Test sensor system and method of using same

Abstract

A system for determining analyte information of a fluid sample includes an electrochemical test sensor, an NFC-enabled dongle, and an NFC-enabled reader. The test sensor includes a base, an enzyme adapted to react with an analyte, electrodes, and test-sensor contacts. The NFC-enabled dongle includes a near-field communication (NFC) tag chip, an analog front end (AFE), and a microcontroller. The dongle includes an exterior cover that forms an opening for receiving the test sensor. The NFC-enabled reader wirelessly receives data from the dongle to assist in determining the analyte information of the fluid sample. Another system for determining analyte information of a fluid sample includes an electrochemical test sensor, a Bluetooth-enabled dongle, and a Bluetooth-enabled reader.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 17 / 102,820, filed November 24, 2020, which is incorporated herein by reference in its entirety.

[0002] Technical Field The present invention relates generally to systems and methods that use electrochemical test sensors to determine analyte concentrations. More particularly, the present invention relates generally to systems and methods that use electrochemical test sensors to determine analyte concentrations in the absence of an analyte meter. [Background technology]

[0003] Quantitative determination of analytes in bodily fluids is very important in the diagnosis and maintenance of certain physical conditions. For example, lactate, cholesterol, and bilirubin should be monitored in certain individuals. In particular, it is important for diabetics to frequently check the glucose levels in their bodily fluids in order to regulate their dietary glucose intake. The results of such tests can be used to determine what, if any, insulin or other medication needs to be administered. In one type of blood glucose testing system, a test sensor is used to test a fluid sample of blood.

[0004] In a typical scenario, a user will carry multiple test sensors (e.g., electrochemical test sensors) and an analyte meter (e.g., a blood glucose meter) to determine an analyte concentration. The analyte meter typically includes an opening for receiving the test sensor, memory, a processor, a display for showing test results, and multiple buttons or other mechanisms for navigating the display. The analyte meter may require some user setup and an associated learning curve.

[0005] It would be desirable to streamline such an approach to provide maximum user convenience while still providing the desired functionality of a typical analyte determination system. Summary of the Invention

[0006] According to one embodiment, a system for determining analyte information of a fluid sample includes an electrochemical test sensor, an NFC-enabled dongle, and an NFC-enabled reader. The electrochemical test sensor is adapted to receive a fluid sample of the analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes and a plurality of test-sensor contacts. The NFC-enabled dongle includes a near-field communication (NFC) tag chip, an analog front end (AFE), and a microcontroller. The NFC-enabled dongle includes an exterior cover. The exterior cover forms an opening for receiving the electrochemical test sensor. The NFC-enabled reader is configured to wirelessly receive data from the NFC-enabled dongle to assist in determining the analyte information of the fluid sample.

[0007] According to another embodiment, a system for determining analyte information of a fluid sample includes an electrochemical test sensor, a Bluetooth-enabled dongle, and a Bluetooth-enabled reader. The electrochemical test sensor is adapted to receive a fluid sample of the analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes and a plurality of test-sensor contacts. The Bluetooth-enabled dongle includes a Bluetooth chip, an analog front end (AFE), a microcontroller, and a battery. The Bluetooth-enabled dongle includes an exterior cover. The exterior cover forms an opening for receiving the electrochemical test sensor. The Bluetooth-enabled reader is configured to wirelessly receive data from the Bluetooth-enabled dongle to assist in determining the analyte information of the fluid sample.

[0008] According to one method, analyte information of a fluid sample is determined using an electrochemical test sensor, an NFC-enabled dongle, and an NFC-enabled reader. An electrochemical test sensor adapted to receive a fluid sample of the analyte is provided. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes and a plurality of test sensor contacts. An NFC-enabled dongle is provided and includes a near field communication (NFC) tag chip, an analog front end (AFE), and a microcontroller. The NFC-enabled dongle includes an exterior cover. The exterior cover forms an opening for receiving the electrochemical test sensor. The electrochemical test sensor is placed in electrical communication with the NFC-enabled dongle through the opening in the NFC-enabled dongle. The fluid sample contacts the electrochemical test sensor. The near field communication (NFC) tag chip and the analog front end (AFE) are powered. The analog front end assists in initiating an electrochemical reaction with the analyte in the fluid sample. The NFC-enabled dongle and the electrochemical test sensor are brought into close proximity to an NFC-enabled reader. Data is transmitted wirelessly from the NFC-enabled dongle to the NFC-enabled reader via the NFC tag chip. Analyte information of the fluid sample is determined via the NFC-enabled reader using the data received from the NFC-enabled dongle.

[0009] According to another method, analyte information of a fluid sample is determined using an electrochemical test sensor, a Bluetooth-enabled dongle, and a Bluetooth-enabled reader. An electrochemical test sensor adapted to receive a fluid sample of the analyte is provided. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes and a plurality of test sensor contacts. A Bluetooth-enabled dongle is provided, including a Bluetooth chip, an analog front end (AFE), and a microcontroller. The Bluetooth-enabled dongle includes an exterior cover. The exterior cover forms an opening for receiving the electrochemical test sensor. The electrochemical test sensor is placed in electrical communication with the Bluetooth-enabled dongle through the opening in the Bluetooth-enabled dongle. The fluid sample is contacted with the electrochemical test sensor. The Bluetooth chip and the analog front end (AFE) are powered. The analog front end assists in initiating an electrochemical reaction with the analyte in the fluid sample. The Bluetooth-enabled dongle is brought into close proximity to the Bluetooth-enabled reader. Data is transmitted wirelessly from the Bluetooth-enabled dongle to the Bluetooth-enabled reader via the Bluetooth chip. Analyte information of the fluid sample is determined via the Bluetooth enabled reader using data received from the Bluetooth enabled dongle.

