Cartridge for measuring analytes in a biological sample and related techniques

Abstract

An analytical cartridge and related techniques are disclosed. The cartridge may be configured for use in measuring levels of one or more analytes in a biological sample obtained from a patient, including electrolytes and / or metabolites. To such ends, the cartridge may include or be configured to host a sensor array configured to receive the biological sample. The cartridge also may include an encapsulated fluid blister containing a calibration fluid that, when expressed, flows along a sample flow path into contact with a self-sealing vent that seals upon contact with the fluid and thus redirects the fluid to flowing further along the sample flow path to contact a sensor membrane and purge the sensor array. In this manner, the cartridge may be configured to allow for appropriate displacement of the flow path volume and enabling capillary draw of the expected range of sample(s) while also allowing for one-point calibration.

Description

[0001] Atty. Docket No.: NOVA 24.01 PCT

[0002] CARTRIDGE FOR MEASURING ANALYTES IN A BIOLOGICAL SAMPLE AND RELATED TECHNIQUES

[0003] FIELD OF THE DISCLOSURE

[0004] The present disclosure relates to cartridges for measuring levels of one or more analytes in a biological sample and related techniques.

[0005] BACKGROUND

[0006] U.S. Patent No. 10,232,369 (Turner et al.) discloses a fluidic cartridge that closes upon fluid contact with a self-sealing polymer at the inlet. The inactivated, self-sealing polymer is air-permeable, and the activated, self-sealing polymer is air-impermeable and fluid-impermeable. In one instance, a hydrogel is attached to the pore wall of a porous substrate, and the self-sealing hydrogel of polymer includes a hydrophilic polyurethane, a hydrophilic polyurea, or a hydrophilic polyurea urethane. In another instance, the porous substrate includes an organic polymer, such as an acrylic, a polyolefin, a polyester, a polyamide, a poly(estersulfone), a polytetraflorethylene, a polyvinylchloride, a polycarbonate, or a polyurethane, and the porous substrate includes an ultra-high molecular weight (UHMW) polyethylene frit.

[0007] U.S. Patent No. 9,075,042 (Cook et al.) discloses a disposable diagnostic cartridge with a self-sealing layer that prevents fluid and gas exchange. This approach involves a multi-layer film structure that may be pierceable, reversibly stretchable, elastic, reversibly compressible, self-sealing, prevents fluid and gas exchange, and seals against a probe.

[0008] U.S. Patent No. 10,654,039 (Marcy et al.) discloses a microfluidic cartridge with a semi-permeable membrane to let air pass through while preventing liquids from leaking out. However, the membrane is not described as porous or self-sealing.

[0009] U.S. Patent No. 10,545,161 (Khattak et al.) discloses a cartridge with a tunnel for sample collection, a reservoir to hold the reagents and to receive the sample, and an analysis channel to receive the liquid having the sample and reagents mixed therein. In this approach, the sample and solution are combined rather than processed sequentially.

[0010] U.S. Patent No. 9,772,302 (Zelin et al.) discloses a quality assurance system for point-of-care testing with a calibrant fluid having known concentrations of analytes, to which each sensor of the subset of electrochemical sensors is specific. However, the calibrant fluid is not specific to the cartridge.Atty. Docket No.: NOVA 24.01 PCT

[0011] U.S. Patent No. 8,828,320 (Bardell et al.) discloses a cartridge with multiple electrodes in contact with the sample in which the voltage and current characteristics can be used to determine the presence of air bubbles, incorrect reagent in the fluid, and / or unacceptable characteristics of the fluid.

[0012] SUMMARY

[0013] A first example embodiment provides a cartridge configured for measuring a level of at least one analyte present in a biological sample via an analyzer. The cartridge includes a sensor array configured to receive the biological sample and detect the level of the at least one analyte present in the biological sample. The cartridge further includes a blister containing a calibration fluid. The cartridge further includes a sample flow path fluidically connecting the blister and the sensor array. In operation of the cartridge, at least some of the calibration fluid enters the sample flow path and is delivered to the sensor array to purge the biological sample from the sensor array.

[0014] In some cases, the at least one analyte comprises at least one electrolyte selected from the group consisting of: sodium; potassium; chloride; magnesium; calcium; bicarbonate; and phosphate.

[0015] In some cases, the at least one analyte comprises at least one metabolite selected from the group consisting of: glucose; blood urea nitrogen; ammonia; creatinine; albumin; bilirubin; alkaline phosphatase; aspartate transaminase; alanine transaminase; cholesterol; uric acid; and lactate.

[0016] In some cases, the sensor array is configured to receive the biological sample, at least in part, via capillary action.

[0017] In some cases, the sensor array is configured to accept a volume of the biological sample in a range of about 0.8-10.0 pL. In some instances, the sensor array is configured to accept a volume of the biological sample in a range of about 3.0-8.0 pL ± 1.0 pL. In some instances, the sensor array is configured to accept a volume of the biological sample in a range of about 2.8 pL ± 0.8 pL.

[0018] In some cases, the sensor array comprises at least one air detection electrode configured to detect when the sensor array has been filled with the biological sample.

[0019] In some cases, the sensor array is further configured to convey test panel information to the analyzer.

[0020] In some cases, the calibration fluid comprises at least one of an analyte requiring calibration, a preservative, and a colorant.Atty. Docket No.: NOVA 24.01 PCT

[0021] In some cases, the at least some of the calibration fluid enters the sample flow path upon being expressed from the blister.

[0022] In some cases, the blister is at least partially disposed within a cavity formed in the cartridge. In some instances, the cavity is configured to receive a plunger of the analyzer such that the plunger applies a pressing force to the blister, causing the at least some of the calibration fluid to exit the blister and enter the sensor array. In some instances, in receiving the plunger of the analyzer within the cavity, the cartridge is prevented from being removed from the analyzer.

[0023] In some cases, the cartridge further includes a seal which seals the calibration fluid within the blister in a liquid-tight manner. In some instances, the seal comprises a metal or alloy. In some instances, the seal comprises a polymer. In some instances, the cartridge further includes a piercing feature configured to pierce the seal to allow the at least a portion of the calibration fluid to be expressed from the blister into the sample flow path.

[0024] In some cases, the cartridge further includes a self-sealing vent fluidically connected with the sample flow path. In some instances, in operation of the cartridge, the at least some of the calibration fluid contacts the self-sealing vent to effectuate self-sealing thereof such that gas exits initially and the calibration fluid flows without leaking out through the selfsealing vent.

[0025] In some cases, at least a portion of the sample flow path has been modified with a treatment.

[0026] In some cases, the cartridge further includes an adjustable cover operatively coupled with a body of the cartridge, wherein the adjustable cover is adjustable to effectuate opening and closing of access to the sensor array within the cartridge. In some instances, the cartridge further includes a feature configured to indicate that the adjustable cover is in a closed position in which access to the interior of the body of the cartridge is prevented.

