CN217385512U - Assay reader system - Google Patents

Abstract

The utility model relates to a survey reader system. Certain aspects relate to systems and techniques for use of a modular lateral flow assay reader device that can receive a plurality of different modules with a barcode scan input device and optional network connection capabilities. The barcode scanning module may provide a simple input method that reduces errors compared to manual data entry. The network connection module may enable transmission of test results over a public network for standardization, tracking, and electronic connection of test results from assay reader devices located throughout the network. Such devices may implement a simplified workflow programmatically, where pressing a single button readies the device for imaging, analysis, and data storage/transmission, and in some embodiments, configures the device to operate in one of a plurality of device operating modes.

Description

Assay reader system

The utility model relates to a divisional application of the chinese patent application with application number 2017207315497, entitled "modular assay reader device" filed on 22.6.2017.

Cross Reference to Related Applications

The benefit of U.S. provisional patent application No.62/393,575 entitled "MODULAR assay reader device (MODULAR ASSAY READER DEVICE)" filed on 12/9/2016 and U.S. provisional patent application No.62/353,505 entitled "MODULAR assay reader device (MODULAR ASSAY READER DEVICE)" filed on 22/6/2016, the contents of which are incorporated herein by reference.

Technical Field

The systems and methods disclosed herein relate to medical testing, and more particularly, to lateral flow assay techniques and devices.

Background

In patient care, immunoassay techniques provide a simple and relatively fast method for determining the presence of an analyte in a sample under test. An analyte is a substance of interest or clinical significance that may be present in a biological or non-biological fluid. The analyte may comprise an antibody, antigen, drug or hormone.

The analyte of interest is typically detected by reaction with a capture agent, which results in a device that is easier to detect and measure than the original analyte. Detection methods may include changes in absorbance, changes in color, changes in fluorescence, changes in luminescence, changes in the potential of a surface, changes in other optical properties, or any other readily measurable physical characteristic indicative of the presence or absence of an analyte in a sample.

SUMMERY OF THE UTILITY MODEL

Immunoassay devices play an important role in fields such as clinical chemistry and have been made portable for use in this field. Assays are routinely performed to detect the presence of a particular analyte that is present 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, is undergoing ovulation or pregnancy, or has a particular drug or compound in their body, etc.

Both skilled clinicians and laymen use such assays and assay reader devices. Thus, assay reader devices according to the present disclosure are designed to be simple and reliable, for example, by including a module for simple barcode scan entry of any required additional information, and by minimizing the number of steps required for a user to perform between sample application and result notification. Barcode scan entry may provide a high level of traceability and compliance by allowing clinics, laboratories, and the like to implement customized test result documentation standards. Some examples may enforce adherence to these standards at the reader level, for example by pre-configuring the reader to require entry of a specified type of information before transmitting the results. As another example, communication between the reader and the centralized database may be used to determine whether the transmitted test data meets such criteria, and if not, to send instructions back to the reader device to alert the user of any missing information. Further, such assays and assay reader devices can be used in a variety of situations both inside and outside of a clinical setting. Accordingly, an assay reader device according to the present disclosure can include a module that provides network connectivity to provide test results to one or more centralized databases.

Accordingly, there is provided an assay reader system comprising: a barcode and connection module having barcode scanning and network connectivity, the barcode and connection module having a first mechanical feature and a first electronic feature; a barcode module having the barcode scanning capability and not having the network connectivity capability, the barcode module having a second mechanical feature and a second electronic feature; an assay reader device, comprising: a cartridge receiving aperture sized and shaped to align a test area of an assay with a detector or detector array provided within the assay reading device; and a chassis configured to lockingly receive the bar code and connection module or the bar code module, the chassis including a third mechanical feature for lockingly mating with the first mechanical feature of the bar code and connection module or the second mechanical feature of the bar code module when the bar code and connection module or the bar code module is inserted, the chassis further including an electrical feature for establishing electronic data communication with the first electronic feature of the bar code and connection module or the second electronic feature of the bar code module when the bar code and connection module or the bar code module is inserted.

Accordingly, one aspect relates to a diagnostic test device comprising an optical sensor positioned to detect a change in an optical characteristic of an assay following application of a biological sample to the assay, the optical sensor configured to generate a signal indicative of the detected change in the optical characteristic of the assay; a module interface including a chassis configured to receive and lockingly engage a connection module of the plurality of interchangeable modules, a first signal path configured to identify a characteristic of the connection module that indicates a presence of a barcode scanner in the connection module and a connection capability of the connection module, and a 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 that configure 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 a connection capability of the connection module, automatically send the test result associated with the identification information to the remote storage device in response to determining that the connection module has the 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 the connection capability with the remote storage device.

Some embodiments may further comprise an additional optical sensor positioned to detect additional information about the assay or a cartridge holding the assay, wherein the at least one processor is configured to use the additional information to establish the operating parameters of the diagnostic test device. Some embodiments may further comprise an additional optical sensor positioned to detect additional information about the assay or a cartridge holding the assay, wherein the at least one processor is configured to store the additional information in association with the test results.

Some embodiments may further comprise 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 comprise an information element, wherein the at least one processor is configured to retrieve module information from the information element via the first signal path and to determine the connection capability of the connection module based on the module information.

Another aspect relates to a non-transitory computer-readable medium configured with computer-executable instructions that, when executed, cause a hardware processor to identify a characteristic of a connection module inserted into a chassis of an assay reader device and a connection capability of the connection module, the characteristic indicating presence of a barcode scanner in the connection module; receiving assay image data from an assay reading image sensor of the assay reader device, the assay image data representing a detected change in an optical characteristic of an assay inserted into or positioned proximate to the assay reader device; determining a test result based at least in part on analyzing the assay image data; determining a connection capability of the connection module based on the identified characteristic; automatically sending the test results to a remote storage device in response to determining that the connection module has a connection capability with the remote storage device physically separate from the assay reader device; and automatically storing the test results in a memory of the assay reader device in response to determining that the connection module does not have connection capability with the remote storage device.

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

The non-transitory computer readable medium may further have instructions stored thereon that, when executed, cause the hardware processor to receive barcode image data representing at least one barcode from the connection module; identifying at least one barcode as an identifying barcode based on the analysis of the barcode image data; determining information represented by the identification barcode; automatically transmitting information represented by the identification barcode to a remote storage device along with the test results in response to determining that the connection module has a connection capability with the remote storage device physically separate from the assay reader device; and automatically storing information represented by the identification barcode in a memory of the assay reader device with the test results in response to determining that the connection module does not have the connection capability with the remote storage device.

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

The process may further 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 the analysis of the barcode image data; and retrieving instructions associated with the instruction barcode. The process may further include determining a test result based at least in part on the instruction. The method may further include instructing, based at least in part on the instructions, the assay reading image sensor to obtain assay image data at a predetermined timing after the assay is inserted into the assay reader device.

The process may further include receiving barcode image data representing at least one barcode from the connection module; identifying at least one barcode as an identifying barcode based on the analysis of the barcode image data; and determining information represented by the identification barcode. The process may further include automatically sending information represented by the identified bar code to a remote storage device along with the test results in response to determining that the connection module has connection capability with the remote storage device physically separate from the assay reader device; and automatically storing information represented by the identification barcode in a memory of the assay reader device with the test results in response to determining that the connection module does not have the connection capability with the remote storage device. The process may further include, in response to determining that the connection module has connection capability with a remote storage device physically separate from the assay reader device, automatically sending instructions to route the test results from the remote storage device to another remote storage device, the other remote storage device identified based on the information represented by the identification barcode. The process may further include automatically sending test results to the personal computing device of the clinician in response to determining that the connection module has connection capability with a remote storage device physically separate from the assay reader device, identifying the clinician based on the information represented by the identification barcode.