[0010] The above summary is not intended to represent each embodiment or every aspect of the present invention. Additional features and advantages of the present invention will be apparent from the detailed description and drawings set forth below. [Brief explanation of the drawings]

[0011] Other advantages of the present invention will become apparent upon reading the following detailed description and upon reference to the following drawings. [Figure 1A] FIG. 1 is a top view of an electrochemical test sensor according to one embodiment used in the system. [Figure 1B]FIG. 1B is a front view of the electrochemical test sensor of FIG. 1A. [Figure 1C] FIG. 1B is a top view of the electrochemical test sensor of FIG. 1A after the lid and spacer have been removed. [Figure 1D] FIG. 1D is an enlarged view of the generally rectangular area 1D shown in FIG. 1C. [Figure 2A] 1A and 1C, a system including a near field communication (NFC) enabled dongle, and a near field communication (NFC) enabled reader, according to one embodiment. [Figure 2B] FIG. 2B is a front view of the NFC-enabled dongle shown in FIG. 2A. [Figure 3A] 2B is a schematic diagram of a near field communication (NFC) tag chip used in the system of FIG. 2A. [Figure 3B] FIG. 2 is a schematic diagram of an NFC tag chip according to another embodiment. [Figure 4A] 1A and 1C, an NFC-enabled dongle, and an NFC-enabled reader, according to another embodiment. [Figure 4B] FIG. 4B is a front view of the NFC-enabled dongle shown in FIG. 4A. [Figure 5] 10 is a flowchart showing steps for determining sample information using one method. [Figure 6A] 1A and 1C, a system including the electrochemical test sensor of FIG. 1A and FIG. 1C, a Bluetooth-enabled dongle, and a Bluetooth-enabled host / reader, according to one embodiment. [Figure 6B] FIG. 6B is a front view of the Bluetooth-enabled dongle shown in FIG. 6A. [Figure 7] FIG. 6B is a schematic diagram of a Bluetooth chip used in the system of FIG. 6A. [Figure 8] 10 is a flowchart of steps for determining sample information according to another method.

[0012] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims. DETAILED DESCRIPTION OF THE INVENTION

[0013] The electrochemical test sensor is adapted to receive a fluid sample. The test sensor assists in determining information related to the analyte, such as analyte concentration. As used within this application, the term "concentration" refers to analyte concentration, activity (e.g., enzymes and electrolytes), titer (e.g., antibodies), or any other measurement concentration used to measure the desired analyte. Analytes that may be measured include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A1C, urea, creatinine, fructose, lactate, or bilirubin. It is contemplated that other analyte concentrations may be determined. The analyte may be in, for example, a whole blood sample, a serum sample, a plasma sample, other bodily fluids such as ISF (interstitial fluid) and urine, as well as non-bodily fluids.

[0014] In one embodiment, the electrochemical test sensor is adapted to receive a fluid sample containing an analyte. The electrochemical test sensor discussed below is used in combination with an NFC-enabled dongle or a Bluetooth®-enabled dongle.

[0015] The electrochemical test sensor includes a base, the base including an enzyme adapted to react with an analyte, and further includes a plurality of electrodes and a plurality of test-sensor contacts.

[0016] The present invention is advantageous in that the electrochemical test sensor functions in the absence of an analyte meter (e.g., a glucose meter). Thus, an analyte meter is not used with the electrochemical test sensor of the present invention. Here, the user conveniently avoids the need to carry an analyte meter to determine the analyte concentration. However, the user is required to carry a near-field communication (NFC)-enabled dongle or a Bluetooth-enabled dongle. Furthermore, unlike using a conventional analyte meter, there is little or no setup or learning curve involved in the method of the present invention.

[0017] The present invention is also advantageous in its ability to more easily modify the algorithm for calculating analyte concentration. In the present invention, the algorithm can be part of the NFC-enabled reader (e.g., a smartphone) in the application or can reside on a server farm in the cloud, for example. In another embodiment, the algorithm can be part of the BLE-enabled reader (e.g., a smartphone) in the application or can reside on a server farm in the cloud, for example. Updating the algorithm in the present invention for the user is convenient and significantly easier, and thus updates can be more frequent if desired. This is in contrast to modifying an algorithm stored in the firmware of the analyte meter, for example, which must be supported with over-the-air updates or replacement of the entire analyte meter. This is also much more difficult to update and is more costly, especially if the analyte meter needs to be replaced.

[0018] The test sensors described herein are electrochemical test sensors. One non-limiting example of an electrochemical test sensor is shown in FIGS. 1A-1D. FIGS. 1A-1D show an electrochemical test sensor 10 including a base 12, a lid 14, a fluid-receiving area or channel 16, and a plurality of electrodes 18, 20, 22, and 24. In one embodiment, the fluid-receiving area 16 is a capillary channel. The plurality of electrodes includes a counter electrode 18, a working (measurement) electrode 20, a detection fill electrode 22, and a hematocrit electrode 24. The fluid-receiving area 16 provides a flow path for introducing a fluid sample into the electrochemical test sensor 10. The electrodes 18, 20, 22, and 24 are coupled to respective ones of a plurality of conductive leads 26a, 26b, 26c, and 26d, which communicate with a plurality of test-sensor contacts 34a, 34b, 34c, and 34d. The electrodes may be made from a variety of conductive materials, including, but not limited to, gold, platinum, rhodium, palladium, ruthenium, carbon, or combinations thereof.

[0019] In other embodiments, it is contemplated that fewer than four electrodes may be used. For example, in one embodiment, the electrochemical test sensor may include two electrodes (a working electrode and a counter electrode). In another embodiment, the electrochemical test sensor may include three electrodes (a working electrode, a counter electrode, and a detection fill electrode). It is contemplated that other electrodes may be used in the electrochemical test sensor.

