Test consumables that maintain sample integrity for use in diagnostic sample analyzers

Abstract

In some embodiments, a test consumable for use in a diagnostic sample analyzer includes an inlet configured to receive a sample; a sample storage area coupled to the inlet and configured to receive and store a sample input to the test consumable; a barrier layer positioned over at least a portion of the sample storage area and configured to reduce gas exchange between any sample stored within the sample storage area and the test consumable; a sample passageway extending from the sample storage area; and one or more sensors each configured to contact the sample along the sample passageway and generate a signal representative of a property of the sample. Numerous other aspects are provided.

Description

TEST CONSUMABLES THAT MAINTAIN SAMPLE INTEGRITY FOR USE IN DIAGNOSTIC SAMPLE ANALYZERS

[0001] This application claims benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 675,827, filed July 26, 2024 and U.S. Provisional Application No. 63 / 675,844, filed July 26, 2024. The entire contents of the above- referenced patent applications are hereby expressly incorporated herein by reference. FIELD

[0002] This disclosure relates to diagnostic sample analyzers and test consumables for use therein to measure one or more fluid properties in a sample. BACKGROUND

[0003] A test consumable is a device that includes one or more sensors (e.g., a sensor panel) for measuring one or more fluid properties (e.g., physical parameters and / or chemical constituents) in a liquid sample. The test consumable is configured to receive a small volume of a sample and to be inserted into a diagnostic sample analyzer for analysis of the sample. The sample may be a biological sample or a non- biological aqueous solution. The biological sample may be, e.g., whole blood, blood serum, blood plasma, saliva, urine, cerebrospinal fluid, interstitial fluid, pleural fluid, dialysate fluid, and the like. The diagnostic sample analyzer with an inserted test consumable therein may measure, e.g., pH, partial pressure of one or more gases (e.g., oxygen, carbon dioxide, etc.), electrolyte concentrations (e.g., sodium, potassium, calcium, etc.), and / or other analyte concentrations(e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, hematocrit, etc.).

[0004] Some known test consumables and diagnostic sample analyzers require extended user interactions that decrease laboratory efficiency. For example, some known diagnostic sample analyzers require a user to first insert the test consumable into the diagnostic sample analyzer and then wait several minutes while the diagnostic sample analyzer performs (1) initial (diagnostic) tests and (2) calibration of the test consumable sensor(s) before prompting the user to apply a liquid sample to the test consumable. Other known diagnostic sample analyzers require the user to first apply a liquid sample to the test consumable before inserting the test consumable into the diagnostic sample analyzer. However, should initial tests performed thereafter by the diagnostic sample analyzer indicate an error that renders the test consumable unusable, the liquid sample already applied to the test consumable would be wasted. Also, should the user excessively delay inserting the test consumable into the diagnostic sample analyzer after applying the liquid sample, one or more fluid properties of the sample may change, compromising the test results.

[0005] Accordingly, improved diagnostic sample analyzers, test consumables, and methods of use thereof are desired. SUMMARY

[0006] In one general aspect, a test consumable for use in a diagnostic sample analyzer is provided that may include an inlet configured to receive a sample. The test consumable may also include a sample storage area coupled to the inlet and configured to receive and store a sample input to the test consumable through the inlet. The test consumable mayfurthermore include a barrier layer positioned over at least a portion of the sample storage area, the barrier layer configured to reduce gas exchange between any sample stored within the sample storage area and the test consumable. The test consumable may in addition include a sample passageway extending from the sample storage area. The test consumable may moreover include one or more sensors, each sensor configured to contact the sample along the sample passageway and generate a signal representative of a property of the sample.

[0007] In one general aspect, a diagnostic sample analyzer may include a test consumable reader configured to receive a test consumable. The diagnostic sample analyzer may also include a pump and an input / output device. The diagnostic analyzer may in addition include a processor coupled to the test consumable reader, the pump, and the input / output device. The diagnostic sample analyzer may moreover include a non- transitory memory coupled to the processor, the non-transitory memory including computer program instructions that when executed by the processor cause the processor to: execute initial tests related to functionality of the test consumable and the pump in response to receiving the test consumable in the test consumable reader, the test consumable including at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of a liquid sample; prompt a user via the input / output device to apply the liquid sample to the test consumable in response to completion of the initial tests indicating no errors; calibrate the at least one sensor in response to the completion of at least one of the initial tests indicating no errors; activate the pump to transfer the liquid sample applied to the test consumable to the at least one sensor in response to completion of sensor calibration; generate an electrical signal with the at leastone sensor in response to the liquid sample contacting the at least one sensor; determine a residence time of the liquid sample within the test consumable; determine the value of the fluid property based on the generated electrical signal received at the test consumable reader from the at least one sensor and the residence time of the liquid sample within the test consumable; and communicate the value of the fluid property via the input / output device.

[0008] In one general aspect, a method may include receiving a test consumable in a diagnostic sample analyzer, the test consumable including at least one sensor; executing initial tests related to functionality of at least the test consumable via a processor of the diagnostic sample analyzer; prompting a user via an input / output device of the diagnostic sample analyzer to apply a liquid sample to the test consumable in response to completion of the initial tests indicating no errors; storing the liquid sample in a sample storage area of the test consumable; calibrating the at least one sensor via the processor in response to the completion of at least one of the initial tests indicating no errors; transferring the liquid sample applied to the test consumable from the sample storage area of the test consumable to the at least one sensor in response to completion of sensor calibration; generating an electrical signal with the at least one sensor in response to the liquid sample contacting the at least one sensor; determining a residence time of the liquid sample within the test consumable; determining a value of a fluid property of the liquid sample based on the generated electrical signal from the at least one sensor and the residence time of the liquid sample within the test consumable; and communicating the value of the fluid property via the input / output device. Other embodiments of this aspect include corresponding computer systems, apparatus, andcomputer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0009] Other features and aspects of the present invention will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings.

[0010] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions. BRIEF DESCRIPTION OF DRAWINGS

[0011] The drawings described below are provided for illustrative purposes and are not necessarily drawn to scale. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The drawings are not intended to limit the scope of the invention in any way.

[0012] FIG. 1 illustrates a perspective view of a diagnostic sample analyzer configured to receive a test consumable for performing a diagnostic sample analysis according to one or more embodiments provided herein.

[0013] FIG. 2 illustrates a plan view layout of a test consumable for use in a diagnostic sample analyzer according to embodiments provided herein.

[0014] FIG. 3 illustrates an enlarged plan view layout of a portion of the test consumable of FIG. 2 according to embodiments provided herein.

[0015] FIG. 4 illustrates a flowchart of a method of operating a diagnostic sample analyzer according to embodiments provided herein.

[0016] FIG. 5 illustrates a block diagram of an example embodiment of the diagnostic sample analyzer of FIG. 1 according to one or more embodiments provided herein.

[0017] FIGS. 6A-6B illustrate a flowchart of a method of operating a diagnostic sample analyzer that accounts for sample residence time within a test consumable according to embodiments provided herein. DETAILED DESCRIPTION

[0018] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.

[0019] As stated above, some test consumable and diagnostic sample analyzers may require extended user interactions during initial (diagnostic) tests and calibration of test consumable sensor(s), preventing laboratory staff from performing other lab functions. Other test consumable and diagnostic sample analyzers that require a liquid sample to be applied to a test consumable before insertion into the diagnostic sample analyzer may result in the liquid sample being wasted should, e.g., the test consumable fail one or more of the initial tests. Also, if a notable delay occurs between applying the liquid sample to the test consumable and inserting the test consumable into the analyzer, fluid properties of the liquid sample may change, compromising sample analysis results. Furthermore, upon application of the liquid sample to the test consumable in known diagnostic sample analyzers, the volumeand flow of the liquid sample from the sample inlet of the test consumable to the sensor(s) of the test consumable may be uncontrolled and thus variable, which may adversely affect the sample analysis results.

