Patent Issued for In-Vitro Diagnostic Device Using External Information In Conjunction With Test Results (USPTO 10,458,972)

2019 NOV 11 (NewsRx) -- By a News Reporter-Staff News Editor at Hospital & Nursing Home Daily -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Hengstler, Stephan (Campbell, CA); Xie, Tong (San Jose, CA), filed on December 16, 2016, was published online on November 11, 2019.

The patent’s assignee for patent number 10,458,972 is Alverix Inc. (Franklin Lakes, New Jersey, United States).

News editors obtained the following quote from the background information supplied by the inventors: “Presently available in-vitro diagnostic (IVD) devices are used in various medical settings to detect the presence of numerous types of biological conditions, such as the presence of infection antibodies, quickly and reliably. Known IVD devices are used in hospitals, clinics, doctors’ offices, and other patient care facilities to enable rapid detection and identification of potentially harmful conditions in patients presenting at these facilities.

“One type of IVD device is configured to read or otherwise analyze lateral flow assays, which can test for a wide variety of medical and environmental conditions or compounds. For example, lateral flow tests can rely on a form of immunoassay in which the test sample flows along a solid substrate via capillary action. Known IVD devices can read lateral flow assay strips to detect the existence of a hormone, metabolite, toxin, or pathogen-derived antigen. This reading can be accomplished with the use of an imager, such as a CMOS imager or a CCD-based imaging device, which is configured to detect the presence or absence of a line on the lateral flow assay based on the presence or absence of a visual line on the assay. Some tests, implemented by IVD devices, are designed to make a quantitative determination, but in many circumstances the tests are designed to return or indicate a positive/negative qualitative indication. Examples of assays that enable such qualitative analysis include blood typing, most types of urinalysis, pregnancy tests, and AIDS tests.

“Certain known IVD devices (including known assay test strip reader devices) are configured to report, store, and/or transmit diagnostic information determined solely resulting from a diagnostic test and not provided by a source external to the IVD device. That is, certain known IVD devices are configured to report, store, or transmit information related to the infection or other condition tested for, as well as to report, store, or transmit additional information manually entered by patient care personnel assisting in the use of the IVD devices. Some IVD devices are provided as stand-alone devices--that is, they perform infection detection by autonomously following a pre-programmed decision-making process or rule. For each test performed by such an IVD device, the same process is undertaken, and a result is generated in the same way. Moreover, in known IVD devices, a built-in or integrated display is used to display the results of the test, and the results may also be printed using a built-in or attached printer.

“Many known IVD devices are not configured to send or receive data to or from any source external to the IVD device. In such devices, the only output enabled by the IVD devices is to display the results of a test on an integrated display. Certain other known IVD devices are configured to exchange data with another device, remote from the IVD device, through a short-range wired or wireless connection. For example, known IVD devices may exchange data with another device through a USB, serial, or proprietary wired connection, or through a Bluetooth, Wireless USB, or proprietary wireless connection. Finally, certain known IVD devices are configured to connect to a local area network (e.g., LAN) through a wired (e.g., Ethernet) or wireless (e.g., WiFi or ZigBee) connection.

“Known IVD devices suffer from many drawbacks. First, known IVD devices suffer from drawbacks in that any data used by known IVD devices to generate outcomes or test results must either be determined by the device as a part of the analysis of the test results, or must be manually entered by medical personnel or other users of the IVD device. This manual entry is frequently limited, and involves the use of a keyboard or a barcode scanner. Even if such data is manually entered, known IVD devices suffer from drawbacks in that the correctness of the entered data is questionable, and in fact may be in jeopardy, depending upon the mechanism for entering data and/or the care given to the correct entry of data by the user of the IVD device. Finally, known IVD devices suffer from drawbacks in that they are limited to receiving and utilizing only that data and/or information known to the individual entering the information into the device. Other information (such as information obtainable from medical or other databases or information repositories, or from a device manufacturer) is not available for use by the IVD device in generating its results.

“Further, known IVD devices suffer from drawbacks in that the limited connectivity options provided with such IVD devices prevents the devices from forming ad-hoc networks and connecting directly to other IVD devices or network elements. To the extent that network capabilities are provided, data generated by IVD devices is limited to transmission within a given patient care facility. Moreover, a patient care facility which enables connection of IVD devices to a network must operate an appropriate LAN or other network, and must provide infrastructure for integrating and maintaining IVD devices within the network, both of which can be costly endeavors. Finally, even with known network-enabled IVD devices, manual interaction is required to access the test results generated by an IVD device and to store it electronically in an appropriate medical facility database. For example, manual intervention is required in known IVD devices to upload data indicative of an outcome of a diagnostic test from an IVD device and store it in an appropriate Hospital Information System (HIS) or Laboratory Information System (LIS) database.