Drawings

The disclosed aspects will hereinafter be described in conjunction with the appended drawings, which are meant to illustrate and not to limit the disclosed aspects and wherein like designations denote like elements.

FIG. 1A shows a set of components for an example of an assay reader system.

FIG. 1B shows an example assembled reader and module of the assay reader system of FIG. 1A.

FIG. 2 shows a schematic block diagram of an example data network including the disclosed assay reader system.

FIG. 3 shows a schematic block diagram of an example assay reader device.

FIG. 4 is a flow chart describing an example operational procedure for the assay reader device disclosed herein.

Fig. 5A illustrates an example hospital workflow without a wireless point of care testing solution.

Fig. 5B illustrates an example hospital workflow implementing a streamlined workflow with the disclosed assay reader device providing a wireless point of care testing solution.

Fig. 6 illustrates various examples of display text that may be presented to an operator on a display screen of an assay reader device described herein.

Detailed Description

Embodiments of the present disclosure relate to systems and techniques for a modular assay reader device that can receive a plurality of different modules with a bar code scan input device and optional network connection capabilities. Embodiments of the reader device may be portable, e.g., relatively small and lightweight, with the option of draining stored power. The disclosed reader device may 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 infectious antibodies. The network connection module may enable standardization, tracking, and electronic connection of test results from reader devices located throughout the network to improve patient care.

One type of reader device is configured to read or otherwise analyze lateral flow assays that can test for a wide variety of medical and environmental conditions or compounds. For example, lateral flow tests may rely on a format of immunoassay in which a sample flows along a solid matrix by capillary action. The lateral flow assay reader device can read the lateral flow assay strip to detect the presence of hormones, metabolites, toxins or pathogen-derived antigens. The reading may be accomplished by using a detector comprising one or more sensing elements, such as, but not limited to, PIN detectors, linear array detectors, CMOS imagers, and CCD-based imaging devices, configured to detect the presence or absence of a line on a lateral flow assay based on the presence or absence of a line of sight (visual line) on the assay. Some tests performed by assay reader devices are designed to make quantitative determinations, but in many cases, tests are designed to return or indicate a negative/positive qualitative indication. Examples of assays for performing such qualitative analyses include blood type analysis, most types of urinalysis, 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 rule. In addition to reader devices configured to analyze lateral flow assays, implementations of the diagnostic reader devices described herein can analyze other types of assays, such as, but not limited to, molecular assays, and provide diagnostic test results.

The assay reader device can be a single-step device in which the user only needs to apply the sample before viewing the results and optionally transmitting the results to an appropriate hospital, laboratory, or medical records database. Such a single-step arrangement may avoid the necessity of performing complex and time-consuming processing steps that may introduce errors in the final result. For example, a user may press a single button on the assay reader device to power the device. Thereafter, insertion of the sample cartridge into the device may automatically activate a reading process to determine and display the test results based on the sample cartridge without additional user input. In some embodiments with network connectivity capabilities, the determined test results may additionally be automatically sent to a remote storage device, e.g., to a centralized database, and then from the centralized database to a designated clinician or another database, e.g., a Hospital Information System (HIS), a Laboratory Information System (LIS), or a database maintained by public health agencies like the CDC, FDA, and WHO, without the need for additional user input. In some embodiments with network connectivity, the determined test results may be sent directly to a designated clinician or database. As used herein, the remote storage device may be a centralized database, a HIS, a LIS, a public health institution database, a clinician-designated device, or any other data store that is not physically coupled to the assay reader device.

The disclosed portable assay device can include a base assay analyzer having a housing (bay) for receiving a plurality of different modules, such as a base assay reader device. One module may include a bar code scanner for the user to enter any additional information required, such as patient identification information, test type, device operating mode, sample information, and any other additional tests or patient information related to the test performed by the IVD device. In some embodiments, the device operating mode may be set via the number or pattern of clicks of a single button of the basal metering analyzer. Another module may include a barcode scanner and additional network connection elements. This modular design approach allows the assay reader device to expand its functionality, such as providing bar code 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 the best functional capability required by his own settings or applications. The module may be an optional accessory to a base assay analyzer, and the base assay analyzer may function without an inserted module to read an inserted assay, such as a lateral flow assay test strip. Modules may be exchanged between analyzers. Once inserted, the modules may become part of the analyzer.

As described above, one of the modules may include both a barcode reader and a communication component for a network connection, 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 housing of an assay reader device and is in electronic communication with the memory and/or processor of the device, the assay reader device becomes able to send or upload data to a remote repository via a network. 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, to enable the assay reader device to communicate directly with network elements or other IVD devices to enable electronic test result transmission, storage, analysis and/or dissemination without requiring separate intervention or action by the user of the device. For example, in some cases, electronic test result transmission, storage, analysis, and/or dissemination occurs automatically as the patient sample is analyzed by the assay reader device. In another example, the transmission, storage, analysis, and/or propagation of the electronic test results occurs immediately upon analysis of the patient sample by the assay reader device. In some embodiments, the modules may provide connectivity to a cloud database, such as server-based data storage. The cloud-based connection module can enable ubiquitous connection of assay reader devices without requiring a localized network infrastructure.

Using a bar code scanner, a device user can customize an assay reader device to perform various workflows that best suit their environment and compliance requirements. This barcode scanning method provides a simple and error-free way for end users to customize diagnostic devices. For example, a bar code may be scanned to set a device operating mode or to specify a desired type of information to comply with requirements, such as medical organization standards, compliance standards, documentation standards, reporting standards, or any other requirements applicable to a testing environment.

In some embodiments, the device operating mode may additionally or alternatively be set via the number or pattern of clicks of a single button of the base metering analyzer. For example, in some embodiments, a single press of a button can power the basal assay analyzer and set the analyzer to a default operating mode, and the device can implement the default operating mode upon insertion of the cartridge. Double-clicking the button may initiate an alternate mode of operation that is different from the default mode of operation. Other times or patterns of user depression of a single button may provide instructions to the processor of the device regarding the desired mode of operation. Embodiments of the base assay analyzer are described herein with reference to a single button, but other features that allow a user to select and switch between device operating modes are possible (such as, but not limited to, a single switch, knob, lever, or handle).

One example of a device operating mode is an end-point read mode. In the endpoint reading mode, the user prepares and incubates the assay outside of the basic assay analyzer and records/tracks the time of development (development) of the assay. For example, a flow sensing assay may have a development time of 10 minutes, so the user applies the sample to the assay and waits 10 minutes. At the end of 10 minutes, the user inserts the assay into the base assay analyzer to obtain the test results. Thus, when operating in an endpoint reading mode, the base assay analyzer can provide instructions, e.g., audibly or on a visual display, that instruct a user to wait a predetermined time after applying a sample to an assay before inserting the assay into the base assay analyzer. In other embodiments, the base assay analyzer may not display any instructions when operating in an endpoint reading mode, but may only read the assay when inserted into the base assay analyzer. Upon insertion of the assay into the basic assay analyzer, the optical reader of the device can collect image data representing the assay for analysis when determining the assay results. In some embodiments, the endpoint reading mode can be a default operating mode of the base assay analyzer.