[0020] Reagent region 28 contains at least one reagent for converting an analyte of interest (e.g., glucose) in a fluid sample (e.g., blood) into a chemical species that is electrochemically measurable by components of the electrode pattern in terms of the electrical current it generates. The reagent typically includes an analyte-specific enzyme that reacts with the analyte and an electron acceptor to produce an electrochemically measurable species that can be detected by the electrodes. When the analyte is glucose, the reagent includes an enzyme such as glucose oxidase or glucose dehydrogenase.

[0021] The reagent typically includes a mediator that assists in transferring electrons between the analyte and the electrode. Non-limiting examples of mediators include phenoxazines, phenothiazines, ferricyanides, or tetrazolium salts, among others familiar to those skilled in the art. The reagent may include binders, buffers, cellulose polymers, surfactants, other inactive ingredients, or combinations thereof, that hold the enzyme and mediator together.

[0022] In one embodiment, a fluid sample (e.g., blood) is applied to reagent area 28 via fluid-receiving area 16. The fluid sample reacts with at least one reagent. After reacting with the reagent, the fluid sample, in conjunction with the plurality of electrodes, generates an electrical signal that assists in determining the analyte concentration. Conductive leads 26a-26d carry the electrical signal back to each test-sensor contact 34a-34d.

[0023] Referring to FIG. 1B, a front view of the electrochemical test sensor 10 of FIG. 1A is shown. As shown in FIG. 1B, the electrochemical test sensor 10 includes a lid 14, a spacer 30, and a base 12. The combination of the lid 14, the spacer 30, and the base 12 forms the fluid-receiving area 16. The base 12, the lid 14, and the spacer 30 can be made from a variety of materials, such as polymeric materials. Non-limiting examples of polymeric materials that can be used to form the base 12, the lid 14, and the spacer 30 include polycarbonate, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polyimide, and combinations thereof. It is contemplated that the base, the spacer, and the lid can be made independently of other materials. It is contemplated that other materials can be used in forming the base 12, the lid 14, and / or the spacer 30.

[0024] 1A-1D, the base 12, spacer 30, and lid 14 are attached, for example, by adhesive or heat sealing. When the base 12, lid 14, and spacer 30 are attached, the fluid-receiving area 16 is formed. As shown in FIG. 1A, the fluid-receiving area 16 is formed at a first or testing end 32 of the electrochemical test sensor 10.

[0025] It is also contemplated that the electrochemical test sensor may be formed in the absence of a spacer. For example, the electrochemical test sensor may include a base and a lid such that a fluid-receiving region (e.g., a capillary channel) is formed when the base and lid are attached to one another. It is contemplated that the electrochemical test sensor may be formed using only a base.

[0026] 1A, 2A, and 2B, a system 200 includes an electrochemical test sensor 10, a near field communication (NFC) enabled dongle 40, and a near field communication (NFC) enabled reader 290. The NFC enabled dongle in one embodiment is small and lightweight. The dongle can be made slightly heavier, if desired, to aid in improved ergonomic considerations.

[0027] The NFC-enabled dongle 40 includes a near field communication (NFC) tag chip 50, an analog front end (AFE), and a microcontroller. Specifically, with reference to FIG. 2B , the NFC-enabled dongle 40 includes an exterior cover 42. The exterior cover 42 is typically made of a polymer material. It is contemplated that the dongle may be made of other materials. The exterior cover 42 forms an opening 44 for receiving the electrochemical test sensor 10. The dongle's exterior cover 42 helps protect the components contained therein.

[0028] The NFC tag chip 50 may be secured to the NFC-enabled dongle 40 by, for example, a suitable adhesive and / or a mechanical coupling mechanism such as prongs. It is contemplated that other methods may be used to secure the NFC tag chip to the NFC-enabled dongle. In one embodiment, the NFC tag chip 50 is located inside the NFC-enabled dongle 40.

[0029] Near Field Communication (NFC) includes a small antenna and hardware for communicating via the NFC standard. Near Field Communication (NFC) is a known global standard that provides wireless data connectivity in close proximity. NFC is currently used at communication distances of less than about 20 cm, and possibly less than about 10 cm. In other embodiments, NFC is typically used at communication distances of less than about 8 cm or less than 6 cm. In other embodiments, NFC is more commonly used at communication distances of less than about 5 cm or approximately less than about 4 cm. The NFC tag chip communicates wirelessly with an NFC-enabled reader when in close proximity.

[0030] Near-field communication (NFC) enables simple transactions, data exchange, and connection with a touch. Founded in 2004, the Near Field Communication Forum (NFC Forum) facilitates sharing, pairing, and transactions between NFC-enabled readers or devices and develops and certifies devices that comply with the NFC standard. NFC operates at 13.56 MHz over the ISO / IEC 18000-3 air interface and at rates ranging from 106 kbit / s to 848 kbit / s. NFC's short range helps keep encrypted information private. Thus, for example, an NFC-enabled reader, such as a smartphone, tablet, computer, or kiosk, can receive information from an NFC-enabled dongle to assist in determining analyte concentration.

[0031] 3A , a near field communication (NFC) tag chip 50 includes an analog front end (AFE) 52, a power management module 54, memory 56, a serial peripheral interface (SPI slave) 58, a microcontroller 60, an on-chip temperature sensor 62, an analog-to-digital (A / D) converter 64, a real-time clock 66, and an antenna 68. The microcontroller 60, in one embodiment, also includes a control or processing logic module 70, a memory interface 72, an encryption module 74, an authentication module 76, and an anti-collision module 78. Note that not all NFC tag chips include all of these modules or functions. For example, some NFC tag chips do not include a temperature sensor.

[0032] In this embodiment, the NFC-enabled dongle 40 does not include a battery. In this embodiment, the near field communication (NFC) tag chip 50 has the ability to accept power from an NFC-enabled reader. Therefore, the NFC-enabled dongle 40 is completely passive. NFC in this embodiment includes an initiator (the NFC-enabled reader) and a target (the NFC-enabled dongle 40). The initiator actively generates an RF field that powers the passive target (the NFC-enabled dongle 40). This allows the NFC target to take a very simple form factor, such as a tag or sticker, that does not require a battery.

