Diagnostic sample analyzer test card channel design for use during calibration and sample testing

Abstract

A test card includes a sample inlet configured to receive a sample; at least one sensor configured to generate an electrical signal indicative of a value of a property of the sample responsive to the sample contacting the at least one sensor; a sensor channel configured to deliver the liquid sample and a calibration fluid to the at least one sensor; a sample channel configured to deliver the liquid sample received at the sample inlet to the sensor channel; a calibration fluid channel configured to deliver the calibration fluid from a calibration fluid source to the sensor channel; and an interface between the sensor channel and the sample channel that provides a divergence angle of greater than 30 degrees in a direction from the sensor channel to the sample channel. Numerous other aspects are provided.

Description

DIAGNOSTIC SAMPLE ANALYZER TEST CARD CHANNEL DESIGN FOR USE DURING CALIBRATION AND SAMPLE TESTING

[0001] This application claims benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 777,274, filed March 25, 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 of the liquid sample. The liquid sample may be a biological sample or a non-biological aqueous solution. The biological sample may be, e.g., whole blood, blood serum, blood plasma, saliva, urine, cerebrospinal fluid, interstitial fluid, pleural fluid, dialysate fluid, and the like. The diagnostic sample analyzer with an inserted test 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 include a number of channels for transporting fluids within the test card. For example, a test card may include a sensor channel that delivers fluid to the sensor panel of the test card and that is fed by both a calibration fluid channel (for delivering calibration fluid to the sensor panel) and a sample channel (for delivering a liquid sample to the sensor panel). Calibration fluid is used to calibrate the sensor panel of the test card prior to delivery of the liquid sample to the sensor panel for testing. Thus, both calibration fluid and the liquid sample flow into the sensor channel of the test card at separate times. This means that two independent channels (e.g., a calibration fluid channel and a sample channel) must merge into one, without allowing the contents of these channels to mix, thereby compromising sensor readings.

[0005] In view of the above, a need exists for a test card channel design for use during calibration and sample testing that prevents mixing of calibration fluid and a liquid sample during test card use. SUMMARY

[0006] In some embodiments, a test card for use in a diagnostic sample analyzer includes a sample inlet configured to receive a liquid sample; and at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor. The test card further includes a sensor channel configured to deliver the liquid sample and a calibration fluid to the at least one sensor; a sample channel configured to deliver the liquid sample received at the sample inlet to the sensor channel; acalibration fluid channel configured to deliver the calibration fluid from a calibration fluid source to the sensor channel; and an interface between the sensor channel and the sample channel, wherein the interface provides a divergence angle of greater than 30 degrees in a direction from the sensor channel to the sample channel.

[0007] In some embodiments, a diagnostic sample analyzer system includes a test card having a sample inlet configured to receive a liquid sample; at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor; a sensor channel configured to deliver the liquid sample and a calibration fluid to the at least one sensor; a sample channel configured to deliver the liquid sample received at the sample inlet to the sensor channel; a calibration fluid channel configured to deliver the calibration fluid from a calibration fluid source to the sensor channel; and an interface between the sensor channel and the sample channel, wherein the interface provides a divergence angle of greater than 30 degrees in a direction from the sensor channel to the sample channel. The diagnostic sample analyzer system further includes a test card reader configured to receive the test card; an input / output device; a processor coupled to the test card reader and the input / output device; and a non-transitory memory coupled to the processor. The non-transitory memory includes computer program instructions that when executed by the processor cause the processor to prompt a user via the input / output device to apply the liquid sample to the test card; calibrate the at least one sensor; process a generated electrical signal received at the test card reader from the at least one sensor to determine the value of the fluid property of the liquidsample; and communicate the value of the fluid property via the input / output device.

[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. 1 illustrates a perspective view of a diagnostic sample analyzer configured to receive a test card for performing a diagnostic sample analysis according to one or more embodiments.

[0011] FIG. 2 illustrates a plan view layout of a test card for use in a diagnostic sample analyzer according to one or more embodiments.

[0012] FIG. 3A illustrates an enlarged plan view layout of a portion of the test card of FIG. 2 according to one or more embodiments.

[0013] FIG. 3B illustrates an enlarged plan view layout of a portion of the sensor module and sensor channel of the test card of FIG. 2 according to one or more embodiments.

[0014] FIG. 3C illustrates a further plan view layout of an enlarged portion of the sensor channel of the test card of FIG. 2 illustrating a first interface between the sensor channel and a sample channel and a second interface between the sensor channel and a calibration fluid channel according to one or more embodiments.

[0015] FIGS. 3D and 3E illustrate enlarged, side views of the first interface and second interface of FIG. 3C, respectively, according to one or more embodiments.

[0016] FIG. 4 illustrates a block diagram of a diagnostic sample analyzer according to one or more embodiments.

[0017] FIG. 5 illustrates a flowchart of a method of operating a diagnostic sample analyzer according to one or more embodiments.

[0018] FIG. 6 illustrates a flowchart of another method of operating a diagnostic sample analyzer 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, a test card for use in a diagnostic sample analyzer may have a calibration fluid channel and a sample channel that merge into and / or feed a sensor channel. This may lead to inadvertent mixing of calibration fluid and the liquid sample and inaccurate test results. Embodimentsdescribed herein provide a test card channel design having an interface that isolates the sample channel and the calibration fluid channel from one another without requiring use of a mechanical valve. Such a channel design is cost effective and reliable without requiring external manipulation to activate a mechanical valve.

[0021] In some embodiments, an interface between the sample channel of the test card and the sensor channel of the test card is modified to increase the divergence angle from the sensor channel to the sample channel. As described further below, increasing the divergence angle in the direction from the sensor channel to the sample channel increases the pressure required for calibration fluid to enter the sample channel (e.g., due to capillary effects). This in turn prevents or reduces the risk of calibration fluid inadvertently flowing from the sensor channel into the sample channel through the interface, and allows or increases the likelihood that the calibration fluid instead flows through the sensor channel, past or over the interface, and toward a sensor(s) positioned downstream of the interface (without flowing into the sample channel).

[0022] These and other embodiments are described below with reference to FIGS. 1-6.

[0023] FIG. 1 illustrates a diagnostic sample analyzer 100 according to one or more embodiments. Diagnostic sample analyzer 100 may be a hand-held device and may be battery powered. Diagnostic sample analyzer 100 includes an analyzer body 102 configured to house various electronics (e.g., a barcode reader, wireless transmitter circuitry, signal processing circuitry, etc.). Analyzer body 102 is configured to also house various user interfaces such as user control haptics (e.g., buttons, switches, touch screens, and the like). In the depicted embodiment, analyzer body 102 maycomprise a computing device 104. Computing device 104 may be fixedly coupled to the analyzer body 102. Alternatively, computing device 104 may be, in some embodiments, detachably mounted to a device mount 102M of a base 102B of diagnostic sample analyzer 100. Computing device 104 may be a hand-held computing device, such as, e.g., a personal digital assistant (PDA), tablet, or other like computing device. In some diagnostic sample analyzers, the processing and memory functions of computing device 104 may be housed inside of analyzer body 102 rather than as a separable / detachable version of computing device 104.

