Modular Assay Reader Device

Abstract

The name of the present invention is a modular assay reader device. Certain aspects relate to systems and use techniques for a modular lateral flow assay reader device that is capable of receiving a plurality of different modules having a barcode scanning input device and optionally network connectivity capabilities. The barcode scanning module can provide a simple input method that reduces errors compared to manual data entry. The network connectivity module can enable the transmission of test results over a common network for standardization, tracking, and electronically linking test results from assay reader devices located throughout the network. Such a device can programmatically implement a simplified workflow where pressing a single button readies the device for imaging, analysis, and data storage / transmission, and in some embodiments, the device is configured to operate in one of a plurality of device operation modes.

Description

[0001] This application is a divisional application. The filing date of the original application is June 9, 2017, the application number is 201780036406.7, and the invention title is "Modular Assay Reader Device".

[0002] Cross - reference to related applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 393,575, filed on September 12, 2016, titled "MODULAR ASSAY READER DEVICE" and U.S. Provisional Patent Application No. 62 / 353,505, filed on June 22, 2016, titled "MODULAR ASSAY READER DEVICE", the contents of which are incorporated herein by reference. Technical Field

[0004] The systems and methods disclosed herein relate to medical testing, and more particularly, to lateral flow assay techniques and devices. Background Art

[0005] In patient care, immunoassay techniques provide a simple and relatively rapid method for determining the presence of an analyte in a test sample. An analyte is a substance of interest or clinical significance that can be present in a biological or non - biological fluid. Analytes can include antibodies, antigens, drugs, or hormones.

[0006] The analyte of interest is typically detected by reacting with a capture agent, which produces a device that is more easily detected and measured compared to the original analyte. Detection methods can include changes in absorbance, color, fluorescence, luminescence, surface potential, changes in other optical properties, or any other easily measurable physical property that indicates the presence or absence of the analyte in the sample. Summary of the Invention

[0007] Immunoassay devices play an important role in fields such as clinical chemistry and have been made portable for use in that field. Assays are routinely performed to detect the presence of specific analytes when a human or non - human subject has a particular disease or condition. For example, the assays described herein can be used to detect whether a patient has influenza A, influenza B, RSV, group A streptococcus, or another disease, whether they are experiencing ovulation or pregnancy, or whether they have a particular drug or compound in their body, etc.

[0008] Both skilled clinicians and laypersons use such assay and assay reader devices. Thus, for example, the assay reader device according to the present disclosure is designed to be simple and reliable by including a module for simple barcode scan input for any desired additional information and by minimizing the number of steps the user has to perform between sample application and result notification. The barcode scan input can provide a high level of traceability and compliance by allowing clinics, laboratories, etc. to implement customized test result documentation standards. Some examples enforce such standards at the reader level, for example, by pre-configuring the reader to require the input of a specified type of information before transmitting the result. As another example, the communication between the reader and a centralized database can be used to determine whether the transmitted test data complies with such standards and, if not, send an instruction back to the reader device to prompt the user for any missing information. In addition, such assay and assay reader devices can be used in a variety of situations both inside and outside of clinical settings. Thus, the assay reader device according to the present disclosure can include a module providing network connectivity to provide test results to one or more centralized databases.

[0009] Thus, one aspect relates to a diagnostic test device that includes an optical sensor positioned to detect a change in an optical property of an analyte after a biological sample has been applied to the analyte, the optical sensor configured to generate a signal indicative of the detected change in the optical property of the analyte; a module interface that includes a chassis, a first signal path, and a second signal path, the chassis configured to receive and lockingly engage a connection module of a plurality of interchangeable modules, the first signal path configured to identify characteristics of the connection module, the characteristics indicating the presence of a barcode scanner in the connection module and the connection capabilities of the connection module, the second signal path configured to receive barcode data from the connection module, the barcode data representing a barcode imaged by the connection module; at least one processor; and a memory having instructions stored thereon, the instructions configuring the at least one processor to determine a test result based at least in part on the signal generated by the optical sensor, identify the barcode as an identification information barcode, determine identification information based on the barcode data, determine the connection capabilities of the connection module, automatically send the test result associated with the identification information to a remote storage device in response to determining that the connection module has a connection capability with the remote storage device, and automatically store the test result associated with the identification information in the memory in response to determining that the connection module does not have a connection capability with the remote storage device.

[0010] Some embodiments may also include an additional optical sensor or a cartridge holding the analyte, the additional optical sensor being positioned to detect additional information regarding the analyte, wherein at least one processor is configured to use the additional information to establish operating parameters of the diagnostic test device. Some embodiments may also include an additional optical sensor or a cartridge holding the analyte, the additional optical sensor being positioned to detect additional information regarding the analyte, wherein at least one processor is configured to store additional information associated with the test result.

[0011] Some embodiments may also include a connection module. The connection module may include a barcode scanner. The connection module may include a cellular modem configured to provide connection capabilities. The connection module may include information components, wherein at least one processor is configured to retrieve module information from the information components via a first signal path and determine the connection capabilities of the connection module based on the module information.

[0012] Another aspect relates to a non-transitory computer-readable medium configured to have computer-executable instructions that, when executed, cause a hardware processor to identify characteristics of a connection module inserted into a rack of a measurement reader device, the characteristics indicating the presence of a barcode scanner in the connection module and the connection capabilities of the connection module; receive measurement image data from a measurement reading image sensor of the measurement reader device, the measurement image data representing detected changes in optical characteristics of an analyte inserted into or positioned adjacent to the measurement reader device; determine a test result based at least in part on analyzing the measurement image data; determine the connection capabilities of the connection module based on the identified characteristics; automatically send the test result to a remote storage device in response to determining that the connection module has connection capabilities with a remote storage device physically separate from the measurement reader device; and automatically store the test result in a memory of the measurement reader device in response to determining that the connection module does not have connection capabilities with the remote storage device.

[0013] The non-transitory computer-readable medium may also have instructions stored thereon that, when executed, cause a hardware processor to receive barcode image data representing at least one barcode from the connection module; identify the at least one barcode as an instruction barcode based on an analysis of the barcode image data; and retrieve instructions associated with the instruction barcode. The non-transitory computer-readable medium may also have instructions stored thereon that, when executed, cause a hardware processor to determine a test result based at least in part on the instructions. The non-transitory computer-readable medium may also have instructions stored thereon that, when executed, cause a hardware processor to instruct the measurement reading image sensor to obtain measurement image data at a predetermined timing after an analyte is inserted into the measurement reader device based at least in part on the instructions.

[0014] A non-transitory computer-readable medium may also have instructions stored thereon that, when executed, cause a hardware processor to receive barcode image data representing at least one barcode from a connection module; identify at least one barcode as an identification barcode based on an analysis of the barcode image data; determine information represented by the identification barcode; automatically send the information represented by the identification barcode together with the test result to a remote storage device in response to determining that the connection module has a connection capability with a remote storage device that is physically separated from the assay reader device; and automatically store the information represented by the identification barcode together with the test result in a memory of the assay reader device in response to determining that the connection module does not have a connection capability with the remote storage device.

[0015] Another aspect relates to a diagnostic test process that includes identifying, by one or more hardware processors, characteristics of a connection module inserted into a chassis of an assay reader device, the characteristics indicating the presence of a barcode scanner in the connection module and the connection capability of the connection module; receiving assay image data from an assay reading image sensor of the assay reader device, the assay image data representing detected changes in optical characteristics of an assay inserted into or positioned adjacent to the assay reader device; determining a test result based at least in part on an analysis of the assay image data; determining the connection capability of the connection module based on the identified characteristics; automatically sending the test result to a remote storage device in response to determining that the connection module has a connection capability with a remote storage device that is physically separated from the assay reader device; and automatically storing the test result in a memory of the assay reader device in response to determining that the connection module does not have a connection capability with the remote storage device.

[0016] The process may also include receiving barcode image data representing at least one barcode from the connection module; identifying at least one barcode as an instruction barcode based on an analysis of the barcode image data; and retrieving instructions associated with the instruction barcode. The process may also include determining the test result based at least in part on the instructions. The method may also include causing the assay reading image sensor to obtain assay image data at a predetermined timing after the assay is inserted into the assay reader device based at least in part on the instructions.