Another example of a device operating mode is a talk away mode (walkaway mode). Thus, when operating in the detached mode, the base assay analyzer can provide instructions to the user to insert the assay immediately after application of the sample, or to insert the assay during application of the sample. In the pull-away mode according to one implementation force, the user can apply the sample to the assay and immediately insert the assay into the basic assay analyzer. The assay will develop within the base assay analyzer, and the base assay analyzer can record the time elapsed after insertion of the assay. At the end of the predetermined development time, the basic assay analyzer may collect image data representing the assay, analyze the image data to determine a test result, and report the test result to the user. The assay development time may be unique for each test, for example, the influenza assay development time may be 10 minutes and the streptococcal assay development time may be 5 minutes. In some embodiments, the escape mode may be set by double-clicking a single button of the basis weight analyzer. Additional inputs may indicate to the reader device the time of development of the assay. For example, a bar code scanned by a bar code reader of an inserted module, or a bar code disposed on an assay or on a cassette used to hold an assay, may indicate to the device the type of assay inserted and the time of development of the assay. Based on the type of assay, the basic assay analyzer may wait a predetermined amount of time after sample application and insertion before collecting image data representing the assay.

In embodiments of the basic metering analyzer described herein, there are many advantages associated with the ability of a user to select and switch between device operating modes. In large laboratories or medical practice facilities where personnel typically batch process multiple tests, a terminal read mode may be convenient. The pull-away mode may be useful 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 train how to accurately record the assay development time). The pull-away mode may advantageously reduce or eliminate the occurrence of false test results due to the assay being inserted and imaged too quickly (too early before the time of development of the assay has elapsed) or too slowly (too long after the time of development of the assay has elapsed). Further, in the stand-off mode, the assay reader is operable to capture a plurality of images of the assay at predetermined time intervals, for example when a kinetic map of the assay reading is required.

One embodiment of the disclosed basal assay analyzer, such as the basal assay reader device described in detail below, includes only a single button on its external housing, such as a single power button that powers down and up the basal assay analyzer. Embodiments of the disclosed basic assay analyzer also enable two different modes of device operation (although more than two modes of device operation are possible). To enable the end user to select and switch between the two device operating modes, the base metering analyzer may include instructions for implementing a double-click function on the power button. Insertion of the assay cartridge may automatically trigger the end-point reading mode after receiving an input to power the device with a single push of the button. When the processor of the device receives an input from the user double-clicking the power button, this may initiate the stored instructions to implement the talk-around mode. This double-click functionality provides an easy and intuitive way for the end user to switch between different operating modes of the underlying assay analyzer. The double-click functionality also enables the user to configure the device in real-time to operate in a talk-around mode without any additional configuration steps or additional programming of the base metering analyzer by the user. It will be appreciated that instead of or in addition to double-clicking to trigger the auxiliary (non-default) device operating mode, the basal metering analyzer may be provided with instructions to identify other click patterns, such as identifying that the user pressed the button any predetermined number of times, pressed the button in a predetermined pattern, and/or pressed and held the button for a predetermined length of time.

As described above, other examples of barcode usage 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 tests or patient information related to tests performed by the IVD device. Some barcodes may unlock device functionality. Some barcodes may provide or update various types of information used by the device to analyze an assay, determine a test result, or perform a function. For example, the scanned bar code may provide assay or reader calibration information to the reader device that is useful or necessary to perform the test. In embodiments where the device does not have a wireless network connection, the test results may be stored in a memory of the device, and to access the stored test results, the user may scan the cryptographic barcode using a barcode scanner.

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

For purposes of illustration, various embodiments are described below in conjunction with the following figures. It is to be understood that many other embodiments of the disclosed concept are possible and that various advantages can be realized with the disclosed embodiments.

Overview of example assay reader devices and operation

FIG. 1A shows an example set of components for anassay reader system 100. The set of components includes abarcode module 120 and a barcode andconnection module 110 that are lockably insertable into arack 132 of a baseassay reader device 130, and also includes acartridge 140 for holding anassay 144, theassay 144 for insertion into the baseassay reader device 130. FIG. 1B shows an example assembly of a baseassay reader device 130 and abarcode module 120, wherein acartridge 140 is inserted into thecartridge receiving aperture 134 of thereader 130. The components of FIGS. 1A and 1B will be discussed together in the discussion that follows.

The baseassay reader device 130 includes ahousing 132 for lockingly and optionally releasably receiving one of a plurality of different modules, acassette receiving aperture 134, adisplay 136, and asingle button 138. Therack 132 may include both mechanical features for locking engagement with corresponding mechanical features of an inserted module and electrical features for establishing electronic data communication with components of an inserted module. The baseassay reader device 130 can be capable of providing base assay analysis and data storage features without any inserted modules, and inserted modules can be selected and inserted to expand the base features. In embodiments where a module is not inserted, a cover may be provided over the opening of theframe 132. For example, thedevice 130 may be initially provided with a cover and the cover may be removed for insertion into one of the interchangeable modules.

Thecartridge receiving aperture 134 may be sized and shaped to align a test area of an assay with a detector or detector array disposed within thedevice 130 when the assay is inserted through thecartridge receiving aperture 134. For example, if the analyte is a lateral flow assay test strip, the test region may comprise one or more of a control zone and a test zone having an immobilized compound capable of specifically binding (bind) a target analyte. The detector may implement an adaptive reading technique to improve the specificity of the test results and reduce false positive results by compensating for background and non-specific binding. The basicassay reader device 130 can be configured for rapid and accurate assay performance, for example as a digital immunoassay configured for detection of Flu A + B, RSV and group A streptococci in 10 minutes or less. This may facilitate rapid diagnosis and facilitate testing and action methods while the patient is in the office.

Thedisplay 136 of the baseassay reader device 130 may be an LED, LCD, OLED, or other suitable digital display, and may implement touch sensitive technology in some embodiments. Thebutton 138 may be a mechanical button for powering the baseassay reader device 130. As described above, the device may include instructions for identifying the pressing mode of thesingle button 138 in order to select the device operating mode. As discussed in more detail below, thebuttons 138 can provide a user with secure one-touch wireless electronic medical record synchronization when the connection module is inserted into thehousing 132 of the device. For example, a simple single press (or press pattern) of a one-touch button can prepare the basicassay reader device 130, store test result data to the device memory, and transmit the test results to the patient electronic medical record through the connection module. Other embodiments of thedevice 130 may be automatically powered on and ready to be powered on or otherwise powered, and thus thebutton 138 may be omitted. In other embodiments, multiple buttons may be provided on thedevice 130. The assay reader device may also include a processor and at least one memory, as discussed in more detail below. The baseassay reader device 130 can enable data storage and printing.

Thebarcode module 120 includes abarcode scanner 122. Thebarcode scanner 122 may include one or more photodetectors and, optionally, a light-emitting device for reading a barcode. For example, one embodiment of thebarcode scanner 122 may include a light source, a lens for focusing the light source on the object, and a light sensor for receiving light reflected from the object and converting the received light into an electrical signal. Some embodiments of the sensor of thebarcode scanner 122 may include an array of many tiny light sensors such that the voltage pattern produced by the array is substantially the same as the pattern in the barcode. Thebarcode scanner 122 may also include decoder circuitry or software for analyzing the image data provided by the sensor, identifying barcode patterns in the image data, determining content associated with the barcode patterns, and outputting the content to a processor, such as an assay reader device. Thebarcode module 120 may also include mechanical features for lockingly engaging corresponding features within thechassis 132 of the baseassay reader device 130, as well as electronic features for establishing electronic data communication with components of the baseassay reader device 130.

