Methods and apparatus for facilitating sample movement and placement within test cards

Abstract

A method of operating a diagnostic sample analyzer is provided that includes receiving a test card in the diagnostic sample analyzer, the test card including at least one test card sensor; receiving a liquid sample into the test card; employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor; analyzing, via a processor of the diagnostic sample analyzer, the liquid sample at the at least one test card sensor; and communicating results of the analyzing. Numerous other aspects are provided.

Description

METHODS AND APPARATUS FOR FACILITATING SAMPLE MOVEMENT AND PLACEMENT WITHIN TEST CARDS

[0001] This application claims benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 846,581, filed July 18, 2025; U.S. Provisional Application No. 63 / 675,844, filed July 26, 2024; and U.S. Provisional Application No. 63 / 675,827, 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 cards for use therein to measure one or more fluid properties in a liquid sample. BACKGROUND

[0003] A test card 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 card is configured to receive a small volume of a liquid sample and to be inserted into a diagnostic sample analyzer for analysis. The liquid sample may be a biological sample or a non-biological aqueous solution. The sample may be, e.g., whole blood, blood serum, blood plasma, saliva, urine, cerebrospinal fluid, interstitial fluid, pleural fluid, dialysate fluid, control fluid, calibration fluid, and the like. The diagnostic sample analyzer with an inserted test card 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, etc.).

[0004] A test card may receive a liquid sample at an inlet of the test card and the liquid sample may then be transported through a sensor channel to a sensor panel of the test card. Because of the small volume of liquid sample transported within a test card, precise control of fluid movements within the test card is important for properly initiating and obtaining accurate analyte measurements. Transporting an insufficient amount of liquid sample to the sensor panel may prevent complete coverage of the sensors of the panel and lead to measurement inaccuracies. Transporting the liquid sample too rapidly makes sample placement more difficult and may create fluidic issues (e.g., turbulence, sample bubble formation, separation of red blood cells from plasma, etc.) that affect measurement accuracy. Too slow of a sample transfer may also reduce measurement accuracy (e.g., as one or more fluid properties of the sample may change over time and / or due to less accurate extrapolation of sensor responses). As such, a need exists for methods and apparatus that facilitate sample movement and placement within test cards. SUMMARY

[0005] In some embodiments, a method of operating a diagnostic sample analyzer is provided that includes receiving a test card in the diagnostic sample analyzer, the test card including at least one test card sensor; receiving a liquid sample into the test card; employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor; analyzing, via a processor of the diagnostic sample analyzer,the liquid sample at the at least one test card sensor; and communicating results of the analyzing.

[0006] In some embodiments, a method of operating a diagnostic sample analyzer is provided that includes receiving a test card in the diagnostic sample analyzer, the test card including a sensor array and a sample storage area; receiving a liquid sample into the sample storage area of the test card; employing a first sample-area optical sensor and a second sample-area optical sensor of the diagnostic sample analyzer to detect the liquid sample within the sample storage area of the test card; calibrating the sensor array via a processor of the diagnostic sample analyzer; transferring the liquid sample from the sample storage area to the sensor array via a pump of the diagnostic sample analyzer in response to completion of the calibrating and the detecting the liquid sample within the sample storage area; employing a first conductivity sensor and a second conductivity sensor to detect the liquid sample at the sensor array; analyzing, via the processor, the liquid sample at the sensor array; and communicating results of the analyzing.

[0007] In some embodiments, a diagnostic sample analyzer is provided that includes a test card reader configured to receive a test card, the test card including at least one test card sensor configured to generate an electrical signal indicative of a value of a fluid property of a liquid sample; at least one optical sensor configured to detect the liquid sample within the test card; a display; a processor coupled to the test card reader, the at least one optical sensor, and the display; and a memory coupled to the processor. The memory includes computer program instructions that, when executed by the processor, cause the processor to prompt a user via the display to apply the liquid sample to the test card; employ the at least one optical sensor to detect the liquid samplewithin the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor; analyze the liquid sample at the at least one test card sensor to produce a test result; and communicate the test result via the display.

[0008] Still other aspects, features, and advantages of this disclosure may be readily apparent from the following detailed description and illustration of a number of example embodiments and implementations, including the best mode contemplated for carrying out the invention. This disclosure may also be capable of other and different embodiments, and its several details may be modified in various respects, all without departing from the scope of the invention. For example, although described herein with respect to diagnostic sample analyzers, this disclosure may be applicable to other devices that handle and / or process small liquid volumes. This disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims below. BRIEF DESCRIPTION OF DRAWINGS

[0009] 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.

[0010] FIG. 1A illustrates an example of a diagnostic sample analyzer according to one or more embodiments.

[0011] FIG. 1B is an enlarged view of the sensor array of FIG. 1A in accordance with one or more embodiments.

[0012] FIG. 2 illustrates a perspective view of an example embodiment of the diagnostic sample analyzer of FIG. 1A according to one or more embodiments.

[0013] FIG. 3A illustrates an example embodiment of a test card for use in a diagnostic sample analyzer according to one or more embodiments.

[0014] FIG. 3B illustrates the test card of FIG. 3A positioned within a test card reader of a diagnostic sample analyzer according to one or more embodiments.

[0015] FIG. 3C illustrates example signal flow during measurements of liquid sample movement within the test card of FIG. 3B with optical sensors of a diagnostic sample analyzer and conductivity sensors of the test card according to one or more embodiments.

[0016] FIG. 4A is a flowchart of an example process for measuring a property of a liquid sample according to one or more embodiments.

[0017] FIG. 4B is a flowchart of another example process for measuring a property of a liquid sample according to one or more embodiments.

[0018] FIG. 5 is a flowchart of another example process for measuring a property of a liquid sample according to one or more embodiments. DETAILED DESCRIPTION

[0019] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.

[0020] As stated above, control of fluidic movements in a sensor channel of a test card is important to properly initiate and obtain accurate analyte measurements. The need for precise sample volume and fluidic movement regulation is particularly critical in a test card that employs small samplevolumes because sensors within the test card must be properly covered by the sample to provide accurate measurements. Additionally, a sample should be delivered with consistent speed to the sensors. Very fast sample delivery complicates proper sample placement and may create fluidics issues and sample bubbles. Slow sample injection also may affect the accuracy of test result calculations as sample properties may change over time.

[0021] Embodiments provided herein address the above issues via methods and apparatus that allow detection of a predetermined (e.g., minimum) volume of a user injected sample that is sufficient for accurate testing within a test card. Additionally, properties of the injected sample such as injection speed, sample type, and sample viscosity may be determined and used for quality control (e.g., to determine if the sample was transferred too quickly, to ensure that the proper sample type was injected such as a patient sample versus a calibration fluid, to ensure the injected sample viscosity will allow for proper transfer of the sample within the test card, etc.). To improve measurement accuracy, transfer of a predetermine (e.g., minimum and / or sufficient) volume of liquid sample to the sensors of the test card may be ensured. Further, the presence of air bubbles within the liquid sample at the sensors may be detected and flagged.

[0022] In some embodiments, optical sensors are provided within a diagnostic sample analyzer and employed to detect an injection of a liquid sample in a test card, measure sample properties (e.g., injection speed, sample type, sample viscosity, etc.), and ensure accurate transfer of the liquid sample to sensors of the test card. Conductivity sensors within the sensor array of the test card may be employed to ensure a sufficient volume of liquid sample is present at the sensors and that the liquid sample is free of air bubbles. Insome embodiments, a sample injected into a test card is stored on the test card and then transferred to the sensor array of the test card using a pump of the diagnostic sample analyzer. This approach provides consistent sample transfer rates and placement within the test card, improves sample fluidics during sample transfer, and provides consistent sensor measurements. The above-described optical and / or conductivity sensors allow for automated instrument-controlled detection of sample injection and automated instrument-controlled regulation of sample volume and movement to the sensor area of at test card. Such embodiments are particularly advantageous for test cards employing small sample volumes.

[0023] These and other embodiments are described below with reference to FIGS. 1A-5.

[0024] FIG. 1A illustrates an example of a diagnostic sample analyzer 100 according to one or more embodiments. Diagnostic sample analyzer 100 includes a test card reader 102R configured to receive a test card 104, a pump 106, a heater 108, and an input / output device 110 (e.g., one or more displays, touch screens, etc.). Diagnostic sample analyzer 100 also includes a processor 112 coupled to a memory 114 having computer program instructions 116 stored therein.

[0025] Test card 104 includes a sample inlet 118 for receiving a liquid sample and a sensor array 120 having one or more sensors configured to measure one or more properties of the liquid sample. For example, sensor array 120 may be configured to measure 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.), other analyte concentrations (e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, etc.), and / or the like.