[0017] The process may further include receiving, from a connection module, barcode image data representing at least one barcode; identifying, based on an analysis of the barcode image data, the at least one barcode as an identification barcode; and determining information represented by the identification barcode. The process may further include automatically sending, in response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device, the information represented by the identified barcode together with the test result to the remote storage device; and automatically storing, in response to determining that the connection module does not have a connection capability with the remote storage device, the information represented by the identification barcode together with the test result in a memory of the assay reader device. The process may further include automatically sending an instruction to route the test result from the remote storage device to another remote storage device, identifying the another remote storage device based on the information represented by the identification barcode, in response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device. The process may further include automatically sending the test result to the personal computing device of a clinician, identifying the clinician based on the information represented by the identification barcode, in response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The disclosed aspects will be described below in conjunction with the accompanying drawings, which are for illustration purposes and not intended to limit the disclosed aspects, where like reference numerals represent like elements.

[0019] Figure 1A A set of components for an example of an assay reader system is shown.

[0020] Figure 1B Shows Figure 1A an example assembly of an assay reader and modules of the assay reader system.

[0021] Figure 2 A schematic block diagram of an example data network including the disclosed assay reader system is shown.

[0022] Figure 3 A schematic block diagram of an example assay reader device is shown.

[0023] Figure 4 is a flowchart depicting an example operation process of the assay reader device disclosed herein.

[0024] Figure 5A An example hospital workflow of a wireless point without a care test solution is shown.

[0025] Figure 5BAn example hospital workflow for pipelining a workflow is shown by the disclosed assay reader device that provides care test solutions at wireless points.

[0026] Figure 6 Various examples of display text that can be presented to an operator on the display screen of the assay reader device described herein are shown. DETAILED DESCRIPTION

[0027] Introduction

[0028] Embodiments of the present disclosure relate to systems and techniques for modular assay reader devices that can receive multiple different modules having a barcode scanning input device and optional network connectivity capabilities. Embodiments of the reader device can be portable, e.g., relatively small and lightweight, with options for draining stored power. The disclosed reader device can be used in hospitals, clinics, doctor's offices, and other patient care facilities to enable rapid detection and identification of many types of biological conditions, such as the presence of infection antibodies. The network connectivity module can enable standardization, tracking, and electronic connection of test results from reader devices located throughout the network to improve patient care.

[0029] One type of reader device is configured to read or otherwise analyze lateral flow assays, which can test a wide variety of medical and environmental conditions or compounds. For example, a lateral flow test can rely on a form of immunoassay where a specimen flows along a solid matrix by capillary action. A lateral flow assay reader device can read a lateral flow assay strip to detect the presence of hormones, metabolites, toxins, or pathogen-derived antigens. This reading can be achieved by using a detector that includes one or more sensing elements, such as, but not limited to, a PIN detector, a linear array detector, a CMOS imager, and a CCD-based imaging device, which are configured to detect the presence or absence of a line on the lateral flow assay based on the presence or absence of a visual line on the assay. Some tests implemented by the assay reader device are designed to make quantitative determinations, but in many cases, the tests are designed to return or indicate a negative / positive qualitative indication. Examples of assays that perform such qualitative analysis include blood type analysis, most types of urine analysis, pregnancy tests, and HIV / AIDS tests. The assay reader device can identify the results of such tests by autonomously following a pre-programmed decision process or rules. In addition to reader devices configured to analyze lateral flow assays, implementations of the diagnostic reader device described herein can analyze other types of assays, such as, but not limited to, molecular assays, and provide diagnostic test results.

[0030] The assay reader device can be a single-step device, where the user only needs to apply the sample before observing the result and optionally transmitting the result to an appropriate hospital, laboratory, or medical record database. Such a single-step device avoids the necessity of performing complex and time-consuming processing steps that can introduce errors in the final result. For example, the user can press a single button on the assay reader device to power it on. Thereafter, inserting the sample cartridge into the device can automatically activate the reading process to determine and display the test result based on the sample cartridge without additional user input. In some embodiments with network connectivity, the determined test result can additionally be automatically sent to a remote storage device, such as a centralized database, and then from the centralized database to a designated clinician or another database, such as a hospital information system (HIS), a laboratory information system (LIS), or a database maintained by a public health agency such as the CDC, FDA, and WHO. In some embodiments with network connectivity, the determined test result can be directly sent to a designated clinician or database. As used herein, a remote storage device can be a centralized database, HIS, LIS, a public health agency database, a device of a designated clinician, or any other data storage that is not physically coupled to the assay reader device.

[0031] The disclosed portable assay device can include a base assay analyzer having a bay for receiving multiple different modules, such as a base assay reader device. One module can include a barcode scanner for user input of any required additional information, such as patient identification information, test type, device operation mode, sample information, and any other additional test or patient information related to the test performed by the IVD device. In some embodiments, the device operation mode can be set via the number of clicks or pattern of clicks of a single button on the base assay analyzer. Another module can include a barcode scanner and additional network connectivity elements. This modular design approach allows the assay reader device to expand its functionality, such as providing barcode scanning and wireless connectivity, while maintaining its portability and cost advantages. The selection of different modules provides the user with the flexibility to decide on their own settings or apply the best functional capabilities required. The module can be an optional accessory to the base assay analyzer, and the base assay analyzer can function without a module inserted to read an inserted analyte, such as a lateral flow assay test strip. Modules can be exchanged between analyzers. Once inserted, the module can become an integral part of the analyzer.

[0032] As described above, one of the modules can include both a barcode reader and a communication component for network connection, such network connection being, for example, via a wireless connection such as a cellular modem, satellite connection, or Wi-Fi, or via a wired connection. When such a module is inserted into the rack of the assay reader device and electronically communicates with the device's memory and / or processor, the assay reader device becomes capable of sending or uploading data via the network to a remote repository. Thus, the test data of these assay reader devices can be stored and analyzed by remote devices or personnel, either individually or collectively. A module with a cellular or satellite modem provides a built-in mechanism for accessing a publicly available network, such as a telephone or cellular network, enabling the assay reader device to communicate directly with network elements or other IVD devices to achieve electronic test result transmission, storage, analysis, and / or dissemination, without the need for separate intervention or action by the user of the device. For example, in some cases, when a patient sample is analyzed by the assay reader device, electronic test result transmission, storage, analysis, and / or dissemination occur automatically. In another example, when a patient sample is analyzed by the assay reader device, electronic test result transmission, storage, analysis, and / or dissemination occur immediately. In some embodiments, the module can provide a connection to a cloud database, such as server-based data storage. The cloud-based connection module can enable universal connection of the assay reader device without the need for a localized network infrastructure.

[0033] Using a barcode scanner, the device user can customize the assay reader device to perform various workflows that are most suitable for their environment and compliance requirements. This barcode scanning method provides a simple and error-free way for the end user to customize the diagnostic device. For example, a barcode can be scanned to set the device operation mode or specify the required type of information to meet requirements, such as medical organization standards, compliance standards, documentation standards, reporting standards, or any other requirements applicable to the test environment.

[0034] In some embodiments, the device operation mode can be additionally or alternatively set via the number of clicks or pattern of a single button on the basic assay analyzer. For example, in some implementations, a single press of the button can power on the basic assay analyzer and set the analyzer to the default operation mode, and the device can implement the default operation mode when a cartridge is inserted. A double click of the button can initiate an alternative operation mode different from the default operation mode. Other numbers of clicks or patterns of the user pressing the single button can provide instructions to the device's processor regarding the desired operation mode. Embodiments of the basic assay analyzer are described herein with reference to a single button, but other features that allow the user to select and switch between device operation modes are possible (such as, but not limited to, a single switch, knob, lever, or handle).

[0035] An example of the device operation mode is the endpoint reading mode. In the endpoint reading mode, the user prepares and incubates the assay outside the basic assay analyzer and records / tracks the development time of the assay. For example, an influenza assay may have a development time of 10 minutes, so the user applies the sample to the assay and waits for 10 minutes. At the end of 10 minutes, the user inserts the assay into the basic assay analyzer to obtain the test result. Thus, when operating in the endpoint reading mode, the basic assay analyzer can provide instructions, for example, audibly or on a visual display, which indicate to the user to wait a predetermined time after applying the sample to the assay and before inserting the assay into the basic assay analyzer. In other embodiments, when operating in the endpoint reading mode, the basic assay analyzer may not display any instructions, but may only read the assay when inserted into the basic assay analyzer. When the assay is inserted into the basic assay analyzer, the optical reader of the device can collect image data representing the assay for analysis when determining the test result. In some embodiments, the endpoint reading mode may be the default operation mode of the basic assay analyzer.

