METHOD

Field of the Invention The present invention relates to the field of diagnostic testing and more particularly to a computer-implemented method and non-transitory computer-readable memory for test result analysis and a device for use with the method.

Background of the Invention

Point-of-care testing (POCT) is becoming increasingly popular and has widespread application including, for example, testing for fertility, infectious diseases, thyroid levels, diabetes and cholesterol.

Whilst various test kits have been designed to test for presence, absence or various levels of biomarkers, reading of test results is usually manually performed which leaves room for error. Accordingly, it would be desirable to provide a computer-implemented method for test result analysis.

Summary of the Invention

Accordingly, in a first aspect, the present invention provides a computer- implemented method for test result analysis. The method includes executing on one or more processors the steps of: obtaining an image having a grayscale section and a test result section; extracting a plurality of grayscale intensities from the grayscale section of the image; generating a calibration curve with the extracted grayscale intensities; calculating an offset of the calibration curve from a reference standard stored in a database; extracting a colour code from the test result section of the image; calibrating the extracted colour code with the offset to determine an actual colour code of the test result section of the image; and converting the actual colour code into a clinical reading. In a second aspect, the present invention provides a non-transitory computer- readable memory storing computer program instructions executable by a computer processor to perform operations for test result analysis. The operations include: obtaining an image having a grayscale section and a test result section; extracting a plurality of grayscale intensities from the grayscale section of the image; generating a calibration curve with the extracted grayscale intensities; calculating an offset of the calibration curve from a reference standard stored in a database; extracting a colour code from the test result section of the image; calibrating the extracted colour code with the offset to determine an actual colour code of the test result section of the image; and converting the actual colour code into a clinical reading.

In a third aspect, the present invention provides a device for use with the computer-implemented method for test result analysis according to the first aspect. The device includes a substrate and the grayscale section on a surface of the substrate.

Other aspects and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the invention.

Brief Description of the Drawings

Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

FIGS. 1A through 1 E are schematic top plan views illustrating devices for use with a computer-implemented method for test result analysis in accordance with embodiments of the present invention;

FIG. 2 is a schematic flow diagram illustrating the computer-implemented method for test result analysis in accordance with an embodiment of the present invention;

FIG. 3 is a graph illustrating a step of calculating an offset of a calibration curve from a reference standard; and FIG. 4 is a schematic block diagram illustrating a computer system suitable for implementing the method for test result analysis disclosed herein and for use with the cards disclosed herein.

Detailed Description of Exemplary Embodiments

The detailed description set forth below in connection with the appended drawings is intended as a description of presently preferred embodiments of the invention, and is not intended to represent the only forms in which the present invention may be practiced. It is to be understood that the same or equivalent functions may be accomplished by different embodiments that are intended to be encompassed within the scope of the invention.

Referring now to FIGS. 1 A through 1 E, devices in the form of cards 10A, 10B and 10C, a test strip 12 and a cassette 14 for use with a computer-implemented method for test result analysis are shown. Each of the cards 10A, 10B and 10C, the test strip 12 and the cassette 14 includes a substrate 16 and a grayscale section 18 on a surface of the substrate 16.

As can be seen from FIGS. 1A through 1 E, each of the grayscale sections 18 includes different grayscale intensities and the different grayscale intensities may be provided as discrete regions as shown, for example, in FIG. 1 A or as a grayscale spectrum as shown, for example, in FIG. 1 B. The grayscale sections 18 may be provided on cards 10A, 10B and 10C packaged and provided with test kits as shown in FIGS. 1A through 1C or directly on the test strip 12 or the cassette 14 as shown in FIGS. 1 D and 1 E, respectively.

Each of the devices 10A, 10B, 10C, 12 and 14 may include an identifier 20 on the surface of the substrate 16 to provide test kit information. As shown in the embodiments, the identifier 20 may be in the form of a unique Quick Response (QR) code. The QR code may be a running serial number and may provide one or more of product information (for example, manufacturer, model, etc.), an expiration date and a lot number. Although illustrated as being in the form of QR codes, it should be appreciated by persons of ordinary skill in the art that the present invention is not limited by the form of the identifier 20 shown. For example, in an alternative embodiment, the identifier 20 may be in the form of a barcode.