[0026] At least a first sensor (referred to as “first conductivity sensor 120C1”) and a second sensor (referred to as“second conductivity sensor 120C2”) of sensor array 120 may be capable of measuring conductivity of a liquid sample. For example, first conductivity sensor 120C1 and second conductivity sensor 120C2 may each be a dedicated conductivity sensor, a dual-use sensor (e.g., a barometric sensor capable of conductivity measurements), or any other type of sensor usable for conductivity measurements. In some embodiments, sensor array 120 may include a plurality of sensor types (e.g., 1, 2, 3, 4, or more different sensor types). Test card 104 therefore includes at least one test card sensor within sensor array 120 configured to generate an electrical signal indicative of a value of a fluid property of a liquid sample introduced to test card 104.

[0027] In some embodiments, a liquid sample injected into sample inlet 118 of test card 104 may travel directly to sensor array 120 (e.g., at a rate determined by the person injecting the liquid sample into sample inlet 118). In other embodiments, test card 104 may include a sample storage area 122 configured to store a liquid sample (introduced via sample inlet 118) within test card 104 for subsequent transfer to sensor array 120 via a pump 106 (e.g., after calibration of sensor array 120 as described below). Test card 104 may also include a calibration fluid source 124 configured to deliver calibration fluid to sensor array 120 during a calibration operation. A waste area 126 within test card 104 may be configured to receive calibration fluid displaced from sensor array 120 when the liquid sample provided to test card 104 is transferred to sensor array 120 for measurement.

[0028] In some embodiments, diagnostic sample analyzer 100 (e.g., within test card reader 102R) may include at least one optical sensor (e.g., a first sample-area optical sensor 128a and a second sample-area optical sensor 128b) configured to detect the presence of a liquid sample in sample storage area122. Another optical sensor (e.g., first test-area optical sensor 130a) may be configured to detect the presence of a liquid sample at sensor array 120, and a further optical sensor (e.g., second test-area optical sensor 130b) may be configured to detect the presence of a liquid within waste area 126.

[0029] Processor 112 is coupled to each of test card reader 102R, optical sensors 128a, 128b, 130a, and 130b, pump 106, heater 108, and input / output device 110. As stated, processor 112 is coupled to memory 114 which includes computer program instructions 116 (e.g., one or more computer programs) executable by processor 112. In one or more embodiments, memory 114 may be a non-transitory memory (e.g., a hard drive, a solid-state drive, a flash-drive, etc.). In some embodiments, processor 112 may be part of one or more controllers (described below). Processor 112 may interface with test card 104 via electrical connectors 132 located within test card reader 102R that interface with electrical contacts (not shown) at sensor array 120 of test card 104.

[0030] Computer program instructions 116 may include computer code that, when executed by processor 112, causes processor 112 to control operation of diagnostic sample analyzer 100 in accordance with one or more of the methods described herein which transforms the processor 112 from a general-purpose processor to a special purpose processor. For example, execution by processor 112 of computer program instructions 116 stored in memory 114 may cause processor 112 to execute initial tests related to functionality of test card 104, optical sensors 128a, 128b, 130a, and 130b, pump 106, and / or heater 108 in response to receiving test card 104 in test card reader 102R. Additionally, execution by processor 112 of computer program instructions 116 stored in memory 114 may cause processor 112 to perform one or more of the processblocks of methods 400A (FIG. 4A), 400B (FIG. 4B), and 500 (FIG. 5).

[0031] In operation, a user of diagnostic sample analyzer 100 may insert a test card 104 into test card reader 102R. In response thereto, processor 112 (e.g., executing computer program instructions 116 within memory 114) may prompt the user via input / output device 110 (or another display) to apply the liquid sample to test card 104 (via sample inlet 118). Processor 112 may then employ at least one optical sensor of diagnostic sample analyzer 100 to detect the liquid sample within test card 104. For example, if test card 104 includes sample storage area 122, first sample-area optical sensor 128a may be positioned to detect entry of the liquid sample into sample storage area 122 and second sample-area optical sensor 128b may be positioned to detect that a predetermined amount of liquid sample is present within sample storage area 122. The predetermined amount may be at least the minimum amount of liquid sample required to cover all of the sensors of sensor array 120 once the liquid sample is transferred to sensor array 120 from sample storage area 122. Thus, first and second sample-area optical sensors 128a, 128b may be positioned a predetermined distance apart that ensures an adequate volume of the liquid sample is present within sample storage area 122 for use during testing. For example, in some embodiments, first and second sample-area optical sensors 128a, 128b within sample storage area 122 may be positioned so that at least 65 microliters of liquid sample can be stored between the sensors. That is, if both sensors (first and second sample- area optical sensors 128a, 128b) detect the liquid sample, at least 65 microliters of the liquid sample is known to be present within sample storage area 122.

[0032] In embodiments in which sample storage area 122 is employed, pump 106 of diagnostic sample analyzer 100 may beemployed to transfer the liquid sample from sample storage area 122 to sensory array 120 for testing. However, in embodiments in which sample storage area 122 is not employed within test card 104, the liquid sample may be directly transferred to sensor array 120 from sample inlet 118 as the user injects the liquid sample into test card 104. In such an embodiment, an insertion channel connecting the sample inlet 118 directly to the sensor array 120 may include the first and second sample-area optical sensors 128a, 128b. The first and second sample-area optical sensors 128a, 128b may be positioned to be spaced apart within the insertion channel such that the predetermined volume of liquid sample present within the insertion channel is detectable. Processor 112 may be configured to indicate such detection to a user (e.g., via a visual, auditory, or tactile indication or alert indicating to the user that the predetermined amount of liquid sample has been injected).

[0033] In either case, once the sample reaches sensor array 120, the sensors of sensor array 120 generate electrical signals representative of properties of the liquid sample. Processor 112 may receive these signals and analyze the liquid sample present at sensor array 120. Further, processor 112 may communicate the results of analyzing the liquid sample via input / output device 110 or another display.

[0034] Because the second sample-area optical sensor 128b is positioned to detect whether a predetermined (e.g., sufficient) amount of liquid sample is present in sample storage area 122, in some embodiments, processor 112 may prompt a user to stop injecting the liquid sample into test card 104 in response to second sample-area optical sensor 128b detecting the liquid sample. The prompt may be, for example, a visual, auditory, or tactile indication or alert indicating tothe user that the predetermined amount of liquid sample has been injected.

[0035] Processor 112 (executing computer program instructions 116 in memory 114) may also employ first and second sample-area optical sensors 128a and 128b to determine one or more of an injection speed, a sample type, and a sample viscosity for the liquid sample provided to test card 104. For example, the injection speed of the liquid sample into sample inlet 118 may be estimated by examining the time between when a liquid sample reaches first sample-area optical sensor 128a and when the liquid sample reaches second sample-area optical sensor 128b.

[0036] Regarding sample type, sample-area optical sensor 128a and / or 128b may distinguish a blood sample from a control fluid within test card 104 because of the opacity difference between these liquids. In one or more embodiments, first and second sample-area optical sensors 128a and 128b may be reflective sensors that direct a light beam at test card 104 and measure the amount of light reflected back from test card 104. As described further below, test card 104 may be formed from multiple layers that are transparent. In some embodiments, a reflective (or white) label may be placed on a backside of test card 104. A light beam from first or second sample-area optical sensors 128a or 128b may travel through test card 104, reflect off of the label on the backside of the test card, travel back through the test card, and be detected by the detector of the respective optical sensor. The light path through test card 104 for first and second sample-area optical sensors 128a and 128b extends through sample storage area 122 (at different locations). As such, if the liquid sample within sample storage area 122 is opaque (e.g., blood, hemolyzed blood, etc.), the intensity of the reflected light beam detected by the detector of first or second sample-areaoptical sensors 128a, 128b will be reduced in comparison to when sample storage area 122 is empty or includes a control fluid (e.g., calibration fluid) which may be clear or more transparent than a patient sample. In some cases, the control fluid may have an index of refraction that is similar to that of the layers forming sample storage area 122 so that a higher intensity light signal is returned to the optical detector of first or second sample-area optical sensors 128a, 128b (e.g., due to less scattering) when compared to an empty sample storage area. Thus, in some embodiments, processor 112 may examine the intensity of light detected by first or second sample-area optical sensors 128a, 128b and determine whether sample storage area 122 contains a patient sample, a control sample (e.g., calibration fluid or another control fluid), or is empty as each will produce a different signal strength. Other sample types may be identified (e.g., by determining a correspondence light intensity reflected back to first sample- area optical sensor 128a or second sample-area optical sensor 128b for each sample type). For example, in one or more embodiments, processor 112 may examine the intensity of light detected by first or second sample-area optical sensors 128a, 128b and determine whether sample storage area 122 contains a non-hemolyzed or hemolyzed blood sample. Additionally or alternatively, due to the use of transparent layers within test card 104, a user may visually inspect sample storage area 122 to determine sample type (e.g., patient sample, calibration fluid, non-hemolyzed versus hemolyzed blood, etc.) such as by referencing a color chart illustrating colors for different sample types (e.g., different degrees of hemolysis).