[0027] In some cases, the cartridge further includes at least one retention feature configured to provide resistance against de-interfacing of the cartridge from the analyzer. In some instances, the at least one retention feature provides a retaining force in a range of about 0.5-2.0 Ibf. In some instances, the retaining force is about 1.0 Ibf ± 0.25 Ibf.

[0028] In some cases, the cartridge is configured for self-containment of waste resulting from usage.

[0029] In some cases, a system is provided, the system including: the cartridge of the first example embodiment; and the analyzer.

[0030] In some cases, the analyzer is a handheld device.Atty. Docket No.: NOVA 24.01 PCT

[0031] In some cases, the analyzer includes a plunger configured to apply a pressing force to the blister and an actuator configured to actuate the plunger. In some instances, the plunger is configured to apply the pressing force to the blister through direct physical contact of the plunger with the blister. In some instances, the plunger is configured to apply the pressing force to the blister indirectly through an element that physically intervenes between the plunger and the blister.

[0032] A second example embodiment provides an analyte testing cartridge configured to be read via an analyzer. The cartridge includes a sensor array configured to detect a level of at least one analyte present in a biological sample. The cartridge further includes a blister containing a calibration fluid. The cartridge further includes a sample flow path fluidically connecting the blister and the sensor array. The cartridge further includes a self-sealing vent fluidically connected with the sample flow path, wherein the self-sealing vent is configured to be gas-permeable during collection of the biological sample and both gas-impermeable and fluid-impermeable during dispensation of the calibration fluid through the sensor array. In operation of the cartridge, at least some of the calibration fluid enters the sample flow path and is delivered to the self-sealing vent to effectuate self-sealing thereof and to the sensor array to purge the biological sample from the sensor array.

[0033] In some cases, the sensor array is configured to draw the biological sample into the sample flow path, at least in part, via capillary action.

[0034] In some cases, the at least one analyte comprises at least one electrolyte selected from the group consisting of sodium; potassium; chloride; magnesium; calcium; bicarbonate; and phosphate.

[0035] In some cases, the at least one analyte comprises at least one metabolite selected from the group consisting of glucose; blood urea nitrogen; ammonia; creatinine; albumin; bilirubin; alkaline phosphatase; aspartate transaminase; alanine transaminase; cholesterol; uric acid; and lactate.

[0036] In some cases, the blister is at least partially disposed within a cavity formed in the cartridge. In some instances, the cavity is configured to receive a plunger of the analyzer such that the at least some of the calibration fluid is expressed from the blister via the plunger and the cartridge is prevented from being removed from the analyzer by the plunger.

[0037] In some cases, the calibration fluid comprises at least one of an analyte requiring calibration, a preservative, and a colorant.

[0038] In some cases, a system is provided, the system including: the cartridge of the second example embodiment; and the analyzer.Atty. Docket No.: NOVA 24.01 PCT

[0039] In some cases, the analyzer includes a plunger configured to apply a pressing force to the blister and an actuator configured to actuate the plunger.

[0040] The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and claims. Moreover, it should be noted that the language used in the specification has been selected principally for readability and instructional purposes and not to limit the scope of the inventive subject matter.

[0041] BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates an isometric view of a cartridge configured for measuring levels of one or more analytes in a biological sample in accordance with an embodiment of the present disclosure.

[0042] FIG. 2 illustrates a side elevation view of the cartridge of FIG. 1.

[0043] FIG. 3 illustrates an exploded isometric view of the cartridge of FIG. 1.

[0044] FIG. 4 illustrates an isometric view of an example sensor array for use in a cartridge configured in accordance with an embodiment of the present disclosure.

[0045] FIG. 5 illustrates an exploded perspective view of the example sensor array of FIG. 4. FIG. 6 illustrates a top-down plan view of internal structure of a cartridge, including a fluid blister, configured in accordance with an embodiment of the present disclosure.

[0046] FIG. 7 illustrates a perspective view of the internal structure of FIG. 6.

[0047] FIG. 8A illustrates a cross-sectional view of a cartridge in a first mode of operation in which a biological sample is received by a sensor array, in accordance with an embodiment of the present disclosure.

[0048] FIG. 8B illustrates a cross-sectional view of a cartridge in a second mode of operation in which a calibration fluid is passed through a sensor array, in accordance with an embodiment of the present disclosure.

[0049] FIG. 9A illustrates a partial perspective view of a sample flow path of a cartridge configured in accordance with an embodiment of the present disclosure.

[0050] FIG. 9B illustrates another partial perspective view of the sample flow path of FIG. 9A.

[0051] FIG. 10 conceptually illustrates the expression of calibration fluid from a blister in a cartridge by a plunger of an analyzer, in accordance with an embodiment of the present disclosure.Atty. Docket No.: NOVA 24.01 PCT

[0052] FIG. 11 illustrates an isometric view of a cartridge with its adjustable cover in an open position, in accordance with an embodiment of the present disclosure.

[0053] FIG. 12 illustrates another perspective view of the cartridge of FIG. 11.

[0054] FIG. 13 is a flow diagram illustrating an example method of using a cartridge with an analyzer in accordance with an embodiment of the present disclosure.

[0055] These and other features of the present embodiments will be understood better by reading the following detailed description, taken together with the figures herein described. The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing.

[0056] DETAILED DESCRIPTION

[0057] General Overview

[0058] In accordance with some embodiments of the present disclosure, an analytical cartridge and related techniques are disclosed. The disclosed cartridge may be configured for use in measuring levels of one or more analytes in a biological sample obtained from a patient, including electrolytes and / or metabolites. To such ends, the cartridge may include or be configured to host a sensor array (e.g., a test strip) configured to receive the biological sample (e.g., by capillary action). The cartridge also may include an encapsulated fluid blister containing a calibration fluid that, when expressed, flows along a sample flow path into contact with a self-sealing vent that seals upon contact with the fluid and thus redirects the fluid to flowing further along the sample flow path to contact a sensor membrane and purge the sensor array. In this manner, the cartridge may be configured to allow for appropriate displacement of the flow path volume and enabling capillary draw of the expected range of sample(s) while also allowing for one-point calibration.

[0059] Generally, the disclosed cartridge may be configured for use with any of a wide range of analytical platforms, including analyzers and meters, both handheld and otherwise. In accordance with some embodiments, the disclosed cartridge may be configured to be at least partially inserted into a given analytical device. In accordance with some embodiments, the disclosed cartridge may be configured for only a single use and, generally, may be disposable by design, though it should be noted that a reusable cartridge also is envisioned and considered within the scope of this disclosure. In some cases, the disclosed cartridgeAtty. Docket No.: NOVA 24.01 PCT

[0060] optionally may include a unique identifier (ID) system, which allows the testing of other analytes without specific input into the analyzer or meter being used.