Although not shown, thebarcode module 120 may include information elements, such as memory devices or other active or passive electrical components. The passive information elements may include a network of transistors, PROMs, ROMs, EPROMs, or other programmable memories, EEPROMs or other reprogrammable memories, gate arrays, PLAs, etc. The information element may be used to identify the capabilities of thebarcode module 120 to the assay reader and/or to authenticate the barcode scanning capabilities of thebarcode module 120 as a module from a particular source or manufacturer.

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

With respect to traceability, a hospital, clinic, laboratory or other healthcare organization may have internal standards that specify the type of information(s) that need to be recorded about each test performed in order for the test results to comply with applicable regulations. The barcode scanner may enable a clinician performing the test to input the desired information by scanning the barcode. In some embodiments, the barcode scanning module may be preprogrammed to output a list of the desired types of information associated with each test, or to output a prompt to the user to enter any desired information that has not been scanned before the test results are sent for storage. In some embodiments, a barcode scanning module with connectivity can communicate with a centralized database to provide a list of the types of information needed. The desired type of information can be wirelessly communicated from the centralized database to the base assay reader device and displayed to the user. By using a barcode scanning module to scan one of a plurality of available barcodes provided to a user, the user can enter a desired type of information. Once the barcode associated with the desired type of information has been scanned, the test results can be associated with the entered information and securely, and in some cases automatically and/or wirelessly, sent to a laboratory information system and/or electronic medical record. Thus, test results transmitted to laboratory information systems and/or electronic medical records 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 test results obtained using the methods and systems described herein.

In some embodiments, the basic assay reader device may allow the 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 may be achieved by scanning a configuration barcode which, once decoded by the device, contains instructions for the preset function scanning configuration. In one embodiment, a healthcare facility administrator may initially select one or more barcodes from a set of printed barcodes that correspond to the type of information required for the administrator's desired configuration for a particular reader device; after this initial configuration selection, a user in the medical facility using a particular reader device may scan the appropriate barcode to enter information corresponding to the pre-selected function of the reader device. The reader device may transmit all available information related to the test to the centralized server, for example, through a connection module or a wired connection with another computing device. In one embodiment, compliance may not be mandatory at the reader level and if the end user provides the patient ID by barcode scanning, this information will be transmitted with the test results, otherwise the patient ID field will be left empty. Other embodiments may prompt the end user for missing information. Local data storage, download, and print options can help ensure compliance and traceability if the reader does not have wireless or cellular connectivity.

To illustrate the advantageous customization options by way of one non-limiting example, an administrator in the physician's office may select data categories A, B and C and configure the reader devices in the office to transmit reports including data corresponding to categories A, B and C, while an administrator in the acute care center may select data categories A, B, D and E and configure the reader devices in the center to transmit reports including data corresponding to categories A, B, D and E. The ability to customize reports can significantly reduce management and record retention time. The data obtained may also more often comply with applicable compliance standards because of the reduced chance of introducing human error in the report.

FIG. 6 illustrates example display text that may be presented to an operator of an assay reader device. As described above, embodiments of the systems and methods described herein may allow an end user to customize the type of information to be stored in association with test results on a particular assay reader device, thereby significantly improving compliance and traceability of test results and reducing transcription and documentation errors. In embodiments including wireless or cellular connectivity capabilities, a custom report including test results associated with a selected category of information may be automatically transmitted to a remote server. The top display in the first column of the example display in fig. 6 shows a display of an assay reader device that prompts a user to scan a configuration barcode to associate a particular type of information with a test result or to disable a particular type of information associated with a test result. In this non-limiting example, after reading a "SCAN configuration bar code" prompt, the user SCANs a bar code that instructs the assay reader device to enable the operator ID functionality (if the user wishes to associate operator ID information with the test results and store the operator ID information), or SCANs a bar code that instructs the assay reader device to disable the operator ID functionality (if the user does not wish to associate operator ID information with the test results and store the operator ID information). After the user scans the barcode indicating the user selection, the assay reader device displays text confirming the user selection. In this non-limiting example, the assay reader device displays "OPERATOR ID SCAN ENABLED (OPERATOR ID SCAN ENABLED)" or "OPERATOR ID SCAN DISABLED (OPERATOR ID SCAN disable)" to the user. The assay reader device may then ask the user to enable or disable other types of information functions, such as, but not limited to, sample ID and kit lot ID (see, e.g., the example display test in fig. 6).

With the operator ID function enabled, the assay reader device will now prompt the user to scan the 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" (scan OPERATOR ID) to the user instructing the user to scan a barcode associated with the user's OPERATOR ID. The assay reader device can sequentially query the user for a particular type of information according to the 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 "scan sample ID (scan serial ID)" display in fig. 6). In some cases, the assay reader device will not prompt the user to enter the assay test strip for analysis until all the information needed for a particular configuration setting has been entered. In some cases, the assay reader device may display a summary of the configuration settings (see, e.g., the example display at the top of the middle column in fig. 6).

The customizable reporting functions may be processed on the server side or by one or more remote computing devices that are physically separate from the reader device but receive information from the reader device. For example, test result data and associated information from scanning the barcode may be stored in one or more remote computing devices, such as a database of a server system, and the remote computing devices may generate custom reports having fields of interest only to the end user. End users may include, but are not limited to, users of reader devices, administrators in healthcare facilities using reader devices, and entities and public health organizations that manage remote server systems.

Test results that do not meet the standard (e.g., blank fields with any information required for internal standards or applicable regulations of the healthcare organization) may be flagged in the database. In some examples, statistical analysis may be performed on the non-compliant results to identify common sources of non-compliance, such as, but not limited to, non-compliant test results issued from a particular lot or batch of test strips, non-compliant information transmitted with the test results by a particular healthcare provider or test site, and non-compliant reporting frequencies or other deficiencies. This information may be automatically provided to a healthcare facility administrator in some embodiments to assist in planning increased compliance with compliance standards. Compliance with a specified information type requirement may facilitate more meaningful statistical analysis of compliance with standard test results by standardizing information collected from many different operators, facilities, or healthcare groups, for example, to identify and track infectious disease trends for disease management planning.

The bar code andconnection module 110 also includes abar code reader 112 as described above, as well as additional connection means represented graphically byconnection indicia 114. The connection means may be a wireless communication means, such as a cellular modem, for accessing a publicly provided, publicly maintained data network. The publicly provided network may be a public telephone network, a public cellular network, or another suitable type of publicly available data network. The barcode andconnection module 110 may further include mechanical features for lockingly engaging corresponding features within thehousing 132 of the baseassay reader device 130, as well as electronic features for establishing electronic data communication with components of the baseassay reader device 130. This may reduce administrative burden and overhead, and help reduce or minimize errors associated with manual result documentation and logging.

Although not shown, the barcode andconnectivity module 110 may include information elements as described above. The information element may be used to identify the barcode scan of the barcode andconnection module 110 and the network connectivity of the barcode andconnection module 110 to the assay reader device, and/or to authenticate the barcode andconnection module 110 as a module from a particular source or manufacturer.

