surface of the bottom cover portion, and these conduits are received in corresponding holes 224 in the top cover portion. The conduits 222 and the openings 224 surround a central opening 223, through which the syringe instrument of the module extends during operation of the cartridge therein to facilitate fluid flow between chambers by the movement of the valve body. Figure 2D shows a bottom view of the underside of the bottom cover of the double-cover device 220, which includes the lower-side main surface and the top side of the top cover portion. The underside of the bottom cover portion is ultrasonically welded to the top edge of the cartridge. To facilitate ultrasonic welding, raised welding ridges 225 continuously surround the perimeter of the bottom cover, located between the edge alignment structure 227 and the outermost wall. When in place in the correct manner, the edge alignment structure 227 and the outermost wall prevent the bottom cover from rotating excessively relative to the fluid container 200, thereby aligning the raised welding ridges 225 of the bottom cover with the welding structure of the cartridge (e.g., the top edge of the wall). The wall 227 extends from the central region of the lower-side main surface and surrounds the central opening 228 in a petal-like arrangement, while the cylindrical wall 223 extends around this central opening. A raised welding pattern is provided on the top edge of the wall. This raised welding pattern is connected to the welding ridges 225. When the fluid container and the bottom cover are welded together via the raised welding pattern and the welding ridges, the sub-containers within the bottom container are fluidically isolated from each other.

[0043] Figure 2E shows the relationship between the dual - lid device 220 and the cassette 200. The cassette 200 includes a plurality of chambers that can be fluidly coupled or uncoupled depending on the position of an internal valve assembly. These chambers are defined by walls that extend to the top of the cassette 200. A welded interface is created between the lid device 220 and the cassette 200 such that the chambers are sealed from each other by way of a welded interface located between the chambers of the container 200 and the raised welding pattern 160 and welding ridges 156. The lid device 220 is welded to the fluid container when the device is positioned on the container 200 by an ultrasonic welding head 1901 that interfaces with a plateau. The welding head 1901 typically includes a metal cylinder that is shaped to interface with and surround the plateau. The welding head is part of a larger welding apparatus (not shown) that supplies energy to the welding head. Typically, the above - mentioned welding operation is performed at a welding station on a manufacturing / production line.

[0044] Thus, it can be appreciated that traditional dual - lid devices 220 include many relatively complex structures (e.g., conduits, plateaus, etc.), and thus the dual - lid device needs to be formed as a separate injection - molded component, which then must be securely attached to the cassette. To ensure a proper seal between the bottom lid portion and the cassette, ultrasonic welding is used, which can introduce damage to various components and is a source of potential defects during the cassette manufacturing process, while the improved film - seal design can avoid all these problems, enabling a significantly simplified single - lid design.

[0045] A. Exemplary Sample Cassette with Single - Lid Design

[0046] Figures 3A - 5C Shows an improved sample cassette design that has a single - lid suitable for use with the film - seal assembly described herein. Figures 3A - 3C Shows various views of an improved sample cassette 100 that has a single - lid 120 integrally molded with the cassette body 110 (shown in the state before applying any film - seal assembly). As Figure 3C shown in the side view, the single - lid 120 is attached to the cassette body 110 by a living hinge, which is a thinned portion of the material that allows the lid to flip between an open position (shown for receiving a fluid sample) and a closed position (for processing the sample cassette in a module). In some embodiments, other aspects of the cassette (e.g., chambers, syringe tube, sample chamber) are the same as in a traditional cassette, so the module can process samples in the same manner as a traditional cassette.