[0037] Additionally, because the pump speed from pump 106 in diagnostic sample analyzer 100 is known, the speed with which the liquid sample travels from sample storage area 122 (as identified by sample-area optical sensors 128a and / or128b) may be used to estimate the viscosity of the liquid sample stored in sample storage area 122. For example, a higher viscosity sample fluid will travel more slowly from sample storage area 122 than a less viscous sample.

[0038] Processor 112 may be further configured to prompt, alert or indicate to the user the determined injection speed, sample type, and / or sample viscosity. For example, processor 112 may be configured to prompt a user to proceed with testing and / or to not proceed with testing of the liquid sample in response to the determined injection speed, sample type, and / or sample viscosity.

[0039] Processor 112 (via computer program instructions 116 in memory 114) may employ first conductivity sensor 120C1 and second conductivity sensor 120C2 to detect a predetermined amount of liquid sample is present at the sensor array 120. FIG. 1B is an enlarged view of sensor array 120 of FIG. 1A in accordance with one or more embodiments. With reference to FIGS. 1A and 1B, when a liquid sample is transferred to sensor array 120 from sample inlet 118 of test card 104 (directly or after travelling to sample storage area 122), the liquid sample travels through a sensor channel 134 (FIG. 1B) and makes contact with each sensor of sensor array 120. If the liquid sample within sensor channel 134 has travelled to second conductivity sensor 120C2 and is also in contact with first conductivity sensor 120C1, then all sensors within sensor array 120 should be in contact with the liquid sample. That is, a predetermined (e.g., sufficient) amount of liquid sample will be present at sensor array 120. Accordingly, in one embodiment the first conductivity sensor 120C1 may be positioned near an inlet of the sensor array 120 (in the direction of fluid flow), such as at the first sensor position, and the second conductivity sensor 120C2 may be positioned near an outlet of the sensor array 120, such as atthe last sensor position. In another embodiment, the first and second conductivity sensors 120C1, 120C2 may be positioned to be spaced apart by the minimum required sample volume to run a test on test card 104.

[0040] In some embodiments, the minimum required sample volume to run a test on test card 104 (e.g., the minimum sample volume required between conductivity sensors 120C1 and 120C2) may be about 45 microliters or more. Other minimum sample volumes may be employed depending on the configuration of sensor array 120. Note that, in one or more embodiments, the minimum sample volume a user should input into test card 104 (as measured by first and second sample-area optical sensors 128a and 128b) may be larger than the minimum sample volume required by sensor array 120 to conduct a test (e.g., to compensate for incomplete transfer of all liquid sample within sample storage area 122 to sensor array 120).

[0041] Even if both conductivity sensors 120C1 and 120C2 detect the liquid sample, it is possible that the liquid sample within sensor channel 134 may have one or more bubbles (e.g., trapped air within the liquid sample). Such bubbles may prevent one or more sensors of sensor array 120 from being in contact with the liquid sample. As such, in some embodiments, processor 112 may be employed to detect a presence of one or more bubbles in the liquid sample at sensor array 120. For example, one or more sensors, such as sensor 120G in FIG. 1B, may serve as an electrical ground relative to either first conductivity sensor 120C1 or second conductivity sensor 120C2. When a liquid sample is present in sensor channel 134 and extends between first conductivity sensor 120C1 and grounded sensor 120G, the liquid sample may complete a circuit 136 (e.g., allowing current to flow through circuit 136). However, if one or more air bubbles are present within the liquid sample in this region, the circuit 136 may be opened (e.g.,preventing current flow) or at least exhibiting a different impedance, each of which is detectable by processor 112. A similar circuit may be completed with second conductivity sensor 120C2 and grounded sensor 120G to detect bubbles in any liquid sample therebetween. Thus, processor 112 may employ sensor 120G as a ground and first and second conductivity sensors 120C1 and 120C2 to determine whether any bubbles are present at sensor array 120.

[0042] As a further measure that a predetermine (e.g., sufficient) amount of liquid sample is present at sensor array 120, processor 112 may employ first test-area optical sensor 130a to detect the liquid sample within sensor channel 134. First test-area optical sensor 130a may be positioned near the outlet of sensor array 120, such as downstream of second conductivity sensor 120C2. Additionally, processor 112 may employ second test-area optical sensor 130b (FIG. 1A) to detect a fluid within waste area 126 of test card 104. For example, the liquid sample may be detected within waste area 126. Responsive to detecting fluid within waste area 126, in some embodiments, processor 112 may stop pump 106 used to transfer the liquid sample to sensor array 120 (from sample storage area 122). Alternatively, when no sample storage area 122 is present within test card 104 and a user injecting the liquid sample causes the liquid sample to travel to sensor array 120, processor 112 may prompt the user (e.g., via input / output device 110) to stop injecting the liquid sample (when second test-area optical sensor 130b detects the liquid in waste area 126).

[0043] FIG. 2 illustrates an example embodiment of diagnostic sample analyzer 100 provided herein. In the embodiment of FIG. 2, diagnostic sample analyzer 100 may be a hand-held device and may be battery powered, for example. Diagnostic sample analyzer 100 includes an analyzer body 102configured 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 control haptics (e.g., buttons, switches, touch screens, and the like). In the depicted embodiment, analyzer body 102 may comprise a computing device 202. Computing device 202 may be fixedly coupled to the analyzer body 102. Alternatively, computing device 202 may be, in some embodiments, detachably mounted to a device mount 102M of a base 102B of diagnostic sample analyzer 100. Computing device 202 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 202 may be housed inside of analyzer body 102 (as shown in FIG. 1) rather than as a separable / detachable version of computing device 202.

[0044] Diagnostic sample analyzer 100 also includes a controller 204, which in this embodiment is configured to include a first controller 204C1, which may be part of base 102B of analyzer body 102, and a second controller 204C2, which may be part of, or integral with, computing device 202. First controller 204C1 and second controller 204C2 are in electronic communication with one another and may perform different functions (e.g., one or more of the functions described above with regard to processor 112 of FIG. 1). In other embodiments, controller 204 may be a single device located in either analyzer body 102 or computing device 202. In still other embodiments, diagnostic sample analyzer 100 may have one or more controllers that may be located anywhere in the analyzer.

[0045] In this embodiment, computing device 202 may include a display 202D enabling user input and visual display ofoperational information, test results, and other information (e.g., as an embodiment of input / output device 110 of FIG. 1). In some embodiments, display 202D may be tiltable about a pivot axis 102A. For example, device mount 102M of base 102B may receive computing device 202 and may be pivotable about pivot axis 102A at a location 102L so as to allow adjustment of the viewing angle. Display 202D 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.

[0046] First controller 204C1 (or alternatively another controller in diagnostic sample analyzer 100) may include electronics for communicating with one or more sensors embodied in a test card 104. 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 array 120. In some embodiments, sensor array 120 may include a potentiometric sensor, an amperometric sensor, and / or a conductometric sensor, and first controller 204C1 may further include electronics for processing amperometric, potentiometric, and / or conductometric signals received from sensor array 120.

[0047] In some embodiments, diagnostic sample analyzer 100 may be, e.g., a blood analyzer and second controller 204C2 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 (e.g., processor 112 in FIG. 1) in second controller 204C2 (or alternatively another controllerin diagnostic sample analyzer 100) for determining a fluid property in a blood sample may be stored in a non-transitory memory (e.g., memory 114 of FIG. 1) of diagnostic sample analyzer 100. Sensor signals (indicative of measured values) received from, e.g., one or more sensors of sensor array 120 may be processed by second controller 204C2 (or alternatively another controller in diagnostic sample analyzer 100) to detect an oxygen level in a blood sample applied to test card 104. Electrical signals from any additional or alternative sensors for measuring other fluid properties of a liquid sample may alternatively or additionally be received and processed by second controller 204C2 (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 204C2 may be performed by first controller 204C1 and vice versa and / or by one or more other controllers in diagnostic sample analyzer 100. In some embodiments, test results and other information may be transmitted to a hospital information system (HIS) 208.

[0048] Diagnostic sample analyzer 100 also includes a test card 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 card 104. Upon insertion of test card 104 into test card reader 102R, test card sensors of sensor array 120 are electrically connected to controller 204 (or first controller 204C1 and / or second controller 204C2) to process sensor signals. As shown, test card reader 102R may comprise a slot that is sized to receive test card 104 therein.

[0049] In some embodiments, test card 104 may resemble a playing card in view of its thin profile as compared to itswidth and length. In some embodiments, test card 104 may have a length of about 85 mm, a width of about 55 mm, and a thickness of about 1.2 mm. In other embodiments, test card 104 may be considered a test cartridge or other test consumable having other length, width, and thickness dimensions. More generally, test card 104 may be any suitable shape or size configured to be received in a correspondingly constructed test card reader 102R. Test card 104 may be manufactured from 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.