[0033] In another embodiment, the NFC-enabled dongle may include a battery for powering the AFE module for near field communication (NFC) and / or signal sampling. Referring to FIG. 3B, the NFC tag chip 150 includes a battery 84. The NFC tag chip 150 includes all of the modules described for the NFC tag chip 50, except for the power management module 54, which is not required when the battery 84 is included. In one embodiment, the battery 84 is a 1.5 or 3 V battery used to power the NFC tag chip 150. NFC peer-to-peer communication is, of course, possible when both devices are powered. For example, an NFC-enabled dongle with an NFC tag chip can be configured to implement peer-to-peer communication with an NFC-enabled reader. Referring to FIGS. 4A and 4B, a system 300 includes an NFC-enabled dongle 140 with an NFC tag chip 150 and an NFC-enabled reader 290.

[0034] A non-limiting commercial example of a Near Field Communication (NFC) tag chip including a microcontroller and analog front end (AFE) that may be used in the present invention is the SL13A-AQFM manufactured / sold by Ams.

[0035] A non-limiting commercial example of a Near Field Communication (NFC) tag chip that may be used in the present invention is the NTAG 210μ family of tags manufactured / sold by NXP Semiconductors of the Netherlands. A non-limiting commercial example of a Near Field Communication (NFC) tag chip that may be used in the present invention is the ST25T family of tags manufactured / sold by ST Microelectronics of Switzerland. Another non-limiting commercial example of a Near Field Communication (NFC) tag chip that includes an Analog Front End (AFE) that may be used in the present invention is the ST25R3916 / 7 manufactured / sold by ST Microelectronics of Switzerland.

[0036] An analog front end (AFE) 52 is used to drive the electrochemistry and sample the results. In one embodiment, the AFE 52 applies a voltage to the reagent area 28, which initiates an electrochemical reaction between the reagent and the analyte in the fluid sample. The resulting current produced from the electrochemical reaction in this embodiment is sampled by the AFE 52. This measurement of the current is wirelessly transmitted to an NFC-enabled reader for further processing.

[0037] In one embodiment, the analog front end (AFE) is powered via an NFC-enabled reader such as shown in NFC tag chip 50 in Figure 3A. In another embodiment, the AFE is powered by a battery 84 located on NFC tag chip 150, as shown in Figure 3B. A non-limiting commercial example of an analog front end (AFE) that may be used in the present invention is the AFE4400 manufactured / sold by Texas Instruments in the USA.

[0038] The memory 56 of the NFC tag chip 50 is typically in the form of EEPROM. One non-limiting example of memory that may be used is an 8kbit EEPROM. It is contemplated that other forms of EEPROM or other types of memory may be used. For example, flash memory may be used in the NFC tag chip.

[0039] The microcontroller 60 in the NFC-enabled dongle 40 performs the operations involved in receiving and transmitting signals to an NFC-enabled reader through an antenna 68. The microcontroller 60 controls the analog front end (AFE) 52 and assists in converting the electrical signals into readable data. The microcontroller 60 instructs the analog front end (AFE) 52 to begin sampling. The NFC-enabled dongle preferably includes a low-end microprocessor. The low-end microprocessor does not execute one or more algorithms for determining analyte information of the fluid sample. A non-limiting commercial example of a microcontroller that may be used in the present invention is the LPC800 series manufactured / sold by NXP Semiconductors of the Netherlands.

[0040] It is contemplated that the analog front end (AFE), microcontroller, and near field communication (NFC) may be separate chips or components. The NFC tag chip in these embodiments would be considered a low-end tag chip. It is contemplated that two or more of these components may be integrated together. In one non-limiting example, the analog front end (AFE) and near field communication (NFC) are integrated together. In another example, the microcontroller and near field communication (NFC) are integrated together. In a further example, the analog front end (AFE) and microcontroller are integrated together. It is contemplated that the analog front end (AFE), microcontroller, and near field communication (NFC) may all be integrated together, as shown with NFC chip tag 50 in FIG. 2A .

[0041] In one embodiment, a system for determining analyte information (e.g., analyte concentration) includes an electrochemical test sensor, an NFC-enabled dongle, and an NFC-enabled reader. The NFC-enabled reader is configured to wirelessly receive data from the NFC-enabled dongle to assist in determining the analyte concentration of the fluid sample. The electrochemical test sensor is adapted to receive a fluid sample containing the analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes and a plurality of test-sensor contacts. The NFC-enabled dongle includes a near-field communication (NFC) tag chip, an analog front end (AFE), and a microcontroller. One non-limiting example of an electrochemical test sensor that may be used is electrochemical test sensor 10. One non-limiting example that may be used is NFC-enabled dongle 40.

[0042] Referring back to FIG. 2A , system 200 includes electrochemical test sensor 10, NFC-enabled dongle 40, and NFC-enabled reader 290. The NFC-enabled reader can read an NFC chip tag on the NFC-enabled dongle to obtain information therefrom. The NFC-enabled reader is typically a smartphone, tablet, or computer. It is contemplated that other NFC-enabled readers may be used. For example, the NFC-enabled reader may be a kiosk. The kiosk may be a kiosk specifically designed for use in determining the analyte concentration of a fluid sample. The kiosk may be useful in a medical setting, such as a hospital.

[0043] The NFC-enabled reader 290 includes a display 292 and one or more buttons 294 or other mechanism for navigating the display 292. The display 292 is typically used to show analyte information or other information about the fluid sample. The display 292 may be analog or digital. The display 292 may be an LCD, LED, OLED, vacuum fluorescent, or other display adapted to show a numeric readout, such as analyte information. It is contemplated that the analyte information (e.g., analyte concentration) may be conveyed via audio communication from the NFC-enabled reader.