[0020] Embodiments provided herein overcome the above disadvantages by providing an improved sample application process, test consumable, and diagnostic sample analyzer. The improved sample application process includes receiving a test consumable in a diagnostic sample analyzer, quickly performing initial tests (e.g., 25-35 seconds or less), and prompting a user to apply a liquid sample to the inserted test consumable in response to successful completion of the initial tests. After applying the sample, a user is free to perform other laboratory tasks while the diagnostic sample analyzer performs the more time-consuming sensor calibration. After sensor calibration and detection of the applied liquid sample in the test consumable, sample analysis is performed by the diagnostic sample analyzer without further user involvement.

[0021] Advantageously, the improved sample application process performed by the diagnostic sample analyzer reduces user interaction therewith. The user no longer has to wait for sensor calibration to complete, which may be several minutes, before applying the liquid sample to the test consumable. This process also avoids wasting the liquid sample should the initial tests indicate a faulty test consumable as in those analyzers that require the user to first apply the liquid sample before inserting the test consumable into the diagnostic sample analyzer. The improved process will notify the user of a faulty test consumable and will not prompt the user to apply the liquid sample to the test consumable. Furthermore, the time between applying the liquid sample to the test consumable and testing of the sample is known (e.g., at most the sensor calibration time), thuspreventing excessive and uncontrolled change in fluid properties of the liquid sample caused by excessive delay between applying the liquid sample to the test consumable and sample testing. This process is thus more efficient and time saving for the user, particularly in a point of care or emergency setting.

[0022] A test consumable according to one or more embodiments has one or more sensors (e.g., a sensor panel) for measuring one or more fluid properties in a liquid sample. The test consumable also has a sample storage area for receiving and holding the liquid sample. An outlet of the storage area is coupled to a sample passageway having a flow configuration that advantageously prevents the liquid sample in the sample storage area from flowing uncontrolled out of the sample storage area to the sensor(s) of the test consumable. After calibration of the sensor(s) by the diagnostic sample analyzer and detection of the liquid sample in the sample storage area, a pump of the diagnostic sample analyzer coupled to the test consumable automatically draws the liquid sample from the sample storage area to the sensor(s). The pump provides uniform / consistent speed and volume flow of the liquid sample to the sensor(s), which may improve the accuracy and reliability of the sample analysis results.

[0023] Additionally, because the sample storage area is positioned in the test consumable to directly receive the liquid sample from the sample inlet of the test consumable and hold the sample therein for a predetermined period of time (e.g., the time to perform the sensor calibration) before it is drawn to the sensor(s), a user does not need to be concerned about the precise speed and volume of the liquid sample being applied (e.g., by an injection or pump device) to the sample inlet of the test consumable by the user providedthe liquid sample is not applied with excessive force or insufficient sample volume. As such, sample application is easier for the user and the subsequent controlled automatic transfer of the liquid sample from the sample storage area to the sensor(s) reduces analytical errors in the test results and improves predictability of the test results.

[0024] A test consumable may have any suitable shape or size such as rectangular, square, card-shaped, cartridge- shaped, or some other test consumable configuration. Typical test consumables may be manufactured out of a thermoplastic polyester such as polyethylene terephthalate glycol (PETG) or the like. Such materials are well suited for molding complex shapes, have a high level of transparency, are inexpensive, and are chemically resistant. However, PETG is oxygen permeable, particularly in the thicknesses used for test consumables, as are the adhesives labels employed by test consumables.

[0025] In embodiments provided herein, a liquid sample may be stored within a sample storage area of a test consumable until sensor calibration is complete. Because the sample storage area for receiving and holding the sample within the test consumable has a large surface area to volume ratio, the gas levels within the sample are more susceptible to change during storage due to the gas permeability of the test consumable (e.g., as both PETG and any adhesive label employed may be gas permeable). Additionally, during sample storage, chemicals from label adhesives employed on a test consumable may diffuse into and change the properties of the stored sample. Additionally, gas exchange may occur between the stored sample and the environment external to the test consumable (e.g., through both the material that forms the sample storage area, such as PETG, and any adhesive label of the test consumable).

[0026] To overcome the above issue, in some embodiments provided herein, a barrier layer is positioned over at least a portion of the sample storage area of a test consumable. For example, in some embodiments, the sample storage area may be formed from a thermoplastic polyester and the barrier layer may be placed over the thermoplastic polyester before any adhesive layer is applied. The barrier layer is configured to reduce gas exchange between any sample stored within the sample storage area and test consumable materials (e.g., to prevent chemicals from the test consumable, such as chemicals associated with adhesive labels, from entering the stored sample) as well as to reduce gas exchange between the stored sample and the external environment. In one or more embodiments, the barrier layer may be formed from a thermoplastic polymer such as polyethylene terephthalate, although other materials may be used. In some embodiments, the barrier layer may define / line the sample storage area to isolate any sample stored therein from both (or either) the thermoplastic polyester of the test consumable and any adhesive label attached thereto.

[0027] In one or more embodiments, the barrier layer may be formed of a material configured to minimize interference with optical measurements used to, for example, detect sample movement and location, such as a transparent or semi- transparent thermoplastic polymer material, although other transparent or semi-transparent materials may be used.

[0028] Use of a barrier layer over the sample storage area reduces gas exchange (e.g., oxygen loss) between any sample in the sample storage area of the test consumable and the test consumable and reduces migration of chemicals (e.g., from adhesive labels attached to the test consumable) into the sample, which preserves sample integrity and improves accuracy of test results. Use of an inexpensive thermoplastic polymeror similar material for the barrier layer provides a cost- effective solution when a sample is stored within a test consumable during sensor calibration.

[0029] Further, in embodiments where the barrier layer is formed of a transparent or semi-transparent thermoplastic polymer or similar material, the barrier layer provides a further advantage of reducing gas exchange without causing interference with optical measurements of the sample stored in the sample storage area, thereby further preserving sample integrity and accuracy of test results.

[0030] These and other embodiments are described herein with reference to FIGS. 1-6B.

[0031] FIG. 1 illustrates a diagnostic sample analyzer 100 according to one or more embodiments. Diagnostic sample analyzer 100 may be a hand-held device and may be battery powered. Diagnostic sample analyzer 100 includes an analyzer body 102 configured to house various electronics (e.g., a barcode reader, wireless transmitter circuitry, signal processing circuitry, etc.). Analyzer body 102 is configured to also house various user interfaces such as user-controlled haptics (e.g., buttons, switches, touch screens, and the like). In the depicted embodiment, analyzer body 102 may comprise a computing device 104. Computing device 104 may be fixedly coupled to the analyzer body 102. Alternatively, computing device 104 may be, in some embodiments, detachably mounted to a device mount 102M of a base 102B of diagnostic sample analyzer 100. Computing device 104 may be a hand-held computing device, such as, e.g., a personal digital assistant (PDA), tablet, or other like computing device. In some diagnostic sample analyzers, the processing and memory functions of computing device 104 may be housed inside of analyzer body 102 rather than as a separable / detachable version of computing device 104.

[0032] Diagnostic sample analyzer 100 also includes a controller 105, which in this embodiment is configured to include a first controller 105C1, which may be part of base 102B of analyzer body 102, and a second controller 105C2, which may be part of, or integral with, computing device 104. First controller 105C1 and second controller 105C2 are in electronic communication with one another and may perform different functions. In other embodiments, controller 105 may be a single device located in either analyzer body 102 or computing device 104. In still other embodiments, diagnostic sample analyzer 100 may have one or more controllers that may be located anywhere in the analyzer.

[0033] In this embodiment, computing device 104 may include a display 104D enabling user input and visual display of operational information, test results, and other information. In some embodiments, display 104D may be tiltable about a pivot axis 102A. For example, the device mount 102M of base 102B may receive the computing device 104 and may be pivotable about pivot axis 102A at a location 102L so as to allow adjustment of the viewing angle. Display 104D may be a touch screen having a user interface that allows a user, in conjunction with one or more haptics (e.g., button, switches, or other user-controlled devices), to control operation of diagnostic sample analyzer 100, observe measurement results from sample testing therein, and / or perform other ancillary functions.

