Cartridges for pipette-free sample preparation and related methods

Abstract

The article comprises a cartridge including a plurality of chambers where each chamber may provide one or more reagents to process or analyze a sample suspected of comprising a pathogen.

Description

[0001] CARTRIDGES FOR PIPETTE-FREE SAMPLE PREPARATION AND RELATED METHODS

[0002] RELATED APPLICATIONS

[0003] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 63 / 696,749, filed September 19, 2024, and entitled “CARTRIDGES FOR PIPETTE-FREE SAMPLE PREPARATION AND RELATED METHODS,” which is incorporated herein by reference in its entirety for all purposes.

[0004] TECHNICAL FIELD

[0005] Articles, systems, and methods for preparing samples and performing some assays on the sample are generally described.

[0006] BACKGROUND

[0007] The coronavirus pandemic of highlighted the need for rapid and efficient pathogen detection outside standard CLIA laboratory settings. Whether relying on derivatives of conventional lateral flow assays or more sophisticated thermal PCR detection, quick and easy detection of the COVID-19 virus was essential for helping thwart the pandemic. Not only was rapid and accurate detection needed but user-friendly and patient-friendly tests were desired so that users could test themselves, for example, in their own homes or locally within their communities, without the need to send potentially contaminated samples long distances for determination.

[0008] Many conventional pathogen-detection assays require some sample preparation before the sample can be accurately determined (e.g., to determine the presence or absence of the pathogen). For example, many conventional tests used during the coronavirus pandemic required the user to obtain a nasal or throat sample with a cotton swab, deposit that sample into a sample preparation container (e.g., an Eppendorf® tube or the like), add reagents to the container to properly process the sample, and then transfer the sample to an appropriate testing apparatus (e.g., a lateral flow trip, a PCR reactor) in order to determine the presence (or absence) of the coronavirus pathogen. While relatively straightforward for the trained user (e.g., a doctor, a nurse, or some other medical professional), the at-home user (e.g., a patient) could find these steps

[0009] #14416201vl cumbersome and confusing. Worse still is that improper processing or transferring of the sample may result in an improper result (e.g., a false negative, a false positive, difficult in determining the results for the at-home user).

[0010] Accordingly, improved articles, systems, and methods for pathogen detection that reduce sample processing and transferring steps are desired.

[0011] SUMMARY

[0012] Articles, systems, and methods for preparing samples and performing some assays on the sample are generally described. The subject matter of the present disclosure involves, in some cases, interrelated products, alternative solutions to a particular problem, and / or a plurality of different uses of one or more systems and / or articles.

[0013] In one aspect, a cartridge is provided. According to some embodiments, the cartridge, comprises: a front planar surface, a back planar surface, a top surface, and a bottom surface; a plurality of chambers positioned between the front planar surface and the back planar surface; a sample input cavity having a main axis extending from the top surface towards the bottom surface, wherein the main axis is parallel to the front planar surface and / or the back planar surface, wherein the sample input cavity has a cylindrical shape, and wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL; and a microfluidic channel in fluidic communication the sample input cavity.

[0014] In another aspect, an article is provided. According to some embodiments, the article comprises: a front planar surface, a back planar surface, a top surface, and a bottom surface; a plurality of chambers positioned between the front planar surface and the back planar surface; a sample input cavity having a main axis extending from the top surface towards the bottom surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL; a sample-receiving inlet positioned within the sample input cavity, wherein the sample-receiving inlet comprises a piercing element; and a microfluidic channel in fluidic communication with the sample receiving inlet.

[0015] In still another aspect, an article is provided. According to some embodiments, the article comprises: a sample processing chamber having a volume of greater than or equal to 1 pL and less than or equal to 2,000 pL; one or more reagent chambers, each

[0016] #14416201vl chamber having a volume of greater than or equal to 1 pL and less than or equal to 2,000 pL; wherein the sample processing chamber and the one or more reagent chambers are fluidically connected to a sample collection chamber.