[0024] Diagnostic sample analyzer 100 also includes a controller 105, which in this embodiment is configured to include a first controller 105C1, which may be part of base 102B of analyzer body 102, and a second controller 105C2, which may be part of, or integral with, computing device 104. First controller 105C1 and second controller 105C2 are in electronic communication with one another and may perform different functions. In other embodiments, controller 105 may be a single device located in either analyzer body 102 or computing device 104. In still other embodiments, diagnostic sample analyzer 100 may have one or more controllers that may be located anywhere in the analyzer.

[0025] In this embodiment, computing device 104 may include a display 104D enabling user input and visual display of operational information, test results, and other information. In some embodiments, display 104D may be tiltable about a pivot axis 102A. For example, the device mount 102M of base 102B may receive the computing device 104 and may be pivotable about pivot axis 102A at a location 102L so as to allow adjustment of the viewing angle. Display 104D may be a touch screen having a user interface that allows a user, in conjunction with one or more haptics (e.g., button, switches,or other user-controlled devices), to control operation of diagnostic sample analyzer 100, observe measurement results from sample testing therein, and / or perform other ancillary functions.

[0026] First controller 105C1 (or alternatively another controller in diagnostic sample analyzer 100) may include electronics for communicating with one or more sensors 103 embodied in a test card 106. The first controller electronics also may perform signal conditioning (including, e.g., filtering, A / D conversion, and / or amplification) of sensor signals received from sensor(s) 103. In some embodiments, sensor(s) 103 may include a potentiometric sensor, an amperometric sensor, and / or a conductometric sensor, and first controller 105C1 may further include electronics for processing amperometric, potentiometric, and / or conductometric signals received from sensor(s) 103.

[0027] In some embodiments, diagnostic sample analyzer 100 may be, e.g., a blood analyzer and second controller 105C2 may be operable to determine, e.g., pH, partial pressure of one or more gases (e.g., oxygen, carbon dioxide, etc.), electrolyte concentrations (e.g., sodium, potassium, calcium, etc.), and / or other analyte concentrations (e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, hematocrit, etc.). Software executable on a processor in second controller 105C2 (or alternatively another controller in diagnostic sample analyzer 100) for determining a fluid property in a blood sample may be stored in a non-transitory memory (not shown) of diagnostic sample analyzer 100. Sensor signals (indicative of measured values) received from, e.g., one or more sensors 103 may be processed by second controller 105C2 (or alternatively another controller in diagnostic sample analyzer 100) to detect an oxygen level in a blood sample applied to test card 106. Electrical signals from any additional or alternative sensors103 for measuring other fluid properties of a liquid sample may alternatively or additionally be received and processed by second controller 105C2 (or alternatively another controller in diagnostic sample analyzer 100) executing appropriate software alternatively or additionally stored in a non- transitory memory of diagnostic sample analyzer 100. In other embodiments, the aforementioned functions performed by second controller 105C2 may be performed by first controller 105C1 and vice versa and / or by one or more other controllers in diagnostic sample analyzer 100. In some embodiments, test results and other information may be transmitted to a hospital information system (HIS) 101.

[0028] 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 106. Upon insertion of test card 106 into test card reader 102R, test card sensor(s) 103 are electrically connected to controller 105 (or first controller 105C1 and / or second controller 105C2) to process sensor signals. As shown, test card reader 102R may comprise a slot that is sized to receive test card 106 therein. In some embodiments, test card 106 may resemble a playing card in view of its thin profile as compared to its width and length. In some embodiments, test card 106 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 106 may be considered a test cartridge or other test consumable having other length, width, and thickness dimensions. More generally, test card 106 may be any suitable shape or size configured to be received in a correspondingly constructed test card reader 102R. Test card 106 may be manufactured from a thermoplastic polyester such as polyethylene terephthalate glycol (PETG) or the like. Suchmaterials are well suited for molding complex shapes, have a high level of transparency, are inexpensive, and are chemically resistant.

[0029] As shown in FIG. 1, test card 106 includes one or more sensors 103 enclosed within test card body 107. Sensor(s) 103 may comprise a panel of sensors operative to test for multiple conditions or analytes, such as, e.g., glucose, BUN (blood urea nitrogen), creatine, etc. Sensor(s) 103 to test for other fluid properties may additionally or alternatively be included. Note that operation of sensor(s) 103 and the subsequent processing of electrical signals generated by sensor(s) 103 to determine a value of one or more fluid properties of a liquid sample are known to persons of skill in the art and will not be described in more detail herein.

[0030] Test card 106 also includes a sample inlet 108, which may be a port, opening, receiving element, or the like, configured to receive a sample 109 to be tested therein. Sample inlet 108 may be provided on a top layer 107T of test card body 107. Sample inlet 108 may comprise a circular or otherwise shaped opening providing a port configured to receive sample 109 therein. Sample 109 may be, e.g., whole blood, blood serum, blood plasma, saliva, urine, cerebrospinal fluid, interstitial fluid, pleural fluid, dialysate fluid, and the like, depending on the type of diagnostic sample analyzer and type or types of sensor(s) 103 included in test card 106. Sample inlet 108 may be configured to allow sample 109 to be dispensed therein or thereon by any suitable sample holder or sample transfer device. For example, in one embodiment, sample inlet 108 may be configured to allow a syringe, a capillary tube, a suitable pump, or other transfer device to be sealingly coupled to sample inlet 108 to provide sample 109 therein. In some embodiments, sample inlet 108 may have awidth or diameter dimension of about 4 mm to about 8 mm, although other width or diameter dimensions and / or shapes may be used. Sample inlet 108 is coupled via one or more sample channels (not shown in FIG. 1) to sensor(s) 103.

[0031] Test card body 107 may be made of multiple layers of material adhered together to form therein the one or more sample channels. The materials used may include one or more different types of plastic (including, e.g., polypropylene, PETG, etc.), paper, foil, and / or laminates. In some embodiments, top layer 107T and / or a bottom layer (not shown) may be a clear (transparent or translucent) material so the flow of sample 109 therethrough may be visually observed and / or optically detected. In those embodiments, diagnostic sample analyzer 100 may further include, e.g., one or more optical sensors (not shown) for detecting fluid presence and / or flow in and / or through the one or more sample channels in test card 106.