The barcode andconnection module 110 may provide all of the functionality and advantages of thebarcode module 120 and additionally provide a cellular or other wireless connection. Such a connection can be used to record test results across multiple sites and integrated with an Electronic Medical Record (EMR) HIS, LIS, and/or other health record database. For example, in some embodiments, test results may 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 may ensure that the results are automatically recorded into the patient record. Further, the automatic transmission of test results may provide real-time alerts to designated medical personnel (e.g., the patient's physician) of the potentially dangerous health condition of the patient, enabling rapid diagnosis and treatment. In addition, automated transmission of test results to public health organizations may enable real-time aggregation and analysis of test result data to identify and possibly suppress infectious disease trends. Such medical information transmission may be performed by compliance with HIPAA, HITECH, ISO 27001: 2013 network security guidelines or other industry standards, and may encrypt the data prior to transmission. A cellular or satellite connection may allow for rapid transmission of test results from locations even outside of standard clinical settings.

Thecartridge 140 can hold theassay 144 for proper alignment within thebase assay reader 130. As shown, thecartridge 140 can include a window for exposing a test area of theassay 144. Theassay 144 can be an immunoassay, for example, implementing colloidal metal particle technology to provide sensitivity and strong assay performance. Theassay 144 may alternatively be a biological assay, a ligand binding assay, or any other type of diagnostic test that can be optically imaged to determine the result of the test. Thecartridge 140 may also include abar code 142 for providing test information, such as a type of test, which may be used in some embodiments to configure an automated process run by thedevice 130 for determining assay results. A user may scan thebarcode 142 of thecassette 140 using a barcode scanner of a module (such as thebarcode module 120 or a barcode scanner of the barcode and connection module 110) lockingly engaged with thebase assay reader 130 as a way to input information to the baseassay reader device 130. Such information may include one or more of patient and/or physician identification information, information related to the assay test, a bar code password used to unlock the functionality of the baseassay reader device 130, and the like.

The baseassay reader device 130 can include one or more additional data communication ports (not shown), such as a USB port. The port may be configured as a generic hardware interface for the underlyingassay reader device 130. Using this interface, theinfrastructure reader device 130 can support external peripheral devices, such as a printer or a keyboard. The port enables the basic assay reader device to be connected to a PC for data download. For example, when a basic assay reader device is connected to a PC through a USB interface, the reader device may function like a USB drive. Furthermore, the end user may update the reader device firmware by connecting a USB drive containing the latest firmware version to the USB port. Furthermore, the USB port provides a convenient way to upload assay calibration data into the reader device, such as batch-specific calibration data.

Although not shown, additional module options may be available, such as connection modules without bar code features, wired connection modules, and modules with power storage features for increasing device battery life, etc. In some embodiments, the module may be or include a printer. In some embodiments, the module may be or include a separate detection unit. Such a test element module can be used to run the same or different type of test as the baseassay reader device 130. In some embodiments, the module may be an incubator for incubating the assay prior to determining the test results. For example, for a lateral flow assay, an incubator module may be used to hold the assay and record development time, and then provide a reminder or indication to the user to remove the cartridge and insert it into the baseassay reader device 130 for reading. For molecular assays, the incubator module can be used for sample preparation and culture.

Referring now to FIG. 2, a schematic diagram of one networked embodiment of asystem 200 is shown. In the illustrated embodiment, arrows between certain devices and public Wide Area Network (WAN)220 orpublic network 230 indicate that such devices are configured to interface in two-way communication via such networks. For example, if the network element shown in fig. 2 is associated with an arrow pointing to the network element and thepublic network 230, the apparatus is configured to transmit data to another apparatus through thepublic network 230 and receive data from another apparatus through thepublic network 230.

Fig. 2 shows an example schematic of apatient care facility 202. Thepatient care facility 202 may represent a patient facility, such as a hospital, doctor's office, or clinic, where one or more diagnostic tests are applied to or administered to a patient. In the illustrated embodiment, thepatient care facility 202 is shown as including or containing a Hospital Information System (HIS) or Laboratory Information System (LIS)database 203. That is, in the illustrated embodiment, thepatient care facility 202 maintains or otherwise provides access to the HIS orLIS database 203. In the illustrated embodiment, the HIS orLIS database 203 is a repository for test results, summary reports, or other data related to patients utilizing thepatient care facility 202. In various embodiments, the HIS orLIS database 203 is additionally coupled with one or more processors (not shown) for performing certain processing tasks, such as analyzing data stored in the HIS orLIS database 203.

In the illustrated embodiment, thepatient care facility 202 also includes a plurality of In Vitro Diagnostic (IVD)devices 204a, 204b, and 204 c. However, as shown by theIVD device 204d, thenetwork environment 200 may 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 may be advantageously used with the disclosed system.

As further shown in fig. 2, eachIVD device 204a, 204b, 204c, and 204d may include anetwork communication device 205a, 205b, 205c, or 205d, respectively. For example, thenetwork communication devices 205a, 205b, 205c, and 205d may be provided by a pluggable accessory module that includes a cellular modem or another transceiver device configured to communicate with, for example, the publicwide area network 220 or thepublic network 230. In one embodiment, thenetwork communication devices 205a, 205b, 205c, and 205d enable the respective IVD devices to communicate with each other, or with another network element, as disclosed herein. Further, in one embodiment, thenetwork communication devices 205a, 205b, 205c, and 205d enable the respective IVD devices to communicate data indicative of the diagnostic test results to a remote resource, such as the HIS orLIS database 203, for storage and/or further analysis. Although not shown, some IVD devices may be equipped with a barcode scanner module, such asbarcode module 120, without a network connection. The results stored by such a device may be uploaded to one or more of the HIS/LIS, patient computer, or another computing device, for example, via a USB connection and an appropriate scanned bar code password, for transmission over thenetwork 230, 220.

Thesystem 200 of fig. 2 indicates byarrow 221 that the patient care facility 202 (and the IVD device/HIS or LIS database contained therein) is configured to communicate via the publicwide area network 220. In one embodiment, one or more of publicwide area network 220 andpublic network 230 at least partially restricts access to the network. Further, in one embodiment, the disclosedsystem 200 enables communication between patient care facilities through encryption or other secure data transfer protocols, as described herein.

Thesystem 200 also includes apatient computer 206, ahealth agency computer 208, aninsurance provider computer 210, and adevice manufacturer computer 212. Each of these network elements is capable of communicating with each other and with thepatient care facility 202 via the commonwide area network 220, as indicated byarrows 222, 223, 224, and 225, respectively.Arrow 226 indicates that the publicwide area network 220 may communicate with another type ofpublic network 220, such as the internet. Thus, the devices shown in fig. 2 are configured to communicate with each other via a publicwide area network 220, apublic network 230, or some combination thereof.

In the illustrated embodiment, each of the computers enables different parties to communicate with thedevice manufacturer computer 212 and theIVD devices 204a, 204b, 204c and the HIS orLIS database 203. For example, thepatient computer 206 enables the patient to communicate with thedevice manufacturer computer 212, the healthcare facility computer 208 enables one or more health care facilities to communicate with thepatient care facility 202, theinsurance provider computer 210 enables the insurance provider to communicate with thepatient care facility 202, and thedevice manufacturer computer 212 enables the manufacturer of the IVD device to communicate with thepatient care facility 202. Thedevice manufacturer computer 212 may enable theIVD devices 204a, 204b, 204c, and 204d to communicate with a data server 212a coupled to thedevice manufacturer computer 212 to receive, among other things, necessary data, such as calibration data, firmware, or other software and data upgrades, as the need arises.

In various embodiments,system 200 enables the transmission and exchange of data including test results and additional data sent with the test results. For example, as described above, data transmitted between the various network elements ofsystem 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 illustratedsystem 200 is encrypted to prevent undesired access to the transmitted data. In addition to protecting the data from interception and undesired consumption, the 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 transmitted data is received.