[0050] As shown in FIG. 2, test card 104 includes one or more sensors 120A-N (a few labelled) enclosed within a test card body 210. Sensor(s) 120A-N may comprise an array or panel of sensors (e.g., sensor array 120) operative to test for multiple conditions or analytes, such as, e.g., glucose, BUN (blood urea nitrogen), creatine, etc. Sensor(s) 120A-N to test for other fluid properties may additionally or alternatively be included. Note that operation of sensor(s) 120A-N and the subsequent processing of electrical signals generated by sensor(s) 120A-N to determine a value of one or more fluid properties of a liquid sample are known to persons of skill in the art and will not be described in more detail herein.

[0051] Test card 104 also includes sample inlet 118, which may be a port, opening, receiving element, or the like, configured to receive a liquid sample 212 to be tested therein. Sample inlet 118 may be provided on a top layer 210T of test card body 210. Sample inlet 118 may comprise a circular or otherwise shaped opening providing a port configured to receive sample 212 therein. Liquid sample 212 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) 120A-N included in test card 104.

[0052] Sample inlet 118 may be configured to allow sample 212 to be dispensed therein or thereon by any suitable sample holder or sample transfer device. For example, in one embodiment, sample inlet 118 may be configured to allow a syringe, a capillary tube, a suitable pump, or other transfer device to be sealingly coupled to sample inlet 118 to provide sample 212 therein. In some embodiments, sample inlet 118 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 118 is coupled via one or more sample passageways (not shown in FIG. 1) to sensor(s) 120A-N.

[0053] Test card body 210 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 210T and / or a bottom layer (not shown) may be a clear (transparent or translucent) material so the flow of sample 212 therethrough may be visually observed and / or optically detected. As stated, diagnostic sample analyzer 100 may include one or more optical sensors (e.g., first and second sample-area optical sensors 128a, 128b and / or first and second test-area optical sensors 130a, 130b of FIG. 1) for detecting fluid presence and / or flow in and / or through the one or more sample passageways in test card 104.

[0054] FIG. 3A illustrates an example embodiment of test card 104 for use in diagnostic sample analyzer 100 according to one or more embodiments. Test card 104 includes sample inlet 118, sample storage area 122, a sample storage area outlet 306, a sample passageway 308, sensor channel 134, andsensor array 120. Sample inlet 118 is configured to receive a liquid sample from a user. In some embodiments, sample inlet 118 may be configured to allow a syringe, a capillary tube, a suitable pump, or other transfer device to be sealingly coupled thereto to provide the liquid sample to test card 104 and may be accessible on top side 210T of test card 104.

[0055] Sample inlet 118 is coupled to sample storage area 122, which is configured to receive and hold a liquid sample therein. Sample storage area 122 may have a vent hole 122H as shown in FIG. 3A to allow air to escape as a liquid sample is injected into sample inlet 118. In some embodiments, sample storage area 122 is configured to hold up to about 170 µL or more of a liquid sample. Sample storage area 122 may be configured as a C-shaped channel, chamber, or conduit having a total length ranging from 56 mm to 66 mm, a width ranging from 1.0 mm to 4.5 mm, and a depth ranging from 0.2 mm to 0.75 mm (in this embodiment, the cross section is rectangular). Other configurations, cross-sectional shapes, and dimensions are possible.

[0056] Outlet 306 is coupled to sample passageway 308, which is coupled to a first end 310 of sensor channel 134. Sensor channel 134 extends over (as viewed in FIG. 3A) sensor array 120 and allows a liquid sample to contact one or more sensor(s) 120A-N through the open bottom of sensor channel 134 (i.e., sensor array 120 forms the bottom of sensor channel 134). Sensor(s) 120A-N (two labeled in FIG. 3A) may be printed into respective wells in sensor array 120. The flow configuration of sample passageway 308 coupled to outlet 306 prevents a liquid sample held in sample storage area 122 from flowing uncontrolled to sensor array 120. Sensor array 120 may be integrally formed or embodied within test card 104.

[0057] Test card 104 further includes a vacuum port 312. Vacuum port 312 is coupled to a second end 314 of sensorchannel 134 via a waste passageway 316 (e.g., which corresponds to waste area 126 of test card 104 of FIG. 1). Vacuum port 312 is configured to connect to a vacuum pump of diagnostic sample analyzer 100 (e.g., pump 106 of FIG. 1) to draw a liquid sample from sample storage area 122 into contact with sensor array 120 via outlet 306, sample passageway 308, and sensor channel 134. In some embodiments, vacuum port 312 may be connectable to a vacuum pump on the bottom side (not shown) of test card 104. 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. In still other embodiments, a positive pressure pump may be connected to vent hole 122H to drive a liquid sample from sample storage area 122 into contact with sensor array 120 (using vacuum port 312 as a vent hole).

[0058] Test card 104 also includes a calibration fluid pack 318 (e.g., corresponding to calibration fluid source 124 in FIG. 1), a valve 320, and a bubble trap 322. Calibration fluid pack 318 is coupled to first end 310 of sensor channel 134 and contains a calibration fluid used to calibrate sensor array 120. In some embodiments, calibration fluid pack 318 may be formed with two layers of foil that are heat-sealed together. Valve 320 and bubble trap 322 are coupled between calibration fluid pack 318 and first end 310 of sensor channel 134. Valve 320 holds the calibration fluid in calibration fluid pack 318 until sensor calibration is performed, at which time a mechanism in diagnostic sample analyzer 100, which may be a plunger and push-pin mechanism, opens valve 320 to deliver calibration fluid to sensor array 120 via sensor channel 134. Bubble trap 322 is configured to collect air pockets from calibration fluid pack 318 to prevent them from entering sensor channel 134.

[0059] Waste passageway 316 is configured (e.g., sized) to hold the calibration fluid after completion of sensor calibration. Upon activation of a vacuum pump of diagnostic sample analyzer 100 (e.g., pump 106 in FIG. 1), calibration fluid in sensor channel 134 is drawn into waste passageway 316 as the liquid sample in sample storage area 122 is drawn through outlet 306 and sample passageway 308 into sensor channel 134.

[0060] FIG. 3B illustrates test card 104 positioned within test card reader 102R of diagnostic sample analyzer 100 according to one or more embodiments. As shown in FIG. 3B, first and second sample-area optical sensors 128a and 128b of diagnostic sample analyzer 100 may be positioned within test card reader 102R so that they can detect fluid within sample storage area 122. Additionally, first test-area optical sensor 130a may be positioned (within test card reader 102R) to detect a liquid sample at sensor array 120 transferred from sample storage area 122 via sensor channel 134 and sample passageway 308. Second test-area optical sensor 130b may be positioned to detect fluid (e.g., calibration fluid or a patient sample) within waste passageway 316. Fewer, additional, and / or other optical sensor positions may be employed.

[0061] FIG. 3C illustrates example signal flow during measurements of liquid sample movement within test card 104 with optical sensors of diagnostic sample analyzer 100 and conductivity sensors of test card 104 according to one or more embodiments. With reference to FIG. 3C, first sample-area optical sensors 128a, 128b (present within test card reader 102R of diagnostic analyzer 100 of FIG. 1) are positioned to detect a liquid sample inserted into test card 104 through sample inlet 118 and stored in sample storage area 122. In some embodiments, first sample-area optical sensor 128a ofdiagnostic sample analyzer 100 may be positioned to detect entry of the liquid sample into sample storage area 122 and second sample-area optical sensor 128b of diagnostic sample analyzer 100 may be positioned to detect that a predetermined (e.g., minimum) amount of liquid sample is present within sample storage area 122.

[0062] During transfer of the liquid sample from sample storage area 122 to sensor array 120, first test-area optical sensor 130a may be positioned to detect that the liquid sample has travelled through sensor channel 134 past the sensors of sensor array 120. This, alone or in combination with conductivity measurements from first and second conductivity sensors 120C1 and 120C2, may confirm that a sufficient volume of liquid sample is present at sensor array 120. Signals from each optical sensor and conductivity sensor are fed to processor 112 (e.g., executing computer program instructions 116 stored in memory 114).

[0063] Processor 112 may include (e.g., via execution of computer program instructions in memory 114) a conductivity level analyzer 330 configured to detect a change in conductivity at first and second conductivity sensors 120C1, 120C2 when they are contacted by the liquid sample transferred to sensor array 120 from sample storage area 122. For example, conductivity sensors 120C1 and 120C2 will initially detect air from sample passageway 308 and then liquid sample from sample storage area 122 during sample transfer with pump 106. Conductivity level analyzer 330 may determine the state of both first conductivity sensor 120C1 and second conductivity sensor 120C2 and provide this information to a test-area state controller 332.