[0047] Figures 4A - 4BAn improved sample cassette 100 with an integrally formed single lid 120 is shown before and after the application of an improved film seal assembly 130. In Figure 4A , the integrally formed single lid 120 is shown in the open position, which is a top view of the internal chamber of the cassette body 110. The lid 120 includes a central hole 123 for the syringe / plunger of the module to pass through, and a convex portion 124 extending forward to facilitate the user to manually open and close the lid. The chamber defined in the cassette body includes a central syringe tube 113 and a plurality of internal chambers 114. These chambers are open at the top, so that one or more reagents and / or treatment agents can be injected into one or more selected chambers before the film seal assembly is applied to the top of the cassette body. These chambers are surrounded by the continuous top edge of the cassette body 110, so that when the planar film is sealed along the top edge seal plane, the planar film will be sealed on each chamber. In some embodiments, the planar film seal assembly is configured to seal most of the chambers, but one or more chambers are reserved for use (e.g., one reagent chamber, sample chamber) to allow the end user to inject fluid samples and / or special reagents as needed. The movable hinge 121 between the lid 120 and the cassette body 110 allows the lid to flip to the closed position. The lid and the cassette include corresponding coupling structures to fix the lid in the closed position. As shown, the bottom side of the lid includes elastic convex portions 122 on opposite sides, which extend downward when the lid is in the closed position. The elastic convex portions 122 are received along the corresponding contour 112 (e.g., groove or lip), and the corresponding contour 112 is shaped to adaptively receive the elastic convex portions to couple the lid to the cassette body by snap connection. It should be understood that although snap structures are described here, various other coupling structures can also be used.

[0048] Figure 4B Shows the same top view as Figure 4B , but with the film seal applied and one or more reagents pre-stored in one or more selected chambers. As shown, the top layer of the film seal assembly has been removed by the user, so that only the bottom layer 132 is visible. This bottom layer 132 includes a plurality of vent holes 133, which are aligned with the corresponding chambers. This bottom layer may also include a larger access opening 134, which is located above the sample chamber, enabling the end user to inject the fluid sample to be analyzed. The bottom layer may further include a central valve perforation 135 (e.g., criss-cross perforation or slit) to allow the automatic plunger / syringe of the instrument in the module to pass through to control the flow of fluid through the sample cassette during the processing.

[0049] Figures 5A - 5B Shows an alternative embodiment of a sample cassette with a single lid, which can be used with the improved film seal assembly described herein. The single lid is configured to fit over a separate cassette body 110', as shown in Figure 5CAs shown. In this embodiment, the cassette 110' can be an open-top separable cassette, and the single lid member 120' assembly can be a separate assembly placed on top of and coupled to the cassette. The lid member remains relatively simple, being the same or similar to the lid member in Figure 4A so that this design retains some of the same benefits and advantages compared to the above-mentioned traditional double-lid design. In this embodiment, the lid member and the cassette include the same engaging structures 112, 122 as described above. Similarly, the lid member can include a front tab and a central hole, so that the lid member operates in a similar manner to the integrally formed lid member. One advantage of this solution is that the lid member can be made of a different material from the cassette, which can further reduce the cost burden. Similar to the foregoing embodiments, one or more reagents and / or treatment agents are stored in selected chambers of the cassette, and then the thin film assembly is permanently welded (e.g., by heat sealing, e.g., by using a laser, a heating component, or any suitable method) to seal the reagents within the cassette. After that, the cassette is stored and finally sent to the end user, who then removes the gasket to vent the reagent chamber and injects a fluid sample into the sample chamber for processing and detection.

[0050] B. Exemplary Thin Film Sealing Assembly

[0051] Figure 6 A schematic diagram showing an improved thin film sealing assembly 130' according to some embodiments. This schematic diagram is consistent with the double-layer scheme described in FIG. 1. As described above, this thin film sealing assembly design seals the reagents within the cassette and allows the use of a cassette with a single lid member. As shown, this assembly is a double-layer assembly that includes a peelable top layer 131 on top of the bottom layer 132 (i.e., the locking / welding layer). The bottom layer 132 is welded (e.g., permanently sealed) to the top of the cassette 110. The bottom layer 132 includes perforations or openings (i.e., vent holes) to allow ventilation of the respective chambers of the cassette and may further include an inlet leading to the sample chamber for the injection of the sample. The peelable layer 131 is sealed on top of the locking / welding layer by heat and / or an adhesive, thereby hermetically sealing the openings in the locking / welding seal film layer, so as to hermetically seal the reagents within the chamber when the cassette is stored and transported to the end user. The peelable top layer may further include one or more protrusions by which the end user can peel the layer to expose the vent holes for preparing the fluid sample filling of the sample chamber and using the cassette for sample detection.