[0017] In yet another aspect, a method is provided. According to some embodiments, the method comprises: inserting a sample tube into a sample input chamber of a cartridge, the cartridge comprising a front planar surface, a back planar surface, a top surface, a bottom surface, and a plurality of chambers positioned between the front planar surface and the back planar surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL, and wherein the sample input cavity comprises a bottom and a sample receiving inlet positioned at the bottom of the sample input chamber; piercing the sample tube with a piercing element positioned at the bottom of the sample input cavity; transferring at least a portion of a sample from the sample tube to a microfluidic channel in fluidic communication with the samplereceiving inlet.

[0018] In another aspect, a kit is provided. According to some embodiments, the kit comprises: a cartridge comprising a front planar surface, a back planar surface, a top surface, and a bottom surface; a plurality of chambers positioned between the front planar surface and the back planar surface; a sample input cavity extending from the top surface towards the bottom surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL; and a microfluidic channel in fluidic communication with a bottom portion of the sample input cavity; a sample tube configured to be inserted into the sample input cavity of the cartridge; a first identification code configured to be applied to and around the sample tube; an identification card comprising a panel, the identification card configured to be attached to the cartridge while displaying the first identification through the panel; and a second identification code, distinct from the first identification code, affixed to the identification card.

[0019] In still another aspect, a cartridge is provided. According to some embodiments, the cartridge comprises: a front planar surface, a back planar surface, a top surface, and a bottom surface; a sample input cavity extending having a main axis extending from the top surface towards the bottom surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL; a plurality of chambers

[0020] #14416201vl including at least a first chamber and a second chamber positioned between front surface and the back surface; a concave portion formed between at least the front planar surface and the back planar surface; and a sample analysis region protruding from the concave portion, wherein the sample analysis region comprises an optical window accessible by a first wavelength of light via a horizontal circumference around the optical window and a vertical circumference around the optical window.

[0021] In yet another aspect, a method is provided. According to some embodiments, the method comprises: inserting a sample tube containing a sample into a sample input cavity of a cartridge, the cartridge comprising: a front planar surface, a back planar surface, a top surface, a bottom surface; a concave portion formed between at least the front planar surface and the back planar surface; a sample analysis region protruding from the concave portion; and a plurality of chambers positioned between the front planar surface and the back planar surface, wherein the sample input cavity comprises a bottom and a sample receiving inlet positioned at the bottom of the sample input cavity; transferring at least a portion of the sample from the sample tube to a microfluidic channel in fluidic communication with the sample-receiving inlet; flowing at least a portion of the sample to the sample analysis region; heating the sample analysis region via a 360° circumference around an optical window of the sample analysis region.

[0022] Other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying figures. In cases where the present specification and a document incorporated by reference include conflicting and / or inconsistent disclosure, the present specification shall control.

[0023] BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the figures:

[0025] #14416201vl Fig. 1A is a schematic illustration showing the back surface of a cartridge and a potion of a front surface of a cartridge, according to some embodiments;

[0026] Fig. IB is back perspective of a cartridge showing a sample input cavity, a plurality of chambers, and an optical window, according to some embodiments; and

[0027] Figs. 1C-1H schematically illustrate the insertion and processing of a sample, according to some embodiments.

[0028] DETAILED DESCRIPTION

[0029] The following disclosure describes articles (e.g., cartridges), systems, and related methods for detecting the presence or absence of a pathogen (e.g., coronaviruses). Many of the embodiments described herein may eliminate the need for one or more pipetting steps so that a user may transfer a collected sample (e.g., a nasal sample, a throat sample) directly to the assay without pipetting or further sample processing. To achieve this, a sample cartridge may comprise a sample input cavity configured to puncture the sample once it is inserted into the cavity and deliver the sample (e.g., via one or more channels in fluidic communication with the sample input cavity) to one or more reagent chambers, where appropriate reagents can be provided to the sample (e.g., lysis reagents, buffers, etc.). In some embodiments, the cartridge also includes an optical window at the end of one or more chambers so that the processed sample can be heated or cooled (e.g., via light, via convection). Advantageously, the need to transfer the sample via pipette may be reduced or eliminated, as well as the number of processing steps required by the user to perform. Any while many of the articles and methods apply to a saliva sample, it should be understood that any type of bodily fluid or discharge (e.g., blood, sera, interstitial fluid, mucus, urine, feces, genitalia fluids) may comprise a pathogen that can be screened according to the articles, systems, and method described below.