[0034] First controller 105C1 (or alternatively another controller in diagnostic sample analyzer 100) may include electronics for communicating with one or more sensors 103 embodied in a test consumable 106. The first controller electronics also may perform signal conditioning (including, e.g., filtering, A / D conversion, and / or amplification) of sensor signals received from sensor(s) 103. In someembodiments, sensor(s) 103 may include a potentiometric sensor, an amperometric sensor, and / or a conductometric sensor, and first controller 105C1 may further include electronics for processing amperometric, potentiometric, and / or conductometric signals received from sensor(s) 103.

[0035] In some embodiments, diagnostic sample analyzer 100 may be, e.g., a blood analyzer and second controller 105C2 may be operable to determine, e.g., pH, partial pressure of one or more gases (e.g., oxygen, carbon dioxide, etc.), electrolyte concentrations (e.g., sodium, potassium, calcium, etc.), and / or other analyte concentrations (e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, hematocrit, etc.). Software executable on a processor in second controller 105C2 (or alternatively another controller in diagnostic sample analyzer 100) for determining a fluid property in a blood sample may be stored in a non-transitory memory (not shown) of diagnostic sample analyzer 100 (see, processor 546 and memory 548 of FIG. 5, for example). Sensor signals (indicative of measured values) received from, e.g., one or more sensors 103 may be processed by second controller 105C2 (or alternatively another controller in diagnostic sample analyzer 100) to detect an oxygen level contained in a blood sample applied to test consumable 106. Electrical signals from any additional or alternative sensors 103 for measuring other fluid properties of a liquid sample may alternatively or additionally be received and processed by second controller 105C2 (or alternatively another controller in diagnostic sample analyzer 100) executing appropriate software alternatively or additionally stored in a non-transitory memory of diagnostic sample analyzer 100. In other embodiments, the aforementioned functions performed by second controller 105C2 may be performed by first controller 105C1 and vice versa and / or by one or more other controllers in diagnostic sample analyzer100. In some embodiments, test results and other information may be transmitted to a hospital information system (HIS) 101.

[0036] Diagnostic sample analyzer 100 also includes a test consumable reader 102R, which may include a port or opening having a suitable coupling feature (e.g., electrical connectors) configured to receive and couple to corresponding electrical contacts on test consumable 106. Upon insertion of test consumable 106 into test consumable reader 102R, test consumable sensor(s) 103 are electrically connected to controller 105 (or first controller 105C1 and / or second controller 105C2) to process sensor signals. As shown, test consumable reader 102R may comprise a slot that is sized to receive test consumable 106 therein. In one or more embodiments, test consumable 106 may resemble a playing card in view of its thin profile as compared to its width and length. In some embodiments, test consumable 106 may have a card-shape having a length of about 85 mm, a width of about 55 mm, and a thickness of about 1.2 mm. In other embodiments, test consumable 106 may have a cartridge or other shape with other length, width, and / or thickness dimensions. More generally, test consumable 106 may be any suitable shape or size configured to be received in a correspondingly constructed test consumable reader 102R.

[0037] As shown in FIG. 1, test consumable 106 includes one or more sensors 103 enclosed within test consumable body 107. Sensor(s) 103 may comprise a panel of sensors operative to test for multiple conditions or analytes, such as, e.g., glucose, BUN (blood urea nitrogen), creatine, hematocrit, etc. Sensor(s) 103 to test for other fluid properties may additionally or alternatively be included. Note that operation of sensor(s) 103 and the subsequent processing of electrical signals generated by sensor(s) 103 to determine a value of one or more fluid properties of a liquid sample areknown to persons of skill in the art and will not be described in more detail herein.

[0038] Test consumable 106 also includes a sample inlet 108, which may be a port, opening, receiving element, or the like, configured to receive a sample 109 to be tested therein. Sample inlet 108 may be provided on a top layer 107T of test consumable body 107. Sample inlet 108 may comprise a circular or otherwise shaped opening providing a port configured to receive sample 109 therein. Sample 109 may be, e.g., whole blood, blood serum, blood plasma, saliva, urine, cerebrospinal fluid, interstitial fluid, pleural fluid, dialysate fluid, and the like, depending on the type of diagnostic sample analyzer and type or types of sensor(s) 103 included in test consumable 106. Sample inlet 108 may be configured to allow sample 109 to be dispensed therein or thereon by any suitable sample holder or sample transfer device. For example, in one embodiment, sample inlet 108 may be configured to allow a syringe, a capillary tube, a suitable pump, or another transfer device to be sealingly coupled to sample inlet 108 to provide sample 109 therein. In some embodiments, sample inlet 108 may have a width or diameter dimension of about 4 mm to about 8 mm, although other width or diameter dimensions and / or shapes may be used. Sample inlet 108 is coupled via one or more sample passageways (not shown in FIG. 1) to sensor(s) 103.

[0039] Test consumable body 107 may be made of multiple layers of material adhered together to form therein the one or more sample passageways. The materials used may include one or more different types of plastic (including, e.g., polypropylene), paper, foil, and / or laminates. In some embodiments, top layer 107T and / or a bottom layer (not shown) may be a clear (transparent or translucent) material so the flow of sample 109 therethrough may be visually observedand / or optically detected. In those embodiments, diagnostic sample analyzer 100 may further include, e.g., one or more optical sensors (e.g., optical sensors 538 in FIG. 5) for detecting fluid presence and / or flow in and / or through the one or more sample passageways in test consumable 106.

[0040] FIG. 2 illustrates a test consumable 206 for use in diagnostic sample analyzer 100 according to one or more embodiments. Test consumable 206 is an embodiment of test consumable 106 and includes the same or similar features as test consumable 106 unless described otherwise herein. Test consumable 206 includes a sample inlet 208, a sample storage area 210, a sample storage area outlet 211, a sample passageway 214, a sensor channel 216, and a sensor module 203. Sample inlet 208 is configured to receive a liquid sample from a user. In some embodiments, sample inlet 208 may be configured to allow a syringe, a capillary tube, a suitable pump, or another transfer device to be sealingly coupled thereto to provide the liquid sample to test consumable 206, and may be accessible on top side 206T of test consumable 206.

[0041] Sample inlet 208 is coupled to sample storage area 210, which is configured to receive and hold a liquid sample therein. Sample storage area 210 may have a vent hole 210H as shown in FIG. 2 to allow air to escape as a liquid sample is injected into inlet 208. In some embodiments, sample storage area 210 is configured to hold up to about 170 µL or more of a liquid sample. Sample storage area 210 may be configured as a C-shaped channel, chamber, or conduit having a total length ranging from about 56 mm to 66 mm, a width ranging from about 1.0 mm to 4.5 mm, and a depth ranging from about 0.2 mm to 0.75 mm (in this embodiment, the cross section is rectangular). Other configurations, cross-sectional shapes, and / or dimensions are possible provided the resulting volume is sufficient to receive and hold the amount of liquid sampleprovided (e.g., as indicated by instructions printed on or accompanying test consumable 206).

[0042] Outlet 211 is coupled to sample passageway 214, which is coupled to a first end 215 of sensor channel 216. Sensor channel 216 extends over (as viewed in FIG. 2) sensor module 203 and allows a liquid sample to contact one or more sensor(s) 217 through the open bottom of sensor channel 216 (i.e., sensor module 203 forms the bottom of sensor channel 216). Sensor(s) 217 (four labeled in FIG. 2) may be printed into respective wells in sensor module 203. The flow configuration of sample passageway 214 coupled to outlet 211 prevents a liquid sample held in sample storage area 210 from flowing uncontrolled to sensor module 203, as better shown in FIG. 3.