In embodiments shown in FIGS. 1A through 1C, each of the cards 10A, 10B and 10C includes a receiving area 22 on the surface of the substrate 16 for receiving a test result 24. The test result 24 of a rapid test kit may be placed on the receiving area 22 for analysis. As can be seen from FIGS. 1 B and 1C, the test result 18 may be in the form of a test strip or a cassette. Advantageously, as the cards 10A, 10B and 10C are compatible with a wide variety of rapid test kits including, for example, strip, cassette and paper type test kits, the cards 10A, 10B and 10C may serve as a universal color card for numerous different types of rapid test kits.

Flaving described various devices for test result analysis, a computer- implemented method 30 for test result analysis using the devices will now be described below with reference to FIGS. 2 and 3.

Referring now to FIG. 2, the computer-implemented method 30 for test result analysis is shown. The method 30 may be executed on one or more processors of a computing device such as, for example, a mobile communications device.

The method begins at step 32 by obtaining information on the test result to be analysed. This information may be obtained by scanning the identifier 20 on the card 10A, 10B or 10C, the test strip 12 or the cassette 14. The information on the test result may be retrieved from a database after scanning the identifier 20. In embodiments where the information on the test result includes an expiration date, the expiration date may be used to check if a test kit has expired. The information on the test result may also be used to limit the number of uses of the cards 10A, 10B and 10C.

At step 34, an image having a grayscale section 18 and a test result section is obtained. The image having the grayscale section 18 and the test result section may be captured by taking a picture of the card 10A, 10B or 10C, the test strip 12 or the cassette 14 with a camera.

At step 36, a plurality of grayscale intensities is extracted from the grayscale section 18 of the image. The grayscale section in the image may be located before extracting the grayscale intensities from the grayscale section 18. This may involve retrieving dimensional information on the grayscale section 18 from the database, and locating a boundary of the grayscale section 18 based on the retrieved dimensional information before extracting the grayscale intensities from the grayscale section.

Between two (2) and ten (10) different grayscale intensities may be extracted from the grayscale section. The different grayscale intensities may be distributed across a grayscale spectrum. For example, in a 0 - 100 colour model system, the following values may be extracted: 20, 40, 60 and 80. As further examples, in a 0 - 255 colour model system, the following sets of values may be extracted: 50, 100, 150 and 200, or 51 , 128 and 205.

A calibration curve is generated at step 38 with the extracted grayscale intensities. The step 38 of generating the calibration curve with the extracted grayscale intensities may include fitting the extracted grayscale intensities into a curve to generate the calibration curve as shown in FIG. 3.

At step 40, an offset of the calibration curve from a reference standard stored in a database is calculated. This may be by comparing the calibration curve to the reference standard, fitting the calibration curve to the reference standard, and then determining the offset based on a difference between the calibration curve and the reference standard.

At step 42, a colour code is extracted from the test result section of the image. To increase processing efficiency, the test result section may be located in the image, and irrelevant portions of the test result section in the image may be cropped away before extracting the colour code from the test result section of the image.

The extracted colour code is calibrated at step 44 with the offset to determine an actual colour code of the test result section of the image. This may be by applying the offset to the extracted colour code to compensate for colour code variations due to lighting conditions (for example, brightness and colour temperature), and then calculating the actual colour code of the test result section of the image.

At step 46, the actual colour code is converted into a clinical reading. This may be by mapping the actual colour code to a clinical value according to a calibrated chart. The calibrated chart provides information on a relationship between colour intensity and concentration and helps relate a visual reading to a clinical reading. Data for the calibrated chart may be provided by a test kit manufacturer. The calibrated chart may be pre-stored in the database.

Computer program instructions executable by a computer processor to perform operations for test result analysis described above may be stored in non-transitory computer-readable memory.

Referring now to FIG. 4, a computer system 100 suitable for use with the cards 10A, 10B and 10C described above and for implementing the method 30 for test result analysis is shown. The computer system 100 includes a processor 102 (which may be referred to as a central processor unit or CPU) that is in communication with memory devices including secondary storage 104, read only memory (ROM) 106, random access memory (RAM) 108, input/output (I/O) devices 110, and network connectivity devices 112. The processor 102 may be implemented as one or more CPU chips.