In one embodiment, thepatient computer 206, the healthcare facility computer 208, theinsurance provider computer 210, and thedevice manufacturer computer 212 are standard desktop or laptop computers accessible by the appropriate parties. In another embodiment, one or more of thepatient computer 206, the healthcare facility computer 208, theinsurance provider computer 210, and thedevice manufacturer computer 212 are mainframe or server computers configured to process large amounts of data and/or provide sophisticated processing and analysis programs. In this embodiment, depending on the purpose of the user's access, some or all of the data uploaded from the IVD device and stored within the system may be accessible by the appropriate entity responsible for the computer device shown (e.g., the insurance company responsible for the insurance provider computer). In another embodiment, one or more of thepatient computer 206, the healthcare facility computer 208, theinsurance provider computer 210, and thedevice manufacturer computer 212 are portable computers, such as Personal Digital Assistants (PDAs) or cellular telephones, configured to enable a user to access data from a handheld portable device. In one embodiment, not shown, one or more medical professionals (such as healthcare personnel equipping the patient care facility 202) use a suitable handheld device (such as a PDA, cell phone, or other handheld portable device) to access data communicated through theIVD devices 204a, 204b, 204c, and 204 d. In this embodiment, the appropriate health care personnel can immediately access or actively learn the patient data when analyzing the patient sample through a diagnostic test using the IVD device. It should be understood that in various embodiments, entities other than the network elements shown in fig. 2 may be able to access data uploaded by the IVD device as needed to perform the respective tasks of these entities.

In one embodiment, the IVD device is configured to upload data to one or more database servers, as described above. The database server may 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 may 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 server through the disclosed connection module results in many advantages of the disclosed system. First, the patient care facility may obtain test results from a database server over a secure Internet or other network connection and store the retrieved results in their own database (e.g., their own HIS or LIS database). Furthermore, aggregated test reports available as a result of processing database servers are valuable to public health agencies like the CDC, FDA and WHO. Such reports may be provided in real-time due to the ability of the disclosed IVD device to communicate diagnostic test result data directly and automatically to a database server.

FIG. 3 illustrates a schematic block diagram of one possible embodiment of the internal components of an example assay reader device 300. The components may include a processor 310 linked to and in electronic communication with a memory 315, a workingmemory 355, a cartridge reader 335, amodule interface 345, and a display 350.

Module interface 345 may include circuitry for reading information from the information element of the inserted module and communicating that information to processor 310 for analysis or verification. Thus, themodule interface 345 may provide a first signal path that may be used by the apparatus 300 to identify a characteristic of the connection module that indicates the presence of the barcode scanner in the connection module, as well as the connectivity capabilities of the connection module.Module interface 345 may also include a path for establishing electronic communication with a bar code reader, a network transceiver, a power supply, or other electronic components plugged into the module. Accordingly, themodule interface 345 may provide a second signal path 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.

The cartridge reader 335 may include one ormore photodetectors 340 for reading the assay held in the inserted cartridge and optionally any information about the inserted cartridge, such as a bar code printed on the cartridge. The cartridge reader 335 may transmit image data from the one or more photodetectors to the processor 310 for analysis of the image data representing the imaged assay to determine a test result for the assay. The cassette reader 335 may also transmit image data from one or more photodetectors representing the imaged cassette for use in determining which of a plurality of automated processes to implement for imaging and/or analyzing the image data of the assay. Photodetector(s) 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, among others. The cartridge reader 335 may also include components for detecting cartridge insertion, such as mechanical buttons, electromagnetic sensors, or other cartridge sensing devices. The indication from this component may instruct the processor 310 to begin the automated assay reading process without any further input or instruction from the user of the device 300.

The processor 310 may be configured to perform various processing operations on image data received from the cartridge reader 335 and/or themodule interface 345 in order to determine and store test result data, as will be described in more detail below. Processor 310 may be a general purpose processing unit that performs assay analysis functions or a processor specifically designed for assay imaging and analysis applications. The processor 310 may be a microcontroller, microprocessor, ASIC, or the like, and in some embodiments may include multiple processors.

As shown, the processor 310 is connected to a memory 315 and a workingmemory 355. In the illustrated embodiment, the memory 315 stores amodule identification component 320, a testresult determination component 325, adata communication component 330, and a test data store 305. These modules include instructions that configure the processor 310 of the device 300 to perform various module interface, image processing, and device management tasks. Workingmemory 355 may be used by processor 310 to store a working set of processor instructions contained in the modules of memory 315. Alternatively, workingmemory 355 may also be used by processor 310 to store dynamic data created during operation of device 300.

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

Thedata communication component 330 may determine whether a module has been inserted into a device that enables wireless data transmission and may manage transmission of test result data to certain personnel and/or remote databases. For example, the test result data transmission may be based on bar code data received with the assay image, where the assay image is used to generate and store in association with the test result, and where the bar code data is further stored in association with the test result. If apparatus 300 is not coupled with a network communication enabled module,data communications component 330 may cause the test results and associated information to be stored locally in test data store 305. If a local wired or wireless connection is established between the device 300 and another computing device (e.g., a hospital, clinician, or patient computer), thedata communication component 330 may prompt the user of the device 300 to scan a cryptographic barcode using the inserted module in order to access the data in the repository 305.

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

The processor 310 may write data, such as data representing a captured image of a barcode and an assay, instructions or information associated with the imaged barcode, and determined test results to the data repository 305. Although data store 305 is represented graphically as a conventional disk device, one skilled in the art will appreciate that data store 305 may be configured as any storage media device. For example, the data store 305 may include a magnetic 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 store 305 can also include a plurality of memory units, and any of the memory units can be configured to be within the assay reader device 300, or can be external to the device 300. For example, the data store 305 may include a ROM memory containing system program instructions stored within the assay reader device 300. The data store 305 may also include a memory card or high speed memory configured to store captured images that may be removed from the apparatus 300.

While fig. 3 shows the device with separate components to include the processor, the cartridge reader, the module interface, and the memory, those skilled in the art will recognize that these separate components may be combined in various ways to achieve specific design goals. For example, in alternative embodiments, memory components may be combined with processor components to save cost and improve performance.

Additionally, although FIG. 3 shows a number of memory components, including memory 315 comprising several modules and aseparate memory 355 comprising a working memory, one skilled in the art will recognize several embodiments utilizing different memory architectures. For example, a design may utilize ROM or static RAM memory to store processor instructions to implement the modules contained in memory 315. The processor instructions may be loaded into RAM to facilitate execution by the processor 310. For example, workingmemory 355 may include RAM memory, wherein instructions are loaded into workingmemory 355 prior to execution by processor 310.

FIG. 4 is a flow chart describing an exampleoperational procedure 400 for the assay reader device disclosed herein. In some embodiments, theprocess 400 may be implemented by theassay reader device 130 and/or the processor 310.

Atblock 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.

Atblock 410, the processor may identify whether a module is inserted into the chassis 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 bar code scanning and network connectivity including cellular or satellite network connectivity.

Atdecision block 415, the processor 310 may identify whether the inserted module capabilities include barcode scanning or barcode scanning and network connectivity.

If the inserted module capability includes a barcode scan,process 400 may pass to block 420 to receive input via the barcode scanner of the inserted module. Such input may include information for storing in association with the test results and/or information configuring operation of the assay reader device, such as instructions regarding an imaging procedure for acquiring image data of an inserted assay. In some embodiments, device operation may be configured via a button press mode as described above. Atblock 425, theprocess 400 may include receiving an assay test retention cartridge in a receiving well within an assay reader device, imaging the assay, and determining a test result based on image data representing the assay.Block 425 may be implemented as any of the disclosed reader operating modes, such as, but not limited to, an endpoint reading mode or a stand-alone mode. Atblock 430, the processor 310 may display and locally store the test results and any associated data.