[0043] FIG. 3 illustrates an enlarged portion 300 of test consumable 206 that includes outlet 211 coupled to a first portion 312 of sample passageway 214 followed by first portion 312 coupled at elbow joint 314E to a second portion 313 of sample passageway 214 according to one or more embodiments. As shown, flow F1 represents the direction of flow a liquid sample follows from sample inlet 208 to sample storage area 210. A flow configuration of sample passageway 214, which includes the two large angle flow changes from outlet 211 into first portion 312 and from first portion 312 into second portion 313, along with first portion 312 having a small width W1 compared to the larger width W2 of sample storage area 210, and a first portion 312 having a decreasing depth from outlet 211 to elbow joint 314E, prevents the liquid sample from flowing uncontrolled out of sample storage area 210 to sensor module 203 via outlet 211, sample passageway 214, and sensor channel 216. In some embodiments, angles A1 and A2 may each range from about 120 degrees to 150 degrees, and small width W1 may range from about 0.3 mm to 0.5 mm, which is about 10%to 20% of width W2. The depth of first portion 312 may decrease from about 0.6 mm at outlet 211 to about 0.2 mm at elbow joint 314E. Second portion 313 of sample passageway 214, which extends from first portion 312 to sensor channel 216, may have a cross-sectional area ranging initially from 0.25 mm2at elbow joint 314E to 0.75 mm2in sample passageway 214 as the depth increases. Angles A1 and A2, widths W1 and W2, and / or cross-sectional area / depths may have other dimensions.

[0044] Returning to FIG. 2, sensor module 203 may be integrally formed or embodied within test consumable 206. Sensor module 203 may include electrical contacts (not shown in FIG. 2) configured to electrically couple to corresponding electrical connectors of diagnostic sample analyzer 100 upon insertion of test consumable 206 into test consumable reader 102R (see description below regarding FIG. 5). The electrical contacts are configured to transmit electrical signals (e.g., voltage, current, or conductivity) representing fluid property values measured by sensor(s) 217. Sensor(s) 217 may be a single sensor configured to test for a single fluid property in a liquid sample, or sensor(s) 217 may be a panel of sensors configured to test for multiple fluid properties in a liquid sample. For example, sensor(s) 217 may test for any one or more of pH, partial pressure of one or more gases (e.g., oxygen, carbon dioxide, etc.), electrolyte concentrations (e.g., sodium, potassium, calcium, etc.), and / or other analyte concentrations (e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, hematocrit, etc.). Other fluid properties may be tested by sensor(s) 217 in other embodiments.

[0045] Test consumable 206 further includes a vacuum port 220. Vacuum port 220 is coupled to a second end 219 of sensor channel 216 via a waste passageway 224. Vacuum port 220 is configured to connect to a vacuum pump (e.g., vacuum pump 540in FIG. 5) of diagnostic sample analyzer 100 to draw a liquid sample from sample storage area 210 into contact with sensor module 203 via outlet 211, sample passageway 214, and sensor channel 216. In some embodiments, vacuum port 220 may be connectable to a vacuum pump on the bottom side (not shown) of test consumable 206. In some embodiments, a vacuum pump of diagnostic analyzer 100 may be, e.g., a peristaltic pump, a diaphragm pump, or a piezoelectric pump having a pressure range of 0 to 200 mbar gauge pressure. Other vacuum pump types and / or pressure ranges may be employed. In still other embodiments, a positive pressure pump may be connected to vent hole 210H to drive a liquid sample from sample storage area 210 into contact with sensor module 203 (using vacuum port 220 as a vent hole).

[0046] Test consumable 206 also includes a calibration fluid pack 226, a valve 228, and a bubble trap 230. Calibration fluid pack 226 is coupled to first end 215 of sensor channel 216 and contains a calibration fluid used to calibrate sensor(s) 217. In some embodiments, calibration fluid pack 226 may be formed with two layers of foil that are heat-sealed together. Valve 228 and bubble trap 230 are coupled between calibration fluid pack 226 and first end 215 of sensor channel 216. Valve 228 holds the calibration fluid in calibration fluid pack 226 until sensor calibration is performed, at which time a mechanism in diagnostic sample analyzer 100, which may be, e.g., a plunger and push-pin mechanism, opens valve 228 to deliver calibration fluid to sensor module 203 via sensor channel 216. Bubble trap 230 is configured to collect air pockets from calibration fluid pack 226 to prevent them from entering sensor channel 216.

[0047] Waste passageway 224 is configured (e.g., sized) to hold the calibration fluid after completion of sensor calibration. Upon activation of the vacuum pump (e.g., vacuumpump 540 of FIG. 5) of diagnostic sample analyzer 100, calibration fluid in sensor channel 216 is drawn into waste passageway 224 as the liquid sample in sample storage area 210 is drawn through outlet 211 and sample passageway 214 into sensor channel 216. In some embodiments, the vacuum pump is deactivated in response to signals from an optical sensor (e.g., optical sensor 538 of FIG. 5) in diagnostic sample analyzer 100 directed at sensor channel 216 indicating that the liquid sample has sufficiently filled sensor channel 216.

[0048] In some embodiments, the test consumable 106 or 206 may be manufactured out of a thermoplastic polyester such as polyethylene terephthalate glycol (PETG) or the like. Such materials are well suited for molding complex shapes, have a high level of transparency, are inexpensive, and are chemically resistant. However, PETG is oxygen permeable, particularly in the thicknesses used for test consumables (e.g., about 1.1-1.2 mm), as are the adhesives labels employed by the test consumables.

[0049] As described further below, in embodiments provided herein, a liquid sample may be stored within the sample storage area 210 of test consumable 206 until sensor calibration is complete. Because of the gas permeability of the materials used for test consumable 206 and large surface area to volume ratio of the sample storage area 210, the gas levels within any liquid sample stored within the sample storage area 210 may change during storage (e.g., during sensor calibration). Additionally, chemicals from any adhesive layers employed on test consumable 206, such as adhesive labels, may migrate into and change the properties of any liquid sample stored within sample storage area 210.

[0050] To overcome the above issue, in some embodiments provided herein, a barrier layer 232 may be positioned over at least a portion of sample storage area 210 (e.g., over thethermoplastic layer used to form the sample storage area and / or between the thermoplastic layer and any adhesive layer employed). Barrier layer 232 is configured to reduce gas exchange between any sample stored within sample storage area 210 and test consumable 206 including migration of chemicals from adhesive layers of test consumable 206 into any sample stored within sample storage area 210. In one or more embodiments, barrier layer 232 may be formed from a thermoplastic polymer such as polyethylene terephthalate, although other materials may be used.

[0051] Use of barrier layer 232 over the sample storage area reduces gas exchange (e.g., oxygen loss) between any sample in sample storage area 210 and test consumable 206 including diffusion of adhesive chemicals into the sample, which preserves sample integrity and improves accuracy of test results. Thus, use of an inexpensive thermoplastic polymer (e.g., polyethylene terephthalate or another suitable material) for barrier layer 232 provides a cost-effective solution when a sample is stored within a test consumable during sensor calibration.

[0052] In some embodiments, the sample storage area 210 may be lined with a barrier layer material to reduce gas exchange with the other materials of the test consumable 206 (e.g., the thermoplastic polyester or other material used to form the main body of the test consumable 206, adhesive layers formed thereon, etc.).

[0053] In some embodiments, barrier layer 232 may be an approximately 1-2 mil polyester film, although other thicknesses may be used. Further, barrier layer 232 may be, in some embodiments, a heat seal material that may be heat sealed to a surface of the test consumable 206. An example heat seal process for attaching barrier layer 232 may include annealing test consumable 206 and barrier layer 232 for approximately100 to 250 milliseconds at a temperature of about 170 to 250°C and a pressure of about 4.5 to 8.0 Bar. Other heat seal times, temperatures, and / or pressures may be used.

