WO2018170572A1

WO2018170572A1 - Lateral flow diagnostic device with radial symmetry, and system for reading a lateral flow diagnostic device with radial symmetry

Info

Publication number: WO2018170572A1
Application number: PCT/BR2018/050080
Authority: WO
Inventors: Marco Aurélio KRIEGER; Leonardo FOTI; Leonardo Berlim SCHNEIDER; Luiz Eduardo Nishino Gomes DO AMARAL; Rudolf Copi ECKELBERG; Cyro Ketzer SAUL; Wido Herwig SCHREINER
Original assignee: Fundação Oswaldo Cruz; Instituto De Biologia Molecular Do Paraná - Ibmp
Priority date: 2017-03-23
Filing date: 2018-03-23
Publication date: 2018-09-27
Also published as: BR102017006004A2

Abstract

The present invention provides a lateral flow diagnostic device with radial symmetry comprising a base (B) and a lid (T), which comprises at least one sample input opening (1) and at least two observation windows (2), and the base (B) comprises at least one sample acquisition element (3) and at least two test-strip beds (5), wherein each observation opening (2) in the lid (T) corresponds to one or more beds (5), and in each bed (5) one or more test strips (4) can be positioned, said at least one sample acquisition element (3) being in communication with the at least two test strips (4). The invention also provides a system for reading a lateral flow diagnostic device with radial symmetry comprising the following modules: image acquisition optical module (13), illumination module, processing and control module (15), and storage module, wherein the image and acquisition optical module (13) is adapted to acquire an image of a lateral flow diagnostic device with radial symmetry, and the processing and control module (15) is adapted to manage and extract information from the system.

Description

"SIDE FLOW RADIAL SYMMETRY DIAGNOSTIC DEVICE, AND READING SYSTEM OF A SIDE FLOW RADIAL DIAGNOSTIC DIAGNOSTIC DEVICE" FIELD OF THE INVENTION

The present invention relates to the field of medical apparatus. More specifically, the present invention relates to lateral flow type diagnostic systems falling within the field of rapid diagnostics.

BACKGROUND OF THE INVENTION

Several side flow type test configurations are known from the state of the art. These devices are simple and designed to detect the presence or absence of an analyte (target in the sample) without the need for expensive and specialized equipment. Typically, these tests are used for medical diagnosis or even self-tests where a user can perform a test without medical supervision. Other applications include veterinary diagnostics, chemical or biological tests, as well as point-of-care tests, which are performed at the patient care facility, or used in laboratory and medical examinations. The best known example of lateral flow testing is the pregnancy test.

[003] Lateral flow testing can also be used in so-called "point-of-need" locations where hospitals, laboratories or health clinics are not accessible. These tests are important, especially in isolated communities, whether geographically or socially, such as slums, indigenous tribes, areas that have suffered natural disasters, countries at war, among others.

[004] Side flow testing technology is based on a series of capillary beds such as porous paper membranes, nitrocellulose and / or polymeric materials. In capillary beds, some elements are responsible for transporting the fluid to be analyzed by the device, and others are chemical or biological markers. Commonly used markers are bioactive nanoparticles optimized to have the chemical reaction between the target molecule (eg an antigen) and its chemical partner (eg antibody) that is immobilized on the surface of the nanoparticle. Bioactive nanoparticles, when biochemically immobilized, are called conjugates.

In addition to nanoparticles, other materials may be used as reaction markers. An example of this is lysosomes, vesicles formed by two lipid layers capable of encapsulating large concentrations of visible or fluorescent pigments, enzymes and electroactive components. However, its relative instability and susceptibility to cell lysis by surfactants makes it easily replaceable in the fast diagnostics market. This gives rise to colloidal products, which are the basis for most known side flow tests.

Reported in the 1970s, colloidal carbon had a setback in its attempt to use in immunoassays, but only in 1993 was the idea of being reintroduced into this context discussed. In this way, doors were opened to colloidal metals. Gold and silver nanoparticles are the most commonly used materials for lateral flow testing for several reasons: ease of production, low relative cost, intense color and stability in liquids all contribute to their implementation in immunoassays and testing in general, among others.

The test consists of several areas defined for their functionality, typically consisting of segments made of different materials. When a test is performed, the sample is added at the most central end of the tape, the sample platform. In this step, the sample is treated to make it compatible with the rest of the test. The treated sample migrates through this region to the conjugate platform where a nanoparticle conjugate has been chemically immobilized. The particles they may typically be colloidal metal, semi-metals or monodisperse colored, fluorescent or paramagnetic polymer. These particles were conjugated to one of the specific assay components, protein, antigen, antibody or other specific molecule, depending on the assay being performed. The sample remobilizes the dried conjugate and the sample analyte interacts with the conjugate. Both migrate to the next section of the range, which is the test line (or reaction matrix).

The test line is a porous nitrocellulose membrane whose other test component has been immobilized. Capture molecules are typically proteins, such as antibodies and antigens and / or organic or inorganic molecules, which have been fixed in bands located in specific areas of the membrane, which serve to capture the target analyte and conjugate as they migrate through the lines. capture (test line and control line). Excess reagents pass beyond the capture lines and are absorbed by the absorbent sample acquisition element. Results can be interpreted with the presence or absence of these conjugate lines captured by operator observation. In many cases, a reader is used to automatically interpret the test result.

Different optical readers, image based systems and optical scanners are known from the state of the art for optically or electronically reading tests of interest in the fields of human health, veterinary and chemical testing.

The tests of interest are generally performed with the aid of small microfluidic devices, which may have a variety of microchannels and arrangements that enable the interaction of the fluids under examination. These fluids may be biological or chemical in nature, depending on the test to be performed. Many of the devices that aid in reading the diagnosis use optical-electronic arrangements. complex, some even with the aid of laser or fluorescence detectors or mirrors.

State-of-the-art rapid flow type detection systems are mostly expensive due to the limitation on both the number of tests and the number of chips used for several different cases. This need for many chips makes the test, despite being said fast, slow and repetitive, thereby increasing human error rates intrinsic to the method. Some of these systems will be listed below.

CN 103740803 discloses a rapid strip detection kit of the pathogenesis caused by Salmonella spp. It belongs to the field of molecular biology and immunology. The invention combines polymerase chain reaction with high sensitivity and specificity in nucleic acid detection and immune colloidal rapid detection technology, thereby performing rapid and accurate detection of Salmonella. Therefore, this invention is directed to the detection of only one pathogen, Salmonella.

WO2016014905 discloses a point-of-care type system that includes a reader with an incubator disposed within a housing, the incubator having a rotationally supported rotor and having a plurality of radially disposed slots. A drive mechanism is configured to perform its processing on a rotor, which rotates the device about a central axis. A plurality of analytical test elements are sized to fit into the incubator slots either manually or on demand. Each analytical test element