[0030] Turning to the figures, some specific, non-limiting embodiments are described in further detail. After this description, additional details some of the various components of the non-limiting embodiments are described. It should be understood that the various systems, components, features, and methods described relative to these non-limiting embodiments may be used either individually and / or in any desired combination as the disclosure is not limited to only the specific embodiments described herein.

[0031] #14416201vl Beginning with Fig. 1A, this figure depicts a schematic illustration of an article, a cartridge 100, positioned such that a front surface 110 of the cartridge 100 faces away from the page (out of view) while a back surface 112 of the cartridge 100 faces towards the page (in view). As described in more detail below, the cartridge 100 may include a variety of features and components to aid in sample preparation and processing. For example, the cartridge 100 includes a sample input cavity 120 with a piercing element 122 disposed towards a distal end of the sample input cavity 120. As is described in more detail below, the piercing element 122 is configured to pierce a sample tube (not shown) inserted into the sample input cavity 120 and may also be configured to put the sample tube in fluidic communication with a microfluidic channel of the cartridge 100.

[0032] The cartridge 100 may also comprise a window or a cutout, such as an ID window 124, shown schematically in Fig. 1A. As described in more detail elsewhere herein, the ID window 124 allows for a sample tube (not shown) inserted into the sample input cavity to display an identification marker (e.g., a tag, a QR code) to the front surface 100. According, the ID window 124 may provide a window between the front surface 110 and the back surface 112 of the cartridge 100.

[0033] The cartridge 100 may also include an optical window 130, shown schematically in Fig. 1A. Described in more detail below, the optical window 130 is disposed at the end of a plurality of chambers within the cartridge 100 so that the processed sample may be subjected to light and / or heat, which may facilitate detection of a pathogen, as described above and elsewhere herein.

[0034] Fig. IB provides another perspective of the cartridge 100 of Fig. 1A. In Fig. IB, the back surface 112 of the cartridge 100 faces the page. A microfluidic channel 132 connects the sample input cavity 120 to one or more of a plurality of chambers of cartridge 100. For example, the microfluidic channel 132 connects to a sample preparation chamber 140, such that a sample tube (not shown), once inserted into the cartridge 100, can convey a sample into the sample preparation chamber 140. As illustrated, the microfluidic channel 132 meets sample input cavity 120 at a fluid inlet fluidically connecting the sample input cavity to the microfluidic channel. The sample preparation chamber 140 may be in fluidic communication with additional chambers, such as chambers 150, 155, 160, 165, and / or 170, and each of these chambers may contain a particular reagent that can be added to the sample preparation chamber 140 to

[0035] #14416201vl manipulate or process the sample in some manner. Valves and / or seals (not shown) may open and / or close microfluidic channels connecting the various chambers of the cartridge 100.

[0036] Figs. 1C-1H describe the cartridge 100 in operation after obtaining a sample from a patient and placing the sample into a sample tube 126 configured to be inserted into the sample input cavity 120 of the cartridge 100. By way of illustration and not limitation, Fig. 1C schematically illustrates the sample tube 126 inserted into the sample input cavity 120. The piercing element (not shown) pierces a cap of the sample tube 126 so its contents are in fluidic communication with the microfluidic channel 132. In some embodiments, positive pressure (e.g., via vacuum, via syringe pump) is used to assist in providing the contents of the sample tube to the cartridge. For example, in Fig. ID, positive pressure 135 is provided to the sample tube 126 such that (at least some of) the contents of sample tube 126 flow into the sample preparation chamber 140. Once the sample is within the sample preparation chamber 140, contents from other chambers of the plurality of chambers of the cartridge 100 can be mixed with the sample. For example, in Fig. IE, a seal to the chamber 145 is broken and the contents of the chamber 145 (e.g., magnetic mixing beads, lysis buffer) flow into the sample preparation chamber 140. In the case of magnetic mixing beads flowing from the chamber 145, the cartridge 100 may include solenoids (not shown) that provide mixing to the magnetic mixing beads in order to mix the contents within the sample preparation chamber 140. The volume of sample within the sample preparation chamber 140 can be reduced by a negative pressure 136, shown in Fig. IF.