[0064] Similarly, processor 112 may include a test-area optical sensor output level analyzer 334 configured to detect a change in intensity of an optical beam from first test-areaoptical sensor 130a due to the presence of the liquid sample as it travels through sensor channel 134 past sensor array 120, as well as a change in intensity of an optical beam from second test-area optical sensor 130b due to the presence of a liquid in waste passageway 316. This information is also provided to test-area state controller 332.

[0065] In one or more embodiments, diagnostic sample analyzer 100 may include at least one optical sensor (e.g., optical sensor 128a or 128b) positioned upstream / before sensor array 120 to detect sample presence in test card 104 (e.g., sample insertion or predetermined volume). That is, a single optical sensor or multiple optical sensors may be employed for sample detection within sample storage area 122 and / or for use by sample-area optical sensor output level analyzer 336 of FIG. 3C. Additionally or alternatively, at least one conductivity sensor (e.g., conductivity sensor 120C1 or 120C2) may be positioned in sensor array 120 to detect sample presence at sensor array 120 (e.g., for detection within sensor array 120 and / or for use by conductivity level analyzer 330 of FIG. 3C). Additionally or alternatively, at least one optical sensor (e.g., optical sensor 130a or 130b) may be positioned downstream / after sensor array 120 to detect a sample and / or calibration fluid presence at sensor array 120 and / or waste passageway 316 (e.g., for use by test-area optical sensor output level analyzer 334 of FIG. 3C).

[0066] In response to detection of the liquid sample at sensor array 120 by one or more of first and second conductivity sensors 120C1 and 120C2 (as analyzed by conductivity level analyzer 330) and / or detection of the liquid sample within sensor channel 134 by first test-area optical sensor 130a (as analyzed by test-area optical sensor output level analyzer 334), test-area state controller 332 may determine that a predetermined (e.g., sufficient) amount ofliquid sample has been transferred to sensor array 120. Processor 112, through test-area state controller 332, may then signal pump 106 to turn off to stop further transfer of the liquid sample. Further, processor 112 (via test-area state controller 332) may trigger the start of testing of the liquid sample by diagnostic sample analyzer 100. Processor 112, through test-area state controller 332, may also signal pump 106 to turn off to stop further transfer of the liquid sample responsive to detection of a liquid (e.g., calibration fluid and / or a patient sample) by second test-area optical sensor 130b in waste passageway 316 near vacuum port 312 (e.g., to prevent fluid from travelling through vent port 312 and flooding diagnostic sample analyzer 100). Detection of fluid by second test-area optical sensor 130b may indicate an error condition (e.g., test card 104 is defective due to air leakage or another error condition). Processor 112 may notify a user of such an error condition (e.g., via a visual, auditory, or tactile indication or alert).

[0067] Processor 112 may further include a sample-area optical sensor output level analyzer 336 configured to detect a change in intensity of an optical beam from first sample- area optical sensor 128a due to the presence of the liquid sample as it travels into sample storage area 122 of test card 104, as well as a change in intensity of an optical beam from second sample-area optical sensor 128b as the liquid sample reaches this sensor. This information is provided to a sample- area state controller 338.

[0068] In response to detection of the liquid sample at second sample-area optical sensor 128b, sample-area state controller 338 may determine that a predetermined (e.g., sufficient) amount of liquid sample is present within sample storage area 122. Processor 112, through sample-area state controller 338, may instruct a user (via input / output device110 of FIG. 1 and / or display 202D of FIG. 2) to stop injecting a sample into test card 104. Processor 112, through sample- area state controller 338, may also initiate sample transfer from sample storage area 122 to sensor array 120 by activating pump 106. As stated, processor 112 may also employ information from first and / or second sample-area optical sensors 128a, 128b to determine one or more of an injection speed, a sample type, and a sample viscosity for the liquid sample.

[0069] In some embodiments, in response to the determination of one or more of an injection speed, a sample type, and a sample viscosity, processor 112 may be configured to proceed with testing and / or alert the user of an error. In further embodiments, processor 112 may cause pump 106 to initiate pumping of the sample from sample storage area 122 to sensor array 120 and / or adjust a pump speed of pump 106 based on the determined injection speed, sample type and / or sample viscosity feedback. Alternatively or additionally, in some embodiments, processor 112 may be configured to adjust sample measurement values and / or other analysis results based on the determined sample type and / or sample viscosity.

[0070] Therefore, detection and precise sample volume positioning over the sensors of sensor array 120 may be achieved by the combination of optical and conductivity sensors (e.g., electrochemical conductivity sensors). To achieve accurate detection of a liquid sample introduced into test card 104, two optical sensors may be employed (e.g., first and second sample-area optical detectors 128a, 128b). The optical sensors are placed at designated locations over sample storage area 122. First sample-area optical sensor 128a is positioned near sample inlet 118 and indicates an injection attempt (start of injection), while second sample-area optical sensor 128b indicates a minimum required sample volume being introduced into test card 104. These sample-area opticalsensors may react to fluid movement detected in the channel forming sample storage area 122 by changing the output voltage level of each sensor, which is analyzed by processor 112.

[0071] When sample-area optical sensor output level analyzer 336 observes a rapid change in the optical sensor response and a change in average output level from first sample-area optical sensor 128a and second sample-area sensor 128b, sample-area state controller 338 determines that a liquid sample has been introduced to sample storage area 122 at a predetermined amount (corresponding to a logical change between 'air' and 'fluid' states). As stated, processor 112 may then provide feedback to the user to stop sample injection into test card 104. Feedback may also be provided to a pump to initiate pumping of the sample from sample storage area 122 to sensor array 120. In addition, the delay in responses between first and second sample-area optical sensors 128a, 128b and the level of sensor responses helps to determine injection speed, sample type, and sample viscosity. Such information may be used by diagnostic sample analyzer 100 during quality control.

[0072] The second set of optical sensors (e.g., first and second test-area optical sensors 130a, 130b) and conductivity sensors 120C1, 120C2 may provide precise sample positioning in the sensor area. The volume of sample between conductivity sensors 120C1 and 120C2 may be considered the minimum required sample volume to accurately run a test. When diagnostic sample analyzer 100, via pump 106, moves a sample from sample storage area 122 over sensor array 120, processor 112 may monitor the response from first test-area optical sensor 130a. A transition from 'air' to 'fluid' at conductivity sensors 120C1 and 120C2 and at first test-area optical sensor 130a indicates that the liquid sample transfer from sample storage area 122 to sensor array 120 is complete. In response to such an event,diagnostic sample analyzer 100 (via processor 112) may stop sample movement by deactivating pump 106. In some embodiments, a predetermined amount of liquid sample at sensor array 120 may be detected by a combination of first test-area optical sensor 130a and second conductivity sensor 120C2.

[0073] Conductivity sensors 120C1 and 120C2 may also be used for quality control purposes. As stated, conductivity sensors 120C1 and 120C2 may be employed to detect bubbles in the liquid sample at sensor array 120 and ensure that the sample is delivered successfully over all of the sensors of sensor array 120. Conductivity sensors 120C1 and 120C2 are positioned at opposite ends of sensor array 120 so that, in combination with first test-area optical sensor 130a positioned at the end of sensor array 120, diagnostic sample analyzer 100 may determine / regulate accurate sample placement of the liquid sample over all sensors of sensor array 120 by detecting voltage changes at conductivity sensors 120C1, 120C2 and first test-area optical sensor 130a (due to the transition from air to fluid at sensor array 120). Responsive thereto, diagnostic sample analyzer 100 (via processor 112) may deactivate pump 106 and initiate performing a test. The 'fluid' state of both conductivity sensors may confirm that all sensors are fully covered with the liquid sample.

[0074] Second test-area optical sensor 130b is positioned in waste passageway 316 and may function as a system safeguard which protects diagnostic sample analyzer 100 from fluid flooding (e.g., exceeding the sample volume requirement for sensor channel 134 that may cause fluid to enter vacuum port 312). That is, an 'air' to 'fluid' state transition of second test-area optical sensor 130b may be detected by processor 112 and processor 112 may trigger an emergency stop of sample movement (e.g., by deactivating pump 106).

[0075] It should be noted that in addition to patient sample fluid regulation, proper fluid movement and positioning of calibration fluid similarly may be controlled using the above-mentioned combination of conductivity sensors 120C1, 120C2 and first and second test-area optical sensors 130a, 130b. Further, first sample-area optical sensor 128a may be used for quality control of the sample delivery system of diagnostic sample analyzer 100. If first sample-area optical sensor 128a detects calibration fluid (e.g., as identified by processor 112 based on the intensity of the reflected signal from test card 104), processor 112 may indicate malfunctioning of a fluidics component (e.g., a vacuum port is blocked, a valve is stuck, etc.) and notify the user regarding instrument failure (e.g., via input / output device 110).

