Modular analyte sensing system

Abstract

A removable cartridge is configured to receive one or more fluid samples for analysis. The cartridge includes a plurality of sample wells. Each sample well includes a sensor with a first electrode, a second electrode, and a third electrode. The electrodes are arranged to contact the sample fluid. A base is configured to receive the cartridge. The base is configured to send and receive signals to the cartridge when the cartridge is received by the base. A controller is configured to exchange signals with the first electrode, the second electrode, and the third electrode. The controller is configured to identify each sample well of the cartridge. The controller is configured to determine a status of each sample well of the cartridge.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Application No. 63 / 380,550, filed October 21, 2022, the contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to devices and methods useful for the detection of analytes in fluid samples. [Background technology]

[0003] Traditional methods of bioanalysis involve preparing a sample containing a target analyte and analyzing the analyte using analyte-specific chemicals (e.g., detecting the analyte by attaching it to the analyte). Sample preparation may include stripping the sample's biological matrix from the analyte to be detected, presenting a "clean" sample for detection. Detection can be performed by a sensor that includes a physical transducer that converts information about the presence of the analyte into a measurable signal (either through an intermediate binding step or directly, as is done in mass spectrometry). The interaction of the transducer with the analyte to be detected may require an intermediate cleaning step to ensure that interference from other biological species in the stripped and sample-prepared matrix is ​​not present in the transducer signal.

[0004] Traditional approaches may require target-specific chemicals, biological reagents, and cleaning steps to be incorporated as part of a multi-step protocol in the detection of an analyte. The use of these target-specific chemicals, biological reagents, and cleaning steps also requires a priori hypothesis / knowledge of the target that will be detected as part of the workflow. Furthermore, each time a new analyte in a sample needs to be analyzed, the sample may need to be prepared again. As a result, traditional methods of bioanalysis can be cumbersome, inefficient, and expensive. Summary of the Invention [Means for solving the problem]

[0005] FIELD OF THE DISCLOSURE The present disclosure relates to techniques involving modular analyte sensing systems.

[0006] One exemplary implementation of the subject matter described in this disclosure is an analyte sensing system with the following features: A removable cartridge includes sample wells, each sample well configured to receive a sample fluid for analysis, A base configured to receive the cartridge, and The base configured to send and receive signals to the cartridge when the cartridge is received by the base.

[0007] Aspects of an exemplary analyte sensing system that may be combined with an exemplary analyte system alone or in combination with other aspects include the following: The sample wells each include a sensor with the following features: A first electrode arranged to contact the sample fluid; A second electrode arranged to contact the sample fluid; A third electrode arranged to contact the sample fluid.

[0008] Aspects of an exemplary analyte sensing system that may be combined with an exemplary analyte system alone or in combination with other aspects include the following: A base includes the following features: A receptacle configured to receive electrical pins coupled to the first electrode, the second electrode, and the third electrode A controller is coupled to the receptacle The controller is configured to direct the exchange of signals by the receptacle and the pins with the first electrode, the second electrode, and the third electrode

[0009] Aspects of an exemplary analyte sensing system that may be combined with an exemplary analyte system alone or in combination with other aspects include the following: A controller configured to identify each sample well of the cartridge. A controller configured to determine a status of each sample well of the cartridge. A controller configured to direct an analysis of a substance to be performed in at least one of the sample wells. A controller configured to generate a spectrum based on the analysis performed.

[0010] Aspects of the exemplary analyte sensing system that may be combined with the exemplary analyte system alone or in combination with other aspects include the following: The controller is further configured to determine the presence of the target analyte based on the produced spectrum.

[0011] Aspects of the exemplary analyte sensing system that may be combined with the exemplary analyte system alone or in combination with other aspects include the following: The controller is further configured to upload the generated spectrum to a cloud service.

[0012] Aspects of the exemplary analyte sensing system that may be combined with the exemplary analyte system alone or in combination with other aspects include the following: The cartridge includes a swing linkage configured to separate the cartridge from the base.

[0013] An exemplary implementation of the subject matter described in this disclosure is a method with the following features: A removable cartridge is received by a base; The cartridge includes a plurality of sample wells; Each sample well of the cartridge is identified; A status of each sample well of the cartridge is determined; An analysis of a substance is performed in at least one of the sample wells; and A spectrum is generated based on the analysis performed.

[0014] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: Determining the status may include: An identity of the sample well is determined; A usage history of the sample well is looked up; A suitability for use status of the sample well is determined.

[0015] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: A fitness for use status is determined based on at least the following criteria: the date the sample well was last used and the date the sample well was last inspected.

[0016] Aspects of the example method that may be combined with the example method alone or in combination with other aspects include the following: Looking up the usage history includes querying a lookup table.