[0044] To assist in determining analyte information (e.g., analyte concentration), in one embodiment, one or more algorithms are downloaded to the NFC-enabled reader 290. Here, the NFC-enabled reader is shown as a smartphone. As discussed above, the NFC-enabled reader may be a tablet, computer, or kiosk. The NFC-enabled reader using one or more algorithms takes the raw data wirelessly transmitted from the NFC-enabled dongle and calculates the analyte information. The one or more algorithms may be downloaded and stored in the NFC-enabled reader.

[0045] In another embodiment, a near field communication (NFC) tag chip in an NFC-enabled dongle may contain and transmit read-only data that identifies the electrochemical test sensor to an NFC-enabled reader, which recognizes the read-only data and runs one or more appropriate algorithms to determine analyte information (e.g., analyte concentration).

[0046] In further embodiments, the NFC-enabled reader may include login information for the user before using algorithms to assist in collecting and sorting the data. The data may be stored locally on the NFC-enabled reader or may be transmitted externally to another storage location, such as a cloud-based storage location. It is contemplated that the data may be transmitted elsewhere.

[0047] One method is shown in the flowchart of FIG. 5 and includes steps for determining and conveying analyte information to a user. Referring to FIG. 5, step 500 provides an electrochemical test sensor. In step 502, a fluid sample contacts the electrochemical test sensor. In step 504, the electrochemical test sensor is physically inserted into an NFC-enabled dongle. In step 506, an analog front end (AFE) is powered to initiate an electrochemical reaction with the analyte. In step 508, data is transmitted from the electrochemical reaction to an NFC-enabled reader. In step 510, analyte information (e.g., analyte concentration) is determined from the fluid sample. In step 512, the analyte information is communicated to a user using the NFC-enabled reader.

[0048] In one method, analyte information of a fluid sample is determined. An electrochemical test sensor is provided. For example, an electrochemical test sensor that may be used is electrochemical test sensor 10. The fluid sample contacts reagent area 28 via fluid-receiving area 16. In one method, the fluid sample is obtained by pricking a finger. In this case, the fluid sample is blood. The fluid sample may be obtained by other methods. It is contemplated that other fluids may be used. The electrochemical test sensor is physically inserted into an NFC-enabled dongle.

[0049] In one method, an NFC-enabled dongle with an inserted electrochemical test sensor is brought into close proximity to or placed in an NFC-enabled reader. It is contemplated that the NFC-enabled dongle may be brought into close proximity to or placed in an NFC-enabled reader, and then the electrochemical test sensor is physically inserted into the NFC-enabled dongle.

[0050] In one method, a near field communication (NFC) tag chip 50 including an analog front end (AFE) 52 is powered after bringing the NFC-enabled dongle into close proximity to an NFC-enabled reader. In one non-limiting example, tapping an NFC-enabled device to an NFC-enabled dongle can be used to instantly share analyte information from an electrochemical test sensor. Tapping an NFC-enabled reader or device to an NFC-enabled dongle can be used to establish a wireless connection between the two devices.

[0051] In another example, an NFC-enabled dongle can be in close proximity, as discussed above. NFC is currently used at communication distances of about 20 cm or less, and perhaps about 10 cm or less. In other embodiments, NFC is typically used at communication distances of less than about 8 cm or less than 6 cm. In other embodiments, NFC is more commonly used at communication distances of less than about 5 cm or approximately less than about 4 cm. The NFC chip tag of the NFC-enabled dongle communicates wirelessly with an NFC-enabled reader when in close proximity.

[0052] The analog front end 52 assists in initiating an electrochemical reaction with the analyte after receiving instructions from the microprocessor 60. After the reaction is initiated, data from the electrochemical reaction via the NFC tag chip of the NFC-enabled dongle is wirelessly transmitted to the NFC-enabled reader. Analyte information of the fluid sample is determined on the NFC-enabled reader using data received from the NFC-enabled dongle and at least one algorithm. The algorithm may be stored on the NFC-enabled reader or on a server farm in the cloud.

[0053] In one method, an analog front end (AFE) provides at least one voltage to the fluid sample to help initiate an electrochemical reaction with the analyte and generate a current formed from the electrochemical reaction. The AFE can provide an excitation signal to initiate the electrochemical reaction. During electrochemical analysis, the excitation signal is applied to the biological fluid sample. The excitation signal can be a potential or a current and can be constant, variable, or a combination thereof. The excitation signal can be applied as a single pulse or as multiple pulses, sequences, or cycles. Various electrochemical processes can be used, such as amperometry, coulometry, voltammetry, gated amperometry, gated voltammetry, etc.

[0054] In one approach, near field communication (NFC) tag chip 50 is powered by an NFC-enabled reader, which may be any of the NFC-enabled readers discussed above, including NFC-enabled reader 290. In another approach, as discussed with respect to FIG. 3B , battery 84 powers NFC tag chip 150 and / or AFE module 52 for signal sampling.

[0055] 1A, 6A, and 6B, system 400 includes electrochemical test sensor 10, a Bluetooth-enabled dongle 440, and a Bluetooth-enabled host / reader 490. The dongle in one embodiment is small and lightweight. The Bluetooth dongle can be made slightly heavier, if desired, to aid in improved ergonomic considerations. A non-limiting example of Bluetooth-enabled dongle 440 is a Bluetooth low energy (BLE) dongle. It is contemplated that the Bluetooth-enabled dongle may use Bluetooth Classic (an older standard) instead of the newer Bluetooth low energy (BLE) standard.