[0037] The plurality of chambers within the cartridge may each deliver its contents to the sample preparation chamber. For example, in Fig. 1G, the contents of the chamber 155 enter into the sample preparation chamber 140 where it can mix with the sample. Flow can be initiated by the actuation of a valve and / or breaking of one or more seals (not shown in the figure). And while Fig. 1G shows the contents of chamber 155 entering into the sample preparation chamber 140, any other chamber, alone or in combination, can be actuated to flow into the sample preparation chamber 140. For example, chamber 160 can be actuated to flow wash buffer into the sample preparation chamber 140 and chamber 165 can be actuated to flow magnetic mixing beads into the sample preparation chamber.

[0038] #14416201vl Once the sample has been mixed and reacted with the appropriate reagents within the appropriate chambers, the sample can than be further processed and analyzed. For example, as shown in Fig. 1H, the sample 180 of Fig. 1G flows to the optical window 130 mentioned above and elsewhere herein (e.g., as indicated by arrow 182). Once within the optical window, the sample 180 may be exposed to heat) and / or light, which may facilitate additional reactions of within the sample. These reactions may aid in determining the presence (or absence) or a pathogen (e.g., an antigen of the pathogen). A device configured to receive the cartridge (not shown in the figure) may provide heat and / or light, e.g., as desired by a user.

[0039] The above description of some embodiments provides a general description of various embodiments disclosed herein. Additional details of some embodiments are provided below.

[0040] As was mentioned above in relation to the figures, some embodiments comprise a cartridge. The cartridge may comprise a plurality of chambers where each chamber may provide one or more reagents to process or analyze a sample suspected of comprising a pathogen (or species related to the pathogen such as an antigen). The cartridge may have any suitable shape. For example, in some embodiments, the cartridge is sized and shaped to fit into a device (e.g., a cartridge-reading device). In some embodiments, the cartridge comprises a front planar surface, a back planar surface, a top surface, and / or a bottom surface.

[0041] In some embodiments, an article (e.g., a cartridge) has a particular dimension (e.g., a height, a width, and / or a length). For example, in some embodiments, a dimension of a cartridge is greater than or equal to 0.1 cm, greater than or equal to 0.5 cm, greater than or equal to 1 cm, greater than or equal to 2 cm, greater than or equal to 5 cm, greater than or equal to 7 cm, greater than or equal to 10 cm, greater than or equal to 15 cm, or greater than or equal to 20 cm. In some embodiments, a dimension of the cartridge is less than or equal to 20 cm, less than or equal to 15 cm, less than or equal to 10 cm, less than or equal to 7 cm, less than or equal to 5 cm, less than or equal to 2 cm, less than or equal to 1 cm, less than or equal to 0.5 cm, or less than or equal to 0.1 cm. Combinations of the above-referenced ranges are also possible (e.g., greater than or equal to 0.1 cm). Other ranges are possible.

[0042] #14416201vl As mentioned above, in some embodiments, a cartridge comprises a sample input cavity. The sample input cavity is configured to receive a sample tube that can be pierced (e.g., a sample tube having a rubber septum as a cap) by a component within or at a distal end of the sample input cavity (e.g., a piercing element). For example, in some embodiments, the sample input cavity comprises a bottom comprising a conical shape and wherein the bottom comprises a piercing element.

[0043] The sample input cavity may be of any suitable volume. For example, in some embodiments, the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL. Advantageously, the size of the sample input cavity may be relatively large compared to the amount of sample required for analysis (e.g., the amount of sample required may be less than 1 mL, less than 1 pL). This relative larger size allows for larger sample tubes, which make sample preparation by a user easier relative to smaller- sized sample tubes. For some embodiments, the volume of the sample input cavity is greater than or equal to 1 mL, greater than or equal to 2 mL, greater than or equal to 5 mL, greater than or equal to 7 mL, or greater than or equal to 10 mL. In some embodiments, the volume of the sample input cavity is less than or equal to 10 mL, less than or equal to 7 mL, less than or equal to 5 mL, less than or equal to 2 mL, or less than or equal to 1 mL. Combinations of the above-referenced ranges are also possible (e.g., greater than or equal to 1 mL and less than or equal to 10 mL). Other ranges are possible.