[0054] In some embodiments, barrier layer 232 may be formed of a material that does not significantly interfere with obtaining accurate optical measurements of the sample stored in the sample storage area 210. Thus, for example, a transparent, semi-transparent, translucent, or semi- translucent material may be used for barrier layer 232, such as any typical amorphous or semicrystalline thermoplastic polymer material.

[0055] Barrier layer 232 may cover all or a portion of test consumable 206. In some embodiments, barrier layer 232 only covers the portion of sample storage area 210 that will contain a sample to be transferred to sensor module 203 during testing with diagnostic sample analyzer 100. In some embodiments, barrier layer 232 may cover approximately 50%-75% of sample storage area 210. Example barrier layer sizes may range from about 21-23 mm by 27-29 mm, dependent upon how much of sample storage area 210 is filled during liquid sample storage. Other percentages of sample storage area 210 may be covered and / or other size barrier layers may be employed.

[0056] In one or more embodiments, test consumable 206 may include an adhesive label 234 (shown as a dashed line). In some embodiments, adhesive label 234 may extend over substantially all of test consumable 206 (e.g., including over at least a portion of barrier layer 232). One or more portions of adhesive label 234 may be colored or otherwise labeled to highlight the location of inlet 208, to indicate a direction of insertion for test consumable 206, or the like. For example, dashed triangle 234C may have a color (e.g., blue, green, red, etc.) to indicate the location of inlet 208 and / ora shape to indicate the direction test consumable 206 should be inserted into diagnostic sample analyzer 100. Any suitable adhesive label may be used such as a 1-2 mil polypropylene film or the like. Other adhesive materials and / or thicknesses may be used. In some embodiments, if the barrier layer 232 extends over a substantial portion of test consumable portion 206, the barrier layer 232 may be labeled with indicators and the adhesive layer 234 may be eliminated.

[0057] FIG. 4 illustrates an example method 400 of operating a diagnostic sample analyzer according to one or more embodiments. The diagnostic sample analyzer may be, e.g., diagnostic sample analyzer 100 (FIG. 1 and FIG. 5). At process block 402, method 400 may include receiving a test consumable in the diagnostic sample analyzer, the test consumable including at least one sensor. Referring to FIGS. 1 and 2, the test consumable may be, e.g., test consumable 106 or 206, which includes one or more sensors 103 or sensor module 203, respectively.

[0058] At process block 404, method 400 may include executing initial tests related to the functionality of at least the test consumable via a processor of the diagnostic sample analyzer. Initial tests related to the functionality of at least the test consumable may include, e.g., a card validation check (via, e.g., a barcode scanner in test consumable reader 102R) to ensure that the test consumable (including, e.g., the calibration fluid and sensor(s) therein) has not expired and / or a dry card check to ensure that the test consumable has not been previously used, and / or a calibration fluid check to ensure a sufficient volume of calibration fluid is delivered to sensor(s) 217. The calibration fluid check may be performed, e.g., by directing, e.g., a plunger and push-pin mechanism to open valve 228 (FIG. 2) to deliver calibration fluid to sensor(s) 217 via sensorchannel 216, wherein one or more (e.g., optical) sensors are operative to detect that a sufficient volume of calibration fluid has been delivered to sensor(s) 217. Optional additional initial tests may include a vacuum check to ensure that the vacuum pump in the diagnostic sample analyzer is working and / or a heater check to ensure that a heater in the diagnostic sample analyzer is working (see, for example, vacuum pump 540 and heater 542 in FIG. 5). Other optional initial tests may include optical sensor checks, temperature sensor checks, accelerometer checks, or the like. The initial tests may be performed quickly (e.g., 25-35 seconds or less), and are separate from and do not include calibration which may require a longer time delay of several minutes (e.g., at least 2-3 minutes). The initial tests may be executed via a processor of controller 105, first controller 105C1 or second controller 105C2 (e.g., processor 546 of FIG. 5), or one or more other controllers of diagnostic sample analyzer 100 executing appropriate software stored in a non-transitory memory of diagnostic sample analyzer 100 (see, processor 546 and memory 548 of FIG. 5, for example).

[0059] At process block 406, method 400 may include prompting a user via an input / output device of the diagnostic sample analyzer to apply a liquid sample to the test consumable in response to completion of the initial tests indicating no errors. For example, the input / output device may be display 104D of computing device 104 of diagnostic sample analyzer 100 (FIG. 1). Additionally or alternatively, the input / output device may include a sound generator or a lighting device that activates in response to successful completion of the initial tests to prompt a user to apply a liquid sample to sample inlet 208 of test consumable 206. In some embodiments, the liquid sample may be applied to inlet208 of test consumable 206 wherein the liquid sample is stored in sample storage area 210.

[0060] At process block 408, method 400 may include calibrating the at least one sensor via the processor in response to completion of at least one of the initial tests indicating no errors. For example, the at least one initial test may be the calibration fluid check, and a processor (e.g., processor 546 of FIG. 5) of controller 105, 105C1, or 105C2 (FIG. 1) may perform sensor calibration by processing one or more calibration measurement signals received from sensor(s) 217 to determine one or more calibration measurement values in response to completion of the calibration fluid check indicating no errors. Process block 408 may begin before, during, or after process block 406.

[0061] At process block 410, method 400 may include analyzing via the processor the liquid sample received at the at least one sensor. Again, e.g., a processor (e.g., processor 546 of FIG. 5) of controller 105, 105C1, or 105C2 may process one or more sample measurement signals received from sensor(s) 217 to determine one or more sample measurement values in response to a liquid sample contacting sensor(s) 217.

[0062] And method 400 may include, at process block 412, communicating results of the analyzing via the input / output device. For example, sample measurement values and / or other analysis results may be displayed on display 104D of diagnostic sample analyzer 100 (FIG. 1).

[0063] Use of barrier layer 232 reduces the amount by which gas levels of a sample may change during storage within sample storage area 210 (e.g., by reducing the gas permeability of test consumable 206 at sample storage area 210 where the sample is stored). As a result, gas level determinations using a test consumable having barrier layer 232 are generallymore accurate than gas level determinations using a test consumable without barrier layer 232. Further, barrier layer 232 may prevent chemicals from adhesive labels present on test consumable 206 from contaminating any sample stored within sample storage area 210, improving sample integrity.

[0064] Method 400 may additionally include receiving a liquid sample at a sample inlet of the test consumable in response to the prompting, wherein the sample inlet is coupled to a sample storage area of the test consumable. Note that a user may apply a liquid sample to the sample inlet in response to the prompting either before or during the sensor calibration. Method 400 may also include detecting a presence of the liquid sample in the sample storage area via an optical sensor (e.g., optical sensor 538 of FIG. 5), and transferring a liquid sample from the sample storage area, via a vacuum pump of the diagnostic sample analyzer, to the at least one sensor in response to completion of the sensor calibration and detecting the liquid sample in the sample storage area (e.g., via an optical sensor). For example, a user may apply a liquid sample at sample inlet 208 (FIG. 2) in response to a prompt by diagnostic sample analyzer 100 at display 104D (FIG. 1), the liquid sample may be detected by optical sensor 538 (FIG. 5), and the liquid sample may be drawn automatically from sample storage area 210 through sample passageway 214 to sensor module 203 via a vacuum pump (e.g., vacuum pump 540 of FIG. 5) of diagnostic sample analyzer 100 coupled to vacuum port 220. The vacuum pump provides uniform / consistent speed and volume flow of the liquid sample to the sensor module 203, which may reduce variability in the sample analysis results. In some embodiments, the delivery time of the liquid sample to the sensor module 203 may range from about 1 second to 10 seconds, and portion 313 (FIG. 3) of sample passageway 214, which extends from portion 312 to sensor channel 216, may havea cross-sectional area ranging initially from about 0.25 mm2in portion 313 to about 0.75 mm2in sample passageway 214 as the depth increases. Other liquid sample delivery times and / or channel cross-sectional areas may be employed.