[0056] The Bluetooth-enabled dongle 440 includes a Bluetooth chip 450, an analog front end (AFE), and a microcontroller. Referring to FIG. 6B, the Bluetooth-enabled dongle 440 includes an exterior cover 442. The exterior cover 442 is typically made of a polymer material. It is contemplated that the dongle may be made of other materials. The exterior cover 442 forms an opening 444 for receiving the electrochemical test sensor 10. The dongle's exterior cover 442 helps protect the components contained therein.

[0057] The Bluetooth chip 450 may be secured to the Bluetooth enabled dongle 440 by, for example, a suitable adhesive and / or a mechanical coupling mechanism such as prongs. It is contemplated that other methods may be used to secure the Bluetooth chip to the Bluetooth enabled dongle. In one embodiment, the Bluetooth chip 450 is located inside the Bluetooth enabled dongle 440.

[0058] Bluetooth pairing occurs when two Bluetooth devices agree to communicate with each other and establish a connection. To pair two Bluetooth wireless devices, a password (passkey) is exchanged between the two devices. The passkey is a code shared by both Bluetooth devices that proves that both users agree to pair with each other. After the passkey code is exchanged, encrypted communication can be established between the paired devices. In Wi-Fi pairing, all pairings can be established with WPA2 encryption or another type of encryption scheme to keep transmissions private. Wi-Fi Direct is an example of a protocol that can be used to establish point-to-point communication between two Wi-Fi devices. This protocol allows a Wi-Fi device to pair directly with another device without first joining a local network. This method allows data sharing and direct communication from a Bluetooth-enabled host / reader (e.g., a phone) even when a router is not present.

[0059] For example, Bluetooth includes a small antenna and hardware for communicating via the Bluetooth standard. Bluetooth is a known worldwide standard that provides wireless data connectivity within fairly close proximity. Bluetooth is currently used at communication ranges of less than about 100 meters, and perhaps less than about 50 meters. In other embodiments, Bluetooth is typically used at communication ranges of less than about 30 meters or less than 20 meters. In other embodiments, Bluetooth is more commonly used at communication ranges of less than about 15 meters or less than about 10 meters. The Bluetooth chip communicates wirelessly with a Bluetooth-enabled host / reader within fairly close proximity.

[0060] Bluetooth enables simple transactions, data exchange, and connectivity within a certain proximity. Bluetooth Classic was developed in 1989, and BLE was developed in 2009. Bluetooth Classic operates at 2.400 GHz to 2.4835 GHz with over-the-air data rates of 1 to 3 Mbit / s and application throughput of 0.7 to 2.1 Mbit / s. BLE operates at 2.400 GHz to 2.4835 GHz with over-the-air data rates of 125 kbit / s to 2 Mbit / s and application throughput of 0.27 to 1.37 Mbit / s. BLE uses a different set of channels than Bluetooth Classic. BLE uses less power than Bluetooth Classic. Bluetooth's short range helps keep encrypted information private. Therefore, a Bluetooth-enabled reader, such as a smartphone, tablet, computer, or kiosk, can receive information from a Bluetooth-enabled dongle to assist in determining analyte concentration.

[0061] 7, Bluetooth chip 450 includes an analog front end (AFE) 452, a battery 454, a microcontroller unit 456, a real-time clock 458, an antenna 460, a memory 462, a filter 464, an RF transceiver 466, and multiple crystals 468, 470. Microcontroller unit 456 includes many additional modules not shown in FIG.

[0062] A non-limiting commercial example of a Bluetooth chip using Bluetooth Classic including a microcontroller and analog front end (AFE) that may be used in the present invention is the CC2564 family manufactured / sold by Texas Instruments. A non-limiting commercial example of a Bluetooth chip using BLE including a microcontroller and analog front end (AFE) that may be used in the present invention is the CYW20732A0 manufactured / sold by Cypress Semiconductor.

[0063] An analog front end (AFE) 452 is used to drive the electrochemistry and sample the results. In one embodiment, the AFE 452 applies a voltage to the reagent region 28, which initiates an electrochemical reaction between the reagent and the analyte in the fluid sample. The resulting current produced from the electrochemical reaction in this embodiment is sampled by the AFE 452. This measurement of the current is wirelessly transmitted to a Bluetooth-enabled reader for further processing.

[0064] The AFE 452 is powered by a battery 454 located on the Bluetooth chip 450, as shown in Figure 7. A non-limiting commercial example of an analog front end (AFE) that may be used in the present invention is the AFE4400 manufactured / sold by Texas Instruments in the USA.

[0065] The memory 462 of the Bluetooth chip 450 may be in the form of an EEPROM. One non-limiting example of memory that may be used is EEPROM. It is contemplated that other types of memory may be used. For example, flash memory may be used in the Bluetooth chip.

[0066] The microcontroller unit 456 in the Bluetooth enabled dongle 440 performs the operations involved in receiving and transmitting signals to the Bluetooth enabled reader through the antenna 460. The microcontroller unit 456 controls the analog front end (AFE) 452 and assists in converting the electrical signals into readable data. The microcontroller unit 456 instructs the analog front end (AFE) 452 to begin sampling. The Bluetooth enabled dongle preferably includes a low-end microprocessor. The low-end microprocessor does not execute one or more algorithms for determining analyte information of the fluid sample. A non-limiting commercial example of a microcontroller that may be used in the present invention is the LPC800 series manufactured / sold by NXP Semiconductors of the Netherlands.

[0067] It is contemplated that the analog front end (AFE), microcontroller, and Bluetooth chip may be separate chips or components. The Bluetooth chip in these embodiments would be considered a low-end chip. It is contemplated that two or more of these components may be integrated together. In one non-limiting example, the analog front end (AFE) and Bluetooth chip are integrated together. In another example, the microcontroller and Bluetooth chip are integrated together. In a further example, the analog front end (AFE) and microcontroller are integrated together. It is contemplated that the analog front end (AFE), microcontroller, and Bluetooth chip may all be integrated together, as shown with Bluetooth chip 450 in FIG. 7.