It is understood that by programming and/or loading executable instructions onto the computer system 100, at least one of the CPU 102, the RAM 108, and the ROM 106 are changed, transforming the computer system 100 in part into a particular machine or apparatus having the novel functionality taught by the present disclosure. It is fundamental to the electrical engineering and software engineering arts that functionality that can be implemented by loading executable software into a computer can be converted to a hardware implementation by well-known design rules. Decisions between implementing a concept in software versus hardware typically hinge on considerations of stability of the design and numbers of units to be produced rather than any issues involved in translating from the software domain to the hardware domain. Generally, a design that is still subject to frequent change may be preferred to be implemented in software, because re-spinning a hardware implementation is more expensive than re spinning a software design. Generally, a design that is stable that will be produced in large volume may be preferred to be implemented in hardware, for example in an application specific integrated circuit (ASIC), because for large production runs the hardware implementation may be less expensive than the software implementation. Often a design may be developed and tested in a software form and later transformed, by well-known design rules, to an equivalent hardware implementation in an application specific integrated circuit that hardwires the instructions of the software. In the same manner as a machine controlled by a new ASIC is a particular machine or apparatus, likewise a computer that has been programmed and/or loaded with executable instructions may be viewed as a particular machine or apparatus.

Additionally, after the system 100 is turned on or booted, the CPU 102 may execute a computer program or application. For example, the CPU 102 may execute software or firmware stored in the ROM 106 or stored in the RAM 108. In some cases, on boot and/or when the application is initiated, the CPU 102 may copy the application or portions of the application from the secondary storage 104 to the RAM 108 or to memory space within the CPU 102 itself, and the CPU 102 may then execute instructions that the application is comprised of. In some cases, the CPU 102 may copy the application or portions of the application from memory accessed via the network connectivity devices 112 or via the I/O devices 110 to the RAM 108 or to memory space within the CPU 102, and the CPU 102 may then execute instructions that the application is comprised of. During execution, an application may load instructions into the CPU 102, for example load some of the instructions of the application into a cache of the CPU 102. In some contexts, an application that is executed may be said to configure the CPU 102 to do something, for example, to configure the CPU 102 to perform the function or functions promoted by the subject application. When the CPU 102 is configured in this way by the application, the CPU 102 becomes a specific purpose computer or a specific purpose machine.

The secondary storage 104 is typically comprised of one or more disk drives or tape drives and is used for non-volatile storage of data and as an over-flow data storage device if RAM 108 is not large enough to hold all working data. Secondary storage 104 may be used to store programs which are loaded into RAM 108 when such programs are selected for execution. The ROM 106 is used to store instructions and perhaps data which are read during program execution. ROM 106 is a non-volatile memory device which typically has a small memory capacity relative to the larger memory capacity of secondary storage 104. The RAM 108 is used to store volatile data and perhaps to store instructions. Access to both ROM 106 and RAM 108 is typically faster than to secondary storage 104. The secondary storage 104, the RAM 108, and/or the ROM 106 may be referred to in some contexts as computer readable storage media and/or non-transitory computer readable media. I/O devices 110 may include cameras, printers, video monitors, liquid crystal displays (LCDs), plasma displays, touch screen displays, keyboards, keypads, switches, dials, mice, track balls, voice recognizers, card readers, paper tape readers, or other well-known input devices. The network connectivity devices 112 may take the form of modems, modem banks, Ethernet cards, universal serial bus (USB) interface cards, serial interfaces, token ring cards, fiber distributed data interface (FDDI) cards, wireless local area network (WLAN) cards, radio transceiver cards that promote radio communications using protocols such as code division multiple access (CDMA), global system for mobile communications (GSM), long-term evolution (LTE), worldwide interoperability for microwave access (WiMAX), near field communications (NFC), radio frequency identity (RFID), and/or other air interface protocol radio transceiver cards, and other well-known network devices. These network connectivity devices 112 may enable the processor 102 to communicate with the Internet or one or more intranets. With such a network connection, it is contemplated that the processor 102 might receive information from the network, or might output information to the network in the course of performing the above-described method steps. Such information, which is often represented as a sequence of instructions to be executed using processor 102, may be received from and outputted to the network, for example, in the form of a computer data signal embodied in a carrier wave. Such information, which may include data or instructions to be executed using processor 102 for example, may be received from and outputted to the network, for example, in the form of a computer data baseband signal or signal embodied in a carrier wave. The baseband signal or signal embedded in the carrier wave, or other types of signals currently used or hereafter developed, may be generated according to several methods well-known to one skilled in the art. The baseband signal and/or signal embedded in the carrier wave may be referred to in some contexts as a transitory signal.