“Known IVD devices do not provide a mechanism to enable near-patient testing results to be provided to a centralized server for analysis, aggregation, and distribution using an established public network, such as a public telephone network. Moreover, known IVD devices do not provide a mechanism by which a centralized server can track, manage, and determine characteristics of those IVD devices to ensure appropriate use of the devices and appropriate use of environmental data detected by the IVD devices.

“Thus, it is desirable to create IVD devices that are configured to receive and store data from sources external to the individuals utilizing the IVD devices, in addition to data currently gathered by known IVD devices, and to utilize the data received from external sources to supplement the analysis capabilities of the IVD device, such as by confirming or verifying part of the diagnostic information generated by the IVD device. It is further desirable to create IVD devices that are network-ready, such that the devices can connect to a network (such as the Internet) and obtain external data independent from the actual test being performed. It is also desirable to create an IVD device that is capable of sending or uploading data to a remote repository via a network, such that data about the tests performed with such IVD devices can be stored and analyzed, alone or in the aggregate, by remote devices or personnel. Finally, it is desirable to provide an IVD device that includes a built-in mechanism for accessing publicly available networks, such as telephone or cellular networks, to enable direct communication by the IVD device 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 IVD device.”

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors’ summary information for this patent: “The present disclosure relates to a system, method, and apparatus for providing enhanced results of known diagnostic tests by augmenting the information used to generate the results of such tests.

“The disclosed system facilitates the transmission of information following the collection of that information in diagnostic examination, such as diagnostic information collected using diagnostic instruments or tests. The disclosed system advantageously focuses on the transmission of information to individuals that most need that information, as opposed to simply focusing on the collection of that information. For example, when one or more diagnostic tests are performed outside of a laboratory or other medical environment, the disclosed system enables the transmission of the results of those diagnostic tests to devices and/or users that consume the data, such as by analyzing or storing the data in a database.

“Furthermore, the disclosed system advantageously enables laboratories and other medical facilities that lack the requisite information transmission infrastructure to transmit data to appropriate, necessary consumers. Thus, for example, if a relatively rural laboratory or facility does not contain network infrastructure, the disclosed system nonetheless enables that laboratory or facility to transmit information to an end-user for analysis, storage, or other consumption. In various embodiments, discussed below, the disclosed system enables this functionality by relying on publicly accessible, established data transmission networks, such as cellular telephone networks.

“In various embodiments, however, the disclosed system facilitates transmission of results from a testing site (such as from a testing device) to a private, centralized server. The server may then distribute the information it has received as appropriate, such as by distributing the information to testing centers, primary care physicians, individuals, insurance companies, or other appropriate recipients of the data. In one embodiment, the centralized server performs at least some aggregation and/or analysis of the data prior to distribution. For example, if a patient has a cardio-monitor in his or her home, the data from the cardio-monitor may be transmitted to the server via a public cellular infrastructure, and the central server may then aggregate the data for submission to the individual’s primary care physician once a week.

“In some embodiments, the server performs additional functions. For example, the server may apply rules to data, may encrypt and/or decrypt data, may track transmitting devices (including the environmental conditions of those transmitting devices), may maintain a registry of devices, and may perform other tasks as appropriate and as discussed in more detail below.

“For example, in a known in-vitro diagnostic (IVD) device, the instant disclosure relates to a mechanism by which the standard, conventional test results are enhanced or expanded by providing the IVD device with additional information or data from which to determine test results, or to store in association with the test results to enable in-depth analysis of the test results. This additional information may be automatically received from a network or other external source, and may be used to aid in confirmation and verification of the diagnostic information generated by the IVD device. In the event the data is received from a network or external source, the IVD device in one embodiment may include a device, such as a cellular modem, to enable the IVD device to connect with a publicly available and publicly maintained data network, such as a public telephone or cellular network. Alternatively or in addition, diagnostic test data obtained by the IVD device can be tagged with hardware and/or environmental information to enable accurate analysis and aggregation of data based on tests performed with or by the IVD device. For example, the diagnostic test data can be tagged with device quality data, device lifetime data, environmental temperature data, and the like.

