OA17359A

OA17359A - Immunoassay rapid diagnostic test universal analysis device, system, method and computer readable medium.

Info

Publication number: OA17359A
Application number: OA1201500023
Authority: OA
Inventors: Qing Xiang; Jeongjin Lee
Original assignee: Fio Corporation
Priority date: 2012-07-24
Filing date: 2013-07-24
Publication date: 2016-09-21

Abstract

A device, system, method, and computer readable medium is provided for universal analysis of immunoassay rapid diagnostic tests. They permit different tests, from varied manufacturers, to be read even though such tests may be associated with reflection and/or emission types of signals. The device, system, method, and computer readable medium use one or more rapid diagnostic test databases, including information on products commercially available on the market and on customized rapid tests. The device, system, method, and computer readable medium identify the type of test to be analyzed by matching it with the test database(s). They capture a corresponding reflection and/or emission signal from the test, as appropriate. The device, system, method, and computer readable medium may transform the signal to an image, or vice-versa, and/or analyze the image to interpret the test result.

Description

[0001] The présent invention relates generally to an rapid diagnostic test analysis device and method, and more particulariy to an immunoassay rapid diagnostic test universal analysis device, System, method and computer readable medium.

BACKGROUND OF THE INVENTION [0002] In the prior art, the rapid immunoassay diagnostic test may hâve achieved great commercial application in many fields - potentially including, for example, in association with pregnancy tests, infectious disease tests, oncology tests, cardiovascular disease tests, animal health tests, and/or tests related to foods and the environment, etc. One of the most successful examples may be ail kinds of latéral flow immunoassay tests.

[0003] Usually, latéral flow types of rapid tests may hâve been visually interpreted by end users. Such visual interprétation by end users may hâve been subject to inconsistency and/or human interférence. There may be a trend to using devices to analyze the results of such tests. There may be a number of US patents and/or published US patent applications which may hâve disclosed methods and/or devices to automatically analyze latéral flow tests. There may be a great amount of diversity in the various prior art latéral flow cassettes, whether by application, manufacture, and/or signal format. It may hâve been almost impossible for a device to read more than one type of these products. Typically, prior art devices for reading latéral flow tests may hâve been adapted to read just one spécifie latéral flow product and/or test.

[0004] Even were it not so, prior art devices may hâve been adapted to just read only a single type of test - i.e., either reflection signais (e.g., from a colloïdal gold and/or colored latex bead type of test) or émission signal (e.g., from a fluorescence type of test).

[0005] Furthermore, prior art devices manufactured by any particular company may hâve been adapted just to read test products which were also manufactured by that particular company. In order to read a different product, such devices would hâve needed to be customized and/or reconfigured based on différences in physical appearance, détection areas, control lines and test line positions in the various products. Such an endeavor might hâve been highly unlikely to hâve been performed, if at ail.

-1 17359 [0006] The présent invention may preferably, but need not necessarily, provide a method, System and/or device to universally analyze various immunoassay rapid diagnostic tests.

[0007] The présent invention may preferably address, mitigate, alleviate, and/or overcome one or more of the aforementioned disadvantages, shortcomings, problems and/or other issues associated with the prior art, and/or to achieve one or more of the aforementioned objects of the invention.

SUMMARY OF THE INVENTION [0008] According to the invention, there is disclosed a device for analysis of various test cassettes for immunoassay rapid diagnostic tests. The device includes one or more walls defining an enclosed chamber, which is adapted to selectively receive the various cassettes one at a time, each as a loaded cassette, in selectively removable relation. The device also includes two or more light emitting diodes (LEDs) within the chamber, which include at least one reflection light emitting diode (LED) adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit. The device also includes an imaging element inside the chamber, which automatically captures a first image of the loaded cassette when at least one of the LEDs is lit. The device also includes at least one processor which, with reference to the first image and to a database that comprises at least one test protocol associated with each of the various test cassettes, automatically identifies an applicable test protocol for the loaded cassette. The processor automatically, after incubation of the loaded cassette and/or depending on the applicable test protocol: (i) détermines when the first image captures a post-incubation test signal from the loaded cartridge; and/or otherwise (ii) lights the fluorescent LED to generate the test signal by émission, and/or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses the imaging element to capture a second image of the loaded cassette and of the test signal. The processor automatically provides the test signal, in the first image and/or the second image, for analysis of the loaded cassette.

[0009] According to an aspect of one preferred embodiment of the invention, the processor may preferably, but need not necessarily, automatically analyze the test signal, preferably with reference to the applicable test protocol for the loaded cassette.

[0010] According to an aspect of one preferred embodiment of the invention, the test signal may preferably, but need not necessarily, include a test line signal, preferably

-217359 corresponding to a test line, preferably présent on the loaded cassette after incubation. The processor may preferably, but need not necessarily, automatically measure an intensity of the test line signal.

[0011] According to an aspect of one preferred embodiment of the invention, the test signal may preferably, but need not necessarily, include a control line signal, preferably corresponding to a control line, preferably présent on the loaded cassette after incubation. The processor may preferably, but need not necessarily, automatically measure an intensity of the control line signal.

[0012] According to an aspect of one preferred embodiment of the invention, the applicable test protocol may preferably, but need not necessarily, include a predetermined assay threshold value. The processor may preferably, but need not necessarily, analyze the test signal, preferably with reference to the assay threshold value and/or to automatically détermine a diagnostic test resuit associated with the loaded cassette.

[0013] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include an output device which may preferably, but need not necessarily, automatically présent the diagnostic test resuit to a user of the device.

[0014] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include a memory onboard the device which may preferably, but need not necessarily, store one or more sets of exécutable instructions, preferably to encode the processor and/or to automatically analyze the test signal as aforesaid.

[0015] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include a memory onboard the device which may preferably, but need not necessarily, store one or more sets of exécutable instructions, preferably to encode the processor and/or to automatically identify the applicable test protocol as aforesaid.

[0016] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include a memory onboard the device which may preferably, but need not necessarily, store the database.

[0017] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include a communications element

-317359 onboard the device which the processor may preferably, but need not necessarily, automatically use to remotely reference the database, preferably as aforesaid.

[0018] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include at least one optical filter. The processor may preferably, but need not necessarily, automatically ensure the optical filter is moved to an engaged position, preferably between the loaded cassette and the imaging element and/or preferably before lighting a corresponding émission LED. The imaging element may preferably, but need not necessarily, then capture the test signal through the optical filter. The processor may preferably, but need not necessarily, automatically ensure the optical filter is moved to a disengaged position, preferably clear of the imaging element and/or preferably before lighting the reflection LED. The imaging element may preferably, but need not necessarily, then capture the test signal clear of the optical filter.