[0036] Another example of the device operation mode is the walkaway mode. Thus, when operating in the walkaway mode, the basic assay analyzer can provide instructions to the user to insert the assay immediately after applying the sample or during the application of the sample. In the walkaway mode according to one embodiment, the user can apply the sample to the assay and immediately insert the assay into the basic assay analyzer. The assay will develop inside the basic assay analyzer, and the basic assay analyzer can record the time elapsed after inserting the assay. At the end of the predetermined development time, the basic assay analyzer can collect image data representing the assay, analyze the image data to determine the test result, and report the test result to the user. The assay development time can be unique for each test. For example, the influenza assay development time can be 10 minutes, while the streptococcus assay development time can be 5 minutes. In some embodiments, the walkaway mode can be set by double-clicking a single button on the basic assay analyzer. Additional input can indicate to the reader device the assay development time. For example, a barcode scanned by a barcode reader of an inserted module, or a barcode set on the assay or on the cartridge used to hold the assay, can indicate to the device the type of the inserted assay and the development time of the assay. Based on the type of the assay, the basic assay analyzer can wait a predetermined amount of time after sample application and insertion and before collecting image data representing the assay.

[0037] In the embodiments of the basic assay analyzer described herein, there are many advantages associated with the ability of the user to select and switch between device operation modes. In large laboratory or medical practice facilities where personnel typically process multiple tests in batches, the end-point reading mode may be convenient. When performing a single test, or when the end user does not want to have to track the assay development time (or does not know or is not trained to accurately record the assay development time), the off-body mode can be useful. The off-body mode can advantageously reduce or eliminate the occurrence of false test results caused by the assay being inserted and imaged too quickly (too early before the assay development time has passed) or too slowly (too long after the assay development time has passed). Additionally, in the off-body mode, for example when a kinetic plot of the assay readings is needed, the assay reader can be operated to capture multiple images of the assay at predetermined time intervals.

[0038] One embodiment of the disclosed basic assay analyzer, such as the basic assay reader device described in detail below, includes only a single button on its outer housing, such as a single power button to power the basic assay analyzer on and off. The disclosed embodiments of the basic assay analyzer also implement two different device operation modes (although more than two device operation modes are possible). To enable the end user to select and switch between the two device operation modes, the basic assay analyzer can include instructions to implement a double-tap function on the power button. After receiving an input of a single button press to power on the device, inserting the assay cartridge can automatically trigger the end-point reading mode. When the processor of the device receives an input of a double-tap on the power button from the user, this can initiate stored instructions to implement the off-body mode. This double-tap function provides an end user with a simple and intuitive way to switch between different operation modes of the basic assay analyzer. The double-tap function also enables the user to configure the device in real time to operate in the off-body mode without any additional configuration steps or additional programming by the user for the basic assay analyzer. It should be understood that instead of or in addition to double-tapping to trigger an auxiliary (non-default) device operation mode, the basic assay analyzer can be provided with instructions to recognize other click patterns, such as recognizing any predetermined number of times the user presses the button, pressing the button in a predetermined pattern, and / or pressing and holding the button for a predetermined length of time.

[0039] As described above, other examples of barcode use include providing additional data for association with test result data, including patient identification information, test type, device operating mode, sample information, and any other additional test or patient information related to tests performed by the IVD device. Some barcodes can unlock device functions. Some barcodes can provide or update various types of information used by the device for analyzing analytes, determining test results, or performing functions. For example, a scanned barcode can provide assay or reader calibration information to the reader device, which is useful or necessary for performing the test. In embodiments where the device does not have a wireless network connection, test results can be stored in the device's memory, and to access the stored test results, the user can use a barcode scanner to scan a password barcode.

[0040] While the disclosed devices are generally described herein as assay reader devices, it should be understood that the modular system design and network connection aspects described herein can be implemented in any suitable in vitro diagnostic device. For example, the features described herein can be implemented in a reader device that analyzes other types of assays (such as but not limited to molecular assays) and provides diagnostic test results.

[0041] For purposes of illustration, various embodiments will be described below in conjunction with the accompanying drawings. It should be understood that many other implementations of the disclosed concepts are possible and that various advantages can be achieved using the disclosed implementations.

[0042] Overview of Example Assay Reader Device and Operation

[0043] Figure 1A A set of example components for an assay reader system 100 is shown. The set of components includes a barcode module 120 and a barcode and connection module 110, which can be lockingly inserted into the chassis 132 of a base assay reader device 130, and the set of components also includes a cartridge 140 for holding an analyte 144, the analyte 144 being for insertion into the base assay reader device 130. Figure 1B An example assembly of the base assay reader device 130 and the barcode module 120 is shown, where the cartridge 140 is inserted into the cartridge receiving hole 134 of the reader 130. Figure 1A and Figure 1B The components of will be discussed together in the following discussion.

[0044] The basic measurement reader device 130 includes a chassis 132 for locking and optionally releasably receiving one of a plurality of different modules, a cassette receiving aperture 134, a display 136, and a single button 138. The chassis 132 may include both mechanical features for locking engagement with corresponding mechanical features of the inserted module and electrical features for establishing electronic data communication with components of the inserted module. The basic measurement reader device 130 may be capable of providing basic measurement analysis and data storage features without any inserted module, and the inserted module may be selected and inserted to expand the basic features. In embodiments where no module is inserted, a cover may be provided over the opening of the chassis 132. For example, the device 130 may initially be provided with a cover, and the cover may be removed to insert one of the interchangeable modules.

[0045] The cassette receiving aperture 134 may be sized and shaped such that when an analyte is inserted through the cassette receiving aperture 134, the test area of the analyte is aligned with a detector or detector array disposed within the device 130. For example, if the analyte is a lateral flow assay test strip, the test area may include one or more of a control area and a test area having immobilized compounds capable of specifically binding a target analyte. The detector may implement adaptive reading techniques to improve the specificity of the test results and reduce false positive results by compensating for background and non-specific binding. The basic measurement reader device 130 may be configured for rapid and accurate assay performance, such as a digital immunoassay configured to detect Flu A+B, RSV, and Group A Streptococcus within 10 minutes or less. This may facilitate rapid diagnosis and be beneficial for testing and course of action while the patient is in the office.

[0046] The display 136 of the basic measurement reader device 130 can be an LED, LCD, OLED, or other suitable digital display, and in some embodiments, touch-sensitive technology can be implemented. The button 138 can be a mechanical button for powering on the basic measurement reader device 130. As described above, the device can include instructions for identifying the pressing pattern of a single button 138 to select the device operation mode. As discussed in more detail below, when the connection module is inserted into the rack 132 of the device, the button 138 can provide the user with a secure single-touch wireless electronic medical record synchronization. For example, a single press (or pressing pattern) of a simple single-touch button can ready the basic measurement reader device 130, store the test result data in the device memory, and transmit the test results to the patient's electronic medical record through the connection module. Other embodiments of the device 130 can power on and be ready automatically when powered on or otherwise powered, and thus the button 138 can be omitted. In other embodiments, multiple buttons can be provided on the device 130. The measurement reader device can also include a processor and at least one memory, as discussed in more detail below. The basic measurement reader device 130 can enable data storage and printing.

[0047] The barcode module 120 includes a barcode scanner 122. The barcode scanner 122 can include one or more photodetectors, and optionally includes a light-emitting device for reading barcodes. For example, one embodiment of the barcode scanner 122 can include a light source, a lens for focusing the light source onto an object, and a photosensor for receiving the light reflected from the object and converting the received light into an electrical signal. Some embodiments of the sensors of the barcode scanner 122 can include an array of many tiny photosensors such that the voltage pattern generated by the array is substantially the same as the pattern in the barcode. The barcode scanner 122 can also include decoder circuitry or software for analyzing the image data provided by the sensor, identifying the barcode pattern in the image data, determining the content associated with the barcode pattern, and outputting the content to, for example, the processor of the measurement reader device. The barcode module 120 can also include mechanical features for lockingly engaging corresponding features within the rack 132 of the basic measurement reader device 130, and electronic features for establishing electronic data communication with components of the basic measurement reader device 130.

[0048] Although not shown, the barcode module 120 may include information elements such as a memory device or other active or passive electrical components. Passive information elements may include transistor networks, PROMs, ROMs, EPROMs or other programmable memories, EEPROMs or other reprogrammable memories, gate arrays, and PLAs, among others. The information elements may be used to identify the capabilities of the barcode module 120 to the assay reader and / or authenticate the barcode scanning capabilities of the barcode module 120 as a module from a specific source or manufacturer.

[0049] The barcode module 120 can ensure a high level of traceability and quality control through customizable documentation features, data storage / download, and printing capabilities, while reducing manual transcription and the risk of errors. As used herein, traceability may refer to the ability to verify the location, time, personnel, patient, or other information associated with a test performed using a reader device through recorded information. The recorded information can advantageously be accessed by many entities in a variety of ways described herein. As noted above, the barcode scanner can be used to input test-related data, change device settings, unlock data access or other features, or change device modes. Test-related data may include user ID, clinician or test administrator ID, sample ID, and kit lot and / or expiration in addition to the test-related information described herein. The multiple operating modes available for the assay reader device provide a flexible workflow enabled by barcode scanning.