[0068] In one embodiment, a system for determining analyte information (e.g., analyte concentration) includes an electrochemical test sensor, a Bluetooth-enabled dongle, and a Bluetooth-enabled reader. The Bluetooth-enabled reader is configured to wirelessly receive data from the Bluetooth-enabled dongle to assist in determining the analyte concentration of the fluid sample. The electrochemical test sensor is adapted to receive a fluid sample containing the analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes and a plurality of test-sensor contacts. The Bluetooth-enabled dongle includes a Bluetooth chip, an analog front end (AFE), and a microcontroller. One non-limiting example of an electrochemical test sensor that may be used is electrochemical test sensor 10. One non-limiting example that may be used is Bluetooth-enabled dongle 440.

[0069] Referring back to FIG. 6A , system 400 includes electrochemical test sensor 10, a Bluetooth-enabled dongle 440, and a Bluetooth-enabled reader 490. The Bluetooth-enabled reader can read the Bluetooth chip information on the Bluetooth-enabled dongle to obtain information therefrom. The Bluetooth-enabled reader is typically a smartphone, tablet, or computer. It is contemplated that other Bluetooth-enabled readers may be used. For example, the Bluetooth-enabled reader may be a kiosk. The kiosk may be a kiosk specifically designed for use in determining the analyte concentration of a fluid sample. The kiosk may be useful in a medical setting, such as a hospital.

[0070] The Bluetooth-enabled reader 490 includes a display 492 and one or more buttons 394 or other mechanism for navigating the display 492. The display 492 is typically used to show analyte information or other information about the fluid sample. The display 492 may be analog or digital. The display 492 may be an LCD, LED, OLED, vacuum fluorescent, or other display adapted to show a numeric reading, such as analyte information. It is contemplated that analyte information (e.g., analyte concentration) may be conveyed via audio communication from the Bluetooth-enabled reader.

[0071] To assist in determining analyte information (e.g., analyte concentration), in one embodiment, one or more algorithms are downloaded to the Bluetooth-enabled reader 490. Here, the Bluetooth-enabled reader is shown as a smartphone. As discussed above, the Bluetooth-enabled reader may be a tablet, computer, or kiosk. The Bluetooth-enabled reader using one or more algorithms takes the raw data transmitted wirelessly from the Bluetooth-enabled dongle and calculates the analyte information. The one or more algorithms may be downloaded and stored in the Bluetooth-enabled reader.

[0072] In another embodiment, the Bluetooth chip in the Bluetooth-enabled dongle may contain and transmit read-only data that identifies the electrochemical test sensor to a Bluetooth-enabled reader, which recognizes the read-only data and executes one or more appropriate algorithms to determine analyte information (e.g., analyte concentration).

[0073] In further embodiments, the Bluetooth enabled reader may include login information for the user before using the algorithm to assist in collecting and sorting the data. The data may be stored locally on the Bluetooth enabled reader or may be transmitted externally to another storage location, such as a cloud-based storage location. It is contemplated that the data may be transmitted elsewhere.

[0074] One method is shown in the flowchart of FIG. 8 and includes steps for determining and communicating analyte information to a user. Referring to FIG. 8, step 600 provides an electrochemical test sensor. In step 602, a fluid sample contacts the electrochemical test sensor. In step 604, the electrochemical test sensor is physically inserted into a Bluetooth-enabled dongle. In step 606, an analog front end (AFE) is powered to initiate an electrochemical reaction with the analyte. In step 608, data is transmitted from the electrochemical reaction to a Bluetooth-enabled reader. In step 610, analyte information (e.g., analyte concentration) is determined from the fluid sample. In step 612, the analyte information is communicated to a user using the Bluetooth-enabled reader.

[0075] It should be noted that a one-time pairing is performed between the Bluetooth enabled dongle and the Bluetooth enabled reader to establish a wireless connection between the two devices before sample information can be determined. The Bluetooth enabled dongle and the Bluetooth enabled reader need to be brought into fairly close proximity to establish this pairing.

[0076] In this method, an electrochemical test sensor is provided to assist in determining analyte information. For example, an electrochemical test sensor that may be used is electrochemical test sensor 10. The fluid sample contacts reagent area 28 via fluid-receiving area 16. In one method, the fluid sample is obtained by pricking a finger. In this case, the fluid sample is blood. The fluid sample may be obtained by other methods. It is contemplated that other fluids may be used.

[0077] The electrochemical test sensor is physically inserted into a Bluetooth-enabled dongle. In this manner, a Bluetooth chip 450, including an analog front end (AFE) 452, is powered. This is accomplished through the use of a battery 454.

[0078] In one method, a Bluetooth-enabled dongle with an inserted electrochemical test sensor is brought into close proximity or placed in close proximity to a Bluetooth-enabled reader to assist in transmitting data. It is contemplated that the Bluetooth-enabled dongle may be brought into very close proximity or placed in very close proximity to the Bluetooth-enabled reader, and then the electrochemical test sensor is physically inserted into the Bluetooth-enabled dongle. Initiation is typically performed by the Bluetooth-enabled reader when the two are in very close proximity. It is contemplated that the Bluetooth-enabled dongle may perform initiation with the Bluetooth-enabled reader.

[0079] Bluetooth is currently used at communication ranges of about 100 meters or less, and perhaps less than about 50 meters. In other embodiments, Bluetooth is typically used at communication ranges of less than about 30 meters or less than 20 meters. In further embodiments, Bluetooth is more commonly used at communication ranges of less than about 15 meters or less than about 10 meters. The Bluetooth chip in the Bluetooth-enabled dongle communicates wirelessly with a Bluetooth-enabled reader when they are in fairly close proximity.