[0019] According to an aspect of one preferred embodiment of the invention, the optical filter may preferably, but need not necessarily, be mounted on a sliding switch which may preferably, but need not necessarily, slide the optical filter, preferably between the engaged position and the disengaged position.

[0020] According to an aspect of one preferred embodiment of the invention, the optical filter may preferably, but need not necessarily, be mounted on a rotatable mechanism which may preferably, but need not necessarily, rotate the optical filter, preferably between the engaged position and the disengaged position.

[0021] According to an aspect of one preferred embodiment of the invention, the optical filter may preferably, but need not necessarily, be an optical band pass filter.

[0022] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include an optical long pass filter, preferably positioned between the loaded cassette and the imaging element. The imaging element may preferably, but need not necessarily, capture the test signal through the optical long pass filter.

[0023] According to an aspect of one preferred embodiment of the invention, the aforesaid at least one reflection LED may preferably, but need not necessarily, include at least one white LED.

[0024] According to an aspect of one preferred embodiment of the invention, the aforesaid at least one fluorescent LED may preferably, but need not necessarily, include at least one ultraviolet LED.

-417359 [0025] According to an aspect of one preferred embodiment of the invention, the aforesaid at least one fluorescent LED may preferably, but need not necessarily, include at least one colored LED.

[0026] According to an aspect of one preferred embodiment of the invention, the processor may preferably, but need not necessarily, identify the applicable test protocol, preferably with reference to one or more of the following which may preferably, but need not necessarily, be captured in the first image and/or the second image, and/or stored in the database for the loaded cassette: one or more cassette dimensions; one or more cassette shapes; one or more détection line dimensions; one or more control line dimensions; one or more détection areas; one or more membrane areas; one or more control line positions; one or more test line positions; one or more cassette colors; one or more line colors; manufacturer indicia; product indicia; brand name indicia; application indicia; disease indicia; test type indicia; incubation time indicia; expected results indicia; barcodes; twodimensional barcodes; labels; and/or other printed and written indicia.

[0027] According to an aspect of one preferred embodiment of the invention, the processor may preferably, but need not necessarily, additionally identify the applicable test protocol, preferably with reference to one or more of the following which may preferably, but need not necessarily, be received by the device from the loaded cassette in the first image, in the second image and/or otherwise, and/or stored in the database for the loaded cassette: magnetically stored data, fluorescence data, and/or radioactive signal data.

[0028] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, be adapted for analysis of various latéral flow cassettes, preferably as the test cassettes.

[0029] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, be adapted for use with a cellular téléphoné which may preferably, but need not necessarily, provide at least one of the imaging element and the processor.

[0030] According to an aspect of one preferred embodiment of the invention, left and/or right channel audio signais, preferably from the cellular téléphoné, may preferably, but need not necessarily, be adapted to turn the reflection LED and/or the fluorescent LED on and/or off.

-517359 [0031] According to an aspect of one preferred embodîment of the invention, the imaging element may preferably, but need not necessarily, include one or more scanning heads.

[0032] According to the invention, there is also disclosed a System for analysis of various test cassettes for immunoassay rapid diagnostic tests. The System includes one or more walls defining an enclosed chamber, which is adapted to selectively receive the various cassettes one at a time, each as a loaded cassette, in selectively removable relation. The System also includes two or more light emitting diodes (LEDs) within the chamber, which include at least one reflection light emitting diode (LED) adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit. The System also includes a database, which includes at least one test protocol associated with each of the various test cassettes. The System also includes a cellular téléphoné received by the walls of the chamber. The cellular téléphoné includes: a caméra inside the chamber which automatically captures a first image of the loaded cassette when at least one of the LEDs is lit; and at least one processor which, with reference to the first image and in communication with the database, automatically identifies an applicable test protocol for the loaded cassette. The processor automatically, after incubation of the loaded cassette and/or depending on the applicable test protocol: (i) détermines when the first image captures a post-incubation test signal from the loaded cartridge; and/or otherwise (ii) lights the fluorescent LED to generate the test signal by émission, and/or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses the imaging element to capture a second image of the loaded cassette and of the test signal. The processor automatically provides the test signal, in the first image and/or the second image, for analysis of the loaded cassette.

[0033] According to an aspect of one preferred embodîment of the invention, left and/or right channel audio signais, preferably from the cellular téléphoné, may preferably, but need not necessarily, be adapted to turn the reflection LED and/or the fluorescent LED on and/or off.

[0034] According to the invention, there is also disclosed a method for analysis of various test cassettes for immunoassay rapid diagnostic tests. The method includes a receiving step of selectively receiving the various cassettes one at a time, each as a loaded cassette, in selectively removable relation within an enclosed chamber which is defined by one or more walls. The method also includes a light emitting diode (LED) step of

-617359 providing two or more LEDs within the chamber, which include at least one reflection LED adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit. The method also includes an imaging step of automatically capturing a first image of the loaded cassette, when at least one of the LEDs is lit, using an imaging element inside the chamber. The method also includes a database step of providing a database, which includes at least one test protocol associated with each of the various test cassettes. The method also includes a processing step of using at least one processor, with reference to the first image and to the database, automatically identifying an applicable test protocol for the loaded cassette. In the processing step, the processor automatically, after incubation of the loaded cassette and/or depending on the applicable one said test protocol: (i) détermines when the first image captures a post-incubation test signal from the loaded cartridge; and/or otherwise (ii) lights the fluorescent LED to generate the test signal by émission, and/or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses the imaging element to capture a second image of the loaded cassette and of the test signal. In the processing step, the processor automatically provides the test signal, in the first image and/or the second image, for analysis of the loaded cassette.

[0035] According to an aspect of one preferred embodiment of the invention, preferably in the processing step, the processor may preferably, but need not necessarily, automatically analyze the test signal, preferably with reference to the applicable test protocol for the loaded cassette.

[0036] According to an aspect of one preferred embodiment of the invention, preferably in the processing step, the test signal may preferably, but need not necessarily, include a test line signal, preferably corresponding to a test line, preferably présent on the loaded cassette after incubation. The processor may preferably, but need not necessarily, automatically measure an intensity of the test line signal.

[0037] According to an aspect of one preferred embodiment of the invention, in the processing step, the test signal comprises a control line signal a test line signal, preferably corresponding to a control line, preferably présent on the loaded cassette after incubation. The processor may preferably, but need not necessarily, automatically measure an intensity of the control line signal.

[0038] According to an aspect of one preferred embodiment of the invention, in the processing step, the applicable test protocol may preferably, but need not necessarily,

-717359 include a predetermined assay threshold value. The processor may preferably, but need not necessarily, analyze the test signal, preferably with reference to the assay threshold value and/or preferably to automatically détermine a diagnostic test resuit and/or preferably associated with the loaded cassette.