Atdecision block 435, the processor may determine whether additional tests are to be performed, for example, by receiving an indication that an additional barcode has been scanned (by looping back to block 420) or that an additional cartridge has been inserted (by looping back to block 425). In this case, the process may loop back throughblocks 420 and 430 in the order shown or by switchingblocks 420 and 425.

If the inserted module capabilities include barcode scanning and network connectivity, theprocess 400 may pass to block 440 to receive input via the barcode scanner of the inserted module. Such inputs may include information for storing in association with the test results and/or information configuring the operation of the assay reader device, such as instructions regarding the imaging process used to acquire image data of the inserted assay, or instructions regarding the location where the test result data should be transmitted. In some embodiments, device operation may be configured via a button press mode as described above. At block 445, theprocess 400 may include receiving an assay test retention cartridge in a receiving well within an assay reader device, imaging the assay, and determining a test result based on image data representing the assay. Block 445 may be implemented as any of the disclosed reader modes of operation, such as an endpoint read mode or a talk-around mode.

Atblock 450, the processor 310 may display and locally store the test results along with any associated data, such as the assay image used to generate the test results and additional information provided via the scanned bar code. Additionally or alternatively, the processor 310 may display and transmit the test results and optionally any associated data to a destination database or contact via a network. For example, in some embodiments, this may be accomplished by theconnection module 110 being inserted into and in electronic communication with the baseassay reader device 130.

Atdecision block 455, the processor may determine whether additional tests are to be performed, for example, by receiving an indication that an additional barcode has been scanned (by looping back to block 440) or that an additional cassette 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 switchingblocks 440 and 445.

If, atblocks 435 or 455, the processor 310 determines that no additional tests are to be performed (e.g., by measuring inactivity of any sensors of the reader device), the process 300 may proceed to block 460. Atblock 460, the processor 310 may wait a predetermined period of time before powering down the assay reader device.

Fig. 5A illustrates an example hospital workflow for a wireless point of care testing solution. As shown, samples are collected and test results are provided at the point of care. Embodiments of the reader devices described herein can provide test results in ten minutes or less. Subsequently, to provide a manual documentation of the results, the results are manually recorded in a log and then manually entered into a laboratory information system or electronic medical record. After entering the results into a 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 document to complete before reviewing the test results and providing care to the patient.

Fig. 5B illustrates an example hospital workflow implementing a streamlined workflow with the disclosed assay reader device providing a wireless point of care testing solution. As shown, samples are collected and test results are provided at the point of care. Embodiments of reader devices including network communication enabled modules described herein may provide test results in ten minutes or less. From a care perspective, the results will be automatically transmitted directly to a laboratory information system or electronic medical record over a network. The transmitted results are immediately available to the physician at the point-of-care through a laboratory information system or electronic medical record, thereby facilitating accelerated patient care. In this workflow, the physician is able to access the patient's test results while the patient is still at the office, without having to wait for manual documentation of the test results, thereby enabling faster treatment of the patient.

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, thereby providing an extensible platform to meet the growing demands of healthcare groups. The basic assay reader device may incorporate other test platforms and instruments through the modular receiving rack. Furthermore, a single assay reader device can be used for multiple functions by interchangeable modules. In one example, a health service provider can purchase and use a basic assay reader device without any of the modules described. As providers expand their capabilities, require increased functionality, or additional procurement resources become available, the provider may purchase one or more modules as needed to meet their particular needs. These modules can be inserted into the base assay reader device in order to quickly and easily extend the functionality of the device without requiring any modification to the previously obtained base assay reader device. As another example, a health service provider may purchase a kit with a base assay reader device and one or more modules, and then may develop a new barcode scanner module with additional functionality. The provider can purchase a new bar code scanner whenever needed and still use the previously acquired basic assay reader device with the old module changed to the new module. In another example, the barcode scanner or some other component in the module may malfunction or be interrupted. When the first bar code scanner is repaired, the spare part may be used with the base assay reader device.

An additional advantage of the disclosed basic assay reader device with a network connection module is that integration with a single access point of an electronic medical record and laboratory information system provides test results quickly, enabling decision making while the patient is on-site. Such automated documentation may facilitate accelerated patient care by accelerating physician access to test results, which may be provided to the physician almost immediately after completion of the test, regardless of the test location. The disclosed basic assay reader device with a barcode scanning module reduces transcription errors compared to systems that require manual entry of identification information.

Implementation System and terminology

Embodiments disclosed herein provide systems, methods, and apparatus for a modular reconfigurable assay reader. Those skilled in the art will recognize that these embodiments may be implemented in hardware or a combination of hardware and software and/or firmware.

The assay reader device may include one or more image sensors, one or more image signal processors, and memory including instructions or modules for performing the above-described processes. The device may also have a processor for data, loading instructions and/or data from 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 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.

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 processor. By way of example, and not limitation, such media can comprise 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 desired program code in the form of instructions or data structures and that can be accessed by a computer. Disk (disk) or disc (disc), as used herein, includes Compact Disc (CD), laser disc, optical disc, Digital Versatile Disc (DVD), floppy disk and blu-ray disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers. It should be noted that computer-readable media can be tangible and non-transitory. The term "computer program product" refers to a computing device or processor in combination with code or instructions (e.g., a "program") that may be executed, processed, or computed by the computing device or processor. As used herein, the term "code" may refer to software, instructions, code or data that is executable by a computing device or processor.

The various illustrative logical blocks and modules described in connection with the embodiments disclosed herein may be implemented or performed with 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. A general purpose processor may be a microprocessor, but in the alternative, the processor may be a controller, microcontroller, or state machine, combinations of these, or the like. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described primarily herein with respect to digital techniques, 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 organizer, a device controller, and a computing engine within an appliance, and the like.

The methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and/or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is required for proper operation of the method being described, the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims.

It should be noted that the term "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 can be indirectly connected to the second component or directly connected to the second component. The term "plurality", as used herein, means two or more. For example, a plurality of components means two or more components.

The term "determining" encompasses a wide variety of actions and, thus, "determining" can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining (ascertain), and the like. Further, "determining" can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Further, "determining" may include resolving, selecting, choosing, establishing, and the like. The phrase "based on" does not mean "based only on," unless expressly specified otherwise. In other words, the phrase "based on" describes both the meaning of "based only on" and "based at least on".

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the 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.

Further, the present disclosure includes embodiments according to the following embodiments:

embodiment 1. a diagnostic test system, comprising:

a sensor configured to detect a change in an optical characteristic of an assay after application of a biological sample to the assay;

a first module having connection capability to connect to a remote storage device, the first module comprising one or more photodetectors for scanning the pattern and circuitry for decoding data associated with the pattern;

a second module comprising one or more photodetectors for scanning the pattern and circuitry for decoding data associated with the pattern;

a module interface, comprising: a chassis configured to interchangeably receive and lockingly engage a first module and a second module, the module interface further comprising a first signal path configured to identify characteristics of the modules engaged in the chassis and a second signal path configured to receive decoded data from the modules engaged in the chassis;

at least one processor; and

a memory having instructions stored thereon that configure the at least one processor to:

determining a test result based at least in part on the change in the optical characteristic detected by the sensor, determining patient information based on the decoded data,

the connectivity of modules engaged in the chassis is determined,

automatically transmitting test results associated with the patient information to a remote storage device in response to determining that the module engaged in the rack is the first module, an

In response to determining that the module engaged in the rack is the second module, automatically storing in the memory test results associated with the patient information.