[0032] FIG. 2 illustrates a test card 206 for use in diagnostic sample analyzer 100 according to one or more embodiments. Test card 206 is an embodiment of test card 106 and includes the same or similar features as test card 106 unless described otherwise herein. Test card 206 includes a sample inlet 208, a sample storage area 210, a sample storage area outlet 211, a sample channel 214, a sensor channel 216, and a sensor module 203. Sample inlet 208 is configured to receive a liquid sample from a user. In some embodiments, sample inlet 208 may be configured to allow a syringe, a capillary tube, a suitable pump, or other transfer device to be sealingly coupled thereto to provide the liquid sample to test card 206 and may be accessible on top side 206T of test card 206.

[0033] Sample inlet 208 is coupled to sample storage area 210, which is configured to receive and hold a liquid sampletherein. Sample storage area 210 may have a vent hole 210H as shown in FIG. 2 to allow air to escape as a liquid sample is injected into inlet 208. In some embodiments, sample storage area 210 is configured to hold up to about 170 µL or more of a liquid sample. Sample storage area 210 may be configured as a C-shaped channel, chamber, or conduit having a total length ranging from 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.

[0034] Outlet 211 is coupled to sample channel 214, which is coupled to a first end 215 of a sensor channel 216. Sensor channel 216 extends over (as viewed in FIG. 2) sensor module 203 and allows a liquid sample to contact one or more sensor(s) 217 through the open bottom of sensor channel 216 (i.e., sensor module 203 forms the bottom of sensor channel 216). Sensor(s) 217 (four labeled in FIG. 2) may be printed into respective wells in sensor module 203. The flow configuration of sample channel 214 coupled to outlet 211 prevents a liquid sample held in sample storage area 210 from flowing uncontrolled to sensor module 203, as better shown in FIG. 3A.

[0035] FIG. 3A illustrates an enlarged portion 300 of test card 206 that includes outlet 211 coupled to a first portion 312 of sample channel 214 followed by first portion 312 coupled at elbow joint 314E to a second portion 313 of sample channel 214 according to one or more embodiments. As shown, flow F1 represents the direction of flow a liquid sample follows from sample inlet 208 to sample storage area 210. A flow configuration of sample channel 214, which includes the two large angle flow changes from outlet 211 into first portion 312 and from first portion 312 into second portion313, along with first portion 312 having a small width W1 compared to the larger width W2 of sample storage area 210, and first portion 312 having a decreasing depth from outlet 211 to elbow joint 314E, prevents the liquid sample from flowing uncontrolled out of sample storage area 210 to sensor module 203 via outlet 211, sample channel 214, and sensor channel 216. In some embodiments, angles A1 and A2 may each range from 120 degrees to 150 degrees, small width W1 may range from 0.3 mm to 0.5 mm, which is 10% to 20% of width W2, and the depth of first portion 312 may decrease from about 0.6 mm at outlet 211 to about 0.2 mm at elbow joint 314E. Second portion 313 of sample channel 214, which extends from first portion 312 to sensor channel 216, may have a cross-sectional area ranging initially from 0.25 mm2at elbow joint 314E to 0.75 mm2in sample channel 214 as the depth increases. Angles A1 and A2, widths W1 and W2, and / or cross-sectional area / depths may have other dimensions.

[0036] Returning to FIG. 2, sensor module 203 may be integrally formed or embodied within test card 206. Sensor module 203 may include electrical contacts (not shown in FIG. 2) configured to electrically couple to corresponding electrical connectors of the diagnostic sample analyzer 100 upon insertion of test card 206 into test card reader 102R (see description below regarding FIG. 4). The electrical contacts are configured to transmit electrical signals (e.g., voltage, current, or conductivity) representing fluid property values measured by sensor(s) 217. Sensor(s) 217 may be a single sensor configured to test for a single fluid property in a liquid sample, or sensor(s) 217 may be a panel of sensors configured to test for multiple fluid properties in a liquid sample. For example, sensor(s) 217 may test for any one or more of pH, partial pressure of one or more gases (e.g., oxygen, carbon dioxide, etc.), electrolyte concentrations (e.g.,sodium, potassium, calcium, etc.), and / or other analyte concentrations (e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, etc.). Other fluid properties may be tested by sensor(s) 217 in other embodiments.

[0037] Test card 206 further includes a vacuum port 220. Vacuum port 220 is coupled to a second end 219 of sensor channel 216 via a waste passageway 224. Vacuum port 220 is configured to connect to a vacuum pump of diagnostic sample analyzer 100 to draw a liquid sample from sample storage area 210 into contact with sensor module 203 via outlet 211, sample channel 214, and sensor channel 216. In some embodiments, vacuum port 220 may be connectable to a vacuum pump on the bottom side (not shown) of test card 206. A vacuum pump of diagnostic sample 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 210H to drive a liquid sample from sample storage area 210 into contact with sensor module 203 (using vacuum port 220 as a vent hole).

[0038] Test card 206 also includes a calibration fluid pack 226, a valve 228, and a bubble trap 230. Calibration fluid pack 226 is coupled to first end 215 of sensor channel 216 (via a calibration fluid channel 232) and contains a calibration fluid used to calibrate sensor(s) 217. In some embodiments, calibration fluid pack 226 may be formed with two layers of foil that are heat-sealed together. Valve 228 and bubble trap 230 are coupled between calibration fluid pack 226 and first end 215 of sensor channel 216 through calibration fluid channel 232. Valve 228 holds the calibration fluid in calibration fluid pack 226 until sensor calibration is performed, at which time a mechanism in diagnostic sample analyzer 100, which may be a plunger and push-pin mechanism,opens valve 228 to deliver calibration fluid to sensor module 203 via sensor channel 216. Bubble trap 230 is configured to collect air pockets from calibration fluid pack 226 to prevent them from entering sensor channel 216.

[0039] Waste passageway 224 is configured (e.g., sized) to hold the calibration fluid after completion of sensor calibration. Upon activation of the vacuum pump, calibration fluid in sensor channel 216 is drawn into waste passageway 224 as the liquid sample in sample storage area 210 is drawn through outlet 211 and sample channel 214 into sensor channel 216. The vacuum pump is deactivated in response to signals from an optical sensor (not shown) in diagnostic sample analyzer 100 directed at sensor channel 216 indicating that the liquid sample has sufficiently filled sensor channel 216.

[0040] FIG. 3B illustrates an enlarged portion 320 of sensor module 203 and sensor channel 216 of test card 206 according to one or more embodiments. FIG. 3C illustrates a further enlarged portion 330 of sensor channel 216 of test card 206 illustrating a first interface 332 between sensor channel 216 and sample channel 214 and a second interface 334 between sensor channel 216 and calibration fluid channel 232 according to one or more embodiments. FIGS. 3D and 3E illustrate enlarged, side views of first interface 332 and second interface 334, respectively, according to one or more embodiments.