[0039] According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, include a présentation step, wherein the diagnostic test resuit may preferably, but need not necessarily, be automatically presented, preferably using an output device.

[0040] According to an aspect of one preferred embodiment of the invention, preferably before the processing step, one or more sets of exécutable instructions may preferably, but need not necessarily, be stored in a memory. Preferably in the processing step, the exécutable instructions may preferably, but need not necessarily, encode the processor, preferably to automatically analyze the test signal as aforesaid.

[0041] According to an aspect of one preferred embodiment of the invention, preferably before the processing step, one or more sets of exécutable instructions may preferably, but need not necessarily, be stored in a memory. Preferably in the processing step, the exécutable instructions may preferably, but need not necessarily, encode the processor, preferably to automatically identify the applicable test protocol as aforesaid.

[0042] According to an aspect of one preferred embodiment of the invention, preferably in the processing step, the processor may preferably, but need not necessarily, automatically use a communications element, preferably to remotely reference the database, preferably as aforesaid.

[0043] According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a filtering step of providing at least one optical filter. Preferably in the processing step, (i) the processor may preferably automatically ensure the optical filter may preferably, but need not necessarily, be moved to an engaged position, preferably between the loaded cassette and the imaging element and/or preferably before lighting a corresponding émission LED. The imaging element may preferably, but need not necessarily, then capture the test signal through the optical filter. And/or, preferably in the processing step, (ii) the processor may preferably automatically ensure the optical filter may preferably, but need not necessarily, be moved to a disengaged position, preferably clear of the imaging element and/or preferably before

-817359 lighting the reflection LED. The imaging element may preferably, but need not necessarily, then capture the test signal clear of the optical filter.

[0044] According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a filtering step of providing an optical long pass filter, preferably positioned between the loaded cassette and the imaging element. In the processing step, the imaging element may preferably, but need not necessarily, capture the test signal, preferably through the optical long pass filter.

[0045] According to an aspect of one preferred embodiment of the invention, preferably in the LED step, at least one white LED may preferably, but need not necessarily, be provided as the aforesaid at least one reflection LED.

[0046] According to an aspect of one preferred embodiment of the invention, preferably in the LED step, at least one ultraviolet LED may preferably, but need not necessarily, be provided as the aforesaid at least one fluorescent LED.

[0047] According to an aspect of one preferred embodiment of the invention, preferably in the LED step, at least one colored LED may preferably, but need not necessarily, be provided as the aforesaid at least one fluorescent LED.

[0048] According to an aspect of one preferred embodiment of the invention, preferably in the processing step, the processor may preferably, but need not necessarily, identify the applicable test protocol with reference to one or more of the following which may preferably, but need not necessarily, be captured in the first image and/or the second image, and/or stored in the database for the loaded cassette: one or more cassette dimensions; one or more cassette shapes; one or more détection line dimensions; one or more control line dimensions; one or more détection areas; one or more membrane areas; one or more control line positions; one or more test line positions; one or more cassette colors; one or more line colors; manufacturer indicia; product indicia; brand name indicia; application indicia; disease indicia; test type indicia; incubation time indicia; expected results indicia; barcodes; two-dimensional barcodes; labels; and/or other printed and written indicia.

[0049] According to an aspect of one preferred embodiment of the invention, preferably in the processing step, the processor may preferably, but need not necessarily, additionally identify the applicable test protocol with reference to one or more of the following which may preferably, but need not necessarily, be received from the loaded cassette in the first image, in the second image and/or otherwise, and/or stored in the

-917359 database for the loaded cassette: magnetically stored data; fluorescence data; and/or radioactive signal data.

[0050] According to an aspect of one preferred embodiment of the invention, preferably at least in the imaging step and/or the processing step, a cellular téléphoné may preferably, but need not necessarily, be provided as the aforesaid imaging element and/or as the aforesaid processor.

[0051] According to an aspect of one preferred embodiment of the invention, preferably at least in the imaging step and/or the processing step, left and/or right channel audio signais, preferably from the cellular téléphoné, may preferably, but need not necessarily, tum the reflection LED and/or the fluorescent LED on and/or off.

[0052] According to an aspect of one preferred embodiment of the invention, preferably in the imaging step, one or more scanning heads may preferably, but need not necessarily, be provided, preferably as at least part of the aforesaid imaging element.

[0053] According to the invention, there is also dîsclosed a computer readable medium for analysis of various test cassettes for immunoassay rapid diagnostic tests. The computer readable medium is for use with one or more walls defming an enclosed chamber, which is adapted to selectively receive the various cassettes one at a time, each as a loaded cassette, in selectively removable relation. The computer readable medium is also for use with two or more light emitting diodes (LEDs) within the chamber, which include at least one reflection light emitting diode (LED) adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit. The computer readable medium is also for use with an imaging element inside the chamber. The computer readable medium is also for use with a database which includes at least one test protocol associated with each of the various test cassettes. The computer readable medium includes exécutable instructions, which are physically stored thereon. The instructions, upon execution, encode at least one processor to automatically capture a first image of the loaded cassette using the imaging element when at least one of the LEDs is lit. The instructions, upon execution, encode the aforesaid at least one processor to automatically identify, with reference to the first image and to the database, an applicable test protocol for the loaded cassette. The instructions, upon execution, encode the aforesaid at least one processor to automatically, after incubation of the loaded cassette and/or depending on the applicable one said test protocol: (i) détermine when the first image captures a post-incubation test signal from the loaded cartridge; and/or

-1017359 otherwise (ii) light the fluorescent LED to generate the test signal by émission, and/or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses the imaging element to capture a second image of the loaded cassette and of the test signal. The instructions, upon execution, encode the aforesaid at least one processor to automatically provide the test signal, in the first image and/or the second image, for analysis of the loaded cassette.

[0054] According to the invention, there is also disclosed a device, System and/or method which may be configured for use in association with one or more latéral flow product databases.

[0055] These databases, and/or any others provided and/or called for according to the invention, may preferably, but need not necessarily, be local to the device, to other components of the System, and/or to the computer readable medium, and/or they may preferably, but need not necessarily, be remote therefrom, preferably with a communications element being used to remotely access and/or reference them. According to the invention, the databases may may preferably, but need not necessarily, take the form of one or more local, remote, distributed, congruent and/or peer-to-peer databases, which may preferably, but need not necessarily, be accessible by the device locally and/or over one or more of its regular wireless (and/or wired) communication networks, including terrestrial and/or satellite networks — e.g., the Internet and/or cloud-based networks.