[0061] Some embodiments may realize one or more advantages or benefits, as compared to existing approaches. For example, in accordance with some embodiments, the disclosed cartridge may incorporate a combination of features that provide a reverse flush and calibration system for a sensor array, thereby providing for testing which previously could not be done in a single-use, disposable analytical cartridge. In accordance with some embodiments, the cartridge may be configured to provide a single-use, sensor array-based, capillary sample acquisition method, which may permit easy sample testing without the need for a phlebotomist or other technician or more complicated fluid-handling devices and systems. In accordance with some embodiments, the cartridge may integrate a novel, onboard calibration method which provides for measurement of multiple analytes via a single-use, sensor array-based technology as opposed to conventional multi-use sensor technologies that are complex and expensive. In accordance with some embodiments, the cartridge may provide for testing at multiple angles and / or stability in a moving environment (e.g., a moving vehicle). In accordance with some embodiments, the cartridge may be compatible for use with a wide range of fluids with different viscosities (e.g., low / high hematocrit, etc.).

[0062] Also, as described herein, the disclosed cartridge may be configured, in accordance with some embodiments, for (a) maximum expression of one or more calibration fluids from a fluid blister, (b) minimal (or otherwise negligible) bubble formation in the calibration fluid(s), and (c) replicable burst timing for the fluid blister. Furthermore, as described herein, the cartridge may be configured, in accordance with some embodiments, to fully contain a biological sample which has been applied to the sensor array in a safe and reliable manner, minimizing (or otherwise reducing) the opportunity for exposure to biohazard materials under testing. Also, as described herein, the cartridge may be configured, in accordance with some embodiments, for self-containment of waste resulting from usage.

[0063] Cartridge Structure and Operation

[0064] FIGS. 1-3 illustrate several views of an analytical cartridge 100 configured for analyzing levels of analytes in a biological sample in accordance with an embodiment of the present disclosure. As described herein, cartridge 100 generally may be configured for use in testing levels of one or more analytes in a given biological sample obtained from a patient. For example, cartridge 100 may be configured, in accordance with some embodiments, forAtty. Docket No.: NOVA 24.01 PCT

[0065] use in testing levels of any one (or combination) of electrolytes and / or metabolites, such as any of those listed in Table 1 below:

[0066]

[0067] Examples of biological samples suitable for use with cartridge 100 may include, for instance, whole blood, plasma, serum, urine, and saliva, to name a few. Moreover, the biological samples may be of human or animal origin. In accordance with some embodiments, cartridge 100 additionally (or alternatively) may be configured for analysis of one or more environmental samples.

[0068] To such ends, cartridge 100 may be configured to be operatively interfaced with an analyzer or meter, which may be a handheld, standalone, or bench device, as desired. More specifically, for performing testing therewith, cartridge 100 may be configured to be at least partially inserted into a corresponding port, slot, or other suitable receptacle of an analyzer or meter.

[0069] Cartridge 100 may include (or otherwise be configured to receive) a sensor array 110 within its interior. For instance, consider FIGS. 4-5, which illustrate several views of an example sensor array 110 for use in a cartridge 100 configured in accordance with an embodiment of the present disclosure. As can be seen, sensor array 110 generally may be configured as a multi-layer structure including, for example, a substrate layer 110a, an electrically conductive layer 110b including a plurality of electrically conductive traces, an electrode-forming layer 110c including a plurality of wells formed therein, a channel -formingAtty. Docket No.: NOVA 24.01 PCT

[0070] layer 1 lOd including a channel which overlies the wells, and a capping layer 1 lOe arranged as generally shown. In some cases, sensor array 110 may be a native component of cartridge 100 which, by design, is not intended to be physically removable without damaging cartridge 100. In some such cases, cartridge 100 generally may be intended to be disposed after use. In other cases, though, sensor array 110 may be a separate and distinct, replaceable component that can be operatively engaged with and disengaged from cartridge 100 freely. In some such cases, cartridge 100 generally may be intended to be used one or more times before disposal. In some embodiments, sensor array 110 may be configured, for example, as a test strip which is sensitive to one or more analytes of interest.

[0071] As previously noted, sensor array 110 may be configured to test for the level of any of a wide range of analytes in a biological sample. To such ends, sensor array 110 may include, in accordance with some embodiments, a corresponding quantity of ion-selective electrodes (ISEs) utilizing a solid-state reference electrode, wherein the ISE sensor(s) selectively measure activity of their respective ionic species with respect to a reference electrode. In this manner, cartridge 100 may be configured to test for a single analyte or for multiple unique analytes (e.g., two, three, four, or more) in the same sampling session.

[0072] As discussed herein, sensor array 110 may be configured, in accordance with some embodiments, to draw in a biological sample via capillary action. The capillary volume limit of sensor array 110 may be customized, as desired for a given target application or end-use. In accordance with some embodiments, sensor array 110 may be configured to accept a sample volume, through capillary action or otherwise, in the range of about 0.8-10.0 pL (e.g., about 0.8-5.0 pL, about 5.0-10.0 pL, or any other sub-range in the range of about 0.8-10.0 pL). In some cases, volumes in the range of about 3.0-8.0 pL ± 1.0 pL may be accepted by sensor array 110, and in a specific example case, a volume of about 2.8 pL ± 0.8 pL may be accepted. As will be appreciated in light of this disclosure, limiting the volume of sensor array 110 in this manner may serve, at least in part, to (a) limit the total volume of biological sample ultimately required for analysis and / or (b) help to better maintain the integrity of the biological sample (e.g., by limiting hemolysis, by preventing or otherwise reducing air bubble formation, and / or by preventing or otherwise reducing gravity-based sample loss during analysis) across a range of values (hematocrit or otherwise), with or without involvement or inclusion of anti coagulation measures.

[0073] In accordance with some embodiments, sensor array 110 optionally may include one or more air detection electrodes configured to detect when sensor array 110 has been sufficiently filled (e.g., via capillary action) with a biological sample. As will be appreciatedAtty. Docket No.: NOVA 24.01 PCT

[0074] in light of this disclosure, the type, sensitivity range, and arrangement of such optional air detection electrode(s) may be customized, as desired for a given target application or end-use.

[0075] In accordance with some embodiments, sensor array 110 optionally may be configured to indicate to the analyzer the specific test panel for which it is designed. To that end, sensor array 110 may include one or more electrically conductive layers (e.g., in substrate layer 110a or otherwise) that serve to convey test panel information to the analyzer. It should be noted, however, that the present disclosure is not intended to be so limited, as in accordance with some other embodiments, additional (or alternative) means for conveying test panel information may be employed. For instance, in some embodiments, sensor array 110 may be configured to convey information via a radio frequency identification (RFID) element, a near-field communication (NFC) element, or a barcode or quick response (QR) code element, to name a few options. In accordance with some embodiments, a two-dimensional barcode may be employed with cartridge 100, which an analyzer may utilize to confirm that the information in substrate layer 110a matches cartridge 100. Numerous suitable alternatives will be apparent in light of this disclosure.

