Test sensor system and method of using test sensor system

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 the analyte, an electrode, 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 a housing forming an opening for receiving the test sensor. The NFC-enabled reader wirelessly receives data from the dongle to help determine 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

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 17 / 102,820, filed November 24, 2020, which is hereby incorporated herein by reference in its entirety. Technical Field

[0003] This invention generally relates to a system and method for determining analyte concentration using an electrochemical testing sensor. More specifically, this invention generally relates to a system using an electrochemical testing sensor and a method for determining analyte concentration in the absence of an analyte meter. Background Technology

[0004] Quantitative determination of analytes in bodily fluids is important in the diagnosis and maintenance of certain health conditions. For example, lactate, cholesterol, and bilirubin levels should be monitored in some individuals. Of particular importance are patients with diabetes who frequently have their fluid glucose levels checked to regulate their dietary glucose intake. The results of such tests can be used to determine how much insulin and / or other medications, if any, are needed. In one type of blood glucose testing system, a test sensor is used to test a fluid sample of blood.

[0005] In a typical scenario, to determine analyte concentration, a user will carry multiple test sensors (e.g., electrochemical test sensors) and an analyte meter (e.g., a blood glucose meter). The analyte meter typically includes an opening for receiving the test sensors, 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.

[0006] This approach needs to be simplified to provide maximum user convenience while still providing typical analytes to determine the desired characteristics of the system. Summary of the Invention

[0007] 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 the 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 multiple electrodes and multiple 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 a housing. The housing 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 aid in determining the analyte information of the fluid sample.

[0008] 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 the 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 multiple electrodes and multiple 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 a housing. The housing 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 aid in determining the analyte information of the fluid sample.

[0009] According to a 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 suitable for receiving the analyte from the fluid sample is provided. The electrochemical test sensor includes a base. The base includes an enzyme suitable for reacting with the analyte. The electrochemical test sensor further includes multiple electrodes and multiple test sensor contacts. An NFC-enabled dongle is provided, and 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 a housing. The housing forms an opening for receiving the electrochemical test sensor. The electrochemical test sensor is placed through the opening of the NFC-enabled dongle to electrically communicate with the NFC-enabled dongle. The fluid sample contacts the electrochemical test sensor. Power is supplied to the near-field communication (NFC) tag chip and the analog front-end (AFE). The analog front-end assists in initiating the electrochemical reaction with the analyte in the fluid sample. The NFC-enabled dongle and the electrochemical test sensor are brought very close to the NFC-enabled reader. Data is wirelessly transmitted from the NFC-enabled dongle to the NFC-enabled reader via the NFC tag chip. The analyte information of the fluid sample is determined using data received from an NFC-enabled dongle via an NFC-enabled reader.

[0010] 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 suitable for receiving the analyte from the fluid sample is provided. The electrochemical test sensor includes a base. The base includes an enzyme suitable for reacting with the analyte. The electrochemical test sensor further includes multiple electrodes and multiple test sensor contacts. A Bluetooth-enabled dongle is provided, and the Bluetooth-enabled dongle includes a Bluetooth chip, an analog front-end (AFE), and a microcontroller. The Bluetooth-enabled dongle includes a housing. The housing forms an opening for receiving the electrochemical test sensor. The electrochemical test sensor is positioned via the opening of the Bluetooth-enabled dongle to electrically communicate with the Bluetooth-enabled dongle. The fluid sample contacts the electrochemical test sensor. Power is supplied to the Bluetooth chip and the analog front-end (AFE). The analog front-end assists in initiating the electrochemical reaction with the analyte in the fluid sample. The Bluetooth-enabled dongle is brought very close to the Bluetooth-enabled reader. Data is wirelessly transmitted from the Bluetooth-enabled dongle to the Bluetooth-enabled reader via the Bluetooth chip. The analyte information of the fluid sample is determined using data received from a Bluetooth-enabled dongle via a Bluetooth-enabled reader.

[0011] The above overview is not intended to represent every embodiment or aspect of the invention. Additional features and benefits of the invention will become apparent from the specific embodiments and drawings set forth below. Attached Figure Description

[0012] Other advantages of the invention will become apparent after reading the following detailed description and referring to the accompanying drawings, in which:

[0013] Figure 1A This is a top view of an electrochemical testing sensor used in a system according to one embodiment.

[0014] Figure 1B yes Figure 1A A front view of the electrochemical testing sensor.

[0015] Figure 1C After the cap and spacers have been removed Figure 1A A top view of the electrochemical testing sensor.

[0016] Figure 1D yes Figure 1C An enlarged view of the roughly rectangular region 1D shown.

[0017] Figure 2A It is included according to one embodiment Figure 1A and 1C The system includes an electrochemical test sensor, a dongle that enables near-field communication (NFC), and a reader that enables near-field communication (NFC).

[0018] Figure 2B yes Figure 2A The image shows a front view of an NFC-enabled dongle.

[0019] Figure 3A It is used for Figure 2A A schematic diagram of a Near Field Communication (NFC) tag chip in the system.

[0020] Figure 3B This is a schematic diagram of an NFC tag chip according to another embodiment.

[0021] Figure 4A It is included according to another embodiment Figure 1A and 1C The system includes an electrochemical test sensor, an NFC-enabled dongle, and an NFC-enabled reader.

[0022] Figure 4B yes Figure 4A The image shows a front view of an NFC-enabled dongle.