[0056] Preferably, the databases may comprise, for each latéral flow product, a collection of data about manufacturer information, product information, test type, identification information, incubation time, and/or expected results, etc. Manufacturer information stored in the databases may preferably comprise information conceming the manufacturer of the product. Product information stored in the databases may preferably comprise information conceming product brand names and/or application information. Identification data stored in the databases may preferably comprise spécifie data which can be used to discriminate the individual product from others, and/or which can be used to identify the test by the device, System and/or method according to the présent invention. Spécifie data may include data conceming one or more physical dimensions and/or colors associated with the product, and/or it may include and/or be encoded in writing and/or prior art labeling techniques (and/or other indicia, labels, writing, printing, markings, text, characters and/or symbols, with these ternis understood by persons skilled in the art to be capable of being used interchangeably mutatis mutandis herein) which may be associated

-1117359 with a particular product and/or test, such as, for example, barcode images, magnetically stored data, fluorescence data, and/or radioactive signal data, etc.

[0057] According to one aspect of the présent invention, test identification may preferably be performed in a process by which the device, System and/or method may preferably automatically recognize a cassette type and/or its manufacturer. Preferably, a pre-defined assay cut-off value (e.g., a positive and/or négative threshold) may be applied for that type of cassette for diagnostic purposes.

[0058] According to one aspect of the présent invention, the device, System and/or method may preferably, but need not necessarily, include an electronic board, a processor (e.g., a microprocessor), image analysis and/or processing software, a light chamber, one or more white (cassette récognition, reflection) LEDs, one or more color (émission) LEDs and/or ultraviolet (“UV”) LEDs, an optical filter, and/or a color caméra. Preferably, the optical filter may be an optical band pass filter and/or an optical long pass filter. Preferably, the optical filter may be mounted on a sliding switch and/or on a rotatable mechanism, and/or it may be moved towards and/or away from the front of the caméra. Preferably, the LEDs may be illuminated (i.e., on) to permit the caméra to take a picture, and may preferably just illuminate the light chamber when the caméra is taking a picture. The processor and/or controlling electronics may control whether one or more of the LEDs is on or off. The device, System and/or method may preferably enable one or more latéral flow cassettes to be received for récognition and analysis. The microprocessor may preferably be adapted with image processing software for analysis of one or more images of the latéral flow cassettes.

[0059] According to one aspect of the présent invention, for reading reflection signal type of tests (e.g., colloïdal gold and/or colored latex bead types of tests), the white LEDs may preferably be on. [References herein to use of the invention with colloïdal gold tests and/or colored latex bead tests may be considered, more generally, as references to its use (if and when appropriate) with reflection signal tests, with any changes which may be necessary and/or appropriate for such use.] In such circumstances, the color and/or UV LEDs may preferably be off. The optical filter may preferably be switched away from the color caméra. Preferably, the color caméra may take an image of the entire cassette, preferably including the plastic case and/or membrane area.

[0060] According to one aspect of the présent invention, the image taken by the caméra may preferably be analyzed by the image analysis and/or processing software in

-12à the microprocessor. [Each reference herein to image analysis software and/or to image processing software may be considered as a reference (if and when appropriate) to the other, to imaging software, and/or to software more generally, with any changes which may be necessary and/or appropriate in such instance.] The function of the image analysis software may preferably include: (1) cassette récognition, preferably with reference to cassette features (such as for example size, aspect ratio, color, shape, letters, etc.) and/or so as to provide a user with information conceming the cassette manufacturer, disease to be tested, etc.; (2) membrane région identification; (3) measurement of the intensity of the test line and/or control line in the membrane région and/or area; and/or (4) presenting diagnostic results according to one or more cut-off values, preferably as pre-set in the software.

[0061] The image processing software may preferably assess one or more images to détermine and/or présent the user cassette type and the diagnostic results to a user of the device, System and/or method according to the invention.

[0062] According to one aspect of the présent invention, for reading émission signal type of tests (e.g., fluorescent latéral flow cassette tests), two or more images may preferably but need not necessarily be taken for each test. [References herein to use of the invention with fluorescent signal tests may be considered, more generally, as references to its use (if and when appropriate) with émission signal tests, with any changes which may be necessary and/or appropriate for such use.] In such circumstances, the first image may preferably be an image of the cassette as taken with the white LED on, and the color LEDs off, and with the optical filter (e.g., an optical band pass filter) moved away from the caméra. [Each reference herein to an optical band pass filter and/or to an optical long pass filter may be considered as a reference (if and when appropriate) to optical filters, more generally, and/or to another spécifie type of optical filter, with any changes which may be necessary and/or appropriate for such filter.] Preferably, after the first image, a further image (e.g., the second image) may be a fluorescent signal image of the membrane région, preferably with the color LEDs on and/or the white LEDs off, and preferably with the optical filter (e.g., the optical band pass filter) in front of the caméra. Preferably, for émission signal tests, there may be no line visible in the membrane area in the first image because, preferably, the color and/or UV LEDs (which may be required for fluorescent latéral flow images) may be off. [Each reference herein to color LEDs and/or to UV LEDs may be considered as a reference (if and when appropriate) to the other and/or to non-

white LEDs, more generally, with any changes which may be necessary and/or appropriate for such LEDs.] The first image may preferably enable software according to the invention to perform cassette récognition. Preferably, the fluorescent control line and/or test signal line may be présent and/or visible in the second image. [According to one aspect of the présent invention, the fluorescent control line and/or test signal line may be rendered visible by the optical filter.] The image processing software may preferably combine and/or assess the two or more images to détermine and/or présent the user cassette type and the diagnostic results to a user of the device, System and/or method according to the invention.

[0063] Other advantages, features and characteristics of the présent invention, as well as methods of operation and functions of the related éléments of the device, System, method, and computer readable medium and the combination of steps, parts and économies of manufacture, will become more apparent upon considération of the following detailed description and the appended claims with reference to the accompanying drawings, the latter of which are briefly described hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS [0064] The novel features which are believed to be characteristic of the device, System, method, and computer readable medium according to the présent invention, as to the structure, organization, use, and method of operation, together with further objectives and advantages thereof, will be better understood from the following drawings in which presently preferred embodiments of the invention will now be illustrated by way of example. It is expressly understood, however, that the drawings are for the purpose of illustration and description only, and are not intended as a définition of the limits of the invention. In the accompanying drawings:

[0065] Figure 1 is a schematic diagram of a universal latéral flow reader device according to a preferred embodiment of the invention;

[0066] Figure 2 depicts three images of three different prior art cassettes made by different manufacturers, taken according to a preferred embodiment of the invention;