[0065] Method 400 may further include preventing flow of the liquid sample from the sample storage area to the at least one sensor prior to completion of the calibrating via a flow configuration of a sample passageway coupled to an outlet of the sample storage area. For example, the flow configuration of portion 300 of FIG. 3 with its two large angle (A1 and A2) flow changes coupled to outlet 211 of sample storage area 210 and its reduced width W1 and decreasing depth of first portion 312 of sample passageway 214 may be used to prevent uncontrolled flow of a liquid sample out of sample storage area 210. Other flow configurations are possible.

[0066] In some embodiments, the dependence of gas concentration on residence time of a sample within the test consumable 206 may be determined and then used by diagnostic sample analyzer 100 during sample analysis. For example, a sample with a known gas concentration may be placed within sample storage area 210 of test consumable 206 for different time periods (e.g., 0 seconds, 45 seconds, 90 seconds, 180 seconds or other intervals) and then transferred to sensor(s) 217 of test consumable 206 to generate a sensor value for each time period (e.g., voltage or current signal). Based on the sensor value, the gas concentration may be determined (e.g., using the algorithm(s) of diagnostic sample analyzer 100 for determining gas concentration based on sensor readings). This “calculated” gas concentration may be compared to the known gas concentration for the sample. By examining how the calculated gas concentration (based on sensor readings) varies with sample storage time within test consumable 206 relative to the known gas concentration, a relationship (e.g.,correction factor) may be determined so that the calculated gas concentration may be adjusted to provide an accurate gas concentration value regardless of sample storage time. In some embodiments, a statistical analysis tool such as linear regression, multiple linear regression, polynomial regression, a machine learning algorithm, or the like may be employed to determine a relationship for gas concentration which is dependent on residence time of a sample within test consumable 206. This relationship may then be used when determining gas concentrations of samples using diagnostic sample analyzer 100 (e.g., by taking residence time of a sample in test consumable 206 into account).

[0067] Although FIG. 4 shows example blocks of process 400, in some implementations, process 400 may include additional blocks, fewer blocks, different blocks, or differently arranged blocks than those depicted in FIG. 4. Additionally, or alternatively, two or more of the blocks of process 400 may be performed in parallel.

[0068] FIG. 5 illustrates an example embodiment of diagnostic sample analyzer 100 according to one or more embodiments. In the embodiment of FIG. 5, diagnostic sample analyzer 100 includes test consumable reader 502R configured to receive a test consumable (e.g., test consumable 106 or 206 of FIG. 1 or 2, respectively), optical sensors 538, a vacuum pump 540, a heater 542, and an input / output device 544 (e.g., a display such as display 104D of FIG. 1). In some embodiments, one optical sensor 538 may be configured to detect the presence of a liquid sample in sample storage area 210 (FIG. 2) and another optical sensor 538 may be configured to detect the presence of a liquid sample in sensor channel 216 (FIG. 2). In some embodiments, diagnostic sample analyzer 100 may record the time the liquid sample has been detected in sample storage area 210 (e.g., as a measure of sampleresidence time within a test consumable as described further below). Diagnostic sample analyzer 100 may further include a processor 546 coupled to each of test consumable reader 502R, optical sensors 538, vacuum pump 540, heater 542, and input / output device 544. Processor 546 may be coupled to a memory 548 which includes computer program instructions 550 (e.g., one or more computer programs) executable by processor 546. In one or more embodiments, memory 548 may be a non- transitory memory (e.g., a hard drive, a solid-state drive, a flash-drive, etc.). In some embodiments, processor 546 may be part of controller 105, first controller 105C1, or second controller 105C2 (FIG. 1). Processor 546 may interface with test consumable 206 (or test consumable 106) via electrical connectors 552 located within test consumable reader 502R that interface with electrical contacts at sensor(s) 217 of test consumable 206.

[0069] In some embodiments, computer program instructions 550 may include computer code that, when executed by processor 546, cause processor 546 to control operation of diagnostic sample analyzer 100 in accordance with one or more of the methods described herein. For example, execution by processor 546 of computer program instructions 550 stored in memory 548 may cause processor 546 to execute initial tests related to functionality of test consumable 206, optical sensors 538, vacuum pump 540, and / or heater 542 in response to receiving test consumable 206 in test consumable reader 502R. More particularly, execution by processor 546 of computer program instructions 550 stored in memory 548 may cause processor 546 to perform one or more of the process blocks of method 400 of FIG. 4 and / or method 600 of FIGS. 6A-6B (described below).

[0070] In some embodiments, execution of computer program instructions 550 stored in memory 548 by processor 546 may cause processor 546 to: (1) prompt a user via input / outputdevice 544 to apply a liquid sample to test consumable 206 in response to completion of the initial tests indicating no errors; (2) calibrate at least one sensor 217 in response to the completion of at least one of the initial tests indicating no errors; (3) activate vacuum pump 540 to transfer the liquid sample applied to test consumable 206 to the at least one sensor 217 in response to completion of sensor calibration; (4) generate an electrical signal with the at least one sensor 217 in response to the liquid sample contacting the at least one sensor 217; (5) determine a residence time of the liquid sample within test consumable 206; (6) determine a value of the fluid property based on the generated electrical signal received at test consumable reader 502R from the at least one sensor 217 and the residence time of the liquid sample within test consumable 206; and / or (7) communicate the value of the fluid property via input / output device 544.

[0071] FIGS. 6A-6B illustrate a flowchart of a method 600 of operating a diagnostic sample analyzer that accounts for sample residence time within a test consumable according to embodiments provided herein. As shown in FIG. 6A, process 600 may include receiving a test consumable in a diagnostic sample analyzer, the test consumable including at least one sensor (block 602). For example, test consumable reader 102R may receive test consumable 206 in diagnostic sample analyzer 100, test consumable 206 including at least one sensor 217, as described above.

[0072] As also shown in FIG. 6A, process 600 may include executing initial tests related to functionality of at least the test consumable via a processor of the diagnostic sample analyzer (block 604). For example, diagnostic sample analyzer 100 may execute initial tests related to the functionality of at least test consumable 206 via processor 546 (FIG. 5) of diagnostic sample analyzer 100, as described above.

[0073] As further shown in FIG. 6A, process 600 may include prompting a user via an input / output device of the diagnostic sample analyzer to apply a liquid sample to the test consumable in response to completion of the initial tests indicating no errors (block 606). For example, diagnostic sample analyzer 100 may prompt a user via input / output device 544 (or display 104D of FIG. 1) of diagnostic sample analyzer 100 to apply a liquid sample to test consumable 206 (e.g., via inlet 208) in response to completion of the initial tests indicating no errors, as described above.

[0074] As also shown in FIG. 6A, process 600 may include storing the liquid sample in a sample storage area of the test consumable (block 608). For example, test consumable 206 may store the liquid sample in sample storage area 210 of test consumable 206, as described above.

[0075] As further shown in FIG. 6A, process 600 may include calibrating the at least one sensor via the processor in response to the completion of at least one of the initial tests indicating no errors (block 610). For example, diagnostic sample analyzer 100 may calibrate one or more sensors 217 via processor 546 in response to the completion of at least one of the initial tests indicating no errors, as described above.

[0076] As also shown in FIG. 6A, process 600 may include transferring the liquid sample applied to the test consumable from the sample storage area of the test consumable to the at least one sensor in response to completion of sensor calibration (block 612). For example, in some embodiments, vacuum pump 540 of diagnostic sample analyzer 100 may apply a vacuum to vacuum port 220 of test consumable 206 to draw a liquid sample from sample storage area 210 into contact with sensor(s) 217 via outlet 211, sample passageway 214, andsensor channel 216 in response to completion of sensor calibration, as described above.

[0077] As further shown in FIG. 6A, process 600 may include generating an electrical signal with the at least one sensor in response to the liquid sample contacting the at least one sensor (block 614). For example, test consumable 206 may generate an electrical signal with sensor(s) 217 in response to the liquid sample contacting sensor(s) 217, as described above.