The processor 102 executes instructions, codes, computer programs, scripts which it accesses from hard disk, floppy disk, optical disk (these various disk based systems may all be considered secondary storage 104), flash drive, ROM 106, RAM 108, or the network connectivity devices 112. While only one processor 102 is shown, multiple processors may be present. Thus, while instructions may be discussed as executed by a processor, the instructions may be executed simultaneously, serially, or otherwise executed by one or multiple processors. Instructions, codes, computer programs, scripts, and/or data that may be accessed from the secondary storage 104, for example, hard drives, floppy disks, optical disks, and/or other device, the ROM 106, and/or the RAM 108 may be referred to in some contexts as non-transitory instructions and/or non- transitory information.

In an embodiment, the computer system 100 may comprise two or more computers in communication with each other that collaborate to perform a task. For example, but not by way of limitation, an application may be partitioned in such a way as to permit concurrent and/or parallel processing of the instructions of the application. Alternatively, the data processed by the application may be partitioned in such a way as to permit concurrent and/or parallel processing of different portions of a data set by the two or more computers. In an embodiment, virtualization software may be employed by the computer system 100 to provide the functionality of a number of servers that is not directly bound to the number of computers in the computer system 100. For example, virtualization software may provide twenty virtual servers on four physical computers. In an embodiment, the functionality disclosed above may be provided by executing the application and/or applications in a cloud computing environment. Cloud computing may comprise providing computing services via a network connection using dynamically scalable computing resources. Cloud computing may be supported, at least in part, by virtualization software. A cloud computing environment may be established by an enterprise and/or may be hired on an as-needed basis from a third party provider. Some cloud computing environments may comprise cloud computing resources owned and operated by the enterprise as well as cloud computing resources hired and/or leased from a third party provider.

In an embodiment, some or all of the functionality disclosed above may be provided as a computer program product. The computer program product may comprise one or more computer readable storage medium having computer usable program code embodied therein to implement the functionality disclosed above. The computer program product may comprise data structures, executable instructions, and other computer usable program code. The computer program product may be embodied in removable computer storage media and/or non-removable computer storage media. The removable computer readable storage medium may comprise, without limitation, a paper tape, a magnetic tape, magnetic disk, an optical disk, a solid state memory chip, for example analog magnetic tape, compact disk read only memory (CD-ROM) disks, floppy disks, jump drives, digital cards, multimedia cards, and others. The computer program product may be suitable for loading, by the computer system 100, at least portions of the contents of the computer program product to the secondary storage 104, to the ROM 106, to the RAM 108, and/or to other non-volatile memory and volatile memory of the computer system 100. The processor 102 may process the executable instructions and/or data structures in part by directly accessing the computer program product, for example by reading from a CD-ROM disk inserted into a disk drive peripheral of the computer system 100. Alternatively, the processor 102 may process the executable instructions and/or data structures by remotely accessing the computer program product, for example by downloading the executable instructions and/or data structures from a remote server through the network connectivity devices 112. The computer program product may comprise instructions that promote the loading and/or copying of data, data structures, files, and/or executable instructions to the secondary storage 104, to the ROM 106, to the RAM 108, and/or to other non-volatile memory and volatile memory of the computer system 100.

In some contexts, the secondary storage 104, the ROM 106, and the RAM 108 may be referred to as a non-transitory computer readable medium or a computer readable storage media. A dynamic RAM embodiment of the RAM 108, likewise, may be referred to as a non-transitory computer readable medium in that while the dynamic RAM receives electrical power and is operated in accordance with its design, for example during a period of time during which the computer system 100 is turned on and operational, the dynamic RAM stores information that is written to it. Similarly, the processor 102 may comprise an internal RAM, an internal ROM, a cache memory, and/or other internal non-transitory storage blocks, sections, or components that may be referred to in some contexts as non-transitory computer readable media or computer readable storage media.

As is evident from the foregoing discussion, the present invention provides a computer-implemented method for test result analysis that compensates for environmental lighting factors and thereby generates more accurate readings. Further advantageously, the present invention is easy to use, does not require any additional equipment and can easily be adapted for use with a wide variety of existing rapid test kits.

While preferred embodiments of the invention have been illustrated and described, it will be clear that the invention is not limited to the described embodiments only. Numerous modifications, changes, variations, substitutions and equivalents will be apparent to those skilled in the art without departing from the scope of the invention as described in the claims.

Further, unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising" and the like are to be construed in an inclusive as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".