[0076] As can be seen further, cartridge 100 also may include a blister 120 at least partially disposed within a cavity 122 of the body of cartridge 100. For instance, consider FIGS. 6-7, which illustrate several views of internal structure of cartridge 100, including a blister 120, in accordance with an embodiment of the present disclosure. Blister 120 may be configured to contain one or more calibration fluids 124 (see FIGS. 8A-8B, discussed below) which may be used for purging a biological sample from the flow path of sensor array 110. A given suitable calibration fluid 124 may be, for example, a custom aqueous solution including any one (or combination) of an analyte requiring calibration, a preservative, and a colorant, among other options.

[0077] As will be appreciated in light of this disclosure, the dimensions and geometry of both blister 120 and cavity 122 may be customized, as desired for a given target application or end-use. At least in some instances, it may be desirable to provide blister 120 with a shape which is able to collapse repeatably with minimal dead volume. As can be seen from the example(s) illustrated in the drawings, blister 120 generally may be hemispherical in shape, though other suitable shapes will be apparent in light of this disclosure. Moreover, the volume of blister 120 may be customized, as desired for a given target application or end-use. At least in some instances, blister 120 may be configured to hold a volume of calibration fluid(s) 124 in the range of about 100-200 pL (e.g., about 100-125 pL, about 125-150 pL,Atty. Docket No.: NOVA 24.01 PCT

[0078] about 150-175 pL, about 175-180 pL, or any other sub-range in the range of about 100-200 pL). In some example cases, the volume may be about 160 pL ± 25 pL.

[0079] Blister 120 may be sealed, at least in part, via a seal 126 (see FIGS. 8A-8B, discussed below). By design, seal 126 may provide blister 120 with a liquid-tight seal for purposes of retaining calibration fluid(s) 124 within blister 120. As will be appreciated in light of this disclosure, the material composition and dimensions (e.g., thickness) of seal 126 may be customized, as desired for a given target application or end-use. In some embodiments, seal 126 may be (or otherwise may include) a foil seal comprising a metal, such as aluminum, or an alloy. In some other embodiments, seal 126 may be (or otherwise may include) a polymer-based seal comprising a high-barrier polymer material, such as ethylene vinyl alcohol. In some embodiments, seal 126 may include one or more coatings comprising an oxide, such as aluminum oxide or silicon oxide, among others. Other suitable configurations for blister 120, seal 126, and cavity 122 will depend on a given target application or end-use and will be apparent in light of this disclosure.

[0080] Cartridge 100 also may include at least one piercing feature 128 disposed within the body thereof, proximate to (e.g., beneath or otherwise subjacent to) blister 120 and seal 126 (see FIGS. 8A-8B, discussed below). Generally, a given piercing feature 128 may be configured to pierce or otherwise rupture seal 126 in one or more places. To that end, a given piercing feature 128 may be (or otherwise may include) a projection having a sharp tip, point, or edge sufficient to puncture, cut, or otherwise penetrate seal 126.

[0081] As will be appreciated in light of this disclosure, it may be desirable, at least in some instances, to ensure that a given piercing feature 128 is strong enough to resist damage while piercing seal 126 and avoiding (or at least reducing) flow restriction after piercing. In some embodiments, a given piercing feature 128 may be formed with a specific quantity and / or pattern of plates configured to target feature tolerance and puncture timing precision. In some embodiments, a given piercing feature 128 may be located, for example, off-center and / or in a well to minimize (or otherwise reduce) the transfer of air from blister 120. In some embodiments, a given piercing feature 128 may include one or more additional features such as a notch cutout configured to reduce sealing to seal 126 and provide a clear flow path for calibration fluid(s) 124 from blister 120.

[0082] By design, piercing of seal 126 by a given piercing feature 128 may occur when sufficient pressing force is applied to blister 120, for example, by an actuated plunger of an analyzer that has received cartridge 100. As will be appreciated in light of this disclosure, it may be desirable, at least in some instances, to ensure that a given piercing feature 128 isAtty. Docket No.: NOVA 24.01 PCT

[0083] configured and disposed so as to pierce seal 126 without piercing the body of blister 120 itself. Other suitable configurations for piercing feature(s) 128 will depend on a given target application or end-use and will be apparent in light of this disclosure.

[0084] Within cartridge 100, blister 120 and sensor array 110 may be fluidically connected with one another. For instance, consider FIGS. 8A-8B and 9A-9B, which illustrate several views of cartridge 100 including a sample flow path 130, in accordance with an embodiment of the present disclosure. As can be seen, sample flow path 130 generally may be configured as a channel, conduit, or other pathway that provides for flow communication between blister 120 and sensor array 110. Specifically, sample flow path 130 may be configured as a bidirectional (i.e., two-way) fluid flow path. That is, in a first mode of operation of cartridge 100, a biological sample may be drawn into sensor array 110 through sample flow path 130 in a first direction, generally flowing from point A in the direction of region B, as labeled in FIG. 8 A. In a second mode of operation of cartridge 100, a calibration fluid 124 may be pushed out through sample flow path 130 from blister 120 in a second direction, generally flowing from point C to point D (at self-sealing vent 140, discussed below) to point A and out of sensor array 110, as labeled in FIG. 8B.

[0085] In some cases, sample flow path 130 optionally may be modified at one or more locations along its length with one or more treatments. When included, such optional treatment(s) may serve, at least in part, to facilitate capillarity and control of flow rate, in accordance with some embodiments.

[0086] As noted above, cartridge 100 may include a self-sealing vent 140. Self-sealing vent 140 may be configured, in accordance with some embodiments, to allow for drawing (e.g., through capillary action) of a biological sample through sensor array 110 (in a first mode of operation of cartridge 100) and subsequently seal upon contact with calibration fluid 124 (in a second mode of operation of cartridge 100). More specifically, self-sealing vent 140 may be configured such that it is (a) gas-permeable (e.g., air-permeable) during collection of the biological sample by sensor array 110 but (b) both gas-impermeable (e.g., air-impermeable) and fluid-impermeable during dispensation of calibration fluid 124 through sensor array 110. In this manner, self-sealing vent 140 may facilitate the ability of cartridge 100 to have calibration fluid 124 wash out and substantially (e.g., completely) replace the biological sample in sensor array 110. To such ends, self-sealing vent 140 may include a frit 142 made from a porous material which allows gases to escape through frit 142 in the opening of selfsealing vent 140 while preventing calibration fluid(s) 124 from escaping, allowing venting toAtty. Docket No.: NOVA 24.01 PCT

[0087] atmosphere and providing for gas flow (e.g., air flow) which promotes fluid flow (e.g., via capillary action) in sensor array 110.