[0067] Figure 3 depicts two different images of a single fluorescent latéral flow cassette: (A) is a first image taken with white LEDs on, color LEDs off, and an optical filter away from a caméra; and (B) is a second image showing a test line, taken with the white LEDs off, the color LEDs on, and the optical filter in front of the caméra; both taken according to a preferred embodiment of the invention;

-1417359 [0068] Figure 4 is an image of a universal latéral flow reader System, including a cellular téléphoné, according to another preferred embodîment of the invention;

[0069] Figure 5 depicts two images of a fluorescent latéral flow cassette: (A) is a first image taken with a white LED on, and an ultraviolet (UV) LED off; and (B) is a second image taken with the white LED off, and the UV LED on; both taken with a long pass optical filter in front of the caméra according to a further preferred embodîment of the invention; and [0070] Figure 6 depicts four flowcharts, each showing a workflow method for lighting and incubation: (A) and (B) are flowcharts with a cassette incubated outside of a reader device; and (C) and (D) are flowcharts with the cassette incubated inside of the reader device; ail according to different preferred embodiments of the invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0071] Preferred embodiments of the device, System, method, and computer readable medium according to the invention are altemately herein referred to, collectively and/or individually, as the universal latéral flow reader, device, System, method and/or computer readable medium (or simply as the reader, device System, method and/or computer readable medium). References to one or more of the reader, device, System, method and/or computer readable medium may, if and as appropriate, be understood by persons having ordinary skill in the art to apply, mutatis mutandis, to the others.

[0072] Persons skilled in the art will appreciate that although some of the components, relations, functionalities and applications of the reader, device, System, method and computer readable medium are not specifîcally referenced or described in conjunction with each other, they may be used or adapted for use in association therewith. The reader, device, System, method and computer readable medium described herein are suitable for use with each other, but they are not so limited.

[0073] How It Works [0074] Figure 1 provides a schematic diagram of one reader device and/or System (and/or for use with a method) according to a preferred embodîment of the invention. It preferably includes a color charge-coupled device (“CCD”) caméra, white LEDs, color LEDs, an optical filter, a printed circuit board (“PCB”), and a latéral flow test cassette. The cassette is preferably enclosed in a chamber when a picture is taken. The white LEDs may hâve a wide illumination angle. Preferably, when on, the white LEDs may make the whole cassette chamber bright and provide a constant lighting environment for the caméra.

-1517359

The color LEDs (and/or UV LEDs) are preferably used as an excitation source of one or more fluorophores in a fluorescence latéral flow test. The light of color LEDs may be collimated. The color LED light may illuminate only the membrane area of the cassette. The caméra is preferably mounted high enough to take an image of the entire cassette. According to one preferred embodiment, the optical filter is an optical band pass filter which passes the fluorescent wavelength of the fluorophore.

[0075] Preferably, for gold latéral flow cassettes (and/or reflection signal tests), the white LEDs are on, the color LEDs are off, and the optical filter is switched away from the caméra. The caméra preferably takes an image of the entire cassette.

[0076] Figure 2 shows images of cassettes from three different manufacturera, as may be taken according to a preferred embodiment of the invention. Those bright color images, as preferably illuminated by the white LEDs, are analyzed by software in the microprocessor. Preferably, some of the functions of the image analysis software include: (1) cassette récognition which may be performed with reference to cassette features such as, for example, cassette size, aspect ratio, color, shape, letters, etc.; (2) membrane région identification for each type of cassette, i.e., in a preferred embodiment according to the invention, identifying a précisé and/or approximate location of a membrane région for each cassette as (and cassette type which may be) inserted into the chamber; (3) measurement of the intensity of one or more test lines and/or control fines in the membrane région; and (4) détermination of diagnostic results. Preferably, for each type of cassette, an assay cut-off value may be tested and/or predetermined, and pre-set as a reference value for and/or in the software. Preferably, in the aforesaid manner, the intensifies of the control and test lines may be measured and determined, and the diagnostic results (such as positive, négative, invalid) can be determined and/or obtained.

[0077] Preferably, two or more images may be taken for each latéral flow cassette which is detected and/or determined to be of the fluorescent and/or émission signal type. The first image is preferably an image of the cassette with the white LED on, the color and/or UV LEDs off, and the optical filter away from the caméra. This image is preferably used for automatic cassette récognition, which may preferably be based on information such as cassette size, shape, writings, and other spécifie features. Preferably, with the color and/or UV LEDs off, this image will not show any line in the membrane area for fluorescent latéral flow cassettes.

-16J [0078] Preferably, the second image is taken with the white LEDs off, the color and/or UV LEDs on, and the optical filter in front of the caméra. The color and/or UV LEDs preferably illuminate only the membrane area of the cassette, preferably to reduce an autofluorescence background signal such as from a plastic case of the cassette. Intensifies of the fluorescent control line and/or test lines are preferably obtained in the second image.

[0079] The image processing software preferably combines the two images, and présents a user with the cassette type and/or the diagnostic results.

[0080] In doing so, the image processing software preferably accesses, references and/or consults one or more databases which are (a) local to the image processing software, to the device, to other components of the System, and/or to the computer readable medium, and/or (b) remote therefrom, with a communications element being used to remotely access, reference and/or consult them. The databases preferably take the form of one or more local, remote, distributed, congruent and/or peer-to-peer databases which are preferably be accessible by the image processing software and/or the device locally and/or over one or more of its regular wireless (and/or wired) communication networks, încluding terrestrial and/or satellite networks — e.g., the Internet and cloud-based networks.

[0081] Figure 3 shows an example of two images such as may be taken of one type of fluorescent latéral flow cassette. Figure 3 (A) shows an image of the cassette. Preferably, the Figure 3(A) image is taken with white LEDs on, color LEDs off, and optical filter away from the caméra. The image in Figure 3 (A) could preferably be used for cassette récognition. Figure 3 (B) shows a fluorescent signal image of the same cassette. The Figure 3 (B) image is preferably taken with white LEDs off, color LEDs on, and optical filter in front of the caméra. Preferably, in the shown fluorescent latéral flow test, Europium dye is used. The image in Figure 3(B) could preferably be used for diagnostic test resuit analysis.

[0082] Functional Check And Fluorescent Signal Calibration [0083] A functional check and calibration (“FCC”) cassette is preferably used to make sure the device, System and/or method are functional for both gold (reflection signal) and fluorescent (émission signal) latéral flow cassette test types. The FCC cassette preferably contains at least one color line and one fluorescent signal line. The plastic case of the FCC cassette may or may not be the same as that of a normal diagnostic cassette, as long as an associated software (“SW”) algorithm [which may be provided according to one

-1717359 preferred embodiment of the invention] is preferably able to differentiate it therefrom. Preferably, the intensities of the color line and fluorescent line are pre-set, and should not appreciably change over a meaningful time relative to the expected lifetime(s) of the FCC cassette and/or the device according to the présent invention. Preferably, to evaluate the device, the intensities of the two lines are tested. The criteria for functional check pass and/or failure is preferably pre-determined, and recorded in and/or accessed by the software.