[0044] The sample input cavity may comprise one or more apertures in fluidic communication with a microfluidic channel. For example, in some embodiments, the sample input cavity comprises a bottom, wherein the bottom comprises one or more apertures fluidically connected to the microfluidic channel. The sample input cavity may also include a cap at a proximal end of the sample input cavity. For example, in some embodiments, a cartridge, comprises a cap configured to conformally close over the top surface of the sample input cavity. The cap may provide a hermetic-type seal to the sample input cavity to minimize or eliminate leakage from the sample input cavity (and / or a sample tube within the sample input cavity).

[0045] In some embodiments, a sample-receiving inlet is located as a portion of the sample input cavity or fluidically connected to a distal end of the sample input cavity. The sample-receiving inlet may comprise one or more openings or apertures to receive fluid from a sample tube once the sample tube has been inserted into the sample input

[0046] #14416201vl cavity. The sample-receiving inlet may include a portion of the piercing element (e.g., a conical piercing element) so that the sample within the sample tube (once inserted into the cartridge) can flow into other portions of the cartridge via the sample-receiving inlet (e.g., through an aperture fluidically connected to a microfluidic channel of the cartridge).

[0047] Any terms as used herein related to shape, orientation, alignment, and / or geometric relationship of or between, for example, one or more piercing elements, components, combinations thereof and / or any other tangible or intangible elements not listed above amenable to characterization by such terms, unless otherwise defined or indicated, shall be understood to not require absolute conformance to a mathematical definition of such term, but, rather, shall be understood to indicate conformance to the mathematical definition of such term to the extent possible for the subject matter so characterized as would be understood by one skilled in the art most closely related to such subject matter. Examples of such terms related to shape, orientation, alignment, and / or geometric relationship include, but are not limited to terms descriptive of: shape - such as, round, square, circular / circle, rectangular / rectangle, triangular / triangle, cylindrical / cylinder, cone / conical, elliptical / ellipse, (n)polygonal / (n)polygon, U-shaped, line-shaped, etc.; angular orientation - such as perpendicular, orthogonal, parallel, vertical, horizontal, collinear, etc.; contour and / or trajectory - such as, plane / planar, coplanar, hemispherical, semi-hemispherical, line / linear, hyperbolic, parabolic, flat, curved, straight, arcuate, sinusoidal, tangent / tangential, etc.; arrangement - array, row, column, and the like. As one example, a fabricated article that would be described herein as being “square" would not require such an article to have faces or sides that are perfectly planar or linear and that intersect at angles of exactly 90 degrees (indeed, such an article can only exist as a mathematical abstraction), but rather, the shape of such article should be interpreted as approximating a “ square," as defined mathematically to an extent typically achievable and achieved for the recited fabrication technique as would be understood by those skilled in the art or as specifically described.

[0048] For various of the embodiments described herein, a cartridge comprises on or more microfluidic channels. These microfluidic channels may convey fluids (e.g., solutions, buffers, reagents) to the various cavities and chambers of the cartridge. For example, in some embodiments, the cartridge comprises a microfluidic channel in fluidic

[0049] #14416201vl communication with the sample input cavity. As a non-limiting example, the microfluidic channel may be in fluidic communication with the sample input cavity via a fluid inlet at the bottom of the sample input cavity. In some such embodiments, the microfluidic channel may convey fluid from a sample tube inserted into the sample input cavity to another portion of the cartridge, such as a sample processing chamber (described elsewhere herein). Microfluidic channels may have a dimension (e.g., a diameter) of less than or equal to 1,000 pm or greater than or equal to 100 nm or greater (e.g., less than or equal to 1,000 pm and greater than or equal to 100 nm).

[0050] As noted elsewhere herein, a cartridge as described herein may include a plurality of chambers. Each of the plurality of chambers may contain reagents for achieving a particular reaction or transformation of a component of the sample (e.g., lysis of cells within the sample, amplification of nucleic acid within the sample). The chambers may be disposed along a fluidic path connecting the sample input cavity and an optical window. Chambers may be fluidically connected to one another via one or more microfluidic channels and may be reversibly or irreversibly opened or closed using one or more seals and / or valves. Additionally, a source of positive or negative pressure may be a part of or configured to connect to the cartridge (e.g., a vacuum pump, a syringe pump) to assist with flow (e.g., non-capillary flow).

[0051] In some embodiments, at least one chamber of the cartridge is a sampleprocessing chamber. The sample processing chamber may be in fluidic communication with the sample input cavity and some (or all) of the other chambers of the cartridge. In this manner, the sample, along with other reagents, can be mixed and / or reacted with one another so that the pathogen can be detected (e.g., by detecting an analyte of the pathogen such as an antigen).

[0052] In addition to a sample processing chamber, a cartridge may include additional chambers for containing reagents, solvents, and / or solutions (e.g., buffer solutions). These additional chambers may be independently fluidically connected to one another and / or independently fluidically connected to the sample processing chamber or some other portion of the cartridge (e.g., an optical window of the cartridge).

[0053] For some embodiments, a chamber (e.g., a sample processing chamber, a reagent chamber) has a particular volume. In some embodiments, a chamber has a volume of greater than or equal to 1 pL, greater than or equal to 10 pL, greater than or equal to 20

[0054] #14416201vl qL, greater than or equal to 30 qL, greater than or equal to 50 pL, greater than or equal to 100 pL, greater than or equal to 200 pL, greater than or equal to 300 pL, greater than or equal to 500 pL, greater than or equal to 700 pL, greater than or equal to 1,000 pL, greater than or equal to 1,200 pL, greater than or equal to 1,500 pL, greater than or equal to 1,700 pL, greater than or equal to 1,900 pL, or greater than or equal to 2,000 pL. In some embodiments, a chamber has a volume of less than or equal to 2,000 pL, less than or equal to 1,900 qL, less than or equal to 1,700 qL, less than or equal to 1,500 qL, less than or equal to 1,200 qL, less than or equal to 1,000 qL, less than or equal to 700 qL, less than or equal to 500 qL, less than or equal to 300 qL, less than or equal to 200 qL, less than or equal to 100 qL, less than or equal to 50 qL, less than or equal to 30 qL, less than or equal to 20 qL, less than or equal to 10 qL, or less than or equal to 1 qL. Combinations of the foregoing ranges are also possible (e.g., greater than or equal to 1 qL and less than or equal to 2,000 qL). Other ranges are possible.

[0055] As is mentioned elsewhere herein, chambers and / or microfluidic channels (e.g., microfluidic channels connecting chambers) may be separated and closed by one or more seals and / or valves. In some embodiments, seals are one way, meaning that once the seal is open, the pathway previously closed by the seal remains irreversibly open. However, in other embodiments, a seal is two way, meaning that the seal may be reversibly opened and closed. Of course, some embodiments may have a combinations of one-way and two-way seals, as this disclosure is not so limiting.

[0056] For some embodiments, a cartridge includes an optical window. The optical window allows sample (e.g., sample that has been processed by one or more reagents) to flow within a region of the device that is transparent to at least some light (e.g., infrared light, visible light). In some embodiments, for example, the optical window is transparent to green light, and the processed sample comprises nanoparticles configured to absorb the green light and emit heat, thereby heating the sample. Heating the sample may increase a reaction rate of the sample (e.g., PCR within the sample), increasing the speed of determining the presence (or absence) of the pathogen. In some embodiments, the optical window may also be relatively thermally conductive and heating may, additionally or alternatively, be provided by flowing a stream of gas (e.g., heated air) towards the optical window.

[0057] #14416201vl In some embodiments, a cartridge includes a window between a front surface and a back surface of the cartridge. In some such embodiments, the window runs along at least a portion of the sample input cavity (e.g., along a main axis of the sample input cavity). In such a configuration, a sample tube inserted into the sample input cavity is viewable through the window. The sample tube may comprise an identification marker (e.g., barcode, a QR code) that can be arranged to show through the window. The cartridge may further comprise an additional identification marker, not affixed to the sample tube. The two identification markers can be used to link pathogen determination to a particular location and / or to a particular subject (e.g., a patient suspected of being infected by the pathogen).

[0058] In some embodiments, a system comprises a first identification code configured to be applied to and around the sample tube. In some embodiments, a cartridge comprises an identification card comprising a panel, the identification card configured to be attached to the cartridge while displaying the first identification through the panel. In some embodiments, the second identification code is distinct from the first identification code affixed to the identification card.

[0059] The cartridges described herein may be inserted into an appropriate device to read perform operations on cartridge (e.g., heating, applying light) and / or to provide a diagnostic (e.g., a positive result, a negative result, an inconclusive result) based on the assay performed within the cartridge.

[0060] In some embodiment, a device heats the sample analysis region via a 360° circumference around an optical window of the sample analysis region. In some embodiments, heating comprises flowing heated air towards the optical window, wherein a temperature of the heated air is greater than or equal to 25 °C (e.g., greater than or equal to 30 °C, greater than or equal to 40 °C, greater than or equal to 50 °C, greater than or equal to 60 °C , greater than or equal to 70 °C, greater than or equal to 80 °C, or greater than or equal to 90 °C, and / or up to 40 °C, 60 °C , 80 °C , or 100 °C). In some embodiments, heating comprises applying light of a first wavelength towards the sample analysis region.

[0061] Some embodiments, describe a kit. The kit may comprise a cartridge comprising a front planar surface, a back planar surface, a top surface, and a bottom surface, a plurality of chambers positioned between the front planar surface and the back planar

[0062] #14416201vl surface, a sample input cavity extending from the top surface towards the bottom surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL, and a microfluidic channel in fluidic communication with of the sample input cavity (e.g., a via a fluid inlet at the bottom portion of the sample input cavity). The kit may further comprise a sample tube configured to be inserted into the sample input cavity of the cartridge.

[0063] While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is / are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, and / or methods, if such features, systems, articles, materials, and / or methods are not mutually inconsistent, is included within the scope of the present disclosure.

[0064] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0065] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other

[0066] #14416201vl elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified unless clearly indicated to the contrary. Thus, as a non-limiting example, a reference to “A and / or B,” when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A without B (optionally including elements other than B); in another embodiment, to B without A (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0067] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0068] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one,

[0069] #14416201vl A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0070] Some embodiments may be embodied as a method, of which various examples have been described. The acts performed as part of the methods may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include different (e.g., more or less) acts than those that are described, and / or that may involve performing some acts simultaneously, even though the acts are shown as being performed sequentially in the embodiments specifically described above.

[0071] Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements.

[0072] In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0073] #14416201vl

Claims

CLAIMSWhat is claimed is:

1. A cartridge, comprising: a front planar surface, a back planar surface, a top surface, and a bottom surface; a plurality of chambers positioned between the front planar surface and the back planar surface; a sample input cavity having a main axis extending from the top surface towards the bottom surface, wherein the main axis is parallel to the front planar surface and / or the back planar surface, wherein the sample input cavity has a cylindrical shape, and wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL; and a microfluidic channel in fluidic communication the sample input cavity.

2. The cartridge of claim 1, wherein the microfluidic channel is in fluidic communication with the sample input cavity via a fluid inlet at a bottom of the sample input cavity.

3. The cartridge of any one of the preceding claims, wherein the microfluidic channel is in fluidic communication with the sample input cavity via a fluid inlet the sample input cavity.

4. The cartridge of any one of the preceding claims, further comprising a cap configured to conformally close over the top surface of the sample input cavity.

5. An article, comprising: a front planar surface, a back planar surface, a top surface, and a bottom surface; a plurality of chambers positioned between the front planar surface and the back planar surface; a sample input cavity having a main axis extending from the top surface towards the bottom surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL;#14416201vla sample-receiving inlet positioned within the sample input cavity, wherein the sample-receiving inlet comprises a piercing element; and a microfluidic channel in fluidic communication with the sample receiving inlet.

6. The article of any one of the preceding claims, wherein the sample input cavity comprises a bottom comprising a conical shape, and wherein the bottom comprises the piercing element.

7. The article of any one of the preceding claims, wherein the sample input cavity comprises a bottom, and wherein the bottom comprises one or more apertures fluidically connected to the microfluidic channel.

8. The article of any one of the preceding claims, wherein the sample -receiving inlet comprises two apertures and wherein the two apertures are in fluidic communication with the microfluidic channel.

9. An article, comprising: a sample processing chamber having a volume of greater than or equal to 1 pL and less than or equal to 2,000 pL; one or more reagent chambers, each chamber having a volume of greater than or equal to 1 pL and less than or equal to 2,000 pL; wherein the sample processing chamber and the one or more reagent chambers are fluidically connected to a sample collection chamber.

10. The article of any one of the preceding claims, wherein there are at least 10 separate reagent chambers fluidically connected to the sample processing chamber.

11. A method, comprising: inserting a sample tube into a sample input chamber of a cartridge, the cartridge comprising a front planar surface, a back planar surface, a top surface, a bottom surface, and a plurality of chambers positioned between the front planar surface and the back planar surface, wherein the sample input cavity has a volume of greater than or equal to 1#14416201vlmL and less than or equal to 10 mL, and wherein the sample input cavity comprises a bottom and a sample receiving inlet positioned at the bottom of the sample input chamber; piercing the sample tube with a piercing element positioned at the bottom of the sample input cavity; transferring at least a portion of a sample from the sample tube to a microfluidic channel in fluidic communication with the sample-receiving inlet.

12. The method of claim 11, further comprising flowing a lysis reagent from a second chamber of the plurality of chambers to the at least portion of the sample in the first chamber.

13. The method of any one of the preceding claims, further comprising mixing at least portion of the sample within the first chamber.

14. The method of any one of the preceding claims, further comprising flowing at least portion of the sample to a third chamber and determining a property of the sample.

15. The method of any one of the preceding claims, further comprising other excitation of the elements contained in the cartridge and sample16. A kit, comprising: a cartridge comprising a front planar surface, a back planar surface, a top surface, and a bottom surface; a plurality of chambers positioned between the front planar surface and the back planar surface; a sample input cavity extending from the top surface towards the bottom surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL; and a microfluidic channel in fluidic communication with a bottom portion of the sample input cavity; a sample tube configured to be inserted into the sample input cavity of the cartridge; a first identification code configured to be applied to and around the sample tube;#14416201vlan identification card comprising a panel, the identification card configured to be attached to the cartridge while displaying the first identification through the panel; and a second identification code, distinct from the first identification code, affixed to the identification card.

17. A cartridge, comprising: a front planar surface, a back planar surface, a top surface, and a bottom surface; a sample input cavity extending having a main axis extending from the top surface towards the bottom surface, wherein the sample input cavity has a volume of greater than or equal to 1 mL and less than or equal to 10 mL; a plurality of chambers including at least a first chamber and a second chamber positioned between front surface and the back surface; a concave portion formed between at least the front planar surface and the back planar surface; and a sample analysis region protruding from the concave portion, wherein the sample analysis region comprises an optical window accessible by a first wavelength of light via a horizontal circumference around the optical window and a vertical circumference around the optical window.

18. A method, comprising: inserting a sample tube containing a sample into a sample input cavity of a cartridge, the cartridge comprising: a front planar surface, a back planar surface, a top surface, a bottom surface; a concave portion formed between at least the front planar surface and the back planar surface; a sample analysis region protruding from the concave portion; and a plurality of chambers positioned between the front planar surface and the back planar surface, wherein the sample input cavity comprises a bottom and a sample receiving inlet positioned at the bottom of the sample input cavity; transferring at least a portion of the sample from the sample tube to a microfluidic channel in fluidic communication with the sample-receiving inlet; flowing at least a portion of the sample to the sample analysis region;#14416201vlheating the sample analysis region via a 360° circumference around an optical window of the sample analysis region.

19. The method of any one of the preceding claims, wherein heating comprises flowing heated air towards the optical window, wherein a temperature of the heated air is greater than or equal to 25 °C.

20. The method of any one of the preceding claims, wherein heating comprises applying light of a first wavelength towards the sample analysis region.#14416201vl

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