[0052] In the present embodiment, the peelable layer 131 can be made of a polymer film, which can be heat-sealed on top of the locking / welding layer 132 to form an airtight seal. In some embodiments, the peelable layer 131 is made of a polymer (such as polyester) and can include a thin adhesive layer composed of a polyester film and a sealing layer. The bottom layer 132 can be formed by one or more sub-layers. In the illustrated embodiment, the layer 132 is formed by two layers, with a polyester layer 132a disposed above a polypropylene layer 132b. The polypropylene layer 132b is more suitable for being permanently locked / sealed (such as welded) to a rigid polypropylene cassette by heat-sealing, while the polyester layer 132a is more suitable for releasably sealing with the top peelable layer 131. Although specific materials are described above, it should be understood that the above layers can be made of any suitable materials and can include additional intermediate layers of the same or different materials.

[0053] As shown, the bottom locking / welding layer 132 includes a vent 133 extending therethrough, and the vent 133 is aligned with the reagent chamber for ventilation purposes. The top layer 131 does not include these vents, so that when releasably sealed on top of the bottom layer, the top layer will airtight seal the vents and seal the reagent within the cassette. Once the end user removes the top layer, the reagent chamber will be ventilated to facilitate the flow of liquid through the sample chamber.

[0054] Figure 7A and 7B Show a front perspective view of a test cassette 110 having an improved film seal assembly as Figure 6 shown, which shows the state before and after peeling the top peelable layer. In Figure 7A , the film seal assembly includes a top layer 131 that airtight seals the reagent within the cassette. In Figure 7B , the user has removed the peelable top layer, thereby exposing the bottom layer 132 having vents and a large access opening for injecting a fluid sample. Figure 8A and 8B Show front perspective views of the same test cassette and film seal assembly, which show the situation before and after the user peels the top peelable layer. In Figure 8B , the bottom layer 132 can further include a larger access opening 134 disposed above the sample chamber, which allows the end user to inject a fluid sample to be analyzed. It should be understood that in addition to the above layers and structures, the film seal assembly can also include various other layers and structures. In some embodiments, the cassette can utilize a peelable layer without the need to provide any rigid cover assembly thereon.

[0055] Figures 9A - 9B Show an alternative embodiment of a double-layer film seal assembly. Compared with Figure 6Similar to the embodiments in, the thin film seal assembly 130' includes at least two layers: a bottom locking / welding layer 132 that is permanently sealed above the cassette; and a top peelable layer 131 that forms an airtight seal over the vent holes in the locking / welding layer. However, in this embodiment, the top peelable layer further includes means for attaching to the lid such that opening the lid will peel the top peelable layer, as shown on the right side of the figure. In some embodiments, the top peelable layer includes a double seal layer, for example, a bottom layer that is releasably sealed to the locking / welding layer and a top layer that is locked / welded to the lid. In some embodiments, the top peelable layer 131 is composed of multiple layers in an order opposite to the configuration of the locking / welding layer 132.

[0056] Figure 10 Shows an alternative embodiment with a single-layer thin film seal assembly 137. In this embodiment, the thin film seal assembly is a single layer, which may include one or more inseparable sub-layers integrated within the single layer. The single layer may include a bottom surface and a top surface, the bottom surface is permanently sealed to the top of the cassette by, such as, heat sealing, induction sealing, weld sealing, and / or adhesive sealing, and the top surface is releasably sealed to the cassette lid such that when the lid is in the closed position, the reagent is airtight sealed within the cassette, and once the end user opens the lid, the airtight seal is released and the chamber is vented. In some embodiments, this can be achieved by applying different types of adhesives to the top and / or bottom of the single layer. In other embodiments, this can be achieved by forming the single layer from one or more sub-layers, for example, a polypropylene bottom layer that is locked / welded to the cassette and a polyester top layer with an adhesive that is releasably sealed (e.g., by heat sealing and / or pressure sensitive) to the lid when heat sealed.