[0023] Figure 5 This is a flowchart of the steps involved in determining analyte information according to a method.

[0024] Figure 6A It is included according to one embodiment Figure 1A and 1C The system includes an electrochemical test sensor, a Bluetooth-enabled dongle, and a Bluetooth-enabled host / reader.

[0025] Figure 6B yes Figure 6A The image shows a front view of a Bluetooth-enabled dongle.

[0026] Figure 7 It is used for Figure 6A A schematic diagram of the Bluetooth chip in the system.

[0027] Figure 8 This is a flowchart of the steps used to determine analyte information according to another method.

[0028] While the invention is open to various modifications and alternatives, specific embodiments thereof have been shown by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that the invention is not intended to be limited to the specific forms disclosed, but rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined in the appended claims. Detailed Implementation

[0029] Electrochemical test sensors are adapted to receive fluid samples. Test sensors help determine information associated with the analyte, such as analyte concentration. The term "concentration" as used in this application refers to the concentration of the analyte used to measure the desired analyte, its activity (e.g., enzymes and electrolytes), titer (e.g., antibodies), or any other measurable concentration. Measurable analytes include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin, hemoglobin A1C, urea, creatinine, fructose, lactate, or bilirubin. It is anticipated that the concentrations of other analytes can be determined. Analytes can be present in, for example, whole blood samples, serum samples, plasma samples, other body fluids (e.g., ISF (interstitial fluid) and urine) and non-body fluids.

[0030] In one embodiment, the electrochemical testing sensor is adapted to receive a fluid sample containing an analyte. The electrochemical testing sensor, as discussed below, will be used in conjunction with an NFC-enabled dongle or a Bluetooth-enabled dongle.

[0031] The electrochemical test sensor includes a base. The base contains an enzyme suitable for reacting with the analyte. The electrochemical test sensor further includes multiple electrodes and multiple test sensor contacts.

[0032] The advantage of this invention is that the electrochemical testing sensor operates without an analyte meter (e.g., a blood glucose meter). Therefore, the analyte meter is not used with the electrochemical testing sensor of this invention. Here, the user conveniently avoids the need to carry an analyte meter to determine analyte concentration. However, the user will need to carry a dongle with Near Field Communication (NFC) enabled or Bluetooth enabled. Furthermore, unlike using a conventional analyte meter, the method of this invention involves almost no setup or learning curve.

[0033] Another advantage of this invention is the ease with which the algorithm used to calculate analyte concentrations can be modified. In this invention, the algorithm may be part of an NFC-enabled reader (e.g., a smartphone) within an application or may reside in a server cluster, for example, in the cloud. In another embodiment, the algorithm may be part of a BLE-enabled reader (e.g., a smartphone) within an application or may reside in a server cluster, for example, in the cloud. For users, updating the algorithm of this invention is convenient and very easy, thus allowing for more frequent updates when necessary. This contrasts with modifying the algorithm stored in the firmware of the analyte meter, which requires support for, for example, over-the-air updates or replacing the entire analyte meter. This is not only difficult to update but also very costly, especially when the analyte meter needs to be replaced.

[0034] The test sensor described in this article is an electrochemical test sensor. Figures 1A to 1D The image shows a non-limiting example of an electrochemical test sensor. Figures 1A to 1DAn electrochemical test sensor 10 is depicted, comprising a base 12, a cap 14, a fluid receiving region or channel 16, and a plurality of electrodes 18, 20, 22, and 24. In one embodiment, the fluid receiving region 16 is a capillary channel. The plurality of electrodes includes a counter electrode 18, a working (measuring) electrode 20, a detection filling electrode 22, and a hematocrit electrode 24. The fluid receiving region 16 provides a flow path for introducing a fluid sample into the electrochemical test sensor 10. Electrodes 18, 20, 22, and 24 are coupled to a corresponding one of a plurality of conductive leads 26a, 26b, 26c, and 26d communicating with a plurality of test sensor contacts 34a, 34b, 34c, and 34d. The plurality of electrodes may be made of various conductive materials, including, but not limited to, gold, platinum, rhodium, palladium, ruthenium, carbon, or combinations thereof.

[0035] It is anticipated that fewer than four electrodes may be used in other embodiments. For example, in one embodiment, the electrochemical test sensor may include two electrodes (working electrode and counter electrode). In another embodiment, the electrochemical test sensor may include three electrodes (working electrode, counter electrode, and detection fill electrode). It is anticipated that other electrodes may be used in the electrochemical test sensor.

[0036] 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 substance that can be electrochemically measured by components of an electrode pattern in terms of the current it generates. The reagent typically contains an analyte-specific enzyme that reacts with the analyte and an electron acceptor to produce an electrochemically measurable substance that can be detected by the electrode. If the analyte is glucose, the reagent will contain an enzyme such as glucose oxidase or glucose dehydrogenase.

[0037] Reagents typically contain a medium that facilitates the transfer of electrons between the analyte and the electrode. Non-limiting examples of media include phenothiazine, ferrocyanide, or tetrazolium salts, as well as other substances familiar to those skilled in the art. Reagents may contain binders, buffers, cellulose polymers, surfactants, other inert components, or combinations thereof, that hold the enzyme and the medium together.

[0038] In one embodiment, a fluid sample (e.g., blood) is applied to a reagent region 28 via a fluid receiving region 16. The fluid sample reacts with at least one reagent. After reacting with the reagent and binding with multiple electrodes, the fluid sample generates an electrical signal that helps determine the analyte concentration. Conductive leads 26a-26d carry the electrical signal back to the corresponding test sensor contacts 34a-34d.

[0039] Referring to Figure IB, it is shown Figure 1A A front view of the electrochemical testing sensor 10. (See image.) Figure 1BAs shown, the electrochemical test sensor 10 includes a cap 14, a spacer 30, and a base 12. The combination of the cap 14, spacer 30, and base 12 forms a fluid receiving region 16. The base 12, cap 14, and spacer 30 can be made of various materials, such as polymeric materials. Non-limiting examples of polymeric materials that can be used to form the base 12, cap 14, and spacer 30 include polycarbonate, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polyimide, and combinations thereof. It is contemplated that the base, spacer, and cap can be made independently of other materials. It is contemplated that other materials can be used to form the base 12, cap 14, and / or spacer 30.

[0040] In order to form Figures 1A to 1D The electrochemical test sensor 10, with its base 12, spacer 30, and cap 14 attached by, for example, adhesive or heat sealing. When the base 12, cap 14, and spacer 30 are attached, a fluid receiving area 16 is formed. Figure 1A As shown, the fluid receiving region 16 is formed at the first end or test end 32 of the electrochemical test sensor 10.

[0041] It is also anticipated that electrochemical testing sensors can be formed without spacers. For example, an electrochemical testing sensor may include a base and a cap, such that when the base and cap are attached to each other, a fluid receiving region (e.g., a capillary channel) is formed. It is anticipated that the electrochemical testing sensor can be formed using only the base.

[0042] refer to Figure 1A , 2A In addition to 2B, system 200 includes an electrochemical test sensor 10, an NFC-enabled dongle 40, and an NFC-enabled reader 290. In one embodiment, the NFC-enabled dongle is small and lightweight. If desired, the dongle can be made heavier to help improve ergonomics.

[0043] The NFC-enabled dongle 40 includes a Near Field Communication (NFC) tag chip 50, an analog front-end (AFE), and a microcontroller. See details in [reference needed]. Figure 2B The NFC-enabled dongle 40 includes a housing 42. The housing 42 is typically made of a polymer material. It is anticipated that the dongle may be made of other materials. The housing 42 forms an opening 44 for receiving the electrochemical test sensor 10. The housing 42 of the dongle helps protect the components contained therein.

[0044] The NFC tag chip 50 can be secured to the NFC-enabled dongle 40 via, for example, a suitable adhesive and / or a mechanical coupling mechanism such as a fork arm. Other methods are contemplated for securing 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.

[0045] Near Field Communication (NFC) comprises a small antenna and hardware that communicates via the NFC standard. NFC is a known global standard that provides wireless data connectivity at extremely close range. NFC is currently used for communication distances of approximately 20 cm or less, and more likely less than approximately 10 cm or less. In other embodiments, NFC is typically used for communication distances of less than approximately 8 cm or less than 6 cm. In yet another embodiment, NFC is more commonly used for communication distances of less than approximately 5 cm or less than approximately 4 cm. When extremely close, the NFC tag chip communicates wirelessly with an NFC-enabled reader.

[0046] Near Field Communication (NFC) simplifies transactions, data exchange, and touch connectivity. The NFC Forum, established in 2004, aims to facilitate sharing, pairing, and transactions between NFC-enabled readers or devices, and to develop and certify NFC-compliant devices. NFC operates at 13.56 MHz over the ISO / IEC 18000-3 air interface with rates ranging from 106 kbit / s to 848 kbit / s. NFC's short range helps protect the privacy of encrypted information. Therefore, NFC-enabled readers, such as smartphones, tablets, computers, or self-service terminals, can receive information from NFC-enabled dongles to help determine analyte concentrations.

[0047] Specifically, refer to Figure 3A The Near Field Communication (NFC) tag chip 50 includes an analog front-end (AFE) 52, a power management module 54, a 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. In one embodiment, the microcontroller 60 further 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. It should be noted that not all NFC tag chips contain all of these modules or features. For example, some NFC tag chips do not include a temperature sensor.

[0048] In this embodiment, the NFC-enabled dongle 40 does not contain a battery. In this embodiment, the Near Field Communication (NFC) tag chip 50 is capable of receiving power from the NFC-enabled reader. Therefore, the NFC-enabled dongle 40 is completely passive. In this embodiment, NFC involves 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 on a very simple form factor, such as a battery-free tag or sticker.

[0049] In another embodiment, the NFC-enabled dongle may include a battery for powering the Near Field Communication (NFC) and / or AFE module for signal sampling. (See reference) Figure 3B The NFC tag chip 150 includes a battery 84. The NFC tag chip 150 includes all the modules described in NFC tag chip 50, except for a power management module 54, which is not needed when the battery 84 is included. In one embodiment, the battery 84 is a 1.5V or 3V battery for powering the NFC tag chip 150. NFC peer-to-peer communication is of course possible when both devices are powered on. 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. (Reference) Figure 4A and 4B The system 300 includes an NFC-enabled dongle 140 with an NFC tag chip 150 and an NFC-enabled reader 290.

[0050] A non-limiting commercial example of a near field communication (NFC) tag chip comprising a microcontroller and an analog front-end (AFE) that can be used in this invention is the SL13A-AQFM manufactured / sold by Ams.

[0051] A non-limiting commercial example of a near-field communication (NFC) tag chip that can be used in this invention is the NT AG 210μ series tag manufactured / sold by NXP Semiconductors, Netherlands. Another non-limiting commercial example of a microcontroller-integrated near-field communication (NFC) tag chip that can be used in this invention is the ST25T series tag manufactured / sold by STMicroelectronics, Switzerland. Another non-limiting commercial example of an analog front-end (AFE)-integrated near-field communication (NFC) tag chip that can be used in this invention is the ST25R3916 / 7 manufactured / sold by STMicroelectronics, Switzerland.

[0052] Analog front-end (AFE) 52 is used to drive the electrochemistry and sample the results. In one embodiment, AFE 52 applies a voltage to reagent region 28, which initiates an electrochemical reaction between the reagent and the analyte in the fluid sample. In this embodiment, the resulting current generated by the electrochemical reaction is sampled by AFE 52. This measurement of the current is wirelessly transmitted to an NFC-enabled reader for further processing.

[0053] In one embodiment, the analog front-end (AFE) is transmitted via, for example, in... Figure 3A The NFC-enabled reader shown in the NFC tag chip 50 is powered. In another embodiment, the AFE is powered by a battery 84 located on the NFC tag chip 150, as... Figure 3B As shown in the figure. A non-limiting commercial example of an analog front-end (AFE) that can be used in this invention is the AFE4400, manufactured / sold by Texas Instruments, Inc.

[0054] The memory 56 of the NFC tag chip 50 is typically in the form of EEPROM. A non-limiting example of a usable memory is an 8kbit EEPROM. Other forms of EEPROM or other types of memory are expected to be used. For example, flash memory can be used in the NFC tag chip.

[0055] The microcontroller 60 in the NFC-enabled dongle 40 performs operations related to receiving signals via antenna 68 and sending signals to the NFC-enabled reader. The microcontroller 60 assists in controlling the analog front-end (AFE) 52 and converting electrical signals into readable data. The microcontroller 60 instructs the analog front-end (AFE) 52 to begin sampling. Ideally, the NFC-enabled dongle contains a low-end microprocessor. The low-end microprocessor does not run one or more algorithms to determine analyte information for the fluid sample. A non-limiting commercial example of a microcontroller that can be used in this invention is the LPC800 series manufactured / sold by NXP Semiconductors, Netherlands.

[0056] The analog front-end (AFE), microcontroller, and near-field communicator (NFC) are expected to be separate chips or components. In these embodiments, the NFC tag chip will be considered as the lower-end tag chip. It is anticipated that two or more of these components can be integrated together. In one non-limiting example, the analog front-end (AFE) and the near-field communicator (NFC) are integrated together. In another example, the microcontroller and the near-field communicator (NFC) are integrated together. In yet another example, the analog front-end (AFE) and the microcontroller are integrated together. It is anticipated that the analog front-end (AFE), microcontroller, and near-field communicator (NFC) can all be integrated together, for example with... Figure 2A The NFC chip tag 50 is shown together with it.

[0057] 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 aid in determining the analyte concentration of a 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 multiple electrodes and multiple test sensor contacts. The NFC-enabled dongle includes a near-field communication (NFC) tag chip, an analog front-end (AFE), and a microcontroller. A non-limiting example of an electrochemical test sensor that can be used is electrochemical test sensor 10. A non-limiting example that can be used is NFC-enabled dongle 40.

[0058] Return to reference Figure 2A System 200 includes an electrochemical testing sensor 10, an NFC-enabled dongle 40, and an NFC-enabled reader 290. The NFC-enabled reader can read the NFC chip tag on the NFC-enabled dongle to obtain information from it. The NFC-enabled reader is typically a smartphone, tablet, or computer. Other NFC-enabled readers are also expected to be used. For example, the NFC-enabled reader could be a self-service terminal. A self-service terminal could be specifically designed for determining the analyte concentration of a fluid sample. Self-service terminals can be used in healthcare environments such as hospitals.

[0059] The NFC-enabled reader 290 includes a display 292 and one or more buttons 294 or other mechanisms for navigating the display 292. The display 292 is typically used to show analyte information or other information about a fluid sample. The display 292 can be analog or digital. The display 292 can be an LCD, LED, OLED, vacuum fluorescent display, or other display suitable for displaying digital readings such as analyte information. Analyte information (e.g., analyte concentration) is expected to be transmitted from the NFC-enabled reader via audio communication.

[0060] To aid in determining analyte information (e.g., analyte concentration), in one embodiment, one or more algorithms are downloaded to an NFC-enabled reader 290. Here, the NFC-enabled reader is shown as a smartphone. As discussed above, the NFC-enabled reader can be a tablet computer, a computer, or a self-service terminal. The NFC-enabled reader using one or more algorithms acquires raw data from a wirelessly transmitted NFC-enabled dongle and calculates the analyte information. One or more algorithms can be downloaded and stored in the NFC-enabled reader.

[0061] In another embodiment, the Near Field Communication (NFC) tag chip in the NFC-enabled dongle can contain and transmit read-only data. This read-only data identifies the electrochemical test sensor to an NFC-enabled reader. The reader recognizes the read-only data and runs one or more appropriate algorithms to determine analyte information (e.g., analyte concentration).

[0062] In another embodiment, the NFC-enabled reader can include the user's login information before using algorithms to help collect and categorize data. The data can be stored locally in the NFC-enabled reader or sent from an external storage location, such as a cloud-based storage location. It is anticipated that the data can be sent to other locations.

[0063] One method in Figure 5 The flowchart illustrates and includes steps for determining analyte information and transmitting that information to the user. (Reference) Figure 5 Step 500 provides an electrochemical test sensor. In step 502, the fluid sample is brought into contact with the electrochemical test sensor. Step 504 physically inserts the electrochemical test sensor into an NFC-enabled dongle. Step 506 powers the analog front-end (AFE) and initiates the electrochemical reaction with the analyte. In step 508, data is transferred 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 transmitted to the user using the NFC-enabled reader.

[0064] In one method, analyte information of a fluid sample is determined. An electrochemical testing sensor is provided. For example, an electrochemical testing sensor 10 can be used. The fluid sample contacts a reagent region 28 via a fluid receiving region 16. In another method, the fluid sample is obtained by pricking a finger. In this case, the fluid sample is blood. The fluid sample can be obtained by other methods. Other fluids are expected to be used. The electrochemical testing sensor is physically inserted into an NFC-enabled dongle.

[0065] In one method, an NFC-enabled dongle with an inserted electrochemical test sensor is brought very close to or placed very close to an NFC-enabled reader. It is contemplated that the NFC-enabled dongle can be brought very close to or placed very close to the NFC-enabled reader, and then the electrochemical test sensor is physically inserted into the NFC-enabled dongle.

[0066] In one approach, a near-field communication (NFC) tag chip 50, comprising an analog front-end (AFE) 52, is powered after bringing an NFC-enabled dongle very close to an NFC-enabled reader. In a non-limiting example, tapping an NFC-enabled device with an NFC-enabled dongle can be used to instantly share analyte information from an electrochemical test sensor. Tapping an NFC-enabled reader or device with an NFC-enabled dongle can be used to establish a wireless connection between the two devices.

[0067] In another example, the NFC-enabled dongle can be extremely close, as discussed above. NFC is currently used for communication distances of approximately 20cm or less, and more likely approximately 10cm or less. In other embodiments, NFC is typically used for communication distances of less than approximately 8cm or less than 6cm. In yet another embodiment, NFC is more commonly used for communication distances of less than approximately 5cm or less than approximately 4cm. When extremely close, the NFC tag chip of the NFC-enabled dongle communicates wirelessly with the NFC-enabled reader.

[0068] The analog front-end 52 assists in initiating the electrochemical reaction with the analyte after receiving instructions from the microprocessor 60. After the reaction begins, data from the electrochemical reaction is wirelessly transmitted via an NFC-enabled dongle's NFC tag chip to an NFC-enabled reader. Using the data received from the NFC-enabled dongle and at least one algorithm, analyte information for the fluid sample is determined on the NFC-enabled reader. The algorithm can be stored on the NFC-enabled reader or in a server cluster in the cloud.

[0069] In one approach, an analog front-end (AFE) facilitates the initiation of an electrochemical reaction with the analyte by providing at least one voltage to the fluid sample, thereby generating a current formed by 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 sample of the biological fluid. 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 in multiple pulses, sequences, or cycles. Various electrochemical processes can be used, such as amperometry, coulometric voltammetry, voltammetry, gated current voltammetry, gated voltammetry, etc.

[0070] In one approach, the Near Field Communication (NFC) tag chip 50 is powered by an NFC-enabled reader. The NFC-enabled reader can be the NFC-enabled reader discussed above, including NFC-enabled reader 290. In another approach, as per [reference to...] Figure 3B As discussed, battery 84 powers NFC tag chip 150 and / or AFE module 52 for signal sampling.

[0071] refer to Figure 1A ,6A In 6B, system 400 includes an electrochemical test sensor 10, a Bluetooth-enabled dongle 440, and a Bluetooth-enabled host / reader 490. In one embodiment, the dongle is small and lightweight. If desired, the Bluetooth dongle can be made heavier to help improve ergonomics. A non-limiting example of the Bluetooth-enabled dongle 440 is a Bluetooth Low Energy (BLE) dongle. It is anticipated that the Bluetooth-enabled dongle can use classic Bluetooth (the older standard) instead of the newer Bluetooth Low Energy (BLE) standard.

[0072] The Bluetooth-enabled dongle 440 includes a Bluetooth chip 450, an analog front-end (AFE), and a microcontroller. (Reference) Figure 6B The Bluetooth-enabled dongle 440 includes a housing 442. The housing 442 is typically made of a polymer material. It is anticipated that the dongle may be made of other materials. The housing 442 forms an opening 444 for receiving the electrochemical test sensor 10. The housing 442 of the dongle helps protect the components contained therein.

[0073] The Bluetooth chip 450 can be secured to the Bluetooth-enabled dongle 440 via, for example, a suitable adhesive and / or a mechanical coupling mechanism such as a fork arm. Other methods are contemplated for securing the Bluetooth chip to the Bluetooth-enabled dongle. In one embodiment, the Bluetooth chip 450 is located inside the Bluetooth-enabled dongle 440.

[0074] Bluetooth pairing occurs when two Bluetooth devices agree to communicate and establish a connection. To pair two Bluetooth wireless devices, a password (key) needs to be exchanged between them. The key is a code shared by both Bluetooth devices, proving that the two users have agreed to pair. After exchanging the key code, encrypted communication can be established between the paired devices. In Wi-Fi pairing, each pairing can be established using WPA2 encryption or another type of encryption scheme to maintain the privacy of transmissions. Wi-Fi Direct is an example of a protocol that can be used to establish peer-to-peer communication between two Wi-Fi devices. The protocol allows Wi-Fi devices to pair directly with another device without first joining a local network. This method can share data and communicate directly from a Bluetooth-enabled host / reader (e.g., a mobile phone), even in the absence of a router.

[0075] For example, Bluetooth includes a small antenna and hardware that communicates via the Bluetooth standard. Bluetooth is a known global standard that provides wireless data connectivity over a fairly close range. Bluetooth is currently used for communication distances of less than about 100 meters, and more likely less than about 50 meters. In other embodiments, Bluetooth is typically used for communication distances of less than about 30 meters or less than 20 meters. In yet another embodiment, Bluetooth is more commonly used for communication distances of less than about 15 meters or less than about 10 meters. The Bluetooth chip communicates wirelessly with a Bluetooth-enabled host / reader over a fairly close range.

[0076] Bluetooth enables simplified transactions, data exchange, and connections within a certain proximity. Bluetooth Classic was established in 1989, while BLE was established in 2009. Bluetooth Classic operates in the 2.400 GHz to 2.4835 GHz band, with an air data rate of 1-3 Mbit / s and application throughput of 0.7 to 2.1 Mbit / s. BLE operates in the 2.400 GHz to 2.4835 GHz band, with an air data rate 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 consumes less power than Bluetooth Classic. Bluetooth's short range helps protect the privacy of encrypted information. Therefore, Bluetooth-enabled readers, such as smartphones, tablets, computers, or self-service terminals, can receive information from Bluetooth-enabled dongles to help determine analyte concentrations.

[0077] Specifically, refer to Figure 7 The 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 and 470. The microcontroller unit 456 includes... Figure 7 Many additional modules not shown in the diagram.

[0078] A non-limiting commercial example of a Bluetooth chip using Bluetooth Classic that includes a microcontroller and an analog front-end (AFE) and can be used in this invention is the CC2564 series manufactured / sold by Texas Instruments. A non-limiting commercial example of a Bluetooth chip using BLE that includes a microcontroller and an analog front-end (AFE) and can be used in this invention is the CYW20732A0 manufactured / sold by Cypress Semiconductor.

[0079] Analog front-end (AFE) 452 is used to drive the electrochemistry and sample the results. In one embodiment, AFE 452 applies a voltage to reagent region 28, which initiates an electrochemical reaction between the reagent and the analyte in the fluid sample. In this embodiment, the resulting current generated by the electrochemical reaction is sampled by AFE 452. This measurement of the current is wirelessly transmitted to a Bluetooth-enabled reader for further processing.

[0080] The AFE 452 is powered by a battery 454 located on the Bluetooth chip 450, such as Figure 7 As shown in the figure. A non-limiting commercial example of an analog front-end (AFE) that can be used in this invention is the AFE4400, manufactured / sold by Texas Instruments, Inc.

[0081] The memory 462 of the Bluetooth chip 450 can be in the form of an EEPROM. One non-limiting example of a memory that can be used is an EEPROM. Other types of memory are also expected to be used. For example, flash memory can be used in the Bluetooth chip.

[0082] The microcontroller unit 456 in the Bluetooth-enabled dongle 440 performs operations related to receiving signals via antenna 460 and transmitting signals to the Bluetooth-enabled reader. The microcontroller unit 456 assists in controlling the analog front-end (AFE) 452 and converting electrical signals into readable data. The microcontroller unit 456 instructs the analog front-end (AFE) 452 to begin sampling. Ideally, the Bluetooth-enabled dongle contains a low-end microprocessor. The low-end microprocessor does not run one or more algorithms to determine analyte information for the fluid sample. A non-limiting commercial example of a microcontroller that can be used in this invention is the LPC800 series manufactured / sold by NXP Semiconductors, Netherlands.

[0083] The analog front-end (AFE), microcontroller, and Bluetooth chip are expected to be separate chips or components. In these embodiments, the Bluetooth chip will be considered as a lower-end tag chip. It is anticipated that two or more of these components can 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 yet another example, the analog front-end (AFE) and microcontroller are integrated together. It is anticipated that the analog front-end (AFE), microcontroller, and Bluetooth chip can all be integrated together, for example, with... Figure 7 The Bluetooth chip 450 is shown together with it.

[0084] 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 aid in determining the analyte concentration of a 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 multiple electrodes and multiple test sensor contacts. The Bluetooth-enabled dongle includes a Bluetooth chip, an analog front-end (AFE), and a microcontroller. A non-limiting example of an electrochemical test sensor that can be used is electrochemical test sensor 10. A non-limiting example that can be used is Bluetooth-enabled dongle 440.

[0085] Return to reference Figure 6A The system 400 includes an electrochemical testing sensor 10, a Bluetooth-enabled dongle 440, and a Bluetooth-enabled reader 490. The Bluetooth-enabled reader can read Bluetooth chip information from the Bluetooth-enabled dongle to obtain information. The Bluetooth-enabled reader is typically a smartphone, tablet, or computer. Other Bluetooth-enabled readers are also expected to be used. For example, the Bluetooth-enabled reader could be a self-service terminal. A self-service terminal could be specifically designed for determining the analyte concentration of a fluid sample. Self-service terminals can be used in healthcare environments such as hospitals.

[0086] The Bluetooth-enabled reader 490 includes a display 492 and one or more buttons 394 or other mechanisms for navigating the display 492. The display 492 is typically used to show analyte information or other information about a fluid sample. The display 492 can be analog or digital. The display 492 can be an LCD, LED, OLED, vacuum fluorescent display, or other display suitable for displaying digital readings such as analyte information. Analyte information (e.g., analyte concentration) is expected to be transmitted from the Bluetooth-enabled reader via audio communication.

[0087] To aid in determining analyte information (e.g., analyte concentration), in one embodiment, one or more algorithms are downloaded to a Bluetooth-enabled reader 490. Here, the Bluetooth-enabled reader is shown as a smartphone. As discussed above, the Bluetooth-enabled reader can be a tablet computer, a computer, or a self-service terminal. The Bluetooth-enabled reader using one or more algorithms acquires raw data from a wirelessly transmitted Bluetooth-enabled dongle and calculates the analyte information. One or more algorithms can be downloaded and stored in the Bluetooth-enabled reader.

[0088] In another embodiment, the Bluetooth chip in the Bluetooth-enabled dongle may contain and transmit read-only data. This read-only data identifies the electrochemical test sensor to a Bluetooth-enabled reader. The reader recognizes the read-only data and runs one or more appropriate algorithms to determine analyte information (e.g., analyte concentration).

[0089] In another embodiment, the Bluetooth-enabled reader can include the user's login information before using algorithms to help collect and categorize data. The data can be stored locally in the Bluetooth-enabled reader or sent from an external storage location, such as a cloud-based storage location. It is anticipated that the data can be sent to other locations.

[0090] One method in Figure 8 The flowchart illustrates and includes steps for determining analyte information and transmitting that information to the user. (Reference) Figure 8 Step 600 provides an electrochemical testing sensor. In step 602, the fluid sample is brought into contact with the electrochemical testing sensor. Step 604 physically inserts the electrochemical testing sensor into a Bluetooth-enabled dongle. Step 606 powers the analog front-end (AFE) and initiates the electrochemical reaction with the analyte. In step 608, data is transferred 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 transmitted to the user using the Bluetooth-enabled reader.

[0091] Before determining the analyte information, it is important to note that a pairing process must be performed between the Bluetooth-enabled dongle and the Bluetooth-enabled reader to establish a wireless connection between the two devices. The Bluetooth-enabled dongle and the Bluetooth-enabled reader need to be very close to each other to establish this pairing.

[0092] In this method, an electrochemical testing sensor is provided to help determine analyte information. For example, an electrochemical testing sensor 10 can be used. The fluid sample comes into contact with the reagent region 28 via the fluid receiving region 16. In one method, the fluid sample is obtained by pricking a finger. In this case, the fluid sample is blood. The fluid sample can be obtained by other methods. Other fluids are expected to be used.

[0093] The electrochemical test sensor is physically inserted into a Bluetooth-enabled dongle. In this method, a Bluetooth chip 450 containing an analog front-end (AFE) 452 is powered. This is achieved using a battery 454.

[0094] In one method, a Bluetooth-enabled dongle with an inserted electrochemical test sensor is brought very close to, or placed very close to, a Bluetooth-enabled reader to facilitate data transmission. It is anticipated that the Bluetooth-enabled dongle can be brought very close to, or placed very close to, the Bluetooth-enabled reader, and then the electrochemical test sensor is physically inserted into the Bluetooth-enabled dongle. When the Bluetooth-enabled reader and the Bluetooth-enabled dongle are very close, initialization is typically performed by the Bluetooth-enabled reader. It is anticipated that the Bluetooth-enabled dongle can be initialized using the Bluetooth-enabled reader.

[0095] Bluetooth is currently used for communication distances of approximately 100 meters or less, and more likely less than approximately 50 meters. In other embodiments, Bluetooth is typically used for communication distances of less than approximately 30 meters or less than 20 meters. In yet another embodiment, Bluetooth is more commonly used for communication distances of less than approximately 15 meters or less than approximately 10 meters. When extremely close, the Bluetooth chip in a Bluetooth-enabled dongle communicates wirelessly with a Bluetooth-enabled reader.

[0096] The simulation front-end 452 assists in initiating the electrochemical reaction with the analyte after receiving instructions from the microprocessor unit 456. After the reaction begins, data from the electrochemical reaction is wirelessly transmitted via a Bluetooth chip of a Bluetooth-enabled dongle to a Bluetooth-enabled reader. Using the data received from the Bluetooth-enabled dongle and at least one algorithm, analyte information for the fluid sample is determined on the Bluetooth-enabled reader. The algorithm can be stored on the Bluetooth-enabled reader or in a server cluster in the cloud.

[0097] In one approach, an analog front-end (AFE) facilitates the initiation of an electrochemical reaction with the analyte by providing at least one voltage to the fluid sample, thereby generating a current formed by 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 sample of the biological fluid. 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 in multiple pulses, sequences, or cycles. Various electrochemical processes can be used, such as amperometry, coulometric voltammetry, voltammetry, gated current voltammetry, gated voltammetry, etc.

[0098] While the invention is open to various modifications and alternatives, specific embodiments and methods thereof have been illustrated by way of example in the accompanying drawings and described in detail herein. However, it should be understood that the invention is not intended to be limited to the specific forms or methods disclosed, but rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Claims

1. A system for determining analyte information of a fluid sample, the system comprising: An electrochemical test sensor adapted to receive a fluid sample of an analyte, the electrochemical test sensor comprising a base containing an enzyme adapted to react with the analyte, the electrochemical test sensor further comprising a plurality of electrodes and a plurality of test sensor contacts; The Bluetooth-enabled dongle includes a Bluetooth chip, an analog front-end, a microcontroller, and a battery. The dongle also includes a housing that forms an opening for receiving signals from the electrochemical test sensor. The microcontroller guides the analog front end: When the microcontroller is powered by the battery, a voltage is applied to the reagent region to initiate the electrochemical reaction; The results generated by the electrochemical reaction that produces the sampling results are sampled; and Once a request to transmit the sampling results is received, the sampling results and test sensor identification information are transmitted. Wherein, the test sensor identification information indicates the electrochemical test sensor; and The Bluetooth-enabled reader is configured as follows: Data is wirelessly received from the Bluetooth-enabled dongle to help determine the analyte information of the fluid sample; Collect user identification information indicating the user of the electrochemical test sensor; The user is authenticated based on the user identification information, and once the user is authenticated: Obtain the sampling results and the test sensor identification information indicating the electrochemical test sensor; Access cloud-based storage for multiple algorithms; Based on the test sensor identification information, one of the multiple algorithms is selected from the cloud-based memory; The algorithm is run to determine the analyte information of the fluid sample based on the sampling results; and The analyte information is classified based on the user identification information.

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

3. The system according to claim 1, wherein the Bluetooth-enabled reader is a self-service terminal.

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

5. The system of claim 1, wherein the Bluetooth chip is adapted to include and transmit read-only data, the read-only data identifying the electrochemical test sensor to the Bluetooth-enabled reader to help determine the analyte information of the fluid sample.

6. The system of claim 1, wherein the analog front end and the microcontroller are integrated into the Bluetooth chip.

7. The system of claim 1, wherein the electrochemical test sensor further comprises a medium.

8. The system of claim 1, wherein the Bluetooth-enabled dongle is formed without a display and one or more buttons.

9. The system according to claim 1, wherein the Bluetooth-enabled dongle is a Bluetooth Low Energy (BLE) enabled dongle, and wherein the Bluetooth chip is a Bluetooth Low Energy (BLE) chip.

10. The system of claim 1, wherein the simulation front end assists in initiating the electrochemical reaction with the analyte by providing at least one voltage to the fluid sample, thereby generating a current formed by the electrochemical reaction with the analyte.

11. A method for determining analyte information of a fluid sample, the method comprising: An electrochemical test sensor is provided, the electrochemical test sensor being adapted to receive the fluid sample of the analyte, the electrochemical test sensor comprising a base containing an enzyme adapted to react with the analyte, and the electrochemical test sensor further comprising a plurality of electrodes and a plurality of test sensor contacts; A Bluetooth-enabled dongle is provided, the Bluetooth-enabled dongle comprising a Bluetooth chip, an analog front end, and a microcontroller, the Bluetooth-enabled dongle comprising a housing, the housing forming an opening for receiving the electrochemical test sensor; The electrochemical test sensor is positioned to communicate electrically with the Bluetooth-enabled dongle via the opening of the Bluetooth-enabled dongle. Bring the fluid sample into contact with the electrochemical testing sensor; Power is supplied to the Bluetooth chip and the analog front end, which helps initiate the electrochemical reaction between the analyte and the fluid sample; The microcontroller guides the simulation front end to sample the results generated by the electrochemical reaction that produces the sampling results; Bring the Bluetooth-enabled dongle close to the Bluetooth-enabled reader; User identification information indicating the user of the electrochemical test sensor is obtained via the Bluetooth-enabled reader; Once the user identification information is received, the user is authenticated based on the user identification information; Once the user is authenticated: The sampling results and test sensor identification information are wirelessly transmitted from the Bluetooth-enabled dongle to the Bluetooth-enabled reader via the Bluetooth chip. The test sensor identification information indicates the electrochemical test sensor; The sampling results and the test sensor identification information are received via the Bluetooth-enabled reader. Access cloud-based storage for multiple algorithms; Based on the test sensor identification information, one of the multiple algorithms is selected from the cloud-based memory; Using the sampling results and the algorithm, the analyte information of the fluid sample is determined via the Bluetooth-enabled reader; and The analyte information is classified based on the user identification information.

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

13. The method of claim 11, wherein the Bluetooth-enabled reader is a self-service terminal.

14. The method of claim 11, wherein the Bluetooth-enabled reader displays the analyte information of the fluid sample.

15. The method of claim 11, wherein the Bluetooth chip is adapted to include and transmit read-only data, the read-only data identifying the electrochemical test sensor to the Bluetooth-enabled reader to help determine the analyte information of the fluid sample.

16. The method of claim 11, wherein the analog front-end and the microcontroller are integrated into the Bluetooth chip.

17. The method of claim 11, wherein the electrochemical test sensor further comprises a medium.

18. The method of claim 11, wherein the Bluetooth-enabled dongle is formed without a display and one or more buttons.

19. The method of claim 11, wherein the Bluetooth-enabled dongle is a Bluetooth Low Energy (BLE) enabled dongle, and wherein the Bluetooth chip is a BLE chip.

20. The method of claim 11, wherein the simulated front end assists in initiating the electrochemical reaction with the analyte by providing at least one voltage to the fluid sample, thereby generating a current formed by the electrochemical reaction with the analyte.

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