[0041] With reference to FIGS. 3B-3E, and as described above, sensor channel 216 is configured to deliver a liquid sample (e.g., from sample storage area 210 of FIG. 2) and calibration fluid (e.g., from calibration fluid pack 226 of FIG. 2) to the at least one sensor (e.g., sensor module 203 having sensors 217). That is, sample channel 214 may be configured to deliver the liquid sample from sample storage area 210 to sensor channel 216 (e.g., at first end 215 ofsensor channel 216) and calibration fluid channel 232 may be configured to deliver calibration fluid from calibration fluid pack 226 to sensor channel 216. Specifically, test card 206 is configured to supply both calibration fluid and the liquid sample into sensor channel 216 at separate times (e.g., during sensor calibration and sample testing, respectively). This means that two independent channels (e.g., sample channel 214 and calibration fluid channel 232) must merge into one (e.g., sensor channel 216).

[0042] During example operation of test card 206, fluid may travel through test card 206 in the following order. First, calibration fluid is pushed out of calibration fluid pack 226 into sensor channel 216 via calibration fluid channel 232 and second interface 334. A liquid sample (e.g., blood, quality control fluid, etc.) is injected through sample inlet 208 into sample storage area 210 (before, during, or after calibration of sensor(s) 217 with the calibration fluid). After sensor calibration, vacuum is then applied to vacuum port 220, which pulls the calibration fluid into waste passageway 224, while pulling the liquid sample out of sample storage area 210 and into sensor channel 216 via sample channel 214 and first interface 332. Initially, a pocket of air exists between the calibration fluid and the liquid sample that equals the volume of empty sample channel 214 and that separates and advantageously prevents mixing of the calibration fluid and the liquid sample. First interface 332 is designed to allow the flow of the liquid sample from sample storage area 210 into sensor channel 216 to happen without accidental mixing of fluids (e.g., accidental mixing of calibration fluid, the liquid sample, and / or air) and / or the unintentional formation of air bubbles that might result from a more turbulent flow path. Such unintentional air bubbles within the calibration fluid or the liquid sample may alter measurements performed bysensors 217. First interface 332 may also be referred to as a capillary stop as described further below.

[0043] FIG. 3C illustrates different potential fluid flow directions at first interface 332. Arrow 336a shows the direction calibration fluid flows when it is pushed into sensor channel 216 from calibration fluid pack 226 via second interface 334. Calibration fluid should flow toward sensor module 203 as indicated by arrow 336b and not into sample channel 214 (the opposite direction of arrow 336c) as this may fill sample channel 214 with calibration fluid. Allowing calibration fluid into sample channel 214 may (1) eliminate the air bubble separating the calibration fluid and the liquid sample, leading to mixing of the liquid sample and calibration fluid and erroneous sensor readings, or (2) reduce the size of the air bubble separating the calibration fluid and the liquid sample, leading to insufficient cleaning of calibration fluid from sensor channel 216 (also leading to erroneous sensor readings).

[0044] Preventing calibration fluid from flowing into sample channel 214 is challenging because pressure slowly builds in sensor channel 216 as calibration fluid pack 226 is compressed and pressure is applied to calibration fluid to force the calibration fluid into sensor channel 216. During calibration fluid delivery, vacuum port 220 is closed and this pressure cannot be vented, increasing the pressure of calibration fluid flowing through sensor channel 216 and thus toward sample channel 214. First interface 332 is designed to prevent such pressurized calibration fluid from flowing into sample channel 214.

[0045] When the liquid sample is pulled from sample storage location 210 through sensor channel 216 by applying vacuum to vacuum port 220, first air, then the liquid sample flows through first interface 332 in the direction of arrow 336cwithin sample channel 214 and then in the direction of arrow 336b within sensor channel 216. When the liquid sample being tested is blood, the diameter of first interface 332 should be large enough to prevent hemolysis of the blood as it is pulled through first interface 332 (e.g., to prevent breaking of the red blood cells within the liquid sample) as hemolysis may lead to erroneous results. For this reason, first interface 332 is also designed to allow easy flow of fluid from sample channel 214 into sensor channel 216. Thus, the liquid sample should flow freely from sample channel 214 to sensor channel 216 but calibration fluid should be restricted from flowing from sensor channel 216 into sample channel 214. First interface 332 achieves both of these objectives.

[0046] With reference to FIG. 3D, to achieve the above objectives, first interface 332 may include a first opening 338 proximate sample channel 214 (having a first diameter D1) and a second opening 340 proximate sensor channel 216 (having a second diameter D2). As shown in FIG. 3D, in some embodiments, first diameter D1 is smaller than the second diameter D2. Because the liquid sample is pulled by vacuum through first interface 332, the vacuum level may be controlled (e.g., minimized) to allow first diameter D1 to be reduced in size when compared to a test card that relies on a user to inject a sample into sensor channel 216. However, first diameter D1 is still made large enough to prevent hemolysis of any blood sample travelling through first interface 332 (e.g., based on the vacuum level applied to draw the liquid sample into sensor channel 216). Example diameters D1 may range from about 0.3 to 0.4 mm and example diameters D2 may range from about 0.65 to 0.9 mm. Other values for diameters D1 and / or D2 may be employed.

[0047] In some embodiments, test card 206 may be configured without sample storage area 210 so that the liquid sampleflows directly from sample inlet 208 to sensor channel 216 (via first interface 332) during sample injection at sample inlet 208. In such embodiments, the pressure applied to the liquid sample and the flow rate of the liquid sample through sample channel 214, first interface 332, and sensor channel 216 is controlled by the technician inserting the sample into sample inlet 208. To accommodate a range of pressures with which sample liquid may be delivered to first interface 332 and sensor channel 216, the diameter D1 of first interface 332 may be altered (e.g., increased). For example, a larger first diameter D1 may be employed to prevent hemolysis of any blood sample travelling through first interface 332 should a technician apply a larger than expected pressure to the liquid sample during injection at sample inlet 208.

[0048] A reduced diameter alone may be insufficient to prevent calibration fluid from travelling from sensor channel 216 into sample channel 214 through first interface 332. As such, first interface 332 may be designed with an increased divergence angle (for liquid flowing from sensor channel 216 into sample channel 214). Specifically, in some embodiments, first interface 332 between sensor channel 216 and sample channel 214 may be provided with a divergence angle, β, (relative to planes P1 and P2 in FIG. 3D) of greater than 30 degrees for fluid travelling from sensor channel 216 into sample channel 214 (through first opening 338). In one or more embodiments, the divergence angle β, may be greater than 60 degrees, and in some embodiments, 90 degrees or more. Other divergence angles may be employed.