[0057] Figures 11A - 11B Shows an alternative embodiment of a double-layer film seal assembly with a molded lid. In this embodiment, the thin film seal assembly includes a top peelable layer 131 above the bottom locking / welding layer 132. Similar to Figure 7A the embodiment shown, the bottom layer is permanently sealed above the cassette and includes a vent and a sample injection port, and the top peelable layer airtight seals the vent during storage and transportation to the end user. In this embodiment, the top layer 131 includes one or more forward-extending protrusions 131a by which the user can remove the gasket. As shown, the lid also includes a forward-extending protrusion 124 such that the user can grasp both the lid protrusion and the gasket protrusion simultaneously and open the lid and release the gasket with a single manual operation. In some embodiments, additional gasket protrusions (e.g., by adhesive or stapling) can be added to facilitate a simplified workflow for simultaneously opening the lid and removing the gasket.

[0058] Figure 12Illustrate an exemplary method of using the thin film sealing assembly described herein to seal a sample cartridge. As shown in the figure, the sealing method may include the following steps: placing the thin film sealing assembly above the cartridge body of a sample cartridge having a chamber defined therein, the chamber including one or more reagent chambers and a sample chamber; permanently sealing the bottom surface of the thin film sealing assembly along the top edge of the cartridge body, wherein the thin film sealing assembly includes one or more vent openings defined therein for ventilating the one or more reagent chambers; and releasably and airtight sealing the one or more vent openings through the top surface of the thin film sealing assembly so as to seal the one or more reagent chambers during storage and / or transportation to the user, wherein the sealing assembly is configured to facilitate release of the airtight seal by the end user. In some embodiments, the cartridge body may include a plurality of interfacing components, such as an inner chamber and an outer chamber, each inner chamber and outer chamber having one or more sub-chambers for accommodating liquid and fluid samples, such a cartridge being described in U.S. Patent Application No. US2022 / 0410150, the entire content of which is incorporated herein by reference for all purposes. In such embodiments, the cartridge body may include a plurality of thin film seals, for example, a first thin film seal having one or more layers sealed on top of the inner chamber to seal the sub-chambers, and a second thin film seal having one or more layers sealed on top of the outer chamber to seal one or more chambers therein. Any thin film sealing concept described herein may be applied to one or both of the inner and outer chambers of such cartridges.

[0059] Figure 13 Illustrate another design of a single-piece cartridge 100', which includes a cartridge body 110' having an integrally formed base 101 and a lid 120. As in the previous embodiment, the lid 120 and the top of the cartridge body 110' include corresponding snap-features, but in this embodiment, the lid 120 includes two profiled slots 122', and the top edge of the cartridge body has two corresponding resilient protrusions 112'. When the lid is closed, the protrusions snap into the slots of the lid, thereby fixing the lid.

[0060] Figure 14 Illustrate another design of a single-piece cartridge 100”, which includes a cartridge body 110”, the cartridge body 110” having an integrally formed base 101 and a lid 120'. As in the previous embodiment, the lid 120' and the top of the cartridge body 110” include corresponding snap-features, but in this embodiment, the lid 120' includes two profiled slots 122', and the top edge of the cartridge body has a single corresponding resilient protrusion 112' extending from the front top edge of the cartridge. When the lid is closed, the protrusion snaps into the slot of the lid, thereby fixing the lid. It should be understood that the single-piece cartridge bodies described herein encompass cartridges of different sizes and shapes.