[0017] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: A fitness for use status indicates that the sample well is unusable, in which case the sample well is excluded from the analysis operation.

[0018] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: A fitness for use status indicates that the sample well is available for use, in which case the sample well is enabled for analytical operations.

[0019] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: The cartridge is inspected.

[0020] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: Servicing the cartridge includes replacing multiple sample wells or cleaning the sample wells.

[0021] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: The presence of the target analyte is determined based on the spectrum produced.

[0022] Aspects of the exemplary method that may be combined with the exemplary method alone or in combination with other aspects include the following: Determining the presence of the target analyte based on the generated spectrum includes: A reference spectrum is generated from a reference sample; The generated spectrum is compared to the reference spectrum.

[0023] Aspects of the example method that may be combined with the example method alone or in combination with other aspects include the following: The generated spectrum is uploaded to a cloud service.

[0024] An exemplary implementation of the subject matter described in this disclosure is an analyte sensing system with the following features: A removable cartridge configured to receive one or more fluids for sample analysis. The cartridge includes a plurality of sample wells. Each of the sample wells includes a sensor with a first electrode, a second electrode, and a third electrode. The electrodes are arranged to contact the sample fluid. A base is configured to receive the cartridge. The base is configured to send and receive signals to the cartridge when the cartridge is received by the base. The base includes the following features: A receptacle configured to receive electrical pins coupled to the first electrode, the second electrode, and the third electrode. A controller is coupled to the receptacle. The controller is configured to direct the receptacle and the pins to exchange signals with the first electrode, the second electrode, and the third electrode. The controller is configured to identify each sample well of the cartridge. The controller is configured to determine a status of each sample well of the cartridge. The controller is configured to direct an analysis of the material in at least one of the sample wells to be performed, the controller is configured to generate a spectrum based on the analysis performed, and the controller is configured to determine the presence of a target analyte based on the generated spectrum.

[0025] Aspects of the exemplary analyte sensing system that may be combined with the exemplary analyte sensing system alone or in combination with other aspects include the following: The controller is further configured to upload the generated spectrum to a cloud service.

[0026] Non-transitory computer program products (i.e., physically embodied computer program products) are also described, which store instructions that, when executed by one or more data processors of one or more computing systems, cause at least one data processor to perform the operations described herein. Similarly, computer systems are also described, which may include one or more data processors and memory coupled to the one or more data processors. The memory may temporarily or permanently store instructions, which cause the at least one processor to perform one or more of the operations described herein. Additionally, methods can be implemented by one or more data processors, where the one or more data processors are either within a single computing system or distributed among two or more computing systems. Such computing systems may be connected via one or more connections, including connections via a network (e.g., the Internet, a wireless wide area network, a local area network, a wide area network, a wired network, or the like), via direct connections between one or more of the computing systems, or the like, and may exchange data and / or commands or other instructions, or the like.

[0027] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative embodiments and features described herein, further aspects, embodiments, objects, and features of the present disclosure will become more fully apparent from the drawings and detailed description and claims. [Brief explanation of the drawings]

[0028] These and other features will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings.

[0029] [Figure 1] FIG. 1 is a perspective view of an exemplary modular analyte system fully assembled.

[0030] [Figure 2] FIG. 2 is a perspective view of an exemplary modular analyte system with the cartridge removed from the base.

[0031] [Figure 3] FIG. 3 is a perspective view of an exemplary modular analyte system base.

[0032] [Figure 4A] FIG. 4A is a top perspective view of an exemplary modular analyte system cartridge.

[0033] [Figure 4B] FIG. 4B is a perspective view of the interior of the analyte system.

[0034] [Figure 5] FIG. 5 is a bottom view of an exemplary modular analyte system cartridge.

[0035] [Figure 6] FIG. 6 is a bottom perspective view of an exemplary modular analyte system cartridge.

[0036] [Figure 7] FIG. 7 is a side perspective view of an exemplary modular analyte system cartridge.

[0037] [Figure 8] FIG. 8 is a top perspective view of an exemplary sample well.

[0038] [Figure 9] FIG. 9 is a bottom perspective view of an exemplary well with a single sensor.

[0039] [Figure 10] FIG. 10 is a bottom perspective view of an exemplary well with multiple sensors.

[0040] [Figure 11] FIG. 11 is a diagram illustrating communication between a modular analyte system, a cloud service, and a local computer.

[0041] [Figure 12] FIG. 12 is a block diagram of an example controller that may be used in conjunction with aspects of the present disclosure.

[0042] [Figure 13] FIG. 13 is a flowchart of an exemplary method that may be used in conjunction with aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0043] (Detailed explanation) The present disclosure generally relates to characterizing samples (e.g., electrochemical solutions containing analytes and redox species). Methods for characterizing biological samples can include workflows that are general (e.g., not specific to a given analyte (due to analyte-specific chemistry)) and simplified (e.g., not requiring extensive sample preparation). In some implementations, the methods rely on biological sample measurement methods (e.g., via a sensor platform including consumables and instruments) and machine learning (ML)-enabled data analysis stacks, where appropriate analyses can be customized from a set of available ML models to predict sample phenotypes or quantification of specific biological properties, including biomarkers, with a high degree of sensitivity and specificity.

[0044] The present disclosure describes an analyte sensing system with a removable cartridge including a plurality of sample wells configured to receive sample fluid for analysis. A base is configured to receive the cartridge. The base is configured to send and receive signals to the cartridge when the cartridge is received by the base. In some implementations, the base can additionally communicate (exchange information between) itself and a computer, a cloud service, or both.

[0045] An assay is described as a process that assigns a phenotypic class to a sample or evaluates the expression / concentration of one or more analytes in a sample. In some implementations, a system (or sensor platform) for performing an assay can include three elements: a consumable, an instrument, and one or more computing systems for running a feature set extraction and analysis software stack (e.g., from raw data obtained by consumable / instrument detection).

[0046] Each element of the system may have multiple implementations. Each implementation can be informed by the customer workflow and the sample type being analyzed. For example, selecting a particular implementation may require evaluating tradeoffs between throughput, power, footprint, and desired noise power-spectral-density (PSD) performance. In some implementations, consumables and / or instruments can be modified to suit specific applications.

[0047] The consumable can include a sensor with an interface geometry configured to interface with a sample containing an analyte. The interface geometry can include a nanoscale electrochemical interface described in U.S. Patent Application No. 16 / 016,468, U.S. Patent Application No. 17 / 317,422, and U.S. Patent No. 9,285,336 (incorporated herein by reference in their entireties). The consumable can be integrated with a sample collection mechanism (e.g., a syringe, a pipette, a breath analyzer). Alternatively, the consumable can be integrated with a sample storage device (e.g., a storage cap, a vial / test tube, a Vacutainer®, a beaker, a dried spot card, a microtiter plate, an incubator / other flask, a microfluidic cartridge, etc.). In some implementations, the consumable and / or instrument can be integrated with a sample handling robot. The instrument can be integrated with the consumable (e.g., configured to receive an electrical signal indicative of detection by the consumable). Instruments can have low throughput (e.g., single consumable read), medium throughput (e.g., 6 consumable read), or high throughput (e.g., 24-1,536 consumable read). Medium and high throughput instruments can perform multiple reads / scans of samples in multiple consumables.

[0048] Computation (e.g., using machine learning models) on raw data obtained by the instrument can be performed locally (e.g., local computation) or on the cloud (cloud computation). The decision to perform computation locally, on the cloud, or a combination thereof can be based on internet connectivity, the need to ensure data security, and / or quick time to results.

[0049] In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification. In the drawings, like symbols generally identify like components unless the context dictates otherwise. The illustrative alternatives described in the detailed description, drawings, and claims are not meant to be limiting. Other alternatives may also be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. In general, it will be readily understood that the aspects as described herein and illustrated in the figures can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are expressly contemplated and made a part of this application.

[0050] Unless otherwise defined, all technical terms, notations, and other scientific or technical terms used herein are intended to have the meanings that are commonly understood by those skilled in the art to which this application pertains.In some cases, terms with commonly understood meanings are defined herein for clarity and / or for immediate reference, and the inclusion of such definitions herein should not necessarily be interpreted as representing a substantial difference from what is commonly understood in the art.Many of the techniques and procedures described or mentioned herein are well understood by those skilled in the art and are commonly employed using conventional methodologies.

[0051] 1 is a perspective view of an exemplary assembled modular analyte system 100. The system 100 includes a removable cartridge 102 with one or more sample wells 104. Each of the sample wells 104 is configured to receive a sample fluid for analysis. A base 106 is configured to receive the cartridge. The base 106 is configured to send and receive signals to the cartridge 102 when the cartridge 102 is received by the base 106.

[0052] Focusing on the cartridge 102, in some implementations, the cartridge 102 is a stand-alone plug-in into which a user can place individual received wells 104 and secure the wells 104 to the cartridge 102 using a locking mechanism (not shown). Each well can be tagged with an identifier, such as a barcode, radio frequency identification (RFID), and / or another identifier. In such implementations, the identifier is configured to transmit a unique well ID to the cloud gateway 1102 ( FIG. 11 ). Further details regarding such operations are provided throughout this disclosure. In some implementations, the well IDs are already written to the cartridge memory 502 ( FIG. 5 ) during manufacture and assembly of the cartridge 102. In such implementations, a user receives the cartridge 102 with the wells 104 already loaded and secured within it.

[0053] In some implementations, the wells 104 are shipped to a user as individual units. In such implementations, a user loads the wells into the cartridge 102, uses the wells 104 for sample measurements, and then discards the used wells 104. That is, in such implementations, the wells 104 are disposable, single-use items. In some implementations, the cartridge 102 is shipped with the wells 104 already integrated. In such implementations, the user can empty the wells 104 of all liquid electrolyte and sample and then return the emptied cartridge to the manufacturer or service provider to have the cartridge 102 serviced. In some implementations, the wells 104 are replaced during such service.

[0054] The base 106 is authorized and provisioned as part of manufacturing to make the base 106 and / or cartridge 102 available to designated users via a cloud service. The provisioning and authorization also create a secure communication port between the modular analyte system 100 and the cloud service 1102 (FIG. 11).

[0055] 2 is a perspective view of the exemplary modular analyte system 100 with the cartridge 102 removed from the base 106. As shown, the base 106 includes a receptacle 202 configured to receive electrical pins 204 of the cartridge 102. Some of these electrical pins are coupled to electrodes (902, 802, 804). The receptacle is coupled to a controller (FIG. 12), which is configured to exchange signals with the cartridge via the receptacle 202 and pins 204.

[0056] FIG. 3 is a perspective view of an exemplary modular analyte system base 106. The base 106 houses electrochemical instrumentation 450 (FIG. 4B), which is configured to scan a voltage bias applied to a sensor 904 (FIG. 9) on the well 104 (FIG. 1) relative to a first electrode 902 in each sample well 104. The applied bias is regulated by a second electrode 802, also within the sample well 104. Details regarding such a process are described in U.S. Patent No. 111,035,810, which is incorporated herein by reference in its entirety. The instrumentation 450 provides feedback regulation of the bias applied between the sensor 904 and the first electrode 804 by supplying a current through the second electrode 802 and maintaining the bias at a desired set point. The instrumentation 450 also measures the supplied current and applies a desired bias to a shielding electrode around the sensing interface, providing a means for mitigating stray parasitic capacitance. To support simultaneous measurements on all of the wells 104, the base 106, in one implementation, can hold individual printed circuit boards that perform feedback regulation and current measurement for each well 104. In some implementations, the feedback regulation circuitry and current measurement circuitry can be integrated onto a single board. In some implementations, the different biases applied to the sensors are sourced from voltage reference integrated circuits.

[0057] The base can include a heat sink 468 and insulators to reduce heating of the sample wells 104 due to power dissipated by the base electronics. Alternatively, or in addition, a fan 452 is affixed to the base 106 to provide forced convection cooling of the base 106. The base 106 chassis housing defines numerous holes to facilitate air circulation to cool the system to desired specifications and enable temperature-resistant operation of the measurement. In some implementations, the base 106 houses temperature sensors in multiple locations to record ambient temperature during measurements. The base 106 can include electrical shielding to protect sensitive electrical measurements from being corrupted by stray electrical interference from the surrounding environment or adjacent circuitry. Alternatively, or in addition, the base 106 can include an accelerometer to monitor mechanical shock to the instrument during measurements. Such an accelerometer can measure physical acceleration (high-speed movement), producing a record of mechanical shock to the instrument chassis and used to assess measurement integrity.

[0058] In some implementations, the base 106 is powered from a standard electrical outlet (e.g., a 120-volt or 240-volt outlet). In some implementations, a voltage converter (e.g., a transformer, a voltage divider) can be included. In either case, power is received by the power port 302. Alternatively, or in addition, the base 106 can include a battery. The base 106 is configured to connect to the Internet, for example, through an Ethernet or universal serial bus (USB) port 304. In some implementations, the base 106 includes a wireless antenna configured to allow the base 106 to connect to the Internet via a wireless network.

[0059] In operation, the controller 454 in the base 106 directs, e.g., by the board 450, a voltage bias signal for the first electrode 804 to the sensor interface 456 and to the shield surrounding the sensor interface 456. In addition, a regulated voltage signal is applied, e.g., by the board 450, to the second electrode 802 in the well as directed by the controller 454. These signals are passed between the base 106 and the cartridge 102 by the receptacles 202 and pins 204 for all of the wells 104. Signals from one or more temperature sensors in the cartridge 102 are also routed to the controller 454 by the receptacles 202 and pins 204.

[0060] FIG. 4A is a top perspective view of an exemplary modular analyte system cartridge 102. The sample wells 104 are secured within cavities on the cartridge 102 with the help of guiding features embossed on the outer edges of the wells 104, keeping the wells 104 aligned with spring-loaded electrical connectors 460 in the cartridge receptacle 202. A mechanical or magnetic hold-down mechanism 464 applies vertical pressure to keep the well sensors 904 in good electrical contact with the spring-loaded connectors 460. The connectors allow for the application of a bias from the sensor to the first electrode, a shield bias, and a current regulation signal at the second electrode 802. In some implementations, all sample wells 104 are identical to one another. In some implementations, each sample well contains one to four integrated sensors. In some implementations, the sample wells 104 can have different configurations; for example, different sample wells can contain different numbers of sensors.

[0061] 4B is a perspective view of the interior of the analyte system 100. In some implementations, spring connectors 460 within the cartridge 102 facilitate electrical connections between the sensors 904 on each well 104 and a printed circuit board 462 within the cartridge 102. The circuit board 462 is configured to carry and / or direct multiple signals from the wells to the underlying base.

[0062] In some implementations, the cartridge 102 includes memory that holds a unique identifier for the cartridge 102, and in some implementations, includes memory that holds a unique identifier for the well 104 associated with the cartridge 102. Such details are written to the cartridge memory 502 during assembly of the cartridge 102. Once a scan is performed on a sample in a well 104, the cartridge memory 502 can also record that the well 104 was used in the measurement. Alternatively, or in addition, such a record can be recorded in a database coupled to or associated with the cloud service 1102.

[0063] In some implementations, the cartridge 102 includes heat sinks and / or insulator panels to insulate the wells 104 from heat sources. In some implementations, electrical shielding is also incorporated to prevent electromagnetic interference from corrupting measurements made within the wells 104.

[0064] 5 is a top view of an exemplary modular analyte system cartridge 102. Pins 204 extend vertically from the lower surface 504 of the cartridge 102 and interface with receptacles 202 in the base 106, as described above. The pins are coupled to various electrodes (902, 802, 804) in the various wells 104. In some implementations, additional pins can be used for power and data transfer (e.g., data indicating the fitness-for-use status of the access wells 104). In some implementations, the pins can be coupled to a cartridge memory, and the base 106 can read and / or write to the cartridge memory 502.

[0065] FIG. 6 is a bottom perspective view of an exemplary modular analyte system cartridge 102. FIG. 7 is a side perspective view of an exemplary modular analyte system cartridge 102. In some implementations, the cartridge 102 is locked to the base 106 once the base is received. The cartridge 102 can be locked to the base 106 using a variety of interlocking mechanisms; for example, mechanical, electronic, pneumatic, and / or magnetic interlocking mechanisms can be used without departing from this disclosure. Because the cartridge 102 can be locked to the base 106 and the cartridge 102 sits flush with the base 106, removing the cartridge 102 from the base 106 without assistance can be difficult. Therefore, in some implementations, the cartridge includes a swing linkage 602 configured to separate the cartridge 102 from the base 106. The swing linkage is arranged to apply pressure to interface 604 as a user alternately presses a first button 702 and a second button 704 coupled to different ends of swing linkage 602 .

[0066] Figure 8 is a top perspective view of an exemplary sample well 104, and Figure 9 is a bottom perspective view of an exemplary well 104 with a single sensor 904. The second electrode 802 and the third electrode 804, in some implementations, are metal pins (gold coated) that are conductively coupled to spring connectors 460 (Figure 4B) within the cartridge 102. In some implementations, such electrodes (802, 804) are inserted into the plastic well 104 during or after molding of the sample well 104.

[0067] 10 is a bottom perspective view of an exemplary well 104 with multiple sensors 904. In some implementations, multiple (e.g., two to four) first electrodes 902 can be coupled to the sample well 104. Each first electrode 902 includes a metal nanoelectrode and an associated shielding electrode patterned on a silicon die, which is affixed to a flexible substrate via a conductive glue layer. Each first electrode constitutes a different sensor, with the metal nanoelectrode functionalized with different surface chemistries at the nanoelectrode-electrolyte interface and / or different charges induced by a bias applied to the shielding electrode.

[0068] 11 is a schematic diagram illustrating communication between a modular analyte system 100, a cloud service 1102, and a local computer 1104. The modular analyte system can communicate with both the local computer 1104 and the cloud service 1102 through, for example, an Ethernet port, a USB port, or a wireless connection such as Wi-Fi or Bluetooth. For example, in some implementations, the modular analyte system 100 is coupled to the local computer during initial setup and communicates directly with the cloud service 1102 for subsequent operation. In such implementations, the local computer 1104 can be used to access data stored on the cloud service 1102 (e.g., test results or details about the cartridge 102). Alternatively, or in addition, the analyte sensing system 100 can be pre-configured such that the analyte sensing system 100 does not interact directly with the local computer 1104, but instead communicates only with the cloud service 1102. Alternatively, or in addition, in some implementations, the analyte sensing system 100 may communicate only with a local computer 1104. Such an arrangement may be used, for example, in locations with unreliable internet connections or in situations where an air-gapped local computer is required.

[0069] FIG. 12 illustrates an example controller 110 that may be used in conjunction with aspects of the present disclosure. The controller 454 may, among other things, monitor parameters of the system 100 and send signals to actuate and / or adjust various operating parameters of such a system. As shown in FIG. 12, the controller 454 may include one or more processors 1250 and a non-transitory computer-readable memory storage device (e.g., memory 1252) containing instructions that cause the processor 1250 to perform the operations described herein. The processor 1250 is coupled to an input / output (I / O) interface 1254, for example, to send and receive communications with components in the system, including the board 450. In some implementations, the controller 454 communicates instructions to the board 450, and the board executes the instructions. In some cases, the controller 454 may additionally communicate status with, and send activation and / or control signals to, one or more of the various system components of the system 100 (e.g., including the computer 1104 or the cloud service 1102), as well as other sensors (e.g., temperature sensors, vibration sensors, and other types of sensors) that provide signals to the system 100.

[0070] The controller can be located in various locations within the system 100. For example, the controller 454 can be located in the base 106, the cartridge 102, or can be distributed such that some of the controllers 454 are in different locations. Alternatively, or in addition, multiple networked controllers 454 can be used; for example, the cartridge can include a cartridge controller and the base can include a base controller. In such implementations, the separate controllers can be networked together and act as a single controller. Alternatively, or in addition, multiple controllers can be included in the base 106, the cartridge 102, or both. In implementations with multiple controllers, the controllers can be used for specialized tasks and can communicate with each other and perform the functions described throughout this disclosure.

[0071] In operation, the controller 454 identifies each sample well 104 of the cartridge 102 and determines the status of each sample well 104. Once sample is added to a selected sample well, the controller then directs an analysis of the substance in the selected sample well to be performed. A spectrum is generated based on the analysis performed, and the spectrum is uploaded to, for example, the cloud service 1102. In some implementations, the presence of the target analyte is then determined by the controller based on the generated spectrum.

[0072] In some implementations, the controller 454 in the base 106 includes a buffer memory and is configured to control individual feedback adjustments in response to specific commands provided by a user via a programmable user interface (communicated to the base via a secure connection to the cloud service 1102). Additionally, the controller 454 performs basic calibration tasks to correct for drift and other errors in the current and voltage measured at the sensor interface.

[0073] 13 is a flowchart of an example method 1300 that may be used in conjunction with aspects of the present disclosure. At 1302, a removable cartridge 102 is received by a base 106, the cartridge including multiple sample wells. At 1304, each sample well 104 of the cartridge 102 is identified, for example, by a controller 454 in the base 106, a local computer 1104, or a cloud service 1102.

[0074] At 1306, the status of each sample well of the cartridge is determined. Determining the status of each cartridge involves looking up the usage history of each identified sample well 104 and determining the suitability-for-use status of each sample well 104. In some implementations, the suitability-for-use status for each sample well 104 is determined based on the date the sample well 104 was last used and the date the sample well 104 was last inspected. For example, if the sample well 104 has been used since the last inspection, the sample well 104 will be considered “unusable,” and if the sample well 104 has not been used since the last inspection, the sample well 104 will be considered “usable.” Such information can be determined, for example, by querying such information in a lookup table. In some implementations, such as when the sample wells 104 are manufactured as consumable items, determining whether the sample well 104 has been used is sufficient to make the suitability-for-inspection determination. If the suitability-for-use status indicates that the sample well is unusable, the sample well is excluded from the analysis operation. That is, any fluid sample added to the excluded sample well will not be analyzed due to an interlock, such as a software interlock, or visual feedback provided to the user via a programmable user interface on the local computing device will inform the user that they should not aliquot valuable sample into an unusable well. If the suitability for use status indicates that the sample well is usable, the sample well is enabled for analysis operations.

[0075] At 1308, an analysis of the material in at least one of the sample wells is performed. In some implementations, upon completion of the analysis at 1308, the user is provided with feedback regarding whether the scan generated good quality data suitable for use in detecting the target. If the scan does not generate usable data, the user is prompted to scan the sample in a new well via a programmable user interface on the local computing device. At 1310, a spectrum is generated based on the analysis performed. The presence of the target analyte is then determined based on the generated spectrum. In some implementations, a reference spectrum has been previously generated from a reference sample known to contain the target analyte. In such implementations, comparing the generated spectrum to the reference spectrum is used to help determine the presence of the target analyte. The spectrum (e.g., the determined spectrum or the reference spectrum) can be stored locally within the base 106, locally on a computer, or uploaded and stored to a cloud service.

[0076] After the sample wells 104 in the cartridge have been used, the cartridge 102 is then serviced. In some implementations, servicing the cartridge 102 involves replacing the sample wells 104 in the cartridge 102, cleaning multiple sample wells 104 in the cartridge 102, or a combination of such options.

[0077] (definition) Unless otherwise defined, all technical terms, notations, and other scientific or technical terms used herein are intended to have the meaning that is generally understood by those skilled in the art to which this disclosure pertains.In some cases, terms with generally understood meanings are defined herein for clarity and / or easy reference, and the inclusion of such definitions herein should not necessarily be interpreted as representing a substantial difference from what is generally understood in the art.Many of the techniques and procedures described or mentioned herein are well understood by those skilled in the art and are commonly employed using conventional methodologies.

[0078] The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "a cell" includes one or more than one cell (including mixtures thereof). "A and / or B" is used herein to include all of the following alternatives: "A," "B," "A or B," and "A and B."

[0079] It should be understood that the aspects and implementations of the disclosure described herein include those that are "comprising," "consisting," and "consisting essentially of."

[0080] As used herein, "comprising" is synonymous with "including," "containing," or "characterized by" and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. In particular, any recitation herein of the term "comprising" in a description of components of a composition or in a description of steps of a method is understood to encompass compositions and methods that consist essentially of the recited components or steps, as well as compositions and methods that consist of the recited components or steps. As used herein, "composed of" excludes any element, step, or ingredient not specified in the claimed composition or method. As used herein, "consisting essentially of" does not exclude materials or steps that do not materially affect the basic and novel characteristics of the claimed composition or method.

[0081] When a range of values ​​is provided, it will be understood by one of ordinary skill in the art that all ranges disclosed herein encompass all possible subranges and combinations of subranges. Any recited range can be readily recognized as fully describing and enabling the same range to be broken down into at least two, three, four, five, ten, etc. divisions. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third, and upper third, etc. Also, as will be understood by one of ordinary skill in the art, all language such as "up to," "at least," "greater than," "less than," and the like, refers to a range that is inclusive of the recited numbers and can subsequently be broken down into the subranges discussed above. As will be understood by one of ordinary skill in the art, a range includes each individual component. Thus, for example, a group having 1 to 3 items refers to a group having 1, 2, or 3 items. Similarly, a group having 1 to 5 items refers to groups having 1, 2, 3, 4, or 5 items, and so on.

[0082] A range is presented herein with numerical values ​​preceded by the term "about." The term "about" is used herein to provide literal support for the exact number preceded by the term "about," as well as a number that is close to or approximately the number preceded by the term. When determining whether a number is close to or approximately a specifically recited number, an unrecited number that is close to or approximately the specifically recited number may be a number that, in the context in which it is presented, provides a substantial equivalent to the specifically recited number. Unless the degree of approximation is otherwise clear from the context, "about" means either ±10% of the provided value or a value rounded to the nearest significant figure, in either case encompassing the provided value.

[0083] Headings, e.g., (a), (b), (i), etc., are provided solely for ease of reading of the specification and claims. The use of headings in this specification or claims does not require the steps or elements to be performed in alphabetical or numerical order or in the order in which they are presented.

[0084] It should be understood that certain features of the present disclosure that are, for clarity, described in the context of separate implementations, may also be provided in combination in a single implementation. Conversely, various features of the present disclosure that are, for brevity, described in the context of a single implementation, may also be provided separately or in any suitable subcombination. All combinations of implementations related to the present disclosure are specifically embraced by the present disclosure and are disclosed herein to the same extent as if each and every combination were individually and explicitly disclosed. In addition, all subcombinations of the various implementations and elements thereof are also specifically embraced by the present disclosure and are disclosed herein to the same extent as if each and every such subcombination were individually and explicitly disclosed herein.

[0085] Non-transitory computer program products (i.e., physically embodied computer program products) are also described, which store instructions that, when executed by one or more data processors of one or more computing systems, cause at least one data processor to perform the operations described herein. Similarly, computer systems are also described, which may include one or more data processors and memory coupled to the one or more data processors. The memory may temporarily or permanently store instructions, which cause the at least one processor to perform one or more of the operations described herein. Additionally, methods can be implemented by one or more data processors, where the one or more data processors are either within a single computing system or distributed among two or more computing systems. Such computing systems may be connected via one or more connections, including connections via a network (e.g., the Internet, a wireless wide area network, a local area network, a wide area network, a wired network, or the like), via direct connections between one or more of the computing systems, or the like, and may exchange data and / or commands or other instructions, or the like.

Claims

1. 1. An analyte sensing system comprising: a removable cartridge comprising a plurality of sample wells, each of the plurality of sample wells configured to receive a sample fluid for analysis; a base configured to receive the cartridge, the base configured to send and receive signals to the cartridge when the cartridge is received by the base; An analyte sensing system comprising:

2. Each of the plurality of sample wells comprises: a first electrode arranged to contact the sample fluid; a second electrode arranged to contact the sample fluid; a third electrode arranged to contact the sample fluid; and 10. The analyte sensing system of claim 1, comprising a sensor comprising:

3. The base portion is a receptacle configured to receive a plurality of electrical pins coupled to the first electrode, the second electrode, and the third electrode; a controller coupled to the receptacle, the controller configured to direct the exchange of signals by the receptacle and pins with the first electrode, the second electrode, and the third electrode; 10. The analyte sensing system of claim 1, comprising:

4. The controller identifying each sample well of the plurality of sample wells of the cartridge; determining the status of each sample well of the cartridge; directing an analysis of a substance in at least one of the sample wells to be performed; generating a spectrum based on said performed analysis; The analyte sensing system of claim 3 configured to:

5. The analyte sensing system of claim 4 , wherein the controller is further configured to determine the presence of a target analyte based on the produced spectrum.

6. 5. The analyte sensing system of claim 4, wherein the controller is further configured to upload the generated spectrum to a cloud service.

7. The cartridge comprises:

10. The analyte sensing system of claim 1, comprising a swing linkage configured to separate the cartridge from the base.

8. 1. A method comprising: receiving a removable cartridge by the base, the cartridge comprising a plurality of sample wells; identifying each sample well of the plurality of sample wells of the cartridge; determining the status of each sample well of the cartridge; conducting an analysis of a substance in at least one of the sample wells; generating a spectrum based on said performed analysis; A method comprising:

9. Determining the status includes: determining the identity of the sample well; looking up a usage history of the sample well; determining a fitness-for-use status of said sample wells; The method of claim 8, comprising:

10. The fitness for use status is: the date the sample well was last used; and The date the sample well was last inspected; The method of claim 9 , wherein the determination is based on criteria including:

11. The method of any one of claims 9-10, wherein looking up the usage history comprises querying a lookup table.

12. The suitability for use status indicates that the sample well is unusable, and the method further comprises: The method of any one of claims 9 to 11, comprising excluding the sample well from the analysis operation.

13. The suitability for use status indicates that the sample well is usable, and the method further comprises: The method of any one of claims 9-11, comprising enabling the sample well for an analytical operation.

14. The method of any one of claims 8-13, further comprising inspecting the cartridge.

15. Inspecting the cartridge includes: replacing the plurality of sample wells; or cleaning the sample wells; 15. The method of claim 14, comprising:

16. The method of any one of claims 8-15, further comprising determining the presence of a target analyte based on the generated spectrum.

17. determining the presence of a target analyte based on the generated spectrum; generating a reference spectrum from a reference sample; comparing the generated spectrum to the reference spectrum; 17. The method of claim 16, comprising:

18. The method of any one of claims 8-15, further comprising uploading the generated spectrum to a cloud service.

19. 1. An analyte sensing system comprising:

1. A removable cartridge configured to receive one or more fluid samples for analysis, said cartridge comprising a plurality of sample wells, each of said plurality of sample wells comprising: a first electrode arranged to contact the sample fluid; a second electrode arranged to contact the sample fluid; a third electrode arranged to contact the sample fluid; and a removable cartridge comprising a sensor comprising: a base configured to receive the cartridge, the base configured to send and receive signals to the cartridge when the cartridge is received by the base, the base comprising: a receptacle configured to receive a plurality of electrical pins coupled to the first electrode, the second electrode, and the third electrode; a controller coupled to the receptacle, the controller configured to direct the exchange of signals by the receptacle and the pin with the first electrode, the second electrode, and the third electrode, the controller comprising: identifying each sample well of the plurality of sample wells of the cartridge; determining the status of each sample well of the cartridge; directing an analysis of a substance in at least one of the sample wells to be performed; generating a spectrum based on said performed analysis; determining the presence of a target analyte based on the generated spectrum; a controller configured to: a base comprising: An analyte sensing system comprising:

20. 20. The analyte sensing system of claim 19, wherein the controller is further configured to upload the generated spectrum to a cloud service.

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