[0076] An example description of operation of diagnostic sample analyzer 100 is as follows. A test card 104 may be received into test card reader 102R of diagnostic sample analyzer 100. Processor 112 may execute initial tests related to the functionality of at least test card 104. Initial tests related to the functionality of at least test card 104 may include, e.g., a card validation check (via, e.g., a barcode scanner in test card reader 102R) to ensure that the test card (including, e.g., the calibration fluid and sensor(s) therein) has not expired, a dry card check to ensure that the test card has not been previously used, and / or a calibration fluid check to ensure a sufficient volume of calibration fluid is delivered to sensor array 120.

[0077] The calibration fluid check may be performed, e.g., by directing, e.g., a plunger and push-pin mechanism to open valve 320 (FIG. 3A) to deliver calibration fluid to sensor array 120 via sensor channel 134, wherein first test-area optical sensor 130a and / or conductivity sensors 120C1, 120C2 are operative to detect that a sufficient volume ofcalibration fluid has been delivered to sensor array 120. Optional additional initial tests may include a vacuum check to ensure that pump 106 in the diagnostic sample analyzer 100 is working and / or a heater check to ensure that heater 108 in diagnostic sample analyzer 100 is working. 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 204, first controller 204C1 or second controller 204C2 (e.g., processor 112 of FIG. 1), 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.

[0078] After the initial tests are complete, a user may be prompted via input / output device 110 of diagnostic sample analyzer 100 (such as display 202D of computing device 202 of FIG. 2) to apply a liquid sample to test card 104 in response to completion of the initial tests indicating no errors. Additionally or alternatively, input / output device 110 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 118 of test card 104.

[0079] Diagnostic sample analyzer 100 (e.g., via processor 112) may calibrate sensor array 120 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 processor 112 may perform sensor calibration by processing one or more calibration measurement signals received from sensor array 120 to determine one or more calibration measurement values in response to completion of the calibration fluid check indicating no errors. For example,processor 112 may perform sensor calibration by directing, e.g., a plunger and push-pin mechanism to open valve 320 (FIG. 2) to deliver calibration fluid to sensor array 120 via sensor channel 134 and then processing one or more calibration measurement signals received from sensor array 120 to determine one or more calibration measurement values.

[0080] After successful calibration, processor 112 may cause the liquid sample within sample storage area 122 to be transferred to sensor array 120 (e.g., by activating pump 106). Processor 112 may then analyze the liquid sample at sensor array 120. Processor 112 may process one or more sample measurement signals received from sensor array 120 to determine one or more sample measurement values in response to a liquid sample contacting the sensors of sensor array 120. Processor 112 may then communicate sample measurement values and / or other analysis results may be displayed on input / output device 110 of diagnostic sample analyzer 100.

[0081] In some embodiments, the liquid sample may be detected by first and / or second sample-area optical sensor 128a, 128b, and the liquid sample may be drawn automatically from sample storage area 122 through sample passageway 308 to sensor array 120 via pump 106 of diagnostic sample analyzer 100 coupled to vacuum port 312. The pump provides uniform / consistent speed and volume flow of the liquid sample to sensor array 120, which may reduce variability in the sample analysis results. In some embodiments, the delivery time of the liquid sample to sensor array 120 may range from 1.0 second to 10 seconds. Other liquid sample delivery times are possible.

[0082] Note that a user may apply a liquid sample to sample inlet 118 in response to prompting either before or during the sensor calibration. The liquid may be transferred from sample storage area 122, via pump 106, to sensor array 120 inresponse to completion of the sensor calibration and / or detection of the liquid sample in sample storage area 122.

[0083] FIG. 4A is a flowchart of an example process 400A for measuring a property of a liquid sample according to one or more embodiments. In some implementations, one or more process blocks of FIG. 4A may be performed by processor 112 of diagnostic sample analyzer 100 (e.g., executing one or more programs in memory 114 such as computer program instructions 116).

[0084] As shown in FIG. 4A, process 400A may include receiving a test card in the diagnostic sample analyzer, the test card including at least one test card sensor (block 402a). For example, diagnostic sample analyzer 100 may receive a test card 104 in test card reader 102R of diagnostic sample analyzer 100, the test card including at least one test card sensor, as described above.

[0085] As also shown in FIG. 4A, process 400A may include receiving a liquid sample into the test card (block 404a). For example, a user may supply a liquid sample to sample inlet 118 of test card 104, as described above.

[0086] As further shown in FIG. 4A, process 400A may include employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor (block 406a). For example, diagnostic sample analyzer 100 (via processor 112) may employ at least one of first sample-area optical sensor 128a, second sample-area optical sensor 128b, first test-area optical sensor 130a, and second test-area optical sensor 130b of diagnostic sample analyzer 100 to detect the liquid sample within test card 104, as described above.

[0087] As also shown in FIG. 4A, process 400A may include analyzing, via a processor of the diagnostic sample analyzer,the liquid sample at the at least one test card sensor (block 408a). For example, diagnostic sample analyzer 100 may analyze, via processor 112, the liquid sample at one or more sensors of sensor array 120, as described above. This may include producing at least one test result.

[0088] As further shown in FIG. 4A, process 400A may include communicating results of the analyzing (block 410a). For example, diagnostic sample analyzer 100 (via processor 112) may communicate results of analyzing the liquid sample using input / output device 110, as described above. This may include communicating a test result via input / output device 110 (or another display).

[0089] Although FIG. 4A shows example blocks of process 400A, in some implementations, process 400A may include additional blocks, fewer blocks, different blocks, or differently arranged blocks than those depicted in FIG. 4A. Additionally, or alternatively, two or more of the blocks of process 400A may be performed in parallel.

[0090] FIG. 4B is a flowchart of an example process 400B for measuring a property of a liquid sample according to one or more embodiments. In some implementations, one or more process blocks of FIG. 4B may be performed by processor 112 of diagnostic sample analyzer 100 (e.g., executing one or more programs in memory 114 such as computer program instructions 116).

[0091] As shown in FIG. 4B, process 400B may include receiving a test card in the diagnostic sample analyzer, the test card including at least one test card sensor (block 402b) and receiving a liquid sample into the test card (block 404b).

[0092] As further shown in FIG. 4B, process 400B may include employing at least one optical sensor of the diagnostic sample analyzer and / or at least one conductivity sensor of the test card to detect the liquid sample within thetest card (block 406b). For example, diagnostic sample analyzer 100 (via processor 112) may employ at least one of first sample-area optical sensor 128a, second sample-area optical sensor 128b, first test-area optical sensor 130a, and second test-area optical sensor 130b of diagnostic sample analyzer 100 to detect the liquid sample within test card 104, as described above. Alternatively, instead of employing an optical sensor, diagnostic sample analyzer 100 (via processor 112) may employ at least one of first conductivity sensor 120C1 and second conductivity sensor 120C2 of test card 104 to detect the liquid sample within test card 104, as described above. In yet other embodiments, both one or more optical sensors and one or more conductivity sensors may be employed to detect the liquid sample within test card 104, as described above.

[0093] As also shown in FIG. 4B, process 400B may include analyzing, via a processor of the diagnostic sample analyzer, the liquid sample at the at least one test card sensor (block 408b) and communicating results of the analyzing (block 410b). For example, diagnostic sample analyzer 100 (via processor 112) may communicate results of analyzing the liquid sample using input / output device 110, as described above. This may include communicating a test result via input / output device 110 (or another display).

[0094] Although FIG. 4B shows example blocks of process 400B, in some implementations, process 400B may include additional blocks, fewer blocks, different blocks, or differently arranged blocks than those depicted in FIG. 4B. Additionally, or alternatively, two or more of the blocks of process 400B may be performed in parallel.

[0095] As shown in FIG. 5, process 500 may include receiving a test card in the diagnostic sample analyzer, the test card including a sensor array and a sample storage area(block 502). For example, diagnostic sample analyzer 100 may receive a test card 104 in test card reader 102R of diagnostic sample analyzer 100, the test card 104 including sensor array 120 and sample storage area 122, as described above.

[0096] As also shown in FIG. 5, process 500 may include receiving a liquid sample into the sample storage area of the test card (block 504). For example, a user may supply a liquid sample to sample inlet 118 of test card 104, as described above.

[0097] As further shown in FIG. 5, process 500 may include employing a first sample-area optical sensor and a second sample-area optical sensor of the diagnostic sample analyzer to detect the liquid sample within the sample storage area of the test card (block 506). For example, diagnostic sample analyzer 100 (via processor 112) may employ first sample-area optical sensor 128a and second sample-area optical sensor 128b of diagnostic sample analyzer 100 to detect the liquid sample within sample storage area 122 of test card 104, as described above.

[0098] As also shown in FIG. 5, process 500 may include calibrating the sensor array via a processor of the diagnostic sample analyzer (block 508). For example, diagnostic sample analyzer 100 may calibrate sensor array 120 via processor 112 of diagnostic sample analyzer 100, as described above.