[0049] A larger divergence angle, β, increases the pressure required for fluid to flow from sensor channel 216 to sample channel 214 (e.g., requiring fluid to overcome a larger capillary force). In other words, such larger divergence angle (in the direction from sensor channel 216 to sample channel214) prevents or minimizes the risk of fluid (e.g., calibration fluid) flowing into the sample channel 214 through the interface 332 (i.e., prevents fluid from flowing in a direction opposite of arrow 336c). In some embodiments, depending on the material employed for first interface 332 (e.g., PET), increasing the divergence angle from 30 to 60 degrees may more than double, and from 30 degrees to 90 degrees may approximately triple, the pressure required for fluid to flow through first interface 332 (through first opening 338) from sensor channel 216 into sample channel 214.

[0050] To further improve flow within sensor channel 216 and simplify manufacturability, in some embodiments, sensor channel 216 may be an approximately straight path as shown in FIGS. 2 and 3B-3C. As also shown in FIGS. 2 and 3B-3C, in one or more embodiments, the width of sensor channel 216 may be narrowed near first interface 332 to be closer to and / or approximately the same as the width of diameter D2 of second opening 340 of first interface 332 (e.g., creating a bowtie shaped sensor channel that e.g., tapers toward and tapers away from first interface 332). Such a sensor channel configuration may improve fluidics (e.g., reducing preferential fluid flow) and / or reduce the capturing of air pockets during fluid transport. For example, in some embodiments, sensor channel 216 may have a first width W1 proximate first interface 332, a second width W2 proximate second interface 334, and a third width W3 proximate sensor panel 203. In at least some embodiments W3>W2>W1. In other embodiments, widths W2 and W3 may be approximately equal. Example values for width W1 range from about 0.75 to 1.0 mm, for width W2 range from about 0.9 to 1.1 mm, and for width W3 range from about 1.3 to 2.0 mm. Other W1, W2, and / or W3 widths may be employed. In some embodiments, second diameter D2 of first interface 332 may beabout 75% to 95% of first width W1 of sensor channel 216 at first interface 332. Other interface diameters may be used.

[0051] Regardless of whether the liquid sample is pushed (via a positive pressure pump) or pulled (via a vacuum pump) to sensor channel 216 from sample channel 214, the liquid sample will not travel into calibration fluid channel 232. This is because the path along sensor channel 216 (to the right of first interface 332 in FIG. 3C) toward calibration fluid channel 232 and calibration pack 226 is closed (e.g., not vented). For this and / or other reasons, the diameters associated with second interface 334 (the interface between sensor channel 216 and calibration fluid channel 232) may be relaxed in comparison to those of first interface 332. For example, in some embodiments, second interface 334 may have a third diameter D3 proximate sensor channel 216 and a fourth diameter D4 proximate calibration fluid channel 232 and diameter D3 may be smaller than diameter D4 despite such an arrangement having a large divergence angle for fluid travelling from calibration fluid channel 232 to sensor channel 216. By making diameter D3 larger than diameter D1, the pressure required for calibration fluid to flow into sensor channel 216 from calibration fluid channel 232 may be reduced (in comparison to the pressure required for calibration fluid to flow into sample channel 214 from sensor channel 216). Diameter D3 may be sized based on the width W2 (e.g., diameter D3 is less than width W2). Different diameters D3 and D4 are employed to provide a draft angle during molding. Other diameters D3 and / or D4 may be employed.

[0052] Embodiments provided herein allow calibration fluid from calibration fluid channel 232 to flow to sensor module 203 and the liquid sample to flow to sensor module 203 via sensor channel 216 without allowing the contents of these channels to mix (e.g., as such mixing might compromise sensorreadings). In some embodiments, sample channel 214 and calibration fluid channel 232 may be isolated through design of the interface between sensor channel 216 and sample channel 214 (e.g., by designing molded features within test card 206 rather than through use of a mechanical valve and / or external manipulation).

[0053] FIG. 4 illustrates an example of a diagnostic sample analyzer 400 according to one or more embodiments. Diagnostic sample analyzer 400 is an embodiment of diagnostic sample analyzer 100. Diagnostic sample analyzer 400 includes test card reader 402R configured to receive a test card (e.g., test card 106 or 206 of FIG. 1 or 2, respectively), optical sensors 438, a vacuum pump 440, a heater 442, and an input / output device 444 (e.g., a display such as display 104D of FIG. 1). In some embodiments, one optical sensor 438 may be configured to detect the presence of a liquid sample in sample storage area 210 (FIG. 2) and another optical sensor 438 may be configured to detect the presence of a liquid sample in sensor channel 216. In other embodiments, sample storage area 210 may include two optical sensors, one near sample inlet 208 to detect the start of a liquid sample injection and a second before vent hole 210H to detect that a sufficient amount of liquid sample has been injected. In some embodiments, diagnostic sample analyzer 400 may record the time the liquid sample has been detected in sample storage area 210. Diagnostic sample analyzer 400 may include other sensors (not shown) for sensing, e.g., temperature, pressure, tilt angle, and humidity.

[0054] Diagnostic sample analyzer 400 may further include a processor 446 coupled to each of test card reader 402R, optical sensors 438, vacuum pump 440, heater 442, and input / output device 444. Processor 446 may be coupled to a memory 448 which includes computer program instructions 450(e.g., one or more computer programs) executable by processor 446. In one or more embodiments, memory 448 may be a non- transitory memory (e.g., a hard drive, a solid-state drive, a flash-drive, etc.). In some embodiments, processor 446 may be part of one or more controllers, such as, e.g., controller 105, first controller 105C1, or second controller 105C2 (FIG. 1). Processor 446 may interface with test card 206 (or test card 106) via electrical connectors 452 located within test card reader 102R that interface with electrical contacts at sensor module 203 of test card 206.

[0055] In some embodiments, computer program instructions 450 may include computer code that, when executed by processor 446, cause processor 446 to control operation of diagnostic sample analyzer 400 in accordance with one or more of the methods described herein. For example, execution by processor 446 of computer program instructions 450 stored in memory 448 may cause processor 446 to execute initial tests related to functionality of test card 206, optical sensors 438, vacuum pump 440, and / or heater 442 in response to receiving test card 206 in test card reader 402R. More particularly, execution by processor 446 of computer program instructions 450 stored in memory 448 may cause processor 446 to perform one or more of the process blocks of method 500 or method 600, as now described. Note that diagnostic sample analyzer 100 or 400 in combination with test card 106 or 206 may form a diagnostic sample analyzer system (referred to as diagnostic sample analyzer system 460 in FIG. 4).

[0056] FIG. 5 illustrates a method 500 of operating a diagnostic sample analyzer according to one or more embodiments. The diagnostic sample analyzer may be, e.g., diagnostic sample analyzer 100 (FIG. 1) or 400 (FIG. 4). At process block 502, method 500 may include receiving a test card in the diagnostic sample analyzer, the test cardincluding at least one sensor. Referring to FIGS. 1 and 2, the test card may be, e.g., test card 106 or 206, which includes one or more sensors 103 or sensor module 203, respectively.