[0061] In the foregoing specification, the invention has been described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. The various structures, embodiments, and aspects of the invention described above may be used alone or in combination. Additionally, the invention may be utilized in any number of environments and applications outside of the scope described herein without departing from the broader spirit and scope of this specification. Accordingly, the specification and drawings are to be regarded as illustrative rather than restrictive. It will be recognized that the terms "comprising," "including," and "having" as used herein are expressly intended to be understood as open-ended technical terms. Any reference to a reference, patent, or patent application is hereby incorporated by reference in its entirety for all purposes.

Claims

1. A method for sealing a sample cartridge, characterized in that, The method includes: Placing a film sealing assembly on top of the housing of a sample cartridge, the sample cartridge having a plurality of chambers defined therein, the plurality of chambers including one or more reagent chambers and a sample chamber; Permanently sealing the bottom surface of the film sealing assembly along the top edge of the housing, wherein the film sealing assembly includes one or more vent openings defined therein for venting the one or more reagent chambers; and Releaseably and airtight sealing the one or more vent openings through the top surface of the film sealing assembly so as to seal the one or more reagent chambers during storage and / or shipment to a user, wherein the sealing assembly is configured to facilitate release of the airtight seal by an end user.

2. The method according to claim 1, characterized in that The top surface is adhered to an integrally formed lid of the sample cartridge by an adhesive layer such that when the user opens the cartridge, the layer of the top surface peels away from the layer of the bottom surface of the film sealing assembly.

3. The method according to claim 1, wherein Permanently sealing includes heat-sealing the bottom surface of the film sealing assembly along the top edge of the housing surrounding the one or more reagent chambers.

4. The method according to claim 1, wherein Further included is: Fixing a single lid of the sample cartridge to the top of the film sealing assembly, wherein the single lid is removable and / or movable between an open position and a closed position, in the closed position, the single lid being fixed to the top of the film assembly.

5. The method according to claim 1, wherein The lid is integrally formed with the housing, and fixing the single lid includes engaging corresponding engaging structures of the lid and the housing.

6. The method according to claim 5, wherein The engaging structure includes resilient protrusions protruding from the housing, the resilient protrusions resiliently snapping into one or more corresponding slot profiles defined along the leading edge of the lid.

7. The method according to claim 4, characterized in that, The single lid is integrally formed with the housing.

8. The method according to claim 7, characterized in that The entire housing including the single lid is integrally formed as a one-piece assembly.

9. The method according to claim 4, wherein The single lid is a component independent of the housing and is releasably coupled to the housing.

10. The method according to claim 4, characterized in that, The single lid is releasably coupled to the housing by corresponding engaging structures.

11. The method according to claim 1, characterized in that, The film sealing assembly includes at least two separable layers, namely a top layer and a bottom layer.

12. The method according to claim 11, wherein Providing a releaseable airtight seal includes heat-sealing and / or adhesively sealing the top layer to the bottom layer.

13. The method according to claim 11, wherein The top layer is an adhesive liner including polyester.

14. The method according to claim 11, wherein The top layer includes one or more protrusions that extend forward beyond the perimeter of the top of the housing to facilitate manual grasping by the user to remove the liner.

15. The method according to claim 14, wherein The film sealing assembly includes an adhesive layer for sealing to the lid, wherein the adhesive layer is disposed above the top layer and extends along the one or more protrusions to facilitate manual grasping by the user to peel off the top layer.

16. The method according to claim 14, characterized in that, Further included is: The single lid is releasably coupled above the housing with the film sealing assembly therebetween, wherein the single lid includes a front protrusion that extends beyond the perimeter of the top of the housing to facilitate manual grasping by the user to remove the liner when opening the single lid.

17. The method according to claim 11, wherein The bottom layer includes one or more sub-layers.

18. The method according to claim 17, wherein The bottom layer includes At least one bottom-most sub-layer, the at least one bottom-most sub-layer including polypropylene for permanently heat-sealing to the housing, wherein the housing is formed of rigid polypropylene.