[0050] Regarding traceability, a hospital, clinic, laboratory, or other healthcare organization may have internal standards that specify the type(s) of information about each test performed that need to be recorded so that test results comply with applicable regulations. A barcode scanner may enable a clinician performing a test to enter the required information by scanning a barcode. In some embodiments, the barcode scanning module may be pre-programmed to output a list of the required types of information associated with each test, or output a prompt to the user to enter any required information that has not been scanned before the test results are sent for storage. In some embodiments, a barcode scanning module with connectivity capabilities may communicate with a centralized database to provide a list of the required types of information. The required types of information may be wirelessly communicated from the centralized database to the underlying assay reader device and displayed to the user. By using the barcode scanning module to scan one of the multiple available barcodes provided to the user, the user may enter the required types of information. Once the barcode associated with the required types of information has been scanned, the test results may be associated with the entered information and securely and in some cases automatically and / or wirelessly sent to a laboratory information system and / or an electronic medical record. Thus, the test results transmitted to the laboratory information system and / or the electronic medical record are seamlessly and automatically associated with information such as, but not limited to, user ID, clinician or test administrator ID, sample ID, and kit lot and / or expiration, significantly enhancing the traceability of the test results obtained using the methods and systems described herein.

[0051] In some embodiments, the basic assay reader device may allow an end user to configure preset functions, such as whether a patient ID barcode scan or an operator ID barcode scan is required at the start of each test. The configuration of these preset functions can be achieved by scanning a configuration barcode which, once decoded by the device, contains instructions for the preset function scan configuration. In one implementation, a healthcare institution administrator may initially select one or more barcodes from a set of printed barcodes that correspond to the types of information required for the administrator's desired configuration for a particular reader device; after this initial configuration selection, a user in a healthcare institution using the particular reader device can scan the appropriate barcode to enter information corresponding to the preselected functions of the reader device. The reader device can transmit all available information related to a test to a centralized server, for example, via a connectivity module or a wired connection to another computing device. In one implementation, compliance may not be enforced at the reader level, and if the end user provides a patient ID via barcode scan, that information will be transmitted along with the test results, otherwise the patient ID field will be left blank. Other implementations may prompt for missing information. If the reader does not have wireless or cellular connectivity capabilities, local data storage, download, and print options can help ensure compliance and traceability.

[0052] To illustrate advantageous customization options by way of a non-limiting example, an administrator in a physician's office may select data categories A, B, and C and configure the reader device within the office to transmit a report that includes data corresponding to categories A, B, and C, while an administrator in an acute care center may select data categories A, B, D, and E and configure the reader device within the center to transmit a report that includes data corresponding to categories A, B, D, and E. The ability to customize reports can significantly reduce administrative and record-keeping time. The data obtained can also more often comply with applicable compliance standards as the opportunity to introduce human error into the reports is reduced.

[0053] Figure 6 Example display text that may be presented to an operator of an assay reader device is shown. As described above, embodiments of the systems and methods described herein may allow an end user to customize the types of information that will be stored in association with test results on a particular assay reader device, thereby significantly enhancing the compliance and traceability of test results and reducing transcription and documentation errors. In embodiments that include wireless or cellular connectivity capabilities, a customized report that includes test results associated with the selected information categories can be automatically transmitted to a remote server. Figure 6The top display in the first column of the example display in shows a display of the assay reader device that prompts the user to scan a configuration barcode to associate a specific type of information with the test results, or to disable a specific type of information associated with the test results. In this non-limiting example, after reading the "SCAN CONFIG BARCODE" prompt, the user scans a barcode that instructs the assay reader device to enable the operator ID function (if the user wishes to associate the operator ID information with the test results and store the operator ID information), or the user scans a barcode that instructs the assay reader device to disable the operator ID function (if the user does not wish to associate the operator ID information with the test results and store the operator ID information). After the user scans the barcode indicating the user's selection, the assay reader device displays text confirming the user's selection. In this non-limiting example, the assay reader device displays "OPERATOR ID SCAN ENABLED" or "OPERATOR ID SCAN DISABLED" to the user. The assay reader device may then ask the user to enable or disable other types of information features, such as, but not limited to, sample ID and kit lot ID (see, e.g., Figure 6 The examples in show tests).

[0054] With the Operator ID feature enabled, the assay reader device will now prompt the user to scan a barcode associated with the operator ID for each test event. For example, prior to prompting the user to input an assay test strip into the device for analysis, the assay reader device will display "SCAN OPERATOR ID" to the user, instructing the user to scan the barcode associated with the user's operator ID. The assay reader device may sequentially query the user to input specific types of information based on previously selected custom configuration settings of the assay reader device. For example, after the user scans the barcode associated with the operator ID, if the device is configured to request sample ID information, the assay reader device may next prompt the user to scan the barcode associated with the sample ID of the test event (e.g., see Figure 6 In some cases, the assay reader device will not prompt the user to enter an assay test strip for analysis until all information required for a particular configuration setting has been entered. In some cases, the assay reader device may display a summary of the configuration settings (e.g., see Figure 6 ) as shown in the example at the top of the middle column in the figure.

[0055] The customizable reporting functionality can be processed on the server side or by one or more remote computing devices that are physically separated from the reader device but receive information from the reader device. For example, test result data and associated information from scanned barcodes can be stored in a database of one or more remote computing devices, such as a server system, and the remote computing device can generate a customized report with fields that are only of interest to the end user. The end user can include, but is not limited to, the user of the reader device, an administrator in a healthcare organization using the reader device, and entities that manage the remote server system and public health organizations.

[0056] Test results that do not meet the standards (e.g., having blank fields for any information required by internal standards of the healthcare organization or applicable regulatory requirements) can be marked in the database. In some examples, statistical analysis can be performed on the non - compliant results to identify common sources of non - compliance, such as, but not limited to, non - compliant test results released from a specific batch or lot of test strips, non - compliant information transmitted together with a specific healthcare provider or test location and test results, and non - compliance in reporting frequency or other deficiencies. This information can be automatically provided to healthcare organization administrators in some embodiments to assist in formulating plans to increase compliance with the compliance standards. Facilitating a more meaningful statistical analysis of compliant test results can be achieved by standardizing information collected from many different operators, facilities, or healthcare groups, for example, in order to identify and track infectious disease trends for use in formulating disease management plans.

[0057] The barcode and connectivity module 110 also includes the barcode reader 112 as described above, and additional connection means graphically represented by the connection marker 114. The connection means can be a wireless communication device such as a cellular modem for accessing a publicly provided, publicly maintained data network. The publicly provided network can be a public telephone network, a public cellular network, or another suitable type of publicly available data network. The barcode and connectivity module 110 can also include mechanical features for lockingly engaging corresponding features within the chassis 132 of the base assay reader device 130, and electronic features for establishing electronic data communication with components of the base assay reader device 130. This can reduce the administrative burden and overhead, and help reduce or minimize errors associated with manual result documentation and record - keeping.

[0058] Although not shown, the barcode and connectivity module 110 can include the information element as described above. The information element can be used to identify the barcode scanning of the barcode and connectivity module 110 and the network connection ability of the barcode and connectivity module 110 to the assay reader device, and / or to authenticate the barcode and connectivity module 110 as a module from a specific source or manufacturer.

[0059] The barcode and connectivity module 110 can provide all the functions and advantages of the barcode module 120 and additionally provide cellular or other wireless connectivity. This connectivity can be used to record test results across multiple sites and integrate with electronic medical records (EMR) HIS, LIS, and / or other health record databases. For example, in some embodiments, test results can be sent to a centralized server-based database and then routed to the appropriate medical record, hospital, or laboratory database. The automatic transmission of test results can ensure that the results are automatically recorded in the patient record. Additionally, the automatic transmission of test results can provide real-time alerts to designated medical personnel (e.g., the patient's doctor) about the patient's potentially dangerous health conditions, enabling rapid diagnosis and treatment. Furthermore, automatically transmitting test results to public health organizations can enable real-time aggregation and analysis of test result data to identify and potentially curb infectious disease trends. Such medical information transmission can be achieved through a secure end-to-end connection that complies with HIPAA, HITECH, ISO 27001:2013 cybersecurity guidelines or other industry standards, and the data can be encrypted before transmission. Cellular or satellite connectivity can allow for the rapid transmission of test results from locations even outside of standard clinical settings.