[0099] As further shown in FIG. 5, process 500 may include transferring the liquid sample from the sample storage area to the sensor array via a pump of the diagnostic sample analyzer in response to completion of the calibrating and the detecting the liquid sample within the sample storage area (block 510). For example, diagnostic sample analyzer 100 may transfer the liquid sample from sample storage area 122 to sensor array 120 via pump 106 of diagnostic sample analyzer 100 in response to completion of calibrating sensor array 120 and detecting theliquid sample within sample storage area 122, as described above.

[0100] As also shown in FIG. 5, process 500 may include employing a first conductivity sensor and a second conductivity sensor to detect the liquid sample at the sensor array (block 512). For example, diagnostic sample analyzer 100 (via processor 112) may employ first conductivity sensor 120C1 and second conductivity sensor 120C2 to detect the liquid sample at sensor array 120, as described above.

[0101] As further shown in FIG. 5, process 500 may include analyzing, via the processor, the liquid sample at the sensor array (block 514). For example, diagnostic sample analyzer 100 may analyze, via processor 112, the liquid sample at sensor array 120, as described above.

[0102] As also shown in FIG. 5, process 500 may include communicating results of the analyzing (block 516). For example, diagnostic sample analyzer 100 (via processor 112) may communicate results of the analyzing using input / output device 110, as described above.

[0103] Although FIG. 5 shows example blocks of process 500, in some implementations, process 500 may include additional blocks, fewer blocks, different blocks, or differently arranged blocks than those depicted in FIG. 5. Additionally, or alternatively, two or more of the blocks of process 500 may be performed in parallel. ILLUSTRATIVE EMBODIMENTS

[0104] The following provides a non-limiting list of illustrative embodiments of this disclosure:

[0105] An illustrative method of operating a diagnostic sample analyzer, the method comprising: receiving a test card in the diagnostic sample analyzer, the test card including at least one test card sensor; receiving a liquid sample into thetest card; employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor; analyzing, via a processor of the diagnostic sample analyzer, the liquid sample at the at least one test card sensor; and communicating results of the analyzing.

[0106] The illustrative method of any one of the proceeding illustrative embodiments, wherein: receiving a liquid sample into the test card comprises receiving the liquid sample at a sample inlet of the test card, the sample inlet coupled to a sample storage area of the test card; and employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card comprises detecting a presence of the liquid sample within the sample storage area via the at least one optical sensor.

[0107] The illustrative method of any one of the proceeding illustrative embodiments, wherein detecting a presence of the liquid sample within the sample storage area via the at least one optical sensor comprises employing a first sample-area optical sensor of the diagnostic sample analyzer to detect entry of the liquid sample into the sample storage area and a second sample-area optical sensor of the diagnostic sample analyzer to detect that a predetermined amount of liquid sample is present within the sample storage area.

[0108] The illustrative method of any one of the proceeding illustrative embodiments, further comprising at least one of: prompting a user to stop injecting the liquid sample into the test card in response to the second sample-area optical sensor detecting the liquid sample; and transferring the liquid sample from the sample storage area to the at least one test card sensor of the test card via a pump of the diagnostic sample analyzer after detecting the presence of the liquidsample within the sample storage area with the second sample- area optical sensor.

[0109] The illustrative method of any one of the proceeding illustrative embodiments, further comprising employing at least one of the first and second sample-area optical sensors to determine one or more of an injection speed, a sample type, and a sample viscosity for the liquid sample.

[0110] The illustrative method of any one of the proceeding illustrative embodiments, wherein the at least one test card sensor includes a sensor array having a plurality of sensors including a first conductivity sensor and a second conductivity sensor and further comprising employing the first and second conductivity sensors to detect a predetermined amount of liquid sample is present at the sensor array.

[0111] The illustrative method of any one of the proceeding illustrative embodiments, further comprising employing the first and second conductivity sensors to detect a presence of one or more bubbles in the liquid sample at the sensor array.

[0112] The illustrative method of any one of the proceeding illustrative embodiments, wherein employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card comprises using a first test-area optical sensor of the diagnostic sample analyzer to confirm the predetermined amount of liquid sample is present at the sensor array.

[0113] The illustrative method of any one of the proceeding illustrative embodiments, further comprising: employing a pump of the diagnostic sample analyzer to transfer the liquid sample from a sample storage area of the test card to the sensor array; and responsive to detecting the liquid sample by the first and second conductivity sensors or the first test- area optical sensor, deactivating the pump.

[0114] The illustrative method of any one of the proceeding illustrative embodiments, further comprising using a second test-area optical sensor of the diagnostic sample analyzer to detect a fluid within a waste passageway of the test card and, responsive to detecting the fluid within the waste passageway of the test card, either prompting a user to stop injecting the liquid sample into the test card or stopping a pump of the diagnostic sample analyzer used to transfer the liquid sample to the sensor array.

[0115] An illustrative method of operating a diagnostic sample analyzer, the method comprising: receiving a test card in the diagnostic sample analyzer, the test card including a sensor array and a sample storage area; receiving a liquid sample into the sample storage area of the test card; employing a first sample-area optical sensor and a second sample-area optical sensor of the diagnostic sample analyzer to detect the liquid sample within the sample storage area of the test card; calibrating the sensor array via a processor of the diagnostic sample analyzer; transferring the liquid sample from the sample storage area to the sensor array via a pump of the diagnostic sample analyzer in response to completion of the calibrating and the detecting the liquid sample within the sample storage area; employing a first conductivity sensor and a second conductivity sensor to detect the liquid sample at the sensor array; analyzing, via the processor, the liquid sample at the sensor array; and communicating results of the analyzing.

[0116] The illustrative method of any one of the proceeding illustrative embodiments, further comprising: employing the first sample-area optical sensor of the diagnostic sample analyzer to detect entry of the liquid sample into the sample storage area of the test card and the second sample-area optical sensor of the diagnostic sample analyzer to detectthat a predetermined amount of liquid sample is present within the sample storage area; and employing the first and second conductivity sensors to determine a predetermined amount of liquid sample is present at the sensor array.

[0117] The illustrative method of any one of the proceeding illustrative embodiments, further comprising employing a first test-area optical sensor of the diagnostic sample analyzer to confirm the predetermined amount of liquid sample is present at the sensor array and a second test-area optical sensor of the diagnostic sample analyzer to detect a fluid within a waste passageway of the test card.

[0118] An illustrative diagnostic sample analyzer, comprising: a test card reader configured to receive a test card, the test card including at least one test card sensor configured to generate an electrical signal indicative of a value of a fluid property of a liquid sample; at least one optical sensor configured to detect the liquid sample within the test card; a display; a processor coupled to the test card reader, the at least one optical sensor, and the display; and a memory coupled to the processor. The memory includes computer program instructions that, when executed by the processor, cause the processor to: prompt a user via the display to apply the liquid sample to the test card; employ the at least one optical sensor to detect the liquid sample within the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor; analyze the liquid sample at the at least one test card sensor to produce a test result; and communicate the test result via the display.

[0119] The illustrative diagnostic sample analyzer of any one of the proceeding illustrative embodiments, wherein the test card includes a sample inlet coupled to a sample storage area and the at least one optical sensor includes a firstsample-area optical sensor positioned to detect entry of the liquid sample into the sample storage area and a second sample-area optical sensor positioned to detect that a predetermined amount of liquid sample is present within the sample storage area of the test card.

[0120] The illustrative diagnostic sample analyzer of any one of the proceeding illustrative embodiments, wherein the memory includes computer program instructions that, when executed by the processor, cause the processor to prompt a user to stop injecting the liquid sample into the test card in response to the second sample-area optical sensor detecting the liquid sample.

[0121] The illustrative diagnostic sample analyzer of any one of the proceeding illustrative embodiments, wherein the memory includes computer program instructions that, when executed by the processor, cause the processor to employ the first and second sample-area optical sensors to determine one or more of an injection speed, a sample type, and a sample viscosity for the liquid sample.

[0122] The illustrative diagnostic sample analyzer of any one of the proceeding illustrative embodiments, wherein the at least one test card sensor of the test card includes a sensor array having a plurality of sensors including a first conductivity sensor and a second conductivity sensor and wherein the memory includes computer program instructions that, when executed by the processor, cause the processor to employ the first and second conductivity sensors to at least one of: detect a predetermined amount of liquid sample is present at the sensor array; and detect a presence of one or more bubbles in the liquid sample at the sensor array.