[0057] At process block 504, method 500 may include executing initial tests related to the functionality of at least the test card via a processor of the diagnostic sample analyzer. Initial tests related to the functionality of at least the test card 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(s) 217. The calibration fluid check may be performed, e.g., by directing, e.g., a plunger and push-pin mechanism to open valve 228 (FIG. 2) to deliver calibration fluid to sensor(s) 217 via sensor channel 216, wherein one or more (e.g., optical) sensors are operative to detect that a sufficient volume of calibration fluid has been delivered to sensor(s) 217. Optional additional initial tests may include a vacuum check to ensure that the vacuum pump in the diagnostic sample analyzer is working and / or a heater check to ensure that a heater in the diagnostic sample analyzer is working. The initial tests are performed quickly (e.g., 25-35 seconds or less), and are separate from and do not include calibration which may require a longer time delay of several minutes (e.g., at least 2-3 minutes). The initial tests may be executed via a processor of controller 105, first controller 105C1 or second controller 105C2 (e.g., processor 446 of FIG. 4), or one or more other controllers of diagnostic sample analyzer 100 executingappropriate software stored in a non-transitory memory of diagnostic sample analyzer 100.

[0058] At process block 506, method 500 may include prompting a user via an input / output device of the diagnostic sample analyzer to apply a liquid sample to the test card in response to completion of the initial tests indicating no errors. For example, the input / output device may be display 104D of computing device 104 of diagnostic sample analyzer 100 (FIG. 1). Additionally or alternatively, the input / output device may include a sound generator or a lighting device that activates in response to successful completion of the initial tests to prompt a user to apply a liquid sample to sample inlet 208 of test card 206.

[0059] At process block 508, method 500 may include calibrating the at least one sensor via the processor in response to completion of at least one of the initial tests indicating no errors. For example, the at least one initial test may be the calibration fluid check, and a processor (e.g., processor 446 of FIG. 4) of controller 105, 105C1, or 105C2 (FIG. 1) may perform sensor calibration by processing one or more calibration measurement signals received from sensor(s) 217 to determine one or more calibration measurement values in response to completion of the calibration fluid check indicating no errors. Process block 508 may begin before, during, or after process block 506.

[0060] At process block 510, method 500 may include analyzing via the processor the liquid sample at the at least one sensor in response to receiving the liquid sample at the one or more sensors. Again, e.g., a processor (e.g., processor 446 of FIG. 4) of controller 105, 105C1, or 105C2 may process one or more sample measurement signals received from sensor(s) 217 to determine one or more sample measurementvalues in response to a liquid sample contacting sensor(s) 217.

[0061] And method 500 may include, at process block 512, communicating results of the analyzing via the input / output device. For example, sample measurement values and / or other analysis results may be displayed on display 104D of diagnostic sample analyzer 100 (FIG. 1).

[0062] Method 500 may additionally include receiving a liquid sample at a sample inlet of the test card in response to the prompting, wherein the sample inlet is coupled to a sample storage area of the test card. Note that a user may apply a liquid sample to the sample inlet in response to the prompting either before or during the sensor calibration. Method 500 may also include detecting a presence of the liquid sample in the sample storage area via an optical sensor, and transferring a liquid sample from the sample storage area, via a vacuum pump of the diagnostic sample analyzer, to the at least one sensor in response to completion of the sensor calibration and / or detection of the liquid sample in the storage area. For example, a user may apply a liquid sample at sample inlet 208 (FIG. 2) in response to a prompt by diagnostic sample analyzer 100 at display 104D (FIG. 1), the liquid sample may be detected by optical sensor 438 (FIG. 4), and the liquid sample may be drawn automatically from sample storage area 210 through sample channel 214 to sensor module 203 via vacuum pump 440 of diagnostic sample analyzer 400 coupled to vacuum port 220. The vacuum pump provides uniform / consistent speed and volume flow of the liquid sample to sensor module 203, which may reduce variability in the sample analysis results. In some embodiments, the delivery time of the liquid sample to sensor module 203 may range from 1.0 second to 10 seconds. Other liquid sample delivery times are possible.

[0063] Method 500 may further include preventing flow of the liquid sample from the sample storage area to the at least one sensor prior to completion of the calibrating via a flow configuration of a sample channel coupled to an outlet of the sample storage area. For example, flow configuration 300 of FIG. 3A with its first and second large angle (A1 and A2) flow changes coupled to outlet 211 of sample storage area 210 and its reduced width W1 and decreasing depth of first portion 312 of sample channel 214 may be used to prevent uncontrolled flow of a liquid sample out of sample storage area 210. Other flow configurations are possible.

[0064] Although FIG. 5 shows example process blocks of method 500, in some embodiments, method 500 may include additional, fewer, and / or different process blocks, or differently arranged process blocks than those shown in FIG. 5. Additionally or alternatively, two or more of the process blocks of method 500 may be performed partially or fully in parallel.

[0065] FIG. 6 illustrates another method of operating a diagnostic sample analyzer according to one or more embodiments. The diagnostic sample analyzer may be, e.g., diagnostic sample analyzer 100 (FIG. 1) or 400 (FIG. 4). At process block 602, method 600 may include receiving a test card in the diagnostic sample analyzer, the test card including at least one sensor. Referring to FIGS. 1 and 2, the test card may be, e.g., test card 106 or 206, which includes one or more sensors 103 or sensor module 203, respectively.

[0066] At process block 604, method 600 may include calibrating the at least one sensor via the processor after receiving the test card. For example, a processor (e.g., processor 446 of FIG. 4) of controller 105, 105C1, or 105C2 (FIG. 1) may perform sensor calibration by directing, e.g., aplunger and push-pin mechanism to open valve 228 (FIG. 2) to deliver calibration fluid to sensor(s) 217 via sensor channel 216 and then processing one or more calibration measurement signals received from sensor(s) 217 to determine one or more calibration measurement values.

[0067] At process block 606, method 600 may include receiving a liquid sample at the test card before or during the calibrating. For example, test card 206 (of FIG. 2) may receive a liquid sample at sample inlet 208.

[0068] At process block 608, method 600 may include analyzing via the processor the liquid sample received at the at least one sensor in response to at least completion of the calibrating. Again, e.g., a processor (e.g., processor 446 of FIG. 4) of controller 105, 105C1, or 105C2 may process one or more sample measurement signals received from sensor(s) 217 to determine one or more sample measurement values in response to a liquid sample contacting sensor(s) 217.

[0069] And method 600 may include, at process block 610, communicating results of the analyzing via the input / output device. For example, sample measurement values and / or other analysis results may be displayed on display 104D of diagnostic sample analyzer 100 (FIG. 1).