19. The method according to claim 18, wherein, The bottom layer includes a top-most layer, the top-most layer including polyester for releaseably sealing to the separated top layer.

20. The method according to claim 1, characterized in that, The film sealing assembly includes a single layer, wherein the top surface is releasably sealed to the lid of the sample cartridge, and the bottom layer is configured to be permanently sealed to the cartridge body.

21. The method according to claim 20, characterized in that, The single layer includes one or more adhesives disposed thereon.

22. The method according to claim 1, characterized in that, The single layer includes at least two inseparable sub-layers, wherein the bottom layer includes a first material for permanently heat-sealing the cartridge body, and the top sub-layer includes a second material different from the first material, and the second material is selected to be releasably sealed to the lid of the sample cartridge.

23. The method according to claim 1, wherein The top surface is releasably sealed by applying pressure to the lid, so that the pressure-sensitive adhesive disposed on the top surface hermetically seals the lid to the top surface of the assembly.

24. The method according to claim 1, wherein The top surface is configured to be releasably sealed by heat sealing.

25. The method according to claim 1, wherein The top surface is configured to be releasably sealed by any one of the following: induction sealing, welding sealing, and / or adhesive sealing.

26. A thin film sealing assembly, characterized in that, Above the cartridge body for sealing a sample cartridge having a plurality of chambers, the plurality of chambers including one or more reagent chambers for containing one or more reagents for analyzing a fluid sample injected into the sample cartridge, wherein the film sealing assembly includes: One or more layers disposed within a planar assembly, wherein each layer of the one or more layers is planar and shaped to cover the perimeter of the top edge of the cartridge body, wherein the planar assembly includes a top surface and a bottom surface, wherein the bottom surface is configured to be permanently sealed along the top edge of the cartridge body to cover the plurality of chambers defined therein, wherein the film sealing assembly includes one or more vent holes that at least partially extend therethrough for venting the one or more reagent chambers, and wherein the top surface is configured to releasably and hermetically seal the one or more vent holes so as to hermetically seal the one or more reagent chambers for storage and / or transportation to an end user.

27. The thin film sealing assembly according to claim 26, wherein The film sealing assembly includes at least two separable layers, and the at least two separable layers include a top layer and a bottom layer.

28. The thin film sealing assembly according to claim 28, wherein, Further includes an adhesive layer for sealing the top layer to the lid.

29. The thin film sealing assembly according to claim 27, wherein The releasable seal includes a heat seal and / or an adhesive seal with the bottom layer.

30. The thin film sealing assembly according to claim 27, wherein, The film sealing assembly is configured to be sealed by any one of the following: induction sealing, welding sealing, and / or adhesive sealing.

31. The thin film sealing assembly according to claim 27, characterized in that, The top layer includes polyester.

32. The thin film sealing assembly according to claim 27, wherein, The top layer includes a peelable adhesive liner.

33. The thin film sealing assembly according to claim 27, wherein, The bottom layer includes one or more inseparable sub-layers, and the one or more vent holes extend through the bottom layer.

34. The thin film sealing assembly according to claim 33, characterized in that, The bottom layer includes at least one bottom-most sub-layer that includes polypropylene for permanently heat-sealing a cartridge body formed of rigid polypropylene.

35. The thin film sealing assembly according to claim 33, wherein, The bottom layer includes a top-most sub-layer that includes polyester for releasably sealing the separable top layer.

36. The thin film sealing assembly according to claim 26, wherein, The film assembly includes a single layer.

37. The thin film sealing assembly according to claim 36, characterized in that, The single layer includes one or more adhesives thereon to facilitate permanent sealing with the cartridge body and / or releasable sealing with the lid of the sample cartridge.

38. The thin film sealing assembly according to claim 36, wherein, The top surface is configured to be releasably sealed by a pressure-sensitive adhesive and / or by heat sealing.