[0123] The illustrative diagnostic sample analyzer of any one of the proceeding illustrative embodiments, further comprising a pump and wherein the test card includes a samplestorage area, the at least one optical sensor includes a first sample-area optical sensor and a second sample-area optical sensor, the at least one test card sensor includes a sensor array having a first conductivity sensor and a second conductivity sensor, and the memory includes computer program instructions that, when executed by the processor, cause the processor to: prompt a user via the display to apply the liquid sample to the sample storage area of the test card; employ the first sample-area optical sensor and the second sample-area optical sensor to detect that a predetermined amount of liquid sample is present within the sample storage area; calibrate the sensor array; transfer the liquid sample from the sample storage area to the sensor array via the pump in response to completion of the calibrating and the detecting the liquid sample within the sample storage area; employ the first conductivity sensor and the second conductivity sensor to determine a predetermined amount of liquid sample is present at the sensor array; analyze the liquid sample at the sensor array; and communicate results of the analyzing via the display.

[0124] The illustrative diagnostic sample analyzer of any one of the proceeding illustrative embodiments, further comprising a first test-area optical sensor and a second test- area optical sensor and wherein the memory includes computer program instructions that, when executed by the processor, cause the processor to: employ the first test-area optical sensor to confirm the predetermined amount of liquid sample is present at the sensor array; employ the second test-area optical sensor to detect a fluid within a waste passageway of the test card; and responsive to detecting the fluid within the waste passageway of the test card, stop the pump used to transfer the liquid sample to the sensor array.

[0125] 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 or the following claims.

Claims

WHAT IS CLAIMED IS:

1. A method of operating a diagnostic sample analyzer, the method comprising: receiving a test card in the diagnostic sample analyzer, the test card including at least one test card sensor; receiving a liquid sample into the test card; employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor; analyzing, via a processor of the diagnostic sample analyzer, the liquid sample at the at least one test card sensor; and communicating results of the analyzing.

2. The method of claim 1, wherein: receiving a liquid sample into the test card comprises receiving the liquid sample at a sample inlet of the test card, the sample inlet coupled to a sample storage area of the test card; and employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card comprises detecting a presence of the liquid sample within the sample storage area via the at least one optical sensor.

3. The method of claim 2, wherein detecting a presence of the liquid sample within the sample storage area via the at least one optical sensor comprises employing a first sample- area optical sensor of the diagnostic sample analyzer to detect entry of the liquid sample into the sample storage area and a second sample-area optical sensor of the diagnosticsample analyzer to detect that a predetermined amount of liquid sample is present within the sample storage area.

4. The method of claim 3, further comprising at least one of: prompting a user to stop injecting the liquid sample into the test card in response to the second sample-area optical sensor detecting the liquid sample; and transferring the liquid sample from the sample storage area to the at least one test card sensor of the test card via a pump of the diagnostic sample analyzer after detecting the presence of the liquid sample within the sample storage area with the second sample-area optical sensor.

5. The method of claim 3, further comprising employing at least one of the first and second sample-area optical sensors to determine one or more of an injection speed, a sample type, and a sample viscosity for the liquid sample.

6. The method of claim 1, wherein the at least one test card sensor includes a sensor array having a plurality of sensors including a first conductivity sensor and a second conductivity sensor and further comprising employing the first and second conductivity sensors to detect a predetermined amount of liquid sample is present at the sensor array.

7. The method of claim 6, further comprising employing the first and second conductivity sensors to detect a presence of one or more bubbles in the liquid sample at the sensor array.

8. The method of claim 6, wherein employing at least one optical sensor of the diagnostic sample analyzer to detect the liquid sample within the test card comprises using a firsttest-area optical sensor of the diagnostic sample analyzer to confirm the predetermined amount of liquid sample is present at the sensor array.

9. The method of claim 8, further comprising: employing a pump of the diagnostic sample analyzer to transfer the liquid sample from a sample storage area of the test card to the sensor array; and responsive to detecting the liquid sample by the first and second conductivity sensors or the first test-area optical sensor, deactivating the pump.

10. The method of claim 8, further comprising using a second test-area optical sensor of the diagnostic sample analyzer to detect a fluid within a waste passageway of the test card and, responsive to detecting the fluid within the waste passageway of the test card, either prompting a user to stop injecting the liquid sample into the test card or stopping a pump of the diagnostic sample analyzer used to transfer the liquid sample to the sensor array.

11. A method of operating a diagnostic sample analyzer, the method comprising: receiving a test card in the diagnostic sample analyzer, the test card including a sensor array and a sample storage area; receiving a liquid sample into the sample storage area of the test card; employing a first sample-area optical sensor and a second sample-area optical sensor of the diagnostic sample analyzer to detect the liquid sample within the sample storage area of the test card;calibrating the sensor array via a processor of the diagnostic sample analyzer; transferring the liquid sample from the sample storage area to the sensor array via a pump of the diagnostic sample analyzer in response to completion of the calibrating and the detecting the liquid sample within the sample storage area; employing a first conductivity sensor and a second conductivity sensor to detect the liquid sample at the sensor array; analyzing, via the processor, the liquid sample at the sensor array; and communicating results of the analyzing.

12. The method of claim 11, further comprising: employing the first sample-area optical sensor of the diagnostic sample analyzer to detect entry of the liquid sample into the sample storage area of the test card and the second sample-area optical sensor of the diagnostic sample analyzer to detect that a predetermined amount of liquid sample is present within the sample storage area; and employing the first and second conductivity sensors to determine a predetermined amount of liquid sample is present at the sensor array.

13. The method of claim 12, further comprising employing a first test-area optical sensor of the diagnostic sample analyzer to confirm the predetermined amount of liquid sample is present at the sensor array and a second test-area optical sensor of the diagnostic sample analyzer to detect a fluid within a waste passageway of the test card.

14. A diagnostic sample analyzer, comprising:a test card reader configured to receive a test card, the test card including at least one test card sensor configured to generate an electrical signal indicative of a value of a fluid property of a liquid sample; at least one optical sensor configured to detect the liquid sample within the test card; a display; a processor coupled to the test card reader, the at least one optical sensor, and the display; and a memory coupled to the processor, the memory including computer program instructions that, when executed by the processor, cause the processor to: prompt a user via the display to apply the liquid sample to the test card; employ the at least one optical sensor to detect the liquid sample within the test card so as to facilitate transfer of the liquid sample to the at least one test card sensor; analyze the liquid sample at the at least one test card sensor to produce a test result; and communicate the test result via the display.

15. The diagnostic sample analyzer of claim 14, wherein the test card includes a sample inlet coupled to a sample storage area and the at least one optical sensor includes a first sample-area optical sensor positioned to detect entry of the liquid sample into the sample storage area and a second sample-area optical sensor positioned to detect that a predetermined amount of liquid sample is present within the sample storage area of the test card.

16. The diagnostic sample analyzer of claim 15, wherein the memory includes computer program instructions that, whenexecuted by the processor, cause the processor to prompt a user to stop injecting the liquid sample into the test card in response to the second sample-area optical sensor detecting the liquid sample.

17. The diagnostic sample analyzer of claim 15, wherein the memory includes computer program instructions that, when executed by the processor, cause the processor to employ the first and second sample-area optical sensors to determine one or more of an injection speed, a sample type, and a sample viscosity for the liquid sample.

18. The diagnostic sample analyzer of claim 14, wherein the at least one test card sensor of the test card includes a sensor array having a plurality of sensors including a first conductivity sensor and a second conductivity sensor and wherein the memory includes computer program instructions that, when executed by the processor, cause the processor to employ the first and second conductivity sensors to at least one of: detect a predetermined amount of liquid sample is present at the sensor array; and detect a presence of one or more bubbles in the liquid sample at the sensor array.

19. The diagnostic sample analyzer of claim 14, further comprising: a pump; wherein the test card includes a sample storage area, the at least one optical sensor includes a first sample-area optical sensor and a second sample-area optical sensor, the at least one test card sensor includes a sensor array having a first conductivity sensor and a second conductivity sensor,and the memory includes computer program instructions that, when executed by the processor, cause the processor to: prompt a user via the display to apply the liquid sample to the sample storage area of the test card; employ the first sample-area optical sensor and the second sample-area optical sensor to detect that a predetermined amount of liquid sample is present within the sample storage area; calibrate the sensor array; transfer the liquid sample from the sample storage area to the sensor array via the pump in response to completion of the calibrating and the detecting the liquid sample within the sample storage area; employ the first conductivity sensor and the second conductivity sensor to determine a predetermined amount of liquid sample is present at the sensor array; analyze the liquid sample at the sensor array; and communicate results of the analyzing via the display.

20. The diagnostic sample analyzer of claim 19, further comprising a first test-area optical sensor and a second test- area optical sensor and wherein the memory includes computer program instructions that, when executed by the processor, cause the processor to: employ the first test-area optical sensor to confirm the predetermined amount of liquid sample is present at the sensor array; employ the second test-area optical sensor to detect a fluid within a waste passageway of the test card; and responsive to detecting the fluid within the waste passageway of the test card, stop the pump used to transfer the liquid sample to the sensor array.

Images