[0084] Other Preferred Embodiments [0085] A latéral flow reader device, System and/or method according to one preferred embodiment of the invention may comprise, be used in conjunction with, and/or be based on a cell phone. Figure 4 shows this preferred embodiment. The cell phone’s back caméra may be used as the color caméra according to this embodiment. Preferably, the cell phone’s multiple fonctions (such as image taking, image processing, and/or information transferring) may afford benefits for the device, System and/or method according to this embodiment.

[0086] In this preferred embodiment, the cassette drawer and the enclosed cassette chamber preferably provide a constant lighting condition, with LEDs on, only when an image is being taken. Preferably, the device, System and/or method may be adapted such that the left channel audio signal from the cell phone may be used to control whether the white LEDs are on or off, and/or such that the right channel audio signal from the cell phone may be used to control whether the color and/or UV LEDs are on or off.

[0087] A device, System and/or method according to another preferred embodiment of the invention may be custom-designed and/or assembled by using separate parts and/or components, so as to afford the same, similar, or greater fonctionality than those comprising, used in conjunction with, and/or based on commercially available cell phones. [0088] A forther preferred embodiment of the device, System and/or method according to the invention may comprise, be used in conjunction with, and/or be based on a scanner device. In this embodiment, a scanning head may preferably be equipped with a red (R) LED, a green (G) LED, a blue (B) LED, and a UV LED. Preferably, for color images of gold (or reflection signal) latéral flow cassettes, only the RGB LEDs (or white LED) may be on when scanning. Preferably, for fluorescent (or émission signal) latéral flow cassette détection, two or more scans may be taken. Preferably, for cassette récognition, the first scan obtains a color image of the cassette, including its plastic case, with the RGB LEDs

-1817359 (or white LED) on and the UV LED off. The second scan preferably obtains the emitted fluorescent signal of the control line and the test line in the membrane area of the cassette, with the RGB LEDs (or white LED) off and the UV LED on. In this preferred embodiment, a band pass filter is placed in from of the image sensor when the UV LED is on.

[0089] Yet another preferred embodiment may be provided with a filter wheel which has two or more, and preferably several, optical band pass filters for different fluorophores and a through-hole (or clear) position for bright and/or white-light images. This embodiment may preferably also contain two or more, and preferably several, color and/or UV LEDs for different fluorophores. Whether each of these LEDs is on, or off, may preferably be controlled by the device software of this embodiment. Preferably, the filter wheel switch may be motorized, or the filter wheel may be tumed manually. The filter wheel may preferably be tumed automatically to the right filter depending on which LED(s) are on and/or which cassette is recognized.

[0090] A yet further preferred embodiment of the invention may be provided without any optical filter sliding switch, without any optical filter wheel, and without any band pass filters. Instead, the device, System and/or method may comprise, be used in conjunction with, and/or be based on a white LED, a UV LED, and a long pass filter. Preferably, in this embodiment, the optical filter may be always placed in front of the caméra. As an example, the wavelength of the UV LED may be about 375 nanometers (nm), and the cutting edge wavelength of the optical long pass filter may be about 420 nanometers (nm). In this embodiment of the invention, the fluorophore of the fluorescent latéral flow test preferably may be Europium dye. Figure 5 shows préférable images of a fluorescent latéral flow cassette according to this embodiment. Figure 5(A) shows a préférable image of the cassette when the white LED is on, the UV LED is off, and the 420 nanometer (nm) long pass filter is placed in front of caméra. Figure 5(B) shows a préférable image of the cassette when the white LED is off, the UV LED is on, and the 420 nanometer (nm) long pass filter is placed in front of the caméra. Preferably, the image in Figure 5(A) may be used for cassette récognition, and/or the image in Figure 5(B) may be used for fluorescent signal détection, according to this embodiment of the invention.

[0091] In still another preferred embodiment, the color caméra may hâve a zoom-in function and/or be able to take a zoomed-in image of the membrane area when the color and/or UV LEDs are on, preferably for better fluorescence détection performance.

-1917359 [0092] In a still further preferred embodiment, there may be provided one or more optical fibers and/or an optical fiber bundle to guide light to a spécifie area.

[0093] Figure 6 shows four potential workflows for use in or in association with the device, System and/or method according to the invention. Figures 6(A) and 6(B) show workflows where the cassette is preferably incubated outside of a reader device according to the invention. In Figure 6(A), the cassette is loaded into the device and the white LEDs are illuminated before the cassette is fully incubated. An image taken at this stage may be used for cassette récognition. In Figure 6(A), the cassette is removed from the device and reloaded again after incubation. In Figure 6(B), the cassette is first loaded into the device after incubation. In both cases, after incubation, the white LEDs are illuminated and images taken for cassette récognition.

[0094] Figures 6(C) and 6(D) show workflows where the cassette is preferably incubated inside of a reader device according to the invention. In both cases, the cassette is loaded into the device before it is fully incubated. Images taken when the white LEDs are first illuminated may be used for cassette récognition. In Figure 6(D) the white LEDs are first illuminated before the cassette is fully incubated, whereas in Figure 6(C) the white LEDs are first illuminated after incubation. In Figure 6(D), for reflection signal tests, the white LEDs are illuminated again after incubation.

[0095] In Figures 6(A) through 6(D), for reflection signal tests, images taken when the white LEDs are illuminated after incubation may be analyzed by the image processing software. For émission signal tests, the color and/or UV LEDs are illuminated to fluoresce the test and control fines and, with the optical filter in front of the caméra, an image is taken for analysis by the image processing software.

[0096] In the workflow shown in Figure 6(A), two images are taken for reflection signal tests and three for émission signal tests. In the workflows shown in Figures 6(B) and 6(C), one image is taken for reflection signal tests and two for émission signal tests. In the workflow shown in Figure 6(D), two images are taken for reflection signal tests and two for émission signal tests.

[0097] Computer Readable Medium [0098] The computer readable medium (e.g., CD-ROM, DVD-ROM, flash USB stick,

RAM, ROM, and/or other computer memory device) includes exécutable instructions which are physically stored thereon and which, upon execution, preferably encode processors to perform the method according to the invention.