[0060] The cassette 140 can hold the analyte 144 in proper alignment within the base assay reader 130. As shown, the cassette 140 can include a window for exposing the test area of the analyte 144. The analyte 144 can be an immunoassay analyte, such as implementing colloidal metal particle technology to provide sensitivity and strong test performance. The analyte 144 can alternatively be a biological analyte, a ligand-binding assay analyte, or any other type of diagnostic test that can be optically imaged to determine the test result. The cassette 140 can also include a barcode 142 for providing test information, such as a test type, which can be used in some embodiments to configure the automated process for determining the assay result run by the device 130. The user can scan the barcode 142 of the cassette 140 using a barcode scanner of a module that is lockingly engaged with the base assay reader 130, such as the barcode scanner of the barcode module 120 or the barcode and connectivity module 110, as a way of inputting information into the base assay reader device 130. Such information can include one or more of patient and / or physician identification information, information related to the analyte test, a barcode password for unlocking the functions of the base assay reader device 130, etc.

[0061] The basic measurement reader device 130 may include one or more additional data communication ports (not shown), such as a USB port. The port may be set as a general hardware interface for the basic measurement reader device 130. Using this interface, the basic measurement reader device 130 may support external peripheral devices, such as a printer or a keyboard. The port may enable the basic measurement reader device to be connected to a PC for data download. For example, when the basic measurement reader device is connected to a PC via a USB interface, the reader device may act like a USB drive. In addition, the end user may update the reader device firmware by connecting a USB drive containing the latest firmware version to the USB port. In addition, the USB port provides a convenient way to upload measurement calibration data into the reader device, such as batch-specific calibration data.

[0062] Although not shown, additional module options may be available, such as a connection module without barcode features, a wired connection module, and a module with a power storage feature for increasing the device battery life, etc. In some embodiments, the module may be a printer or include a printer. In some embodiments, the module may be a separate detection unit or include a separate detection unit. Such a detection unit module may be used to run the same or different types of tests as the basic measurement reader device 130. In some embodiments, the module may be an incubator for culturing the analyte before determining the test result. For example, for a lateral flow assay, an incubator module may be used to hold the analyte and record the development time, and then provide a reminder or indication to the user to remove the cartridge and insert it into the basic measurement reader device 130 for reading. For a molecular assay, the incubator module may be used for sample preparation and culturing.

[0063] Now referring to Figure 2 , a schematic diagram of a networked embodiment of the system 200 is shown. In the illustrated embodiment, the arrows between certain devices and the public wide area network (WAN) 220 or the public network 230 indicate that such devices are configured to engage in two-way communication via such networks. For example, if Figure 2 the network element shown is associated with an arrow pointing to the network element and the public network 230, then the device is configured to send data to another device via the public network 230 and receive data from another device via the public network 230.

[0064] Figure 2Shows an example schematic diagram of a patient care facility 202. The patient care facility 202 can represent a patient facility, such as a hospital, a doctor's office, or a clinic, where one or more diagnostic tests are applied to or administered to a patient. In the illustrated embodiment, the patient care facility 202 is shown as including or containing a hospital information system (HIS) or a laboratory information system (LIS) database 203. That is, in the illustrated embodiment, the patient care facility 202 maintains or otherwise provides access to the HIS or LIS database 203. In the illustrated embodiment, the HIS or LIS database 203 is a repository for test results, summary reports, or other data related to patients utilizing the patient care facility 202. In various embodiments, the HIS or LIS database 203 is additionally coupled to one or more processors (not shown) for performing certain processing tasks, such as analyzing data stored in the HIS or LIS database 203.

[0065] In the illustrated embodiment, the patient care facility 202 also includes a plurality of in vitro diagnostic (IVD) devices 204a, 204b, and 204c. However, as shown by the IVD device 204d, the network environment 200 can also include IVD devices outside of the patient care facility settings. In one embodiment, the IVD device is a diagnostic test device, such as a device configured to optically image a lateral flow assay test strip having an applied biological sample and determine diagnostic test result information based on image data representative of the test strip. It should be understood that any suitable IVD device can be advantageously used in conjunction with the disclosed system.

[0066] As Figure 2Further shown, each of the IVD devices 204a, 204b, 204c, and 204d may respectively include a network communication device 205a, 205b, 205c, or 205d. For example, the network communication devices 205a, 205b, 205c, and 205d may be provided by an insertable accessory module that includes a cellular modem or another transceiver device configured to communicate with a public wide area network 220 or a public network 230, such as. In one embodiment, the network communication devices 205a, 205b, 205c, and 205d enable the corresponding IVD devices to communicate with each other or with another network element, as disclosed herein. Additionally, in one embodiment, the network communication devices 205a, 205b, 205c, and 205d enable the corresponding IVD devices to communicate data indicative of diagnostic test results to a remote resource, such as a HIS or LIS database 203, for storage and / or further analysis. Although not shown, some IVD devices may be equipped with a barcode scanner module, such as barcode module 120, in the absence of a network connection. Results stored by such devices may be uploaded, for example, via a USB connection and a scanned barcode password to one or more of a HIS / LIS, a patient computer, or another computing device for transmission via networks 230, 220.

[0067] Figure 2 System 200 is indicated by arrow 221 that the patient care facility 202 (and the IVD device / HIS or LIS database contained therein) is configured to communicate via the public wide area network 220. In one embodiment, access to the network is at least partially restricted by one or more of the public wide area network 220 and the public network 230. Additionally, in one embodiment, the disclosed system 200 implements communication between patient care facilities through encryption or other secure data transmission protocols, as described herein.

[0068] System 200 further includes a patient computer 206, a health agency computer 208, an insurance provider computer 210, and a device manufacturer computer 212. Each of these network elements is capable of communicating with each other and with the patient care facility 202 via the public wide area network 220, as indicated by arrows 222, 223, 224, and 225. Arrow 226 indicates that the public wide area network 220 may communicate with another type of public network, such as the Internet. Thus, Figure 2 the devices shown are configured to communicate with each other via the public wide area network 220, the public network 230, or some combination thereof.

[0069] In the illustrated embodiment, each of the computers enables a different party to communicate with the device manufacturer computer 212 and the IVD devices 204a, 204b, 204c and the HIS or LIS database 203. For example, the patient computer 206 enables a patient to communicate with the device manufacturer computer 212, the healthcare institution computer 208 enables one or more healthcare institutions to communicate with the patient care facility 202, the insurance provider computer 210 enables an insurance provider to communicate with the patient care facility 202, and the device manufacturer computer 212 enables the manufacturer of the IVD devices to communicate with the patient care facility 202. The device manufacturer computer 212 may enable the IVD devices 204a, 204b, 204c and 204d to communicate with a data server 212a coupled to the device manufacturer computer 212 to receive, among other things, necessary data such as calibration data, firmware or other software and data upgrades when needed.

[0070] In various embodiments, the system 200 implements the transmission and exchange of data including test results and additional data sent with the test results. For example, as described above, the data transmitted between the various network elements of the system 200 may include diagnostic data and information, network information, hardware information and environmental information. In one embodiment, some or all of the data transmitted between the various elements of the illustrated system 200 is encrypted to prevent unauthorized access to the transmitted data. In addition to protecting the data from interception and unauthorized consumption, this encryption may also verify or maintain the integrity of the transmitted data, such as by providing a checksum or other mechanism to ensure that all of the transmitted data is received.

[0071] In one embodiment, the patient computer 206, the healthcare institution computer 208, the insurance provider computer 210, and the device manufacturer computer 212 are standard desktop or laptop computers accessible by appropriate parties. In another embodiment, one or more of the patient computer 206, the healthcare institution computer 208, the insurance provider computer 210, and the device manufacturer computer 212 are mainframe or server computers configured to handle large amounts of data and / or provide complex processing and analysis programs. In this embodiment, depending on the purpose of the user's access, the appropriate entity responsible for the indicated computer device (e.g., the insurance company responsible for the insurance provider computer) may access some or all of the data uploaded from the IVD device and stored within the system. In another embodiment, one or more of the patient computer 206, the healthcare institution computer 208, the insurance provider computer 210, and the device manufacturer computer 212 are portable computers such as personal digital assistants (PDAs) or cellular telephones, which are configured to enable users to access data from the handheld portable device. In one embodiment (not shown), one or more healthcare professionals (such as healthcare personnel equipped with the patient care facility 202) use appropriate handheld devices (such as PDAs, cellular telephones, or other handheld portable devices) to access data communicated through the IVD devices 204a, 204b, 204c, and 204d. In this embodiment, the appropriate healthcare personnel may immediately access patient data or actively learn about patient data while analyzing patient samples through diagnostic tests using the IVD device. It should be understood that in various embodiments, Figure 2 Entities other than the network elements shown may be able to access data uploaded by the IVD device as needed to perform the corresponding tasks of these entities.