39. The thin film sealing assembly according to claim 36, wherein The single layer includes at least two inseparable sub-layers, the at least two inseparable sub-layers including a bottom sub-layer and a top sub-layer, the bottom sub-layer containing a first material for permanently heat-sealing the sample cartridge, and the top sub-layer containing a second material different from the first material, the second material being selected for releasably sealing the lid member.

40. The thin film sealing assembly according to claim 39, wherein, The topmost layer includes polyester, and the bottommost layer includes polypropylene.

41. Sample cartridge, characterized in that, Comprising: A cartridge having a plurality of chambers disposed therein, wherein the plurality of chambers include a sample chamber for receiving a fluid sample and one or more reagent chambers for storing one or more reagents for performing analytical tests on the fluid sample, wherein the plurality of chambers are open along the top of the cartridge; A lid member attached to and covering the top of the cartridge and the plurality of chambers; and The thin film sealing assembly as described in claim 26.

42. The sample cartridge according to claim 41, wherein The thin film sealing assembly includes at least two separable layers, the at least two separable layers including: A bottom layer configured to permanently seal the upper bottom surface of the cartridge, the bottom layer having one or more vent openings defined therein; and A top peelable layer disposed on the bottom layer, airtight sealing the one or more vent openings in the bottom layer, wherein the top peelable layer can be removed by an end user.

43. The sample cartridge according to claim 42, wherein The top layer includes a polyester liner, and the bottom layer includes polypropylene.

44. The sample cassette according to claim 43, characterized in that, The bottom layer includes a plurality of inseparable sub-layers, the plurality of inseparable sub-layers including: A bottommost sub-layer containing polypropylene for permanently sealing the cartridge, and A topmost sub-layer containing polyester for releasably and airtight sealing to the polyester liner.

45. The sample cassette according to claim 41, wherein, The thin film sealing assembly includes a single layer.

46. The sample cassette according to claim 45, wherein, The top surface is configured to be releasably sealed to the lid member of the sample cartridge by a pressure-sensitive adhesive and / or by heat-sealing.

47. The sample cartridge according to claim 45, characterized in that, The single layer includes one or more adhesives thereon to facilitate permanent sealing to the cartridge and / or releasable sealing to the lid member of the sample cartridge.

48. The sample cartridge according to claim 45, characterized in that, A single one-piece layer includes at least two sub-layers, wherein the bottom layer contains a first material for permanently heat-sealing the cartridge, and the top sub-layer contains a second material different from the first material, the second material being selected for releasably sealing the lid member.

49. The sample cartridge according to claim 45, wherein, The topmost sub-layer contains polyester, and the bottommost sub-layer contains polypropylene.

50. The sample cartridge according to claim 43, wherein, The thin film sealing assembly is configured to be sealed to the cartridge by any one of the following: heat-sealing, induction-sealing, weld-sealing, and adhesive-sealing.

51. A method of using a sample cassette, characterized in that, The sample cartridge is sealed by the thin film sealing assembly as described in claim 28, the method comprising: Opening the lid member of the sample cartridge, thereby peeling off the top layer of the thin film sealing assembly to expose the bottom layer of the thin film assembly sealed to the top of the cartridge, the bottom layer having one or more openings corresponding to the sample chamber and one or more reagent chambers; Injecting a biological sample into the sample chamber through one or more of the openings in the bottom layer; And Closing the lid member of the sample chamber, thereby sealing the sample container for subsequent testing of the sample.

52. The method according to claim 51, wherein, The thin film sealing assembly includes an adhesive layer disposed above the top layer to fix the top layer to the lid member, such that when the lid member is opened, the top layer peels off from the bottom layer of the thin film sealing assembly.

53. The method according to claim 51, wherein At least the top layer and the adhesive layer include forward-projecting convex portions that extend forward from the periphery of the top of the cartridge and correspond to the forward-projecting convex portions of the lid member to facilitate peeling of the top layer when the lid member is opened.

54. The method according to claim 51, wherein The lid member is manually opened by a user.

55. The method according to claim 51, characterized in that, The lid member is opened by an automated system.

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