[0088] In accordance with some embodiments, frit 142 may be made, at least in part, from an ultra-high-molecular-weight (UHMW) polyethylene (PE). In some embodiments, frit 142 may include a porous polymer with embedded sealing agent(s) or similar. More generally, the porosity and exposed vent surface area of self-sealing vent 140 may be customized, as desired for a given target application or end-use, to achieve a given target flow rate for a given biological sample across a given target analytical range. In accordance with some embodiments, one or more additional side openings also may be provided in the body of cartridge 100, further facilitating the desired flow of both the biological sample and calibration fluids 124. Other suitable configurations for self-sealing vent 140 and its constituent frit 142 will depend on a given target application or end-use and will be apparent in light of this disclosure.

[0089] Generally, cartridge 100 may be configured such that, in operation with an analyzer, a plunger (or other suitable force-applying structure) of the analyzer may enter into cavity 122 and press blister 120 directly or indirectly (e.g., via one or more intervening structures or layers). To that end, the plunger may be actuated, for example, by a linear or other suitable actuator of the analyzer. As a consequence of applying a pressing force to blister 120, seal 126 may be pierced by piercing feature(s) 128, and calibration fluid(s) 124 may be expressed from blister 120 into sample flow path 130 of cartridge 100 (e.g., heading toward sensor array 110). FIG. 10 conceptually illustrates the expression of calibration fluid 124 from blister 120 in cartridge 100 by a plunger of an analyzer, in accordance with an embodiment of the present disclosure.

[0090] In accordance with some embodiments, cartridge 100 also may include an adjustable cover 150 configured to at least partially enclose an open end of cartridge 100 (e.g., proximate to where sensor array 110 is to reside), in accordance with some embodiments. FIGS. 11-12 illustrate several views of cartridge 100 with its adjustable cover 150 in an open position, in accordance with an embodiment of the present disclosure. In some embodiments, adjustable cover 150 may be operatively connected to the body of cartridge 100 such that it is pivotable along an axis of rotation with respect to the body of cartridge 100. In this manner, adjustable cover 150 may be permitted to rotate between (a) an open position in which sensor array 110 and the interior of cartridge 100 are accessible and (b) a closed position in which sensor array 110 and the interior of cartridge 100 are not accessible from outside cartridge 100. In some other embodiments, adjustable cover 150 may be slidable (e.g., translatingAtty. Docket No.: NOVA 24.01 PCT

[0091] along a longitudinal length of cartridge 100) between its open and closed positions. To such ends, the shape and dimensions of adjustable cover 150 may be customized, as desired for a given target application or end-use.

[0092] In accordance with some embodiments, cartridge 100 optionally may include one or more cover locking features 152 configured to lock adjustable cover 150 in a given position with respect to the body of cartridge 100. In this manner, cover locking feature(s) 152 may hold adjustable cover 150 in its open and / or closed position, as desired. To such ends, cover locking feature(s) 152 may be (or otherwise may include) a detent, slot, friction surface, interference feature, or clip feature, for example, in accordance with some embodiments. In an example embodiment, a given cover locking feature 152 may be a boss which provides a shoulder near the pivot point of adjustable cover 150. By design, the holding of adjustable cover 150 in its closed position may help to ensure that any biological sample and / or dispensed calibration fluid 124 stay fully (or else sufficiently) self-contained within cartridge 100, in accordance with some embodiments. Other suitable configurations for adjustable cover 150 and associated optional cover locking feature(s) 152 will depend on a given target application or end-use and will be apparent in light of this disclosure.

[0093] In accordance with some embodiments, cartridge 100 optionally may include one or more fluid-catching features 160 configured to receive and retain any calibration fluid 124 and / or biological sample flowing out of sensor array 110 within cartridge 100. Additionally (or alternatively), cartridge 100 optionally may include one or more absorbent features 162 configured to absorb any calibration fluid 124 and / or biological sample flowing out of sensor array 110. Generally, features 160, 162 may help to ensure that any biohazardous materials involved with use of cartridge 100 stay fully (or else sufficiently) contained within cartridge 100. Also, features 160, 162 may be configured to help ensure that fluids are kept separate from one another or out of any important area (e.g., sensor array 110 may remain clear of the biological sample when calibration fluid 124 is being measured). When included, features 160, 162 may be disposed proximate to the sample intake end of sensor array 110 (e.g., in the region of adjustable cover 150 or on cartridge 100 under sensor array 110), in accordance with some embodiments. In some cases, a given fluid-catching feature 160 may be (or otherwise may include) a material which is fast-wicking and exhibits sufficiently high absorbency. In some cases, a given absorbent feature 162 may be (or otherwise may include), for example, an absorbent pad. The dimensions and location of a given feature 160, 162 may be customized, as desired for a given target application or end-use. Other suitableAtty. Docket No.: NOVA 24.01 PCT

[0094] configurations for fluid-catching feature(s) 160 and absorbent feature(s) 162 will depend on a given target application or end-use and will be apparent in light of this disclosure.

[0095] In accordance with some embodiments, cartridge 100 optionally may include one or more overmolded, gasketed interfaces between blister 120 and sensor array 110 to ensure the desired flow of calibration fluid 124 within cartridge 100. In at least some cases, such interface(s) may provide for liquid-tight sealing without distortion of the components involved.

[0096] In accordance with some embodiments, cartridge 100 may include one or more features which serve to help physically secure it in engagement with an analyzer. For example, in accordance with some embodiments, insertion of a plunger of the analyzer into cavity 122 physically may prevent removal of cartridge 100 from the analyzer without first withdrawing the plunger. In this manner, cartridge 100 may be secured in place, for example, while being run by the analyzer. Additionally (or alternatively), the exterior of cartridge 100 may include one or more retention features 170 configured as recesses which are to be held by corresponding features (e.g., clips or other suitable retention means) of the analyzer. In this manner, cartridge 100 may be secured in place in the analyzer regardless of whether it is actively being run by the analyzer. When retention feature(s) 170 are included, cartridge 100 may be held in place thereby with a retaining force in the range of about 0.5-2.0 Ibf (e.g., about 0.5-1.0 Ibf, about 1.0-1.5 Ibf, about 1.5-2.0 Ibf, or any other sub-range in the range of about 0.5-2.0 Ibf). In some cases, the retaining force may be about 1.0 Ibf ± 0.25 Ibf. Other suitable configurations for retention feature(s) 170 will depend on a given target application or end-use and will be apparent in light of this disclosure.