“In an embodiment of the disclosed system, a diagnostic data generation device, such as an IVD device, is configured to generate a test result or other diagnostic data based on a biological sample. For example, an IVD device is configured to analyze the results of a lateral flow assay test by analyzing whether certain reactions occur along the length of a lateral flow assay test strip when the strip is brought into contact with a biological sample. In addition to the biological sample (and the data obtainable therefrom), the disclosed IVD device is configured to receive additional information, from which additional conclusions and/or analyses can be drawn with regard to the test. Examples of this additional information usable by an IVD device as disclosed herein include diagnostic information specific to the IVD device or the test itself, network information relating to the network to which the IVD device is connected, environmental data about the environment in which the IVD device was created, stored, or used, or other suitable additional information to enable augmentation of the test results generated by the IVD device.

“In one embodiment, the additional information is provided automatically (i.e., without a user of the IVD device requesting it) via a network connection. In one such embodiment, each IVD device includes a device, such as a cellular modem, for accessing a publicly provided, publicly maintained data network. The publicly provided network could be a public telephone network, a public cellular network, or another suitable kind of publicly available data network. In one embodiment, the disclosed IVD device is configured to receive additional information via a network, such as a Local Area Network or a cellular network, and is further configured to use this additional information to generate further or more detailed test results. This additional information may relate to the specifics of the network to which the IVD device is connected (e.g., the IP address of the IVD device on the network), or may relate to specific characteristics of the IVD device on which the diagnostic data was generated (e.g., the storage temperature of the IVD device). Alternatively, the additional information usable by the IVD device to augment or enhance its test results may be input by the user of the IVD device and/or by a health care professional or other individual remote from the IVD device.

“Upon receiving the additional information, the IVD device of one embodiment is configured to utilize the received information in combination with the diagnostic information generated by the IVD device itself. Hardware and environmental information may be used to ensure quality and integrity of the diagnostic test result. For example, the IVD device may utilize data about the temperature at which it was stored to validate or confirm the results of the performed diagnostic test. Alternatively or in addition, the disclosed IVD device may upload or otherwise provide both the data indicative of the diagnostic test result and the additional information to a remote network element, such as a Hospital Information System (HIS), a Laboratory Information System (LIS), or over an ad-hoc network to another IVD device for aggregation and further analysis, as discussed in detail below. This sharing of data via publicly maintained data networks enables known IVD devices to provide accurate results, enables the disclosed system to perform analyses on aggregations of real-time data from a plurality of IVD devices, enables IVD devices to be calibrated on-the-fly, and enables tests themselves to be calibrated or enhanced based on real-time results, thus advantageously enhancing the effectiveness of tests enabled by such IVD devices and the utility of data generated by such IVD devices.

“It should thus be appreciated that one embodiment of the disclosed system and methods enable IVD devices to obtain and utilize independent and additional data to further augment the results of tests performed by the IVD devices. This additional data may be external to the test itself and/or to the facility at which the test is performed, and may be provided to the IVD device via a network or based on the environment of the IVD device. The external data may be advantageously used for many purposes, including complementing or confirming the diagnostic information generated by the IVD device.

“It should be further appreciated that one embodiment of the disclosed system and methods enable IVD devices to connect to certain network infrastructure elements over one or more publicly provided data networks, such as a cellular network, using a built-in connection device. Such network connectivity enables IVD devices to automatically communicate diagnostic test data, as well as additional data determined by the IVD device itself or via the connection to the data network, to certain network elements for aggregation, analysis, and reporting. This augmented set of data further enables IVD devices themselves, as well as criteria and protocols for performing tests, to be updated on-the-fly, and enables real-time analysis of large sets of IVD data.

“Additional features and advantages are described herein, and will be apparent from, the following Detailed Description.”

The claims supplied by the inventors are:

“The invention is claimed as follows:

“1. A diagnostic test analysis system comprising an in vitro-diagnostic device, the in vitro-diagnostic device comprising: at least one processor; at least one display device; at least one input device; and at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one input device and the at least one display device to: enable a local user of a diagnostic test to provide a biological sample, determine a first result of the diagnostic test based on the biological sample, the first result indicating at least the presence or absence of a condition, receive a set of additional data via a network connection, the set of additional data indicative of a characteristic of the diagnostic test not determinable based on the biological sample; alter the first result of the diagnostic test based, at least in part, on the additional data, to generate an altered first result, the altered first result having an improved accuracy relative to the first result of the diagnostic test, and display the altered first result of the diagnostic test to the local user.

“2. The diagnostic test analysis system of claim 1, wherein the plurality of instructions cause the at least one processor to alter the first result of the diagnostic test by re-calibrating the diagnostic test based on the received set of additional data.