[0078] Referring to FIG. 6B, process 600 may include determining a residence time of the liquid sample within the test consumable (block 616). For example, diagnostic sample analyzer 100 may determine a residence time of the liquid sample within test consumable 206 (e.g., how long the sample was stored in sample storage area 210 before being transferred to sensor(s) 217 after calibration), as described above. In some embodiments, the residence time may be based on an estimated or average time required for calibration of sensor(s) 217. In other embodiments, an actual residence time may be determined by processor 546 (e.g., by prompting the user to indicate when the sample has been inserted into the test consumable, by employing an optical device such as one or more optical sensors 538 (FIG. 5) within diagnostic sample analyzer 100 to optically observe when the sample has been input to test consumable 206 and then transferred to sensor(s) 217, etc.).

[0079] As further shown in FIG. 6B, process 600 may include determining a value of a fluid property of the liquid sample based on the generated electrical signal from the at least one sensor and the residence time of the liquid sample within the test consumable (block 618). For example, processor 546 may determine the value of the fluid property based on the generated electrical signal from at least one sensor 217 andthe residence time of the liquid sample within test consumable 206, as described above. In some embodiments, a correction factor may be applied to the fluid property based on the residence time of the sample within test consumable 206.

[0080] As also shown in FIG. 6B, process 600 may include communicating the value of the fluid property via the input / output device (block 620). For example, processor 546 may communicate the value of the fluid property via input / output device 544, as described above.

[0081] Although FIGS. 6A-6B show example blocks of process 600, in some implementations, process 600 may include additional blocks, fewer blocks, different blocks, or differently arranged blocks than those depicted in FIGS. 6A- 6B. Additionally, or alternatively, two or more of the blocks of process 600 may be performed in parallel.

[0082] In some embodiments, process 600 may include preventing flow of the liquid sample from the sample storage area (e.g., sample storage area 210) to the at least one sensor prior to completion of the calibrating via a flow configuration (e.g., flow configuration 300 of FIG. 3) of a sample passageway coupled to an outlet of the sample storage area.

[0083] In one or more embodiments, the initial tests of process 600 may include a card validation check to ensure that the test consumable has not expired or a dry card check to ensure that the test consumable has not been used before or a vacuum check to ensure that a vacuum pump in the diagnostic sample analyzer is working or a heater check to ensure that a heater in the diagnostic sample analyzer is working. Other initial (diagnostic) tests may be performed such as optical sensor checks, temperature sensor checks, accelerometer checks, other system diagnostic checks, or the like.

[0084] In some embodiments, process 600 may include delivering a calibration fluid having a known fluid property to the at least one sensor and measuring via the at least one sensor an electrical signal indicative of a value of the fluid property of the calibration fluid.

[0085] Further, in some embodiments, process 600 may include, upon receiving the test consumable, executing the initial tests and prompting a user to apply a liquid sample to the test consumable within 35 seconds. ILLUSTRATIVE EMBODIMENTS

[0086] The following provides a non-limiting list of illustrative embodiments of this disclosure:

[0087] An illustrative test consumable for use in a diagnostic sample analyzer, comprising an inlet configured to receive a sample; a sample storage area coupled to the inlet and configured to receive and store a sample input to the test consumable through the inlet; a barrier layer positioned over at least a portion of the sample storage area, the barrier layer configured to reduce gas exchange between any sample stored within the sample storage area and the test consumable; a sample passageway extending from the sample storage area; and one or more sensors, each sensor configured to contact the sample along the sample passageway and generate a signal representative of a property of the sample.

[0088] The illustrative test consumable of any of the proceeding illustrative embodiments, further comprising a vacuum port configured to connect to a vacuum pump of a diagnostic sample analyzer to draw the sample from the sample storage area into contact with the one or more sensors.

[0089] The illustrative test consumable of any of the proceeding illustrative embodiments, wherein the barrier layer comprises a thermoplastic polymer.

[0090] The illustrative test consumable of any of the proceeding illustrative embodiments, wherein the barrier layer only covers a portion of the sample storage area that will contain a sample to be transferred to the one or more sensors during testing with the diagnostic sample analyzer.

[0091] The illustrative test consumable of any of the proceeding illustrative embodiments, further comprising an adhesive label positioned over at least a portion of the barrier layer.

[0092] An illustrative diagnostic sample analyzer, comprising a test consumable reader configured to receive a test consumable; a pump; an input / output device; a processor coupled to the test consumable reader, the pump, and the input / output device; and a non-transitory memory coupled to the processor, the non-transitory memory including computer program instructions that when executed by the processor cause the processor to: execute initial tests related to functionality of the test consumable and the pump in response to receiving the test consumable in the test consumable reader, the test consumable including at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of a liquid sample; prompt a user via the input / output device to apply the liquid sample to the test consumable in response to completion of the initial tests indicating no errors; calibrate the at least one sensor in response to the completion of at least one of the initial tests indicating no errors; activate the pump to transfer the liquid sample applied to the test consumable to the at least one sensor in response to completion of sensor calibration; generate an electrical signal with the at least one sensor inresponse to the liquid sample contacting the at least one sensor; determine a residence time of the liquid sample within the test consumable; determine the value of the fluid property based on the generated electrical signal received at the test consumable reader from the at least one sensor and the residence time of the liquid sample within the test consumable; and communicate the value of the fluid property via the input / output device.

[0093] The illustrative diagnostic sample analyzer of any of the proceeding illustrative embodiments, wherein the at least one sensor is configured to generate a voltage, current, or conductivity signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor.

[0094] The illustrative diagnostic sample analyzer of any of the proceeding illustrative embodiments, further comprising the test consumable.

[0095] The illustrative diagnostic sample analyzer of any of the proceeding illustrative embodiments, wherein the test consumable includes: an inlet configured to receive a sample; a sample storage area coupled to the inlet and configured to receive and store a sample input to the test consumable through the inlet; a sample passageway extending from the sample storage area; one or more sensors, each sensor configured to contact the sample along the sample passageway and generate a signal representative of a property of the sample; and a vacuum port configured to connect to the pump of the diagnostic sample analyzer to draw the liquid sample from the sample storage area into contact with the one or more sensors.

[0096] The illustrative diagnostic sample analyzer of any of the proceeding illustrative embodiments, wherein the testconsumable includes a barrier layer positioned over at least a portion of the sample storage area, the barrier layer configured to reduce gas exchange between any sample stored within the sample storage area and the test consumable.

[0097] The illustrative diagnostic sample analyzer of any of the proceeding illustrative embodiments, wherein the barrier layer only covers a portion of the sample storage area that will contain a sample to be transferred to the one or more sensors during testing with the diagnostic sample analyzer.

[0098] The illustrative diagnostic sample analyzer of any of the proceeding illustrative embodiments, wherein the input / output device comprises a display, a sound generator, or a lighting device.

[0099] The illustrative diagnostic sample analyzer of any of the proceeding illustrative embodiments, wherein the diagnostic sample analyzer is or comprises a hand-held device.

[0100] An illustrative method of operating a diagnostic sample analyzer, the method comprising: receiving a test consumable in a diagnostic sample analyzer, the test consumable including at least one sensor; executing initial tests related to functionality of at least the test consumable via a processor of the diagnostic sample analyzer; prompting a user via an input / output device of the diagnostic sample analyzer to apply a liquid sample to the test consumable in response to completion of the initial tests indicating no errors; storing the liquid sample in a sample storage area of the test consumable; calibrating the at least one sensor via the processor in response to the completion of at least one of the initial tests indicating no errors; transferring the liquid sample applied to the test consumable from the sample storage area of the test consumable to the at least one sensorin response to completion of sensor calibration; generating an electrical signal with the at least one sensor in response to the liquid sample contacting the at least one sensor; determining a residence time of the liquid sample within the test consumable; determining a value of a fluid property of the liquid sample based on the generated electrical signal from the at least one sensor and the residence time of the liquid sample within the test consumable; and communicating the value of the fluid property via the input / output device.