[0070] Method 600 may additionally include executing initial tests related to the functionality of at least the test card via a processor of the diagnostic sample analyzer in response to receiving the test card. Initial tests related to the functionality of at least the test card 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 and / or a dry card check to ensure that the test card has not been previously used. Optional additional initial tests may include a vacuum check to ensure that the vacuumpump in the diagnostic sample analyzer is working and / or a heater check to ensure that a heater in the diagnostic sample analyzer is working. The initial tests are performed quickly (e.g., 25-35 seconds or less), and are separate from and do not include calibration. The initial tests may be executed via a processor of controller 105, first controller 105C1 or second controller 105C2 (e.g., processor 446 of FIG. 4), 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.

[0071] Method 600 may further include prompting a user via an input / output device of the diagnostic sample analyzer to apply a liquid sample to the test card in response to completion of the initial tests indicating no errors. For example, the input / output device may be display 104D of computing device 104 of diagnostic sample analyzer 100 (FIG. 1). Additionally or alternatively, the input / output device may include a sound generator or a lighting device that activates in response to successful completion of the initial tests to prompt a user to apply a liquid sample to sample inlet 208 of test card 206.

[0072] Although FIG. 6 shows example process blocks of method 600, in some embodiments, method 600 may include additional, fewer, and / or different process blocks, or differently arranged process blocks than those shown in FIG. 6. Additionally or alternatively, two or more of the process blocks of method 600 may be performed partially or fully in parallel.

[0073] It should be understood that the interface 332 configuration may be applicable to other embodiments where two channels, carrying different fluids, are merged into one and the mixing of said different fluids is not desired. For example, in one embodiment, the interface 332 as describedherein may be included in a device having a merged channel configured to deliver a first fluid and a second fluid to a region downstream of the interface 332, wherein the second fluid is different than the first fluid. A first channel is configured to deliver the first fluid to the region and the second channel is configured to deliver the second fluid to the region. The first channel and the second channel merge into the merged channel via the interface 332, where the interface 332 comprises the configuration / divergence angle as described herein.

[0074] 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. ILLUSTRATIVE EMBODIMENTS

[0075] The following provides a non-limiting list of illustrative embodiments of this disclosure:

[0076] An illustrative test card for use in a diagnostic sample analyzer, the test card comprising: a sample inlet configured to receive a liquid sample; at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor; a sensor channel configured to deliver the liquid sample and a calibration fluid to the at least one sensor; a sample channel configured to deliver the liquid sample received at the sample inlet to the sensor channel; a calibration fluid channel configured to deliver the calibration fluid from a calibration fluid source to the sensor channel; and an interface betweenthe sensor channel and the sample channel, wherein the interface provides a divergence angle of greater than 30 degrees in a direction from the sensor channel to the sample channel.

[0077] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the divergence angle is greater than 60 degrees.

[0078] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the divergence angle is 90 degrees or more.

[0079] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the interface comprises a first opening proximate the sample channel having a first diameter and a second opening proximate the sensor channel having a second diameter.

[0080] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the first diameter is smaller than the second diameter.

[0081] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the sensor channel has a first width at the interface between the sensor channel and the sample channel and wherein the second diameter of the interface is between 75% and 95% of the first width.

[0082] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the sensor channel has a first width at the interface between the sample channel and the sensor channel and a second width at an interface between the calibration fluid channel and the sensor channel and wherein the first width is smaller than the second width.

[0083] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the sensorchannel has a third width at the at least one sensor and wherein the third width is greater than the first width.

[0084] The illustrative test card of any one of the proceeding illustrative embodiments, further comprising a sample storage area coupled to the sample inlet configured to receive and store the liquid sample, and wherein the sample channel is configured to deliver the liquid sample from the sample storage area to the sensor channel.

[0085] The illustrative test card of any one of the proceeding illustrative embodiments, further comprising a vacuum port configured to connect to a vacuum pump of a diagnostic sample analyzer to draw the liquid sample from the sample storage area into contact with the at least one sensor.

[0086] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the sample storage area comprises an outlet and the test card comprises a flow configuration of the sample channel coupled to the outlet that prevents the liquid sample from flowing out of the sample storage area until the vacuum pump is activated.

[0087] The illustrative test card of any one of the proceeding illustrative embodiments, further comprising a vent hole in the sample storage area operative to allow air to escape as a liquid sample is injected into the sample inlet, wherein the vent hole is configured to connect to a positive pressure pump and the vacuum port is operative to function as a vent in conjunction with a positive pressure pump connected to the vent hole.

[0088] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the sensor channel is configured for enabling the liquid sample to contact the at least one sensor and a vacuum port is coupled to the sensor channel and is configured to connect to a vacuum pump of a diagnostic sample analyzer to draw the liquid samplefrom the sample storage area through the sample channel and sensor channel into contact with the at least one sensor.

[0089] The illustrative test card of any one of the proceeding illustrative embodiments, wherein the at least one sensor is configured to generate a voltage, current, or conductivity signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor.

[0090] The illustrative test card of any one of the proceeding illustrative embodiments, further comprising a calibration fluid pack coupled to the calibration fluid channel.

[0091] An illustrative diagnostic sample analyzer system, comprising: a test card having: a sample inlet configured to receive a liquid sample; at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor; a sensor channel configured to deliver the liquid sample and a calibration fluid to the at least one sensor; a sample channel configured to deliver the liquid sample received at the sample inlet to the sensor channel; a calibration fluid channel configured to deliver the calibration fluid from a calibration fluid source to the sensor channel; and an interface between the sensor channel and the sample channel, wherein the interface provides a divergence angle of greater than 30 degrees in a direction from the sensor channel to the sample channel. The illustrative diagnostic sample analyzer includes a test card reader configured to receive the test card; an input / output device; a processor coupled to the test card reader, and the input / output device; and a non-transitory memory coupled to the processor, the non-transitory memory including computer program instructions that when executed by the processor causethe processor to: prompt a user via the input / output device to apply the liquid sample to the test card; calibrate the at least one sensor; process a generated electrical signal received at the test card reader from the at least one sensor to determine the value of the fluid property of the liquid sample; and communicate the value of the fluid property via the input / output device.

[0092] The illustrative diagnostic sample analyzer system of any one of the proceeding illustrative embodiments, wherein the divergence angle of the interface of the test card is greater than 60 degrees.

[0093] The illustrative diagnostic sample analyzer system of any one of the proceeding illustrative embodiments, wherein the divergence angle of the test card is 90 degrees or more.

[0094] The illustrative diagnostic sample analyzer system of any one of the proceeding illustrative embodiments, wherein the interface of the test card comprises a first opening proximate the sample channel having a first diameter and a second opening proximate the sensor channel having a second diameter and wherein the first diameter is smaller than the second diameter.