-2017359 [0099] Ail of the aforementioned, depicted and various structures, configurations, relationships, processes, utilities and the like may be, but are not necessarily, incorporated into and/or achieved by the invention. Any one or more of the aforementioned structures, configurations, relationships, processes, utilities and the like may be implemented in and/or by the invention, on their own, and/or without reference, regard or likewise implémentation of any of the other aforementioned structures, configurations, relationships, processes, utilities and the like, in various permutations and combinations, as will be readily apparent to those skilled in the art, without departing from the pith, marrow, and spirit of the disclosed invention.

[0100] This concludes the description of presently preferred embodiments of the invention. The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive or to limit the invention to the précisé form disclosed. Other modifications, variations and alterations are possible in light of the above teaching and will be apparent to those skilled in the art, and may be used in the design and manufacture of other embodiments according to the présent invention without departing from the spirit and scope of the invention. It is intended the scope of the invention be limited not by this description but only by any daims forming a part of this application, and/or the daims of any application claiming priority from this application, and/or any patent issuing thereon.

Claims

WHAT IS CLAIMED IS:

1. A device for analysis of various test cassettes for immunoassay rapid diagnostic tests, the device comprising:

one or more walls defining an endosed chamber which is adapted to selectively receive the various cassettes one at a time, each as a loaded cassette, in selectively removable relation;

two or more light emitting diodes (LEDs) within the chamber, which comprise at least one reflection light emitting diode (LED) adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit;

an imaging element inside the chamber which automatically captures a first image of the loaded cassette when at least one of the LEDs is lit; and at least one processor which, with reference to the first image and to a database that comprises at least one test protocol associated with each of the various test cassettes, automatically identifies an applicable one said test protocol for the loaded cassette;

wherein the processor automatically, after incubation of the loaded cassette and depending on the applicable one said test protocol:

(i) détermines when the first image captures a post-incubation test signal from the loaded cartridge; and otherwise (ii) lights the fluorescent LED to generate the test signal by émission, or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses the imaging element to capture a second image of the loaded cassette and of the test signal; and wherein the processor automatically provides the test signal, in the first image or the second image, for analysis of the loaded cassette.

2. A device according to claim 1, wherein the processor automatically analyzes the test signal with reference to the applicable one said test protocol for the loaded cassette.

3. A device according to claim 2, wherein the test signal comprises a test line signal correspondîng to a test line présent on the loaded cassette after incubation, and the processor automatically measures an intensity of the test line signal; and wherein the test signal comprises a control line signal correspondîng to a control line présent on the loaded cassette after incubation, and the processor automatically measures an intensity of the control line signal.

4. A device according to any one of claims 2 to 3, wherein the applicable one said test protocol comprises a predetermined assay threshold value, and wherein the processor analyzes the

-2217359 test signal with reference to the assay threshold value to automatically détermine a diagnostic test resuit associated with the loaded cassette.

5. A device according to any one of claims 2 to 4, further comprising any one or more of an output device which automatically présents the diagnostic test resuit to a user of the device, a memory onboard the device which stores one or more sets of exécutable instructions to encode the processor to automatically analyze the test signal as aforesaid and a memory onboard the device which stores one or more sets of exécutable instructions to encode the processor to automatically identify the applicable one said test protocol as aforesaid.

6. A device according to any one of claims 1 to 5, further comprising any one or both of a memory onboard the device which stores the database, and a communications element onboard the device which the processor automatically uses to remotely reference the database as aforesaid.

7. A device according to any one of claims 1 to 6, further comprising at least one optical filter, and wherein (i) the processor automatically ensures the optical filter is moved to an engaged position between the loaded cassette and the imaging element, before lighting a corresponding one said émission LED, and the imaging element then captures the test signal through the optical filter, and (ii) the processor automatically ensures the optical filter is moved to a disengaged position clear of the imaging element, before lighting the reflection LED, and the imaging element then captures the test signal clear of the optical filter.

8. A device according to claim 7, wherein the optical filter is either mounted on a sliding switch which slides the optical filter between the engaged position and the disengaged position or mounted on a rotatable mechanism which rotâtes the optical filter between the engaged position and the disengaged position.

9. A device according to any one of claims 7 to 8, wherein the optical filter is an optical band pass filter.

10. A device according to any one of claims 1 to 6, further comprising an optical long pass filter positioned between the loaded cassette and the imaging element, and wherein the imaging element captures the test signal through the optical long pass filter.

11. A device according to any one of claims 1 to 10, wherein said at least one reflection LED comprises at least one white LED.

12. A device according to any one of claims 1 to 11, wherein said at least one fluorescent LED comprises of any one or both of at least one ultraviolet LED and at least one colored LED.

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13. A device according to any one of claims 1 to 12, wherein the processor identifies the applicable one said test protocol with reference to one or more of the following which are captured in the first image, and stored in the database, for the loaded cassette: one or more cassette dimensions, one or more cassette shapes, one or more détection line dimensions, one or more control line dimensions, one or more détection areas, one or more membrane areas, one or more control line positions, one or more test line positions, one or more cassette colors, one or more line colors, manufacturer indicia, product indicia, brand name indicia, application indicia, disease indicia, test type indicia, incubation time indicia, expected results indicia, barcodes, twodimensional barcodes, labels, and other printed and written indicia.

14. A device according to any one of claims 1 to 13, wherein the processor additionally identifies the applicable one said test protocol with reference to one or more of the following which are received from the loaded cassette, and stored in the database for the loaded cassette: magnetically stored data, fluorescence data, and radioactive signal data.

15. A device according to any one of claims 1 to 14, adapted for any one or both of analysis of various latéral flow cassettes as the test cassettes and for use with a connected device to provide at least one of said imaging element and said processor.

16. A device according to claim 15, wherein left and right channel audio signais from the connected device are adapted to turn the reflection LED and the fluorescent LED on and off.

17. A device according to any one of claims 1 to 16, wherein the imaging element comprises one or more scanning heads.

18. A System for analysis of various test cassettes for immunoassay rapid diagnostic tests, the System comprising:

one or more walls defining an enclosed chamber which is adapted to selectively receive the various cassettes one at a time, each as a loaded cassette, in selectively removable relation;

a database that comprises at least one test protocol associated with each of the various test cassettes;

a connected device received by the walls of the chamber, with the connected device comprising: a caméra inside the chamber which automatically captures a first image of the loaded cassette when at least one of the LEDs is lit; and at least one processor which, with reference to the

-2417359 first image and in communication with the database, automatically identifies an applicable one said test protocol for the loaded cassette;

19. A System according to claim 18, wherein left and right channel audio signais from the connected device are adapted to tum the reflection LED and the fluorescent LED on and off.