“3. The diagnostic test analysis system of claim 2, wherein the received set of additional data comprises configuration data, and wherein the plurality of instructions cause the at least one processor to determine the altered first result as a more precise result than the first result based on the configuration data.

“4. The diagnostic test analysis system of claim 1, further comprising a sensor positioned to optically detect a change in a characteristic of an assay test device, wherein the plurality of instructions cause the at least one processor to determine the first result of the diagnostic test based on data from the sensor indicating the change in the characteristic of the assay test device.

“5. The diagnostic test analysis system of claim 1, further comprising a sensor positioned to detect the presence or absence of one or more lines on a lateral flow assay test strip following application of the biological sample to the lateral flow assay test strip, wherein the plurality of instructions cause the at least one processor to determine the first result of the diagnostic test based on data from the sensor indicating the presence of absence of the one or more lines.

“6. The diagnostic test analysis system of claim 5, wherein the received set of additional data comprises calibration data, and wherein the plurality of instructions cause the at least one processor to use the calibration data to: determine an intensity of the one or more lines; and alter the first result of the diagnostic test based on the determined intensity.

“7. The diagnostic test analysis system of claim 6, wherein the plurality of instructions cause the at least one processor to determine a severity of a condition based on the intensity of the one or more lines.

“8. The diagnostic test analysis system of claim 1, further comprising at least one network communication device configured to provide the network connection by enabling a telemetric connection over a publicly accessible network.

“9. The diagnostic test analysis system of claim 8, wherein the plurality of instructions cause the at least one processor to automatically transmit the altered test result to a remote network element via the telemetric connection.

“10. The diagnostic test analysis system of claim 8, wherein the publicly accessible network is a cellular data network, and wherein the at least one network communication device includes a cellular modem.

“11. The diagnostic test analysis system of claim 1, wherein the set of additional data comprises hardware data or environmental data associated with the in vitro-diagnostic device.

“12. A diagnostic test analysis method comprising: receiving data from a sensor within a patient care facility positioned to detect the presence or absence of one or more lines on a lateral flow assay test strip following application of a biological sample to the lateral flow assay test strip; determining a first result of a diagnostic test associated with the sensor based on data from the sensor indicating the presence or absence of the one or more lines; receiving a set of additional data via a network connection, the additional data comprising hardware data or environmental data associated with the patient care facility and indicative of a characteristic of the diagnostic test not determinable based on the data from the sensor; altering the first result of the diagnostic test based, at least in part, on the additional data, to generate an altered first result, the altered first result having an improved accuracy relative to the first result of the diagnostic test, and outputting the altered first result of the diagnostic test for display to a user.

“13. The diagnostic test analysis method of claim 12, performed by at least one processor in communication with at least one memory device storing a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to perform the method.

“14. The diagnostic test analysis method of claim 12, further comprising altering the first result of the diagnostic test by re-calibrating the diagnostic test based on the additional data.

“15. The diagnostic test analysis method of claim 12, further comprising combining the additional data with the first result to generate the altered first result.

“16. The diagnostic test analysis method of claim 12, further comprising: determining an intensity of the one or more lines; and altering the first result of the diagnostic test based on the determined intensity.

“17. The diagnostic test analysis method of claim 16, further comprising determining a severity of a condition based on the intensity of the one or more lines.

“18. The diagnostic test analysis method of claim 17, wherein the determining the first result comprises determining a presence of the condition based on a presence of the one or more lines, and wherein the altered test result comprises the severity of the condition.

“19. The diagnostic test analysis method of claim 12, further comprising automatically transmitting the altered test result to a remote network element via a telemetric connection.

“20. The diagnostic test analysis method of claim 12, further comprising receiving the additional data automatically without a request from the user.

“21. The diagnostic test analysis method of claim 12, wherein an in vitro-diagnostic device comprises the sensor and wherein the first test result comprises a voltage detected by the sensor, the method further comprising: providing the voltage to another device in an ad-hoc network with the in vitro-diagnostic device; receiving the additional data as an analysis of the voltage from the another device; and determining the altered first result as a valid test result in the absence of correct functioning of the in vitro-diagnostic device.”

For additional information on this patent, see: Hengstler, Stephan; Xie, Tong. In-Vitro Diagnostic Device Using External Information In Conjunction With Test Results. U.S. Patent Number 10,458,972, filed December 16, 2016, and published online on November 11, 2019. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10,458,972.PN.&OS=PN/10,458,972RS=PN/10,458,972

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