[0097] As will be appreciated in light of this disclosure, the material construction, general form factor, and various dimensions of cartridge 100 may be customized, as desired for a given target application or end-use. In at least some cases, it may be desirable to provide cartridge 100 with an asymmetrical construction (e.g., such as by having one end differ from the other), such that cartridge 100 can be operatively interfaced with (e.g., inserted into) the intended analyzer in one orientation only. This may help to reduce the likelihood of user error in operating cartridge 100 with a given analyzer. Also, asymmetric construction of this type may serve to help indicate to a user whether cartridge 100 has been closed properly for use.Atty. Docket No.: NOVA 24.01 PCT

[0098] Methodology

[0099] FIG. 13 is a flow diagram illustrating an example method 300 of using an analytical cartridge 100 with an analyzer in accordance with an embodiment of the present disclosure.

[0100] As can be seen, method 300 may begin, as in block 302, with operatively interfacing cartridge 100 with an analyzer, such as by inserting cartridge 100, in part or in whole, into the analyzer.

[0101] Method 300 may continue, as in block 304, with opening adjustable cover 150 of cartridge 100 to expose sensor array 110 therein or else to permit insertion of a sensor array 110 into cartridge 100. To that end, adjustable cover 150 may be rotated and / or slid relative to the body of cartridge 100, exposing the open end thereof.

[0102] Method 300 may continue, as in block 306, with presenting the biological sample to sensor array 110, wherein at least a portion of the biological sample is drawn into sensor array 110 (e.g., via capillary action). In the case of a blood sample, for instance, a user of cartridge 100 may lance the finger of a patient, express a blood droplet of appropriate size, and present the blood droplet to the sample intake end of sensor array 110.

[0103] Method 300 may continue, as in block 308, with sensing (e.g., via one or more air detection electrodes) whether the sample flow path of sensor array 110 is sufficiently full. The analyzer may provide feedback notification (e.g., audio and / or visual notification) that collection of the biological sample is complete or incomplete, as the case may be.

[0104] Method 300 may continue, as in block 310, with the user closing adjustable cover 150 and detection of the same by the analyzer. In accordance with some embodiments, the analyzer may prompt the user to close adjustable cover 150.

[0105] Method 300 may continue, as in block 312, with the analyzer recording a first reading from the biological sample in sensor array 110. The first reading may include data pertaining to the current level of one or more analytes (e.g., electrolytes and / or metabolites) in the biological sample.

[0106] Method 300 may continue, as in block 314, with a plunger of the analyzer compressing blister 120 to pierce its seal 126 with a piercing feature 128. Application of the plunger to blister 120 may force calibration fluid 124 out of blister 120 into sample flow path 130 toward sensor array 110. Moreover, entry of the plunger within cavity 122 also physically may secure cartridge 100 within the analyzer, thereby preventing cartridge 100 from being removed (accidentally or otherwise) from the analyzer while in use.Atty. Docket No.: NOVA 24.01 PCT

[0107] Method 300 may continue, as in block 316, with calibration fluid 124 flowing along sample flow path 130 into contact with frit 142 of self-sealing vent 140, thereby causing frit 142 to seal and thus directing calibration fluid 124 further through sample flow path 130 to sensor array 110. In this manner, calibration fluid 124 may serve to wash out or otherwise purge the biological sample from sensor array 110, leaving any excess to be (a) received and retained by any optionally included fluid-catching feature(s) 160 and / or (b) absorbed by any optionally included absorbent feature(s) 162.

[0108] Method 300 may continue, as in block 318, with the analyzer recording a second reading on calibration fluid 124 now found in sensor array 110. This may be done once the biological sample has been sufficiently purged from sensor array 110 by calibration fluid 124.

[0109] Method 300 may continue, as in block 320, with the plunger of the analyzer retracting. This may free cartridge 100 to be removed from the analyzer (e.g., for safe disposal of cartridge 100).

[0110] Method 300 may continue, as in block 322, with the analyzer (or other suitable analytical platform) calculating the patient’s test value(s) of interest based on the first and second readings. This data optionally may be displayed on or otherwise relayed to a user interface (UI) or graphical user interface (GUI).

[0111] Further Examples

[0112] The following examples pertain to some further embodiments of the disclosure, from which numerous permutations and combinations will be apparent.

[0113] Example 1 includes a cartridge configured for measuring a level of at least one analyte present in a biological sample via an analyzer. The cartridge further includes a sensor array configured to receive the biological sample and detect the level of the at least one analyte present in the biological sample. The cartridge further includes a blister containing a calibration fluid. The cartridge further includes a sample flow path fluidically connecting the blister and the sensor array. In operation of the cartridge, at least some of the calibration fluid enters the sample flow path and is delivered to the sensor array to purge the biological sample from the sensor array.

[0114] Example 2 includes the subject matter of any of Examples 1 and 3-32, wherein the at least one analyte comprises at least one electrolyte selected from the group consisting of: sodium; potassium; chloride; magnesium; calcium; bicarbonate; and phosphate.

[0115] Example 3 includes the subject matter of any of Examples 1-2 and 4-32, wherein the at least one analyte comprises at least one metabolite selected from the group consisting of:Atty. Docket No.: NOVA 24.01 PCT

[0116] glucose; blood urea nitrogen; ammonia; creatinine; albumin; bilirubin; alkaline phosphatase; aspartate transaminase; alanine transaminase; cholesterol; uric acid; and lactate.

[0117] Example 4 includes the subject matter of any of Examples 1-3 and 5-32, wherein the sensor array is configured to receive the biological sample, at least in part, via capillary action.

[0118] Example 5 includes the subject matter of any of Examples 1-4 and 6-32, wherein the sensor array is configured to accept a volume of the biological sample in a range of about 0.8-10.0 pL.

[0119] Example 6 includes the subject matter of any of Examples 1-5 and 7-32, wherein the sensor array is configured to accept a volume of the biological sample in a range of about 3.0-8.0 pL ± 1.0 pL.

[0120] Example 7 includes the subject matter of any of Examples 1-6 and 8-32, wherein the sensor array is configured to accept a volume of the biological sample in a range of about 2.8 pL ± 0.8 pL.

[0121] Example 8 includes the subject matter of any of Examples 1-7 and 9-32, wherein the sensor array comprises at least one air detection electrode configured to detect when the sensor array has been filled with the biological sample.

[0122] Example 9 includes the subject matter of any of Examples 1-8 and 10-32, wherein the sensor array is further configured to convey test panel information to the analyzer.

[0123] Example 10 includes the subject matter of any of Examples 1-9 and 11-32, wherein the calibration fluid comprises at least one of an analyte requiring calibration, a preservative, and a colorant.

[0124] Example 11 includes the subject matter of any of Examples 1-10 and 12-32, wherein the at least some of the calibration fluid enters the sample flow path upon being expressed from the blister.