20. A method for analysis of various test cassettes for immunoassay rapid diagnostic tests, the method comprising:

a receiving step of selectively receiving the various cassettes one at a time, each as a loaded cassette, in selectively removable relation within an enclosed chamber which is defined by one or more walls;

a light emitting diode (LED) step of providing two or more LEDs within the chamber, which comprise at least one reflection LED adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit;

an imaging step of automatically capturing a first image of the loaded cassette, when at least one of the LEDs is lit, using an imaging element inside the chamber;

a database step of providing a database which comprises at least one test protocol associated with each of the various test cassettes; and a processing step of using at least one processor, with reference to the first image and to the database, automatically identifying an applicable one said test protocol for the loaded cassette;

wherein in the processing step, the processor automatically, after incubation of the loaded cassette and depending on the applicable one said test protocol:

(i) détermines when the first image captures a post-incubation test signal from the loaded cartridge; and otherwise (ii) lights the fluorescent LED to generate the test signal by émission, or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses the imaging element to capture a second image of the loaded cassette and of the test signal; and

-2517359 wherein in the processing step, the processor automatically provides the test signal, in the first image or the second image, for analysis of the loaded cassette.

21. A method according to claim 20 wherein, in the processing step, any one or more of the following occurs; in the processing step that the processor automatically analyzes the test signal with reference to the applicable one said test protocol for the loaded cassette, in the processing step that the processor automatically uses a communications element to remotely reference the database, in the processing step that the test signal comprises a test line signal corresponding to a test line présent on the loaded cassette after incubation, and the processor automatically measures an intensity of the test line signal and in the processing step, the test signal comprises a control line signal corresponding to a control line présent on the loaded cassette after incubation wherein the processor automatically measures an intensity of the control line signal and in the processing step that the applicable one said test protocol comprises a predetermined assay threshold value and wherein the processor analyzes the test signal with reference to the assay threshold value to automatically détermine a diagnostic test resuit associated with the loaded cassette.

22. A method according to claim 21, further comprising a présentation step, wherein the diagnostic test resuit is automatically presented using an output device.

23. A method according to any one of claims 21 to 22 wherein, before the processing step, one or more sets of exécutable instructions are stored in a memory and, in the processing step, the exécutable instructions encode the processor to automatically analyze the test signal as aforesaid.

24. A method according to any one of claims 20 to 22 wherein, before the processing step, one or more sets of exécutable instructions are stored in a memory and, in the processing step, the exécutable instructions encode the processor to automatically identify the applicable one said test protocol as aforesaid.

25. A method according to any one of claims 20 to 24, further comprising a filtering step of providing at least one optical fïlter, and wherein in the processing step, (i) the processor automatically ensures the optical fïlter is moved to an engaged position between the loaded cassette and the imaging element, before lighting a corresponding one said émission LED, and the imaging element then captures the test signal through the optical fïlter, and (ii) the processor automatically ensures the optical fïlter is moved to a disengaged position clear of the imaging element, before lighting the reflection LED, and the imaging element then captures the test signal clear of the optical fïlter.

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26. A method according to any one of claims 20 to 25, further comprising a filtering step of providing an optical long pass filter positioned between the loaded cassette and the imaging element, and wherein in the processing step, the imaging element captures the test signal through the optical long pass filter.

27. A method according to any one of claims 20 to 26 wherein, in the LED step, any one or more of at least one white LED is provided as said at least one reflection LED, at least one ultraviolet LED is provided as said at least one fluorescent LED and at least one colored LED is provided as said at least one fluorescent LED.

28. A method according to any one of claims 20 to 27 wherein, in the processing step, the processor identifies the applicable one said test protocol with reference to one or more of the following which are captured in the first image, and stored in the database, for the loaded cassette: one or more cassette dimensions, one or more cassette shapes, one or more détection line dimensions, one or more control line dimensions, one or more détection areas, one or more membrane areas, one or more control line positions, one or more test line positions, one or more cassette colors, one or more line colors, manufacturer indicia, product indicia, brand name indicia, application indicia, disease indicia, test type indicia, incubation time indicia, expected results indicia, barcodes, two-dimensional barcodes, labels, and other printed and written indicia.

29. A method according to any one of claims 20 to 28 wherein, in the processing step, the processor additionally identifies the applicable one said test protocol with reference to one or more of the following which are received from the loaded cassette, and stored in the database for the loaded cassette: magnetically stored data, fluorescence data, and radioactive signal data.

30. A method according to any one of claims 20 to 29 wherein, in the imaging step, one or more scanning heads are provided as at least part of said imaging element.

31. A computer readable medium for analysis of various test cassettes for immunoassay rapid diagnostic tests, and for use with: one or more walls defining an enclosed chamber which is adapted to selectively receive the various cassettes one at a time, each as a loaded cassette, in selectively removable relation; two or more light emitting diodes (LEDs) within the chamber, which comprise at least one reflection light emitting diode (LED) adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit; an imaging element inside the chamber; and a database that comprises at least one test protocol associated with each of the various test cassettes;

-2717359 with the computer readable medium comprising exécutable instructions which are physically stored thereon and which, upon execution, encode at least one processor to automatically:

capture a first image of the loaded cassette using the imaging element when at least one of the LEDs is lit;

identify, with reference to the first image and to the database, an applicable one said test protocol for the loaded cassette;

after incubation of the loaded cassette and depending on the applicable one said test protocol: (i) détermine when the first image captures a post-incubation test signal from the loaded cartridge; and otherwise (ii) light the fluorescent LED to generate the test signal by émission, or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses the imaging element to capture a second image of the loaded cassette and of the test signal; and provide the test signal, in the first image or the second image, for analysis of the loaded cassette.

32. A device for analysis of various test cassettes for immunoassay rapid diagnostic tests, the cassettes loaded in selectively removable relation in an enclosed chamber which is adapted to selectively receive the various cassettes one at a time, the device comprising:

two or more light emitting diodes (LEDs), which comprise at least one reflection light emitting diode (LED) adapted to illuminate the loaded cassette when lit, and at least one fluorescent LED adapted to fluoresce the loaded cassette when lit;

an imaging element which automatically captures a first image of the loaded cassette when at least one of the LEDs is lit;

at least one processor which, with reference to the first image and to a database that comprises at least one test protocol associated with each of the various test cassettes, automatically identifies an applicable one said test protocol for the loaded cassette; and a communication element for communication with the database;

(i) détermines when the first image captures a post-incubation test signal from the loaded cartridge; and otherwise (ii) lights the fluorescent LED to generate the test signal by émission, or the reflection LED to generate the test signal by reflection, from the loaded cassette and uses

-2817359 the imaging element to capture a second image of the loaded cassette and of the test signal; and wherein the processor automatically provides the test signal, in the first image or the second image, for analysis of the loaded cassette.

5 33. A device according to claim 32, wherein the device is a cellular téléphoné.