[0101] The illustrative method of any of the proceeding illustrative embodiments, wherein the test consumable includes a barrier layer positioned over at least a portion of the sample storage area, the barrier layer configured to reduce gas exchange between any sample stored within the sample storage area and the test consumable.

[0102] The illustrative method of any of the proceeding illustrative embodiments, further comprising: receiving a liquid sample at a sample inlet of the test consumable in response to the prompting, the sample inlet coupled to the sample storage area of the test consumable; and transferring the liquid sample from the sample storage area comprises employing a vacuum pump of the diagnostic sample analyzer to transfer the liquid sample from the sample storage area to the at least one sensor in response to completion of the calibrating.

[0103] The illustrative method of any of the proceeding illustrative embodiments, further comprising preventing flow of the liquid sample from the sample storage area to the at least one sensor prior to completion of the calibrating via a flow configuration of a sample passageway coupled to an outlet of the sample storage area.

[0104] The illustrative method of any of the proceeding illustrative embodiments, wherein the initial tests comprise a card validation check to ensure that the test consumable has not expired or a dry card check to ensure that the test consumable has not been used before or a vacuum check to ensure that a vacuum pump in the diagnostic sample analyzer is working or a heater check to ensure that a heater in the diagnostic sample analyzer is working.

[0105] The illustrative method of any of the proceeding illustrative embodiments, wherein the calibrating comprises delivering a calibration fluid having a known fluid property to the at least one sensor and measuring via the at least one sensor an electrical signal indicative of a value of the fluid property.

[0106] The illustrative method of any of the proceeding illustrative embodiments, wherein upon receiving the test consumable, the executing of the initial tests and the prompting of a user are performed within 35 seconds.

[0107] While this disclosure is susceptible to various modifications and alternative forms, specific method and apparatus embodiments have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that the particular methods and apparatus disclosed herein are not intended to limit the disclosure orthe following claims.

Claims

THE INVENTION CLAIMED IS:

1. A test consumable for use in a diagnostic sample analyzer, comprising: an inlet configured to receive a sample; a sample storage area coupled to the inlet and configured to receive and store a sample input to the test consumable through the inlet; a barrier layer positioned over at least a portion of the sample storage area, the barrier layer configured to reduce gas exchange between any sample stored within the sample storage area and the test consumable; a sample passageway extending from the sample storage area; and one or more sensors, each sensor configured to contact the sample along the sample passageway and generate a signal representative of a property of the sample.

2. The test consumable of claim 1 further comprising a vacuum port configured to connect to a vacuum pump of a diagnostic sample analyzer to draw the sample from the sample storage area into contact with the one or more sensors.

3. The test consumable of claim 1 wherein the barrier layer comprises a thermoplastic polymer.

4. The test consumable of claim 1 wherein the barrier layer only covers a portion of the sample storage area that will contain a sample to be transferred to the one or more sensors during testing with the diagnostic sample analyzer.

5. The test consumable of claim 1 further comprising an adhesive label positioned over at least a portion of the barrier layer.

6. A diagnostic sample analyzer, comprising: a test consumable reader configured to receive a test consumable; a pump; an input / output device; a processor coupled to the test consumable reader, the pump, and the input / output device; and a non-transitory memory coupled to the processor, the non-transitory memory including computer program instructions that when executed by the processor cause the processor to: execute initial tests related to functionality of the test consumable and the pump in response to receiving the test consumable in the test consumable reader, the test consumable including at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of a liquid sample; prompt a user via the input / output device to apply the liquid sample to the test consumable in response to completion of the initial tests indicating no errors; calibrate the at least one sensor in response to the completion of at least one of the initial tests indicating no errors; activate the pump to transfer the liquid sample applied to the test consumable to the at least one sensor in response to completion of sensor calibration; generate an electrical signal with the at least one sensor in response to the liquid sample contacting the at least one sensor; determine a residence time of the liquid sample within the test consumable; determine the value of the fluid property based on the generated electrical signal received at the testconsumable reader from the at least one sensor and the residence time of the liquid sample within the test consumable; and communicate the value of the fluid property via the input / output device.

7. The diagnostic sample analyzer of claim 6, wherein the at least one sensor is configured to generate a voltage, current, or conductivity signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor.

8. The diagnostic sample analyzer of claim 6, further comprising the test consumable.

9. The diagnostic sample analyzer of claim 8, wherein the test consumable includes: an inlet configured to receive a sample; a sample storage area coupled to the inlet and configured to receive and store a sample input to the test consumable through the inlet; a sample passageway extending from the sample storage area; one or more sensors, each sensor configured to contact the sample along the sample passageway and generate a signal representative of a property of the sample; and a vacuum port configured to connect to the pump of the diagnostic sample analyzer to draw the liquid sample from the sample storage area into contact with the one or more sensors.

10. The diagnostic sample analyzer of claim 9, wherein the test consumable includes a barrier layer positioned over at least a portion of the sample storage area, the barrier layer configured to reduce gas exchange between any sample storedwithin the sample storage area and the test consumable.

11. The diagnostic sample analyzer of claim 10 wherein the barrier layer only covers a portion of the sample storage area that will contain a sample to be transferred to the one or more sensors during testing with the diagnostic sample analyzer.

12. The diagnostic sample analyzer of claim 6, wherein the input / output device comprises a display, a sound generator, or a lighting device.

13. The diagnostic sample analyzer of claim 6, wherein the diagnostic sample analyzer is or comprises a hand-held device.

14. A method of operating a diagnostic sample analyzer, the method comprising: receiving a test consumable in a diagnostic sample analyzer, the test consumable including at least one sensor; executing initial tests related to functionality of at least the test consumable via a processor of the diagnostic sample analyzer; prompting a user via an input / output device of the diagnostic sample analyzer to apply a liquid sample to the test consumable in response to completion of the initial tests indicating no errors; storing the liquid sample in a sample storage area of the test consumable; calibrating the at least one sensor via the processor in response to the completion of at least one of the initial tests indicating no errors; transferring the liquid sample applied to the test consumable from the sample storage area of the test consumableto the at least one sensor in response to completion of sensor calibration; generating an electrical signal with the at least one sensor in response to the liquid sample contacting the at least one sensor; determining a residence time of the liquid sample within the test consumable; determining a value of a fluid property of the liquid sample based on the generated electrical signal from the at least one sensor and the residence time of the liquid sample within the test consumable; and communicating the value of the fluid property via the input / output device.

15. The method of claim 14, wherein the test consumable includes a barrier layer positioned over at least a portion of the sample storage area, the barrier layer configured to reduce gas exchange between any sample stored within the sample storage area and the test consumable.

16. The method of claim 14, further comprising: receiving a liquid sample at a sample inlet of the test consumable in response to the prompting, the sample inlet coupled to the sample storage area of the test consumable; and transferring the liquid sample from the sample storage area comprises employing a vacuum pump of the diagnostic sample analyzer to transfer the liquid sample from the sample storage area to the at least one sensor in response to completion of the calibrating.

17. The method of claim 16, further comprising preventing flow of the liquid sample from the sample storage area to the at least one sensor prior to completion of the calibrating via aflow configuration of a sample passageway coupled to an outlet of the sample storage area.

18. The method of claim 14, wherein the initial tests comprise a card validation check to ensure that the test consumable has not expired or a dry card check to ensure that the test consumable has not been used before or a vacuum check to ensure that a vacuum pump in the diagnostic sample analyzer is working or a heater check to ensure that a heater in the diagnostic sample analyzer is working.

19. The method of claim 14, wherein the calibrating comprises delivering a calibration fluid having a known fluid property to the at least one sensor and measuring via the at least one sensor an electrical signal indicative of a value of the fluid property.

20. The method of claim 14, wherein upon receiving the test consumable, the executing of the initial tests and the prompting of a user are performed within 35 seconds.

Images