[0095] The illustrative diagnostic sample analyzer system of any one of the proceeding illustrative embodiments, wherein: the sensor channel of the test card has a first width at the interface between the sample channel and the sensor channel, a second width at an interface between the calibration fluid channel and the sensor channel, and a third width at the at least one sensor; and the second and third widths are greater than the first width.

[0096] The illustrative diagnostic sample analyzer system of any one of the proceeding illustrative embodiments, wherein: the test card includes a sample storage area coupled to the sample inlet configured to receive and store the liquidsample; the sample channel is configured to deliver the liquid sample from the sample storage area to the sensor channel; the diagnostic sample analyzer system includes a pump; and the non-transitory memory includes computer program instructions that, when executed by the processor, cause the processor to activate the pump to transfer the liquid sample applied to the test card to the at least one sensor in response to completion of sensor calibration, detection of the liquid sample received in the test card, or both.

[0097] The illustrative diagnostic sample analyzer system of any one of the proceeding illustrative embodiments, wherein the test card comprises a vacuum port configured to connect to the pump of the diagnostic sample analyzer system to draw the liquid sample from the sample storage area into contact with the at least one sensor.

Claims

WHAT IS CLAIMED IS:

1. A test card for use in a diagnostic sample analyzer, the test card comprising: a sample inlet configured to receive a liquid sample; at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor; a sensor channel configured to deliver the liquid sample and a calibration fluid to the at least one sensor; a sample channel configured to deliver the liquid sample received at the sample inlet to the sensor channel; a calibration fluid channel configured to deliver the calibration fluid from a calibration fluid source to the sensor channel; and an interface between the sensor channel and the sample channel, wherein the interface provides a divergence angle of greater than 30 degrees in a direction from the sensor channel to the sample channel.

2. The test card of claim 1, wherein the divergence angle is greater than 60 degrees.

3. The test card of claim 1, wherein the divergence angle is 90 degrees or more.

4. The test card of claim 1, wherein the interface comprises a first opening proximate the sample channel having a first diameter and a second opening proximate the sensor channel having a second diameter.

5. The test card of claim 4, wherein the first diameter is smaller than the second diameter.

6. The test card of claim 4, wherein the sensor channel has a first width at the interface between the sensor channel and the sample channel and wherein the second diameter of the interface is between 75% and 95% of the first width.

7. The test card of claim 1, wherein the sensor channel has a first width at the interface between the sample channel and the sensor channel and a second width at an interface between the calibration fluid channel and the sensor channel and wherein the first width is smaller than the second width.

8. The test card of claim 7, wherein the sensor channel has a third width at the at least one sensor and wherein the third width is greater than the first width.

9. The test card of claim 1, further comprising a sample storage area coupled to the sample inlet configured to receive and store the liquid sample, and wherein the sample channel is configured to deliver the liquid sample from the sample storage area to the sensor channel.

10. The test card of claim 9, further comprising a vacuum port configured to connect to a vacuum pump of a diagnostic sample analyzer to draw the liquid sample from the sample storage area into contact with the at least one sensor.

11. The test card of claim 10, wherein the sample storage area comprises an outlet and the test card comprises a flow configuration of the sample channel coupled to the outlet that prevents the liquid sample from flowing out of the sample storage area until the vacuum pump is activated.

12. The test card of claim 9, further comprising a vent hole in the sample storage area operative to allow air to escape as a liquid sample is injected into the sample inlet, wherein the vent hole is configured to connect to a positive pressure pump and the vacuum port is operative to function as a vent in conjunction with a positive pressure pump connected to the vent hole.

13. The test card of claim 9, wherein the sensor channel is configured for enabling the liquid sample to contact the at least one sensor and a vacuum port is coupled to the sensor channel and is configured to connect to a vacuum pump of a diagnostic sample analyzer to draw the liquid sample from the sample storage area through the sample channel and sensor channel into contact with the at least one sensor.

14. The test card of claim 1, wherein the at least one sensor is configured to generate a voltage, current, or conductivity signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contacting the at least one sensor.

15. The test card of claim 1, further comprising a calibration fluid pack coupled to the calibration fluid channel.

16. A diagnostic sample analyzer system, comprising: a test card having: a sample inlet configured to receive a liquid sample; at least one sensor configured to generate an electrical signal indicative of a value of a fluid property of the liquid sample in response to the liquid sample contactingthe at least one sensor; a sensor channel configured to deliver the liquid sample and a calibration fluid to the at least one sensor; a sample channel configured to deliver the liquid sample received at the sample inlet to the sensor channel; a calibration fluid channel configured to deliver the calibration fluid from a calibration fluid source to the sensor channel; and an interface between the sensor channel and the sample channel, wherein the interface provides a divergence angle of greater than 30 degrees in a direction from the sensor channel to the sample channel; a test card reader configured to receive the test card; an input / output device; a processor coupled to the test card reader and the input / output device; and a non-transitory memory coupled to the processor, the non-transitory memory including computer program instructions that when executed by the processor cause the processor to: prompt a user via the input / output device to apply the liquid sample to the test card; calibrate the at least one sensor; process a generated electrical signal received at the test card reader from the at least one sensor to determine the value of the fluid property of the liquid sample; and communicate the value of the fluid property via the input / output device.

17. The diagnostic sample analyzer system of claim 16, wherein the divergence angle of the interface of the test card is greater than 60 degrees.

18. The diagnostic sample analyzer system of claim 16,wherein the divergence angle of the test card is 90 degrees or more.

19. The diagnostic sample analyzer system of claim 16, wherein the interface of the test card comprises a first opening proximate the sample channel having a first diameter and a second opening proximate the sensor channel having a second diameter and wherein the first diameter is smaller than the second diameter.

20. The diagnostic sample analyzer system of claim 16, wherein: the sensor channel of the test card has a first width at the interface between the sample channel and the sensor channel, a second width at an interface between the calibration fluid channel and the sensor channel, and a third width at the at least one sensor; and the second and third widths are greater than the first width.

21. The diagnostic sample analyzer system of claim 16, wherein: the test card includes a sample storage area coupled to the sample inlet configured to receive and store the liquid sample; the sample channel is configured to deliver the liquid sample from the sample storage area to the sensor channel; the diagnostic sample analyzer system includes a pump; and the non-transitory memory includes computer program instructions that, when executed by the processor, cause the processor to activate the pump to transfer the liquid sample applied to the test card to the at least one sensor inresponse to completion of sensor calibration, detection of the liquid sample received in the test card, or both.

22. The diagnostic sample analyzer system of claim 21, wherein the test card comprises a vacuum port configured to connect to the pump of the diagnostic sample analyzer system to draw the liquid sample from the sample storage area into contact with the at least one sensor.

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