[0080] The analog front end 452 assists in initiating an electrochemical reaction with the analyte after receiving instructions from the microprocessor unit 456. After the reaction is initiated, data is transmitted wirelessly from the electrochemical reaction to the Bluetooth enabled reader via the Bluetooth chip in the Bluetooth enabled dongle. Analyte information of the fluid sample is determined on the Bluetooth enabled reader using data received from the Bluetooth enabled dongle and at least one algorithm. The algorithm may be stored on the Bluetooth enabled reader or on a server farm in the cloud.

[0081] In one method, an analog front end (AFE) provides at least one voltage to the fluid sample to help initiate an electrochemical reaction with the analyte and generate a current formed from the electrochemical reaction. The AFE can provide an excitation signal to initiate the electrochemical reaction. During electrochemical analysis, the excitation signal is applied to the biological fluid sample. The excitation signal can be a potential or a current and can be constant, variable, or a combination thereof. The excitation signal can be applied as a single pulse or as multiple pulses, sequences, or cycles. Various electrochemical processes can be used, such as amperometry, coulometry, voltammetry, gated amperometry, gated voltammetry, etc.

[0082] While the invention is susceptible to various modifications and alternative forms, specific embodiments and methods thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that it is not intended to limit the invention to the specific forms or methods disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Claims

1. 1. A system for determining analyte information of a fluid sample, comprising: an electrochemical test sensor adapted to receive the fluid sample of an analyte, the electrochemical test sensor including a base, the base including an enzyme adapted to react with the analyte, the electrochemical test sensor further including a plurality of electrodes and a plurality of test sensor contacts; an NFC-enabled dongle configured to receive the electrochemical test sensor and including a near field communication (NFC) tag chip, an analog front end (AFE), and a microcontroller, the NFC-enabled dongle including an exterior cover, the exterior cover forming an opening for receiving the electrochemical test sensor, wherein when the NFC-enabled dongle is coupled to the electrochemical test sensor, the NFC-enabled dongle is configured to provide a voltage to the electrochemical test sensor by the AFE; receive measurement data indicative of an electrochemical reaction from the electrochemical test sensor by the AFE; and transmit the measurement data by the NFC tag chip; and To collect user identification information indicative of the user; to authenticate the user based on the user identification information, and if the user is authenticated: obtaining the measurement data and test sensor identification information; Access cloud-based storage of multiple algorithms; selecting an algorithm based on the test sensor identification information from the cloud-based store; executing an algorithm to determine the analyte information of the fluid sample based on the measurement data; and classifying the specimen information based on the user identification information; and an NFC-enabled reader configured therewith.

2. The system of claim 1 , wherein the NFC-enabled reader is a smartphone, a tablet, or a computer.

3. The system of claim 1 , wherein the NFC-enabled reader is a kiosk.

4. The system of claim 1 , wherein the NFC-enabled reader displays the analyte information of the fluid sample.

5. 10. The system of claim 1, wherein the NFC tag chip contains and is adapted to transmit read-only data, the read-only data identifying the electrochemical test sensor to the NFC-enabled reader to assist in determining the analyte information of the fluid sample.

6. The system of claim 1 , wherein the NFC-enabled reader contains login information.

7. The system of claim 1 , wherein the AFE and the microcontroller are integrated into the NFC tag chip.

8. The system of claim 1 , wherein the electrochemical test sensor further comprises a mediator.

9. The system of claim 1 , wherein the NFC-enabled dongle is configured without a display and one or more buttons.

10. The system of claim 1 , wherein the NFC-enabled dongle further includes a battery.

11. 1. A method for determining analyte information of a fluid sample, comprising: providing an electrochemical test sensor adapted to receive the fluid sample of an analyte, the electrochemical test sensor including a base, the base including an enzyme adapted to react with the analyte, the electrochemical test sensor further including a plurality of electrodes and a plurality of test-sensor contacts; providing a near field communication (NFC) enabled dongle including an NFC tag chip, an analog front end (AFE), and a microcontroller, the NFC enabled dongle including an outer cover, the outer cover forming an opening for receiving the electrochemical test sensor; placing the electrochemical test sensor in electrical communication with the NFC enabled dongle through the opening in the NFC enabled dongle; contacting the fluid sample with the electrochemical test sensor; powering a near field communication (NFC) tag chip and the analog front end (AFE), the analog front end (AFE) helping to initiate an electrochemical reaction with the analyte of the fluid sample; receiving a current from the electrochemical test sensor by the AFE; generating measurement data by the microcontroller; obtaining user identification information indicative of a user by an NFC enabled reader; upon receiving the user identification information, wirelessly transmitting the measurement data and test sensor identification information from the NFC enabled dongle to the NFC enabled reader via the NFC tag chip, wherein the test sensor identification information indicates the electrochemical test sensor; receiving, by the NFC enabled reader, the measurement data and the test sensor identification information; authenticating the user based on the user identification information, and if the user is authenticated: Accessing a cloud-based store that stores multiple algorithms; selecting an algorithm from the plurality of algorithms based on the test sensor identification information from the cloud-based store; determining the analyte information of the fluid sample via the NFC-enabled reader using the measurement data and the algorithm; and classifying the analyte information based at least in part on the user identification information; A method comprising:

12. The method of claim 11 , wherein the fluid sample is blood.

13. The method of claim 11 , wherein the NFC-enabled reader is a smartphone, a tablet, or a computer.

14. The method of claim 11 , wherein the distance between the electrochemical test sensor and the NFC-enabled reader is less than 10 cm.

15. The method of claim 11 , wherein the analyte information of the fluid sample is an analyte concentration.

16. 12. The method of claim 11, wherein the AFE provides at least one voltage to the fluid sample to initiate the electrochemical reaction with the analyte and assist in generating a current formed from the electrochemical reaction with the analyte.

17. 12. The method of claim 11, wherein the analyte information of the fluid sample is communicated to a user via a display or in an audio communication.

Images