[0072] In one embodiment, as described above, the IVD device is configured to upload data to one or more database servers. The database servers can be configured to archive test results, aggregate test results into summary reports, or analyze test results for spatial, temporal, or other correlations. These database servers can also be configured to perform other analyses on the data as appropriate, depending on the type of data uploaded and the goals of the parties managing and implementing the database servers. The ability of the IVD device to upload data directly to the database servers via the disclosed connection module results in many advantages of the disclosed system. First, patient care facilities can obtain test results from the database servers via a secure Internet or other network connection and store the retrieved results in their own databases (e.g., their own HIS or LIS databases). Additionally, the aggregated test reports available due to the processing by the database servers are valuable to public health agencies such as the CDC, FDA, and WHO. Such reports can be provided in real time due to the ability of the disclosed IVD device to communicate diagnostic test result data directly and automatically to the database servers.

[0073] Figure 3 FIG. shows a schematic block diagram of a possible embodiment of the internal components of an exemplary assay reader device 300. The components can include a processor 310 linked and in electronic communication with a memory 315, a working memory 355, a cassette reader 335, a module interface 345, and a display 350.

[0074] The module interface 345 can include circuitry for reading information from an information element of an inserted module and transmitting the information to the processor 310 for analysis or verification. Thus, the module interface 345 can provide a first signal path by which the device 300 can identify characteristics of the connection module, the characteristics indicating the presence of a barcode scanner in the connection module and the connection capabilities of the connection module. The module interface 345 can also include paths for establishing electronic communication with a barcode reader, a network transceiver, a power supply, or other electronic components of the inserted module. Thus, the module interface 345 can provide a second signal path that is configured to receive barcode data from the connection module, the barcode data representing a barcode imaged by the connection module and / or information or instructions represented by the barcode.

[0075] The cartridge reader 335 may include one or more photodetectors 340 for reading the analyte held in the inserted cartridge and optionally any information about the inserted cartridge, such as a barcode printed on the cartridge. The cartridge reader 335 may send image data from the one or more photodetectors to the processor 310 for analyzing the image data representative of the imaged analyte to determine the test result of the analyte. The cartridge reader 335 may also send image data from the one or more photodetectors representative of the imaged cartridge for determining which of a plurality of automated operation procedures is to be implemented for imaging the analyte and / or analyzing the image data of the analyte. The (one or more) photodetectors 340 may be any device suitable for generating an electrical signal representative of incident light, such as a PIN diode or PIN diode array, a charge-coupled device (CCD), or a complementary metal-oxide semiconductor (CMOS) sensor, etc. The cartridge reader 335 may also include components for detecting cartridge insertion, such as a mechanical button, an electromagnetic sensor, or other cartridge sensing devices. An indication from the component may instruct the processor 310 to start the automated assay reading process without any additional input or instruction from a user of the device 300.

[0076] The processor 310 may be configured to perform various processing operations on the image data received from the cartridge reader 335 and / or the module interface 345 to determine and store test result data, as will be described in more detail below. The processor 310 may be a general-purpose processing unit implementing assay analysis functions or a processor specifically designed for analyte imaging and analysis applications. The processor 310 may be a microcontroller, a microprocessor, or an ASIC, etc., and may include multiple processors in some embodiments.

[0077] As shown, the processor 310 is connected to a memory 315 and a working memory 355. In the illustrated embodiment, the memory 315 stores a module identification component 320, a test result determination component 325, a data communication component 330, and a test data repository 305. These modules include instructions for configuring the processor 310 of the device 300 to perform various module interface, image processing, and device management tasks. The working memory 355 may be used by the processor 310 to store a working group of processor instructions contained in the modules of the memory 315. Alternatively, the working memory 355 may also be used by the processor 310 to store dynamic data created during the operation of the device 300.

[0078] As described above, the processor 310 may be configured by a number of modules stored in the memory 315. The module identification component 320 may include instructions that control the electronic communication between the processor and the module interface 345. For example, the module identification component 320 may include instructions to call a subroutine to configure the processor 310 to read the information elements of an inserted module, to authenticate the module as being compatible with the device 300, and to determine the capabilities of the inserted module. The test result determination component 325 may include instructions to call a subroutine to configure the processor 310 to analyze the measured image data received from the photodetector(s) 340 to determine the measurement result. For example, the processor may compare the image data with a number of templates or pre-identified patterns to determine the test result. In some embodiments, the test result determination component 325 may configure the processor 310 to perform an adaptive read process on the image data from the photodetector(s) 340 to improve the specificity of the test result and to reduce false positive results by compensating for background and non-specific binding.

[0079] The data communication component 330 may determine whether a module has been inserted into the device that enables wireless data transmission, and may manage the transmission of the test result data to a determined person and / or a remote database. For example, the test result data transmission may be based on barcode data received together with the measured image, where the measured image is used to generate the test result and is stored in association with the test result, and where the barcode data is further stored in association with the test result. If the device 300 is not coupled to a module that enables network communication, the data communication component 330 may cause the test result and associated information to be stored locally in the test data repository 305. If a local wired or wireless connection is established between the device 300 and another computing device (such as a hospital, clinician, or patient computer), the data communication component 330 may prompt the user of the device 300 to use the inserted module to scan a password barcode in order to access the data in the repository 305.

[0080] The processor 310 may be configured to control the display 350 to display, for example, the captured image data, the imaged barcode, the test result, and user instructions. The display 350 may include a panel display, such as an LCD screen, an LED screen, or other display technology, and may implement touch-sensitive technology.

[0081] The processor 310 may write data to the data repository 305, such as data representing captured images of barcodes and analytes, instructions or information associated with the imaged barcodes, and determined test results. Although the data repository 305 is graphically represented as a conventional disk device, those skilled in the art will understand that the data repository 305 may be configured as any storage medium device. For example, the data repository 305 may include a disk drive such as a hard disk drive, an optical disk drive, or a magneto-optical disk drive, or solid state memory such as FLASH memory, RAM, ROM, and / or EEPROM. The data repository 305 may also include multiple memory units, and any of the memory units may be configured to be within the assay reader device 300 or may be external to the device 300. For example, the data repository 305 may include a ROM memory that contains system program instructions stored within the assay reader device 300. The data repository 305 may also include a memory card or high speed memory configured to store captured images removable from the device 300.

[0082] Although Figure 3 An apparatus is shown having separate components to include a processor, a cassette reader, a module interface, and a memory, but those skilled in the art will recognize that these separate components may be combined in various ways to achieve a particular design objective. For example, in an alternative embodiment, the memory component may be combined with the processor component to save cost and improve performance.

[0083] Additionally, although Figure 3 Multiple memory components are shown, including a memory 315 that contains several modules and a separate memory 355 that includes a working memory, but those skilled in the art will recognize several embodiments that utilize different memory architectures. For example, the design may utilize ROM or static RAM memory to store processor instructions that implement the modules contained in the memory 315. The processor instructions may be loaded into RAM to facilitate execution by the processor 310. For example, the working memory 355 may include RAM memory into which instructions are loaded before being executed by the processor 310.

[0084] Figure 4 is a flowchart depicting an example operational procedure 400 of the assay reader device disclosed herein. In some embodiments, the procedure 400 may be implemented by the assay reader device 130 and / or the processor 310.

[0085] At block 405, the processor 310 may receive a power-on indication, for example, in response to a user pressing a single button located on the assay reader device.

[0086] At block 410, the processor may identify whether a module is inserted into the rack of the assay reader device and, if so, may identify the capabilities of the inserted module. As described above, these capabilities may include one or more of barcode scanning and network connectivity including cellular or satellite network connections.

[0087] At decision block 415, the processor 310 may identify whether the capabilities of the inserted module include barcode scanning or include both barcode scanning and network connectivity.

[0088] If the capabilities of the inserted module include barcode scanning, process 400 may proceed to block 420 to receive input via the barcode scanner of the inserted module. Such input may include information to be stored in association with test results and / or information to configure the operation of the assay reader device, such as instructions regarding an imaging process for obtaining image data of the inserted analyte. In some embodiments, the device operation may be configured via the button press mode described above. At block 425, process 400 may include receiving an analyte test holding cartridge in a receiving aperture within the assay reader device, imaging the analyte, and determining a test result based on the image data representative of the analyte. Block 425 may be implemented as any of the disclosed reader operation modes, such as but not limited to an endpoint read mode or a pull-off mode. At block 430, the processor 310 may display and locally store the test result and any associated data.

[0089] At decision block 435, the processor may determine whether to perform an additional test, for example by receiving an indication that an additional barcode has been scanned (by looping back to block 420) or an additional cartridge has been inserted (by looping back to block 425). In such a case, the process may loop back through blocks 420 - 430 in the order shown or by toggling blocks 420 and 425.