Embodiment 2. the diagnostic test system of embodiment 1, further comprising a sensor or a cartridge holding the assay, the sensor positioned to detect additional information about the assay, wherein the at least one processor is configured to use the additional information to establish the operating parameters of the diagnostic test system.

Embodiment 3. the diagnostic test system of embodiment 1, further comprising a sensor or a cartridge holding the assay, the sensor positioned to detect additional information about the assay, wherein the at least one processor is configured to store the additional information in association with the test results.

Embodiment 4. the diagnostic test system of embodiment 1, wherein the first module and the second module comprise a bar code scanner.

Embodiment 5 the diagnostic test system of embodiment 1, wherein the first module comprises a cellular modem configured to provide connectivity capability.

Embodiment 6. the diagnostic test system of embodiment 1, wherein the one or more photodetectors and circuitry comprise a barcode scanner, and wherein the characteristics of the modules engaged in the rack comprise characteristics indicative of the presence of the barcode scanner in the module and the connectivity capabilities of the module.

An embodiment 7. a non-transitory computer-readable medium configured with computer-executable instructions that, when executed, cause a hardware processor to:

identifying a characteristic of a connection module inserted into a chassis of an assay reader device, and a connectivity capability of the connection module, the characteristic indicating a presence of a barcode scanner in the connection module;

receiving assay image data from an assay reading image sensor of an assay reader device, the assay image data representing a detected change in an optical characteristic of an assay inserted into or positioned proximate to the assay reader device;

determining a test result based at least in part on analyzing the assay image data;

determining a connection capability of the connection module based on the identified characteristic;

automatically sending the test results to a remote storage device in response to determining that the connection module has a connection capability with the remote storage device physically separate from the assay reader device; and

automatically storing the test results in a memory of the assay reader device in response to determining that the connection module does not have connection capability with the remote storage device.

Embodiment 8. a non-transitory computer readable medium according to embodiment 7, further having instructions stored thereon that, when executed, cause a hardware processor to:

receiving barcode image data representing at least one barcode from a connection module;

identifying at least one barcode as an instruction barcode based on the analysis of the barcode image data; and

an instruction associated with the instruction barcode is retrieved.

Embodiment 9. a non-transitory computer readable medium according to embodiment 8, further having instructions stored thereon that, when executed, cause a hardware processor to determine a test result based at least in part on the instructions.

Embodiment 10 a non-transitory computer readable medium according to embodiment 8, further having instructions stored thereon that, when executed, cause a hardware processor to instruct an assay reading image sensor to obtain assay image data at a predetermined timing after inserting an assay into an assay reader device based at least in part on the instructions.

Embodiment 11. a non-transitory computer readable medium according to embodiment 7, further having instructions stored thereon that, when executed, cause a hardware processor to:

receiving barcode image data representing at least one barcode from a connection module;

identifying at least one barcode as an identifying barcode based on the analysis of the barcode image data;

determining information represented by the identifying barcode;

automatically sending information represented by the identification barcode to the remote storage device along with the test results in response to determining that the connection module has a connection capability with the remote storage device physically separate from the assay reader device; and

in response to determining that the connection module does not have the connection capability with the remote storage device, information represented by the identification barcode is automatically stored in a memory of the assay reader device along with the test results.

Embodiment 12. a diagnostic test procedure, comprising, by one or more hardware processors:

identifying a characteristic of a connection module inserted into a chassis of an assay reader device, and a connectivity capability of the connection module, the characteristic indicating a presence of a barcode scanner in the connection module;

receiving assay image data from an assay reading image sensor of an assay reader device, the assay image data representing a detected change in an optical characteristic of an assay inserted into or positioned proximate to the assay reader device;

determining a test result based at least in part on analyzing the assay image data;

determining a connection capability of the connection module based on the identified characteristic;

automatically sending the test results to a remote storage device in response to determining that the connection module has a connection capability with the remote storage device physically separate from the assay reader device; and

automatically storing the test results in a memory of the assay reader device in response to determining that the connection module does not have connection capability with the remote storage device.

Embodiment 13. the method according to embodiment 12, further comprising:

receiving barcode image data representing at least one barcode from a connection module;

identifying at least one barcode as an instruction barcode based on the analysis of the barcode image data; and

an instruction associated with the instruction barcode is retrieved.

Embodiment 14 the method of embodiment 13, further comprising determining a test result based at least in part on the instruction.

Embodiment 15 the method of embodiment 13, further comprising instructing, based at least in part on the instructions, the assay reading image sensor to obtain assay image data at a predetermined timing after inserting the assay into the assay reader device.

Embodiment 16. the method according to embodiment 12, further comprising:

receiving barcode image data representing at least one barcode from a connection module;

identifying at least one barcode as an identifying barcode based on the analysis of the barcode image data; and

information represented by the identification barcode is determined.

Embodiment 17. the method of embodiment 16, further comprising:

automatically transmitting information represented by the identification barcode to the remote storage device along with the test results in response to determining that the connection module has a connection capability with the remote storage device physically separate from the assay reader device; and

in response to determining that the connection module does not have the connection capability with the remote storage device, information represented by the identification barcode is automatically stored in a memory of the assay reader device along with the test results.

Embodiment 18. the method of embodiment 16, further comprising automatically sending instructions to route test results from the remote storage device to another remote storage device in response to determining that the connection module has connection capability with the remote storage device physically separate from the assay reader device, the another remote storage device identified based on the information represented by the identification barcode.

Embodiment 19. the method of embodiment 16, further comprising automatically transmitting the test results to a clinician's personal computing device in response to determining that the connection module has connection capability with a remote storage device physically separate from the assay reader device, identifying the clinician based on the information represented by the identification barcode.

This written description uses examples to disclose various embodiments, including the best mode, and also to enable any person skilled in the art to practice the various embodiments, including making and using any devices or systems and performing any incorporated methods. The patentable scope of various embodiments is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.

Claims (5)

1. An assay reader system, comprising:

a barcode and connection module with barcode scanning and network connectivity, the barcode and connection module having a first mechanical feature and a first electronic feature;

a barcode module having the barcode scanning capability and not having the network connectivity capability, the barcode module having a second mechanical feature and a second electronic feature;

an assay reader device, comprising:

a cartridge receiving aperture sized and shaped to align a test area of an assay with a detector or detector array provided within the assay reading device; and

a rack configured to lockingly receive the bar code and connection module or the bar code module, the rack including a third mechanical feature for lockingly mating with the first mechanical feature of the bar code and connection module or the second mechanical feature of the bar code module when the bar code and connection module or the bar code module is inserted, the rack further including an electrical feature for establishing electronic data communication with the first electronic feature of the bar code and connection module or the second electronic feature of the bar code module when the bar code and connection module or the bar code module is inserted.

2. The assay reader system of claim 1, further comprising a sensor positioned to detect additional information about the assay or a cartridge holding the assay.

3. The assay reader system of claim 1, wherein the housing and the cartridge receiving aperture are located on different surfaces of the assay reader device.

4. The assay reader system of claim 1, further comprising a removable cover disposed over an opening in the rack when neither the barcode and connection module nor the barcode module is inserted into the rack.

5. The assay reader system of claim 1, wherein the barcode and connection module and each of the barcode module comprise a barcode scanner.

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