[0125] Example 12 includes the subject matter of any of Examples 1-11 and 13-32, wherein the blister is at least partially disposed within a cavity formed in the cartridge.

[0126] Example 13 includes the subject matter of any of Examples 1-12 and 14-32, wherein the cavity is configured to receive a plunger of the analyzer such that the plunger applies a pressing force to the blister, causing the at least some of the calibration fluid to exit the blister and enter the sensor array.

[0127] Example 14 includes the subject matter of any of Examples 1-13 and 15-32, wherein in receiving the plunger of the analyzer within the cavity, the cartridge is prevented from being removed from the analyzer.Atty. Docket No.: NOVA 24.01 PCT

[0128] Example 15 includes the subject matter of any of Examples 1-14 and 16-32, further comprising a seal which seals the calibration fluid within the blister in a liquid-tight manner.

[0129] Example 16 includes the subject matter of any of Examples 1-15 and 17-32, wherein the seal comprises a metal or alloy.

[0130] Example 17 includes the subject matter of any of Examples 1-16 and 18-32, wherein the seal comprises a polymer.

[0131] Example 18 includes the subject matter of any of Examples 1-17 and 19-32, further comprising a piercing feature configured to pierce the seal to allow the at least a portion of the calibration fluid to be expressed from the blister into the sample flow path.

[0132] Example 19 includes the subject matter of any of Examples 1-18 and 20-32, further comprising a self-sealing vent fluidically connected with the sample flow path.

[0133] Example 20 includes the subject matter of any of the Examples 1-19 and 21-32, wherein in operation of the cartridge, the at least some of the calibration fluid contacts the self-sealing vent to effectuate self-sealing thereof such that gas exits initially and the calibration fluid flows without leaking out through the self-sealing vent.

[0134] Example 21 includes the subject matter of any of the Examples 1-20 and 22-32, wherein at least a portion of the sample flow path has been modified with a treatment.

[0135] Example 22 includes the subject matter of any of the Examples 1-21 and 23-32, further comprising an adjustable cover operatively coupled with a body of the cartridge, wherein the adjustable cover is adjustable to effectuate opening and closing of access to the sensor array within the cartridge.

[0136] Example 23 includes the subject matter of any of the Examples 1-22 and 24-32, further comprising a feature configured to indicate that the adjustable cover is in a closed position in which access to the interior of the body of the cartridge is prevented.

[0137] Example 24 includes the subject matter of any of the Examples 1-23 and 25-32, further comprising at least one retention feature configured to provide resistance against deinterfacing of the cartridge from the analyzer.

[0138] Example 25 includes the subject matter of any of the Examples 1-24 and 26-32, wherein the at least one retention feature provides a retaining force in a range of about 0.5-2.0 Ibf.

[0139] Example 26 includes the subject matter of any of the Examples 1-25 and 27-32, wherein the retaining force is about 1.0 Ibf ± 0.25 Ibf.

[0140] Example 27 includes the subject matter of any of the Examples 1-26 and 28-32, wherein the cartridge is configured for self-containment of waste resulting from usage.Atty. Docket No.: NOVA 24.01 PCT

[0141] Example 28 is a system. The system includes: the cartridge including the subject matter of any of Examples 1-27 and 29-32; and the analyzer.

[0142] Example 29 includes the subject matter of any of Examples 28 and 30-32, wherein the analyzer is a handheld device.

[0143] Example 30 includes the subject matter of any of Examples 28-29 and 31-32, wherein the analyzer comprises a plunger configured to apply a pressing force to the blister and an actuator configured to actuate the plunger.

[0144] Example 31 includes the subject matter of any of Examples 28-30 and 32, wherein the plunger is configured to apply the pressing force to the blister through direct physical contact of the plunger with the blister.

[0145] Example 32 includes the subject matter of any of Examples 28-31, wherein the plunger is configured to apply the pressing force to the blister indirectly through an element that physically intervenes between the plunger and the blister.

[0146] Example 33 includes an analyte testing cartridge configured to be read via an analyzer. The cartridge includes a sensor array configured to detect a level of at least one analyte present in a biological sample. The cartridge further includes a blister containing a calibration fluid. The cartridge further includes a sample flow path fluidically connecting the blister and the sensor array. The cartridge further includes a self-sealing vent fluidically connected with the sample flow path, wherein the self-sealing vent is configured to be gas-permeable during collection of the biological sample and both gas-impermeable and fluid-impermeable during dispensation of the calibration fluid through the sensor array. In operation of the cartridge, at least some of the calibration fluid enters the sample flow path and is delivered to the self-sealing vent to effectuate self-sealing thereof and to the sensor array to purge the biological sample from the sensor array.

[0147] Example 34 includes the subject matter of any of Examples 33 and 35-41, wherein the sensor array is configured to draw the biological sample into the sample flow path, at least in part, via capillary action.

[0148] Example 35 includes the subject matter of any of Examples 33-34 and 36-41, wherein the at least one analyte comprises at least one electrolyte selected from the group consisting of: sodium; potassium; chloride; magnesium; calcium; bicarbonate; and phosphate.

[0149] Example 36 includes the subject matter of any of Examples 33-35 and 37-41, wherein the at least one analyte comprises at least one metabolite selected from the group consisting of: glucose; blood urea nitrogen; ammonia; creatinine; albumin; bilirubin; alkaline phosphatase; aspartate transaminase; alanine transaminase; cholesterol; uric acid; and lactate.Atty. Docket No.: NOVA 24.01 PCT

[0150] Example 37 includes the subject matter of any of Examples 33-36 and 38-41, wherein the blister is at least partially disposed within a cavity formed in the cartridge.

[0151] Example 38 includes the subject matter of any of Examples 33-37 and 39-41, wherein the cavity is configured to receive a plunger of the analyzer such that the at least some of the calibration fluid is expressed from the blister via the plunger and the cartridge is prevented from being removed from the analyzer by the plunger.

[0152] Example 39 includes the subject matter of any of Examples 33-38 and 40-41, wherein the calibration fluid comprises at least one of an analyte requiring calibration, a preservative, and a colorant.

[0153] Example 40 is a system. The system includes: the cartridge including the subject matter of any of Examples 33-39 and 41; and the analyzer.

[0154] Example 41 includes the subject matter of Example 40, wherein the analyzer includes a plunger configured to apply a pressing force to the blister and an actuator configured to actuate the plunger.

[0155] The foregoing description of example embodiments has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the present disclosure not be limited by this detailed description. Future-filed applications claiming priority to this application may claim the disclosed subject matter in a different manner and generally may include any set of one or more limitations as variously disclosed or otherwise demonstrated herein.

Claims

Atty. Docket No.: NOVA 24.01 PCTCLAIMSWhat is claimed is:

1. A cartridge configured for measuring a level of at least one analyte present in a biological sample via an analyzer, the cartridge comprising:a sensor array configured to receive the biological sample and detect the level of the at least one analyte present in the biological sample;a blister containing a calibration fluid; anda sample flow path fluidically connecting the blister and the sensor array; wherein in operation of the cartridge, at least some of the calibration fluid enters the sample flow path and is delivered to the sensor array to purge the biological sample from the sensor array.

2. The cartridge of claim 1, wherein the at least one analyte comprises at least one electrolyte selected from the group consisting of: sodium; potassium; chloride; magnesium; calcium; bicarbonate; and phosphate.

3. The cartridge of claim 1, wherein the at least one analyte comprises at least one metabolite selected from the group consisting of: glucose; blood urea nitrogen; ammonia; creatinine; albumin; bilirubin; alkaline phosphatase; aspartate transaminase; alanine transaminase; cholesterol; uric acid; and lactate.

4. The cartridge of claim 1, wherein the sensor array is configured to receive the biological sample, at least in part, via capillary action.

5. The cartridge of claim 1, wherein the sensor array is configured to accept a volume of the biological sample in a range of about 0.8-10.0 pL.

6. The cartridge of claim 1, wherein the sensor array is configured to accept a volume of the biological sample in a range of about 3.0-8.0 pL ± 1.0 pL.

7. The cartridge of claim 1, wherein the sensor array is configured to accept a volume of the biological sample in a range of about 2.8 pL ± 0.8 pL.Atty. Docket No.: NOVA 24.01 PCT8. The cartridge of claim 1, wherein the sensor array comprises at least one air detection electrode configured to detect when the sensor array has been filled with the biological sample.

9. The cartridge of claim 1, wherein the sensor array is further configured to convey test panel information to the analyzer.

10. The cartridge of claim 1, wherein the calibration fluid comprises at least one of an analyte requiring calibration, a preservative, and a colorant.

11. The cartridge of claim 1, wherein the at least some of the calibration fluid enters the sample flow path upon being expressed from the blister.

12. The cartridge of claim 1, wherein the blister is at least partially disposed within a cavity formed in the cartridge.

13. The cartridge of claim 12, wherein the cavity is configured to receive a plunger of the analyzer such that the plunger applies a pressing force to the blister, causing the at least some of the calibration fluid to exit the blister and enter the sensor array.

14. The cartridge of claim 13, wherein in receiving the plunger of the analyzer within the cavity, the cartridge is prevented from being removed from the analyzer.

15. The cartridge of claim 1, further comprising a seal which seals the calibration fluid within the blister in a liquid-tight manner.

16. The cartridge of claim 15, wherein the seal comprises a metal or alloy.

17. The cartridge of claim 15, wherein the seal comprises a polymer.

18. The cartridge of claim 15, further comprising a piercing feature configured to pierce the seal to allow the at least a portion of the calibration fluid to be expressed from the blister into the sample flow path.Atty. Docket No.: NOVA 24.01 PCT19. The cartridge of claim 1, further comprising a self-sealing vent fluidically connected with the sample flow path.

20. The cartridge of claim 19, wherein in operation of the cartridge, the at least some of the calibration fluid contacts the self-sealing vent to effectuate self-sealing thereof such that gas exits initially and the calibration fluid flows without leaking out through the self-sealing vent.

21. The cartridge of claim 1, wherein at least a portion of the sample flow path has been modified with a treatment.

22. The cartridge of claim 1, further comprising an adjustable cover operatively coupled with a body of the cartridge, wherein the adjustable cover is adjustable to effectuate opening and closing of access to the sensor array within the cartridge.

23. The cartridge of claim 22, further comprising a feature configured to indicate that the adjustable cover is in a closed position in which access to the interior of the body of the cartridge is prevented.

24. The cartridge of claim 1, further comprising at least one retention feature configured to provide resistance against de-interfacing of the cartridge from the analyzer.

25. The cartridge of claim 24, wherein the at least one retention feature provides a retaining force in a range of about 0.5-2.0 Ibf.

26. The cartridge of claim 25, wherein the retaining force is about 1.0 Ibf ± 0.25 Ibf.

27. The cartridge of claim 1, wherein the cartridge is configured for selfcontainment of waste resulting from usage.

28. A system comprising:the cartridge of any of claims 1-27; andAtty. Docket No.: NOVA 24.01 PCTthe analyzer.

29. The system of claim 28, wherein the analyzer is a handheld device.

30. The system of claim 28, wherein the analyzer comprises:a plunger configured to apply a pressing force to the blister; andan actuator configured to actuate the plunger.

31. The system of claim 30, wherein the plunger is configured to apply the pressing force to the blister through direct physical contact of the plunger with the blister.

32. The system of claim 30, wherein the plunger is configured to apply the pressing force to the blister indirectly through an element that physically intervenes between the plunger and the blister.

33. An analyte testing cartridge configured to be read via an analyzer, the cartridge comprising:a sensor array configured to detect a level of at least one analyte present in a biological sample;a blister containing a calibration fluid;a sample flow path fluidically connecting the blister and the sensor array; and a self-sealing vent fluidically connected with the sample flow path, wherein the selfsealing vent is configured to be:gas-permeable during collection of the biological sample; andboth gas-impermeable and fluid-impermeable during dispensation of the calibration fluid through the sensor array;wherein in operation of the cartridge, at least some of the calibration fluid enters the sample flow path and is delivered to the self-sealing vent to effectuate selfsealing thereof and to the sensor array to purge the biological sample from the sensor array.

34. The cartridge of claim 33, wherein the sensor array is configured to draw the biological sample into the sample flow path, at least in part, via capillary action.Atty. Docket No.: NOVA 24.01 PCT35. The cartridge of claim 33, wherein the at least one analyte comprises at least one electrolyte selected from the group consisting of: sodium; potassium; chloride; magnesium; calcium; bicarbonate; and phosphate.

36. The cartridge of claim 33, wherein the at least one analyte comprises at least one metabolite selected from the group consisting of: glucose; blood urea nitrogen; ammonia; creatinine; albumin; bilirubin; alkaline phosphatase; aspartate transaminase; alanine transaminase; cholesterol; uric acid; and lactate.

37. The cartridge of claim 33, wherein the blister is at least partially disposed within a cavity formed in the cartridge.

38. The cartridge of claim 37, wherein the cavity is configured to receive a plunger of the analyzer such that:the at least some of the calibration fluid is expressed from the blister via the plunger;andthe cartridge is prevented from being removed from the analyzer by the plunger.

39. The cartridge of claim 33, wherein the calibration fluid comprises at least one of an analyte requiring calibration, a preservative, and a colorant.

40. A system comprising:the cartridge of any of claims 33-39; andthe analyzer.

41. The system of claim 40, wherein the analyzer comprises:a plunger configured to apply a pressing force to the blister; andan actuator configured to actuate the plunger.

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