[0090] If the capabilities of the inserted module include both barcode scanning and network connectivity, process 400 may proceed to block 440 to receive input via the barcode scanner of the inserted module. Such input may include information to be stored in association with test results and / or information to configure the operation of the assay reader device, such as instructions regarding an imaging process for obtaining image data of the inserted analyte, or instructions regarding the location where the test result data should be transmitted. In some embodiments, the device operation may be configured via the button press mode described above. At block 445, process 400 may include receiving an analyte test holding cartridge in a receiving aperture within the assay reader device, imaging the analyte, and determining a test result based on the image data representative of the analyte. Block 445 may be implemented as any of the disclosed reader operation modes, such as an endpoint read mode or a pull-off mode.

[0091] At block 450, the processor 310 may display and locally store the test results and any associated data, such as the analyte image used to generate the test results and additional information provided via a scanned barcode. Additionally or alternatively, the processor 310 may display and transmit the test results and optionally any associated data via a network to a destination database or contact. For example, in some embodiments, this may be achieved via a connection module 110 inserted into and in electronic communication with the base assay reader device 130.

[0092] At decision block 455, the processor may determine whether to perform an additional test, for example by receiving an indication that an additional barcode has been scanned (by looping back to block 440) or an additional cartridge has been inserted (by looping back to block 445). In this case, the process may loop back through blocks 440 - 450 in the order shown or by switching blocks 440 and 445.

[0093] If at block 435 or 455 the processor 310 determines not to perform an additional test (e.g., by the inactivity of any sensor of the assay reader device), then process 300 may proceed to block 460. At block 460, the processor 310 may wait for a predetermined period of time before powering down the assay reader device.

[0094] Figure 5A An example hospital workflow for a wireless point with no care test solution is shown. As shown, samples are collected and test results are provided at the point of care. Embodiments of the reader devices described herein may provide test results in ten minutes or less. Subsequently, for manual documentation of the results, the results are manually recorded in a log and then manually entered into the laboratory information system or electronic medical record. After the results are entered into the laboratory information system or electronic medical record, the physician can access the test results and provide patient care. In such a workflow, the physician must wait for the manual documentation to be completed before reviewing the test results and providing patient care.

[0095] Figure 5BAn example hospital workflow for streamlining the workflow is shown by the disclosed assay reader device that provides a care testing solution at a wireless point. As shown, samples are collected and test results are provided at the point of care. Embodiments of the reader device including the network communication enabling modules described herein can provide test results in ten minutes or less. From a care perspective, the results are automatically transmitted directly to the laboratory information system or electronic medical record over the network. Through the laboratory information system or electronic medical record, the transmitted results are immediately available to the physician at the point of care, thus helping to accelerate patient care. In this workflow, the physician can access the patient's test results while the patient is still in the office, without having to wait for a manual document of the test results, thus enabling faster treatment of the patient.

[0096] One advantage of the basic assay reader device described herein is that each device can be upgraded at any time, for example by providing new modules, thus providing a scalable platform to meet the growing needs of the healthcare group. The basic assay reader device can receive racks through modules to integrate with other test platforms and instruments. In addition, a single assay reader device can be used for multiple functions through interchangeable modules. In one example, a health service provider can purchase and use the basic assay reader device without any of the described modules. As the provider expands its capabilities, requires additional functionality, or additional procurement resources become available, the vendor can purchase one or more modules as needed to meet its specific needs. These modules can be inserted into the basic assay reader device to quickly and easily expand the functionality of the device without any modification to the previously acquired basic assay reader device. As another example, a health service provider can purchase a kit with a basic assay reader device and one or more modules, and then develop a new barcode scanner module with additional functionality. The provider can purchase a new barcode scanner at any time when needed and still use the previously acquired basic assay reader device, where the old module is changed to the new module. In another example, some other component in the barcode scanner or module may fail or break. When the first barcode scanner is repaired, the spare part can be used with the basic assay reader device.

[0097] Other advantages of the disclosed basic assay reader device with a network connection module are that integration with a single access point to the electronic medical record and laboratory information system quickly provides test results, thus enabling decision-making when the patient is on-site. This automated documentation can facilitate accelerated patient care by accelerating the physician's access to test results, and the results are provided to the physician almost immediately after the test is completed regardless of the test location. Compared with systems that require manual entry of identification information, the disclosed basic assay reader device with a barcode scanning module reduces transcription errors.

[0098] Implementation System and Terminology

[0099] The embodiments disclosed herein provide systems, methods, and apparatuses for modular reconfigurable assay readers. Those skilled in the art will recognize that these embodiments can be implemented in hardware or in a combination of hardware and software and / or firmware.

[0100] The assay reader device may include one or more image sensors, one or more image signal processors, and a memory including instructions or modules for performing the above processes. The device may also have data, a processor for loading instructions and / or data from the memory, one or more communication interfaces, one or more input devices, one or more output devices, such as a display device and a power supply / interface. The device may additionally include a transmitter and a receiver. The transmitter and the receiver may be collectively referred to as a transceiver. The transceiver may be coupled to one or more antennas for transmitting and / or receiving wireless signals.

[0101] The functions described herein may be stored as one or more instructions on a processor-readable or computer-readable medium. The term "computer-readable medium" refers to any available medium that can be accessed by a computer or a processor. By way of example and not limitation, such a medium may include RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the required program code in the form of instructions or data structures and that can be accessed by a computer. As used herein, a disk or an optical disc includes a compact disc (CD), a laser disc, an optical disc, a digital versatile disc (DVD), a floppy disk, and a Blu-ray disc, where a disk typically reproduces data magnetically, while an optical disc reproduces data optically with a laser. It should be noted that the computer-readable medium can be tangible and non-transitory. The term "computer program product" refers to a computing device or a processor in combination with code or instructions (e.g., "program") that can be executed, processed, or computed by the computing device or the processor. As used herein, the term "code" may refer to software, instructions, code, or data that can be executed by a computing device or a processor.

[0102] The various illustrative logical blocks and modules described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a general-purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. The general-purpose processor may be a microprocessor, but in the alternative, the processor may be a controller, microcontroller, or state machine, combinations thereof, etc. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described primarily in the context of digital technology herein, the processor may also include primarily analog components. For example, any of the signal processing algorithms described herein may be implemented in analog circuitry. The computing environment may include any type of computer system, including but not limited to a microprocessor-based computer system, a mainframe computer, a digital signal processor, a portable computing device, a personal memorandum, a device controller, and a computing engine within a device, etc.

[0103] The methods disclosed herein include one or more steps or acts for implementing the methods. Without departing from the scope of the claims, the method steps and / or acts may be interchanged with one another. In other words, unless the correct operation of the method being described requires a particular order of steps or acts, the order and / or use of particular steps and / or acts may be modified without departing from the scope of the claims.

[0104] It should be noted that the term "couple (couple, coupling, coupled)" or other variations as used herein may indicate an indirect connection or a direct connection. For example, if a first component is "coupled" to a second component, the first component may be indirectly connected to the second component or directly connected to the second component. As used herein, the term "plurality" means two or more. For example, a plurality of components means two or more components.

[0105] The term "determine" encompasses a variety of actions, and thus, "determine" may include operations, calculations, processing, derivation, investigation, lookup (e.g., looking up in a table, database, or another data structure), ascertaining, etc. In addition, "determine" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), etc. In addition, "determine" may include resolving, selecting, picking, establishing, etc. The phrase "based on" does not mean "based only on" unless expressly specified otherwise. In other words, the phrase "based on" describes both the meanings of "based only on" and "based at least on".

[0106] A prior description of the disclosed embodiments is provided so that any person skilled in the art can make or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be applied to other embodiments without departing from the spirit or scope of the present invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A diagnostic test device, comprising: An optical sensor configured to generate a signal indicative of one or more optical characteristics of an analyte after applying a sample to the analyte; A module interface, comprising: A chassis configured to receive connection modules of a plurality of interchangeable modules, and A circuit for reading information from an information element of the connection module; At least one processor; and A memory having instructions stored thereon, the instructions configuring the at least one processor to: Determine a test result based at least in part on the signal generated by the optical sensor, Receive module information of an information element of the connection module from the connection module via the circuit, Determine the connection capability of the connection module based on the module information, Automatically send the test result to the remote storage device in response to determining that the connection module has a connection capability with the remote storage device, and Automatically store the test result in the memory in response to determining that the connection module does not have a connection capability with the remote storage device.

2. The diagnostic test device according to claim 1, further comprising an additional optical sensor positioned to detect additional information about the analyte, wherein the at least one processor is configured to use the additional information to establish operating parameters of the diagnostic test device.

3. The diagnostic test device according to claim 1, further comprising a cartridge holding the analyte, wherein the at least one processor is configured to use additional information to establish operating parameters of the diagnostic test device.

4. The diagnostic test device according to claim 1, further comprising an additional optical sensor positioned to detect additional information about the analyte, wherein the at least one processor is configured to store the additional information associated with the test result.

5. The diagnostic test device according to claim 1, further comprising a cartridge holding the analyte, wherein the at least one processor is configured to store additional information associated with the test result.

6. The diagnostic test device according to claim 1, further comprising the connection module.

7. The diagnostic test device according to claim 6, wherein the connection module includes a barcode scanner.

8. The diagnostic test device according to claim 6, wherein the connection module includes a cellular modem configured to provide the connection capability.

9. A non-transitory computer-readable medium configured with computer-executable instructions that, when executed, cause a hardware processor to: Determine the connection capability of a connection module inserted into a chassis of an analyte reader device; Receive analyte image data from an analyte reading image sensor of the analyte reader device, the analyte image data representing one or more optical characteristics of an analyte inserted into or positioned adjacent to the analyte reader device; Determine a test result based at least in part on analyzing the analyte image data; Automatically send the test result to the remote storage device in response to determining that the connection module has the connection ability with a remote storage device physically separated from the assay reader device; And Automatically store the test result in the memory of the assay reader device in response to determining that the connection module does not have the connection ability with a remote storage device.

10. The non - transitory computer - readable medium according to claim 9, further having instructions stored thereon, which when executed cause the hardware processor to: Determine that a barcode scanner exists in the connection module; Receive barcode image data representing at least one barcode from the connection module; Based on the analysis of the barcode image data, identify the at least one barcode as an instruction barcode; and Retrieve instructions associated with the instruction barcode.

11. The non - transitory computer - readable medium according to claim 10, further having instructions stored thereon, which when executed cause the hardware processor to determine the test result at least in part based on the instructions associated with the instruction barcode.

12. The non - transitory computer - readable medium according to claim 10, further having instructions stored thereon, which when executed cause the hardware processor to instruct the assay reading image sensor to obtain the assay image data at a predetermined timing after inserting the assay into the assay reader device at least in part based on the instructions associated with the instruction barcode.

13. The non - transitory computer - readable medium according to claim 9, further having instructions stored thereon, which when executed cause the hardware processor to: Determine that a barcode scanner exists in the connection module; Receive barcode image data representing at least one barcode from the connection module; Based on the analysis of the barcode image data, identify the at least one barcode as an identification barcode; Determine the information represented by the identification barcode; In response to determining that the connection module has the connection ability with a remote storage device physically separated from the assay reader device, automatically send the information represented by the identification barcode together with the test result to the remote storage device; And In response to determining that the connection module does not have the connection ability with a remote storage device, automatically store the information represented by the identification barcode together with the test result in the memory of the assay reader device.

14. A diagnostic test method, comprising, by one or more hardware processors: Determine the connection ability of a connection module inserted into a rack of an assay reader device; Receive assay image data from an assay reading image sensor of the assay reader device, the assay image data representing one or more optical characteristics of an assay inserted into or positioned adjacent to the assay reader device; Determine a test result at least in part based on analyzing the assay image data; Automatically send the test result to the remote storage device in response to determining that the connection module has the ability to connect to a remote storage device physically separated from the assay reader device; And Automatically store the test result in the memory of the assay reader device in response to determining that the connection module does not have the ability to connect to a remote storage device.

15. The method according to claim 14, further comprising: Determine that a barcode scanner is present in the connection module; Receive barcode image data representing at least one barcode from the connection module; Based on the analysis of the barcode image data, identify the at least one barcode as an instruction barcode; And Retrieve the instruction associated with the instruction barcode.

16. The method according to claim 15, further comprising determining the test result at least in part based on the instruction.

17. The method according to claim 15, further comprising instructing the assay reading image sensor to obtain the assay image data at a predetermined timing after inserting the assay into the assay reader device at least in part based on the instruction.

18. The method according to claim 14, further comprising: Determine that a barcode scanner is present in the connection module; Receive barcode image data representing at least one barcode from the connection module; Based on the analysis of the barcode image data, identify the at least one barcode as an identification barcode; And Determine the information represented by the identification barcode.

19. The method according to claim 18, further comprising: Automatically send the information represented by the identification barcode together with the test result to the remote storage device in response to determining that the connection module has the ability to connect to a remote storage device physically separated from the assay reader device; And Automatically store the information represented by the identification barcode together with the test result in the memory of the assay reader device in response to determining that the connection module does not have the ability to connect to a remote storage device.

20. The method according to claim 18, further comprising automatically sending an instruction to route the test result from the remote storage device to another remote storage device based on the information represented by the identification barcode to identify the another remote storage device in response to determining that the connection module has the ability to connect to a remote storage device physically separated from the assay reader device.

21. The method according to claim 18, further comprising automatically sending the test result to the personal computing device of a clinician based on the information represented by the identification barcode to identify the clinician in response to determining that the connection module has the ability to connect to a remote storage device physically separated from the assay reader device.

22. An interchangeable module for a diagnostic test device, the interchangeable module comprising: A housing sized and shaped to engage a frame of a module interface of the diagnostic test device; A barcode scanner configured to image a barcode and generate barcode data based on the imaged barcode; A communication component configured to communicate wirelessly with a remote storage device; And A processing circuit configured by computer-executable instructions to: Provide a first signal to a first signal path of the module interface of the diagnostic test device, the first signal including module information indicating the presence of the barcode scanner in the interchangeable module and the connection ability of the interchangeable module; Provide a second signal to a second signal path of the module interface of the diagnostic test device, the second signal including the barcode data; Receive a test result from the diagnostic test device, the test result being determined by the test device based on a change in an optical characteristic of the analyte detected at an optical sensor of the diagnostic test device after a biological sample is applied to the analyte; Receive identification information from the diagnostic test device, the identification information being determined by the diagnostic test device based on the barcode data; and Cause the communication component to send the test result associated with the identification information to the remote storage device.

23. The interchangeable module according to claim 22, wherein the processing circuit is further configured to receive additional information from the diagnostic test device optically detected by the diagnostic test device from the analyte or a cartridge fixing the analyte, and wherein the additional information is further sent associated with the test result.

24. The interchangeable module according to claim 22, wherein the communication component includes a cellular modem configured to provide connection ability.

25. The interchangeable module according to claim 22, wherein the communication component includes a Wi-Fi communication device configured to provide the connection ability.

26. The interchangeable module according to claim 22, wherein the processing circuit includes an information element configured to send the first signal to the first signal path.

27. The interchangeable module according to claim 22, wherein the diagnostic test device is capable of operating with a barcode scanner module lacking connection ability to the remote storage device, and wherein the module information enables one or more processors of the diagnostic test device to distinguish the interchangeable module from the barcode scanner module.

28. The interchangeable module according to claim 22, wherein the barcode is an instruction barcode, and wherein the barcode data enables the diagnostic test device to retrieve instructions associated with the instruction barcode.

29. The interchangeable module according to claim 28, wherein the instructions cause the diagnostic test device to determine the test result at least in part based on the instructions.

30. The interchangeable module according to claim 22, wherein the processing circuit is further configured to send instructions to the remote storage device to route the test result from the remote storage device to another remote storage device.

31. The interchangeable module according to claim 30, wherein the other remote storage device is identified at the diagnostic test device based on the barcode data.

32. The interchangeable module according to claim 22, wherein the processing circuit is further configured to send the test result to a personal computing device of a clinician, the clinician being identified based on the barcode data.

33. The interchangeable module according to claim 22, wherein the housing further includes mechanical features configured to lockingly engage corresponding features within a rack of the module interface.

34. The interchangeable module according to claim 33, wherein when the mechanical features engage corresponding features within the rack, the rack of the module interface at least partially surrounds the housing of the interchangeable module.

35. A kit comprising the interchangeable module according to claim 22 and a barcode scanner module, the barcode scanner module comprising: a housing sized and shaped to engage a rack of a module interface of the diagnostic test device; a barcode scanner configured to image a barcode and generate barcode data based on the imaged barcode; and a processing circuit configured by computer-executable instructions to: provide a first signal to a first signal path of the module interface of the diagnostic test device, the first signal including module information indicating the presence of the barcode scanner in the barcode scanner module and indicating that the barcode scanner module does not have a connection capability with a remote storage device; and provide a second signal to a second signal path of the module interface of the diagnostic test device, the second signal including the barcode data; wherein the first signal causes the diagnostic test device to automatically store one or more test results in a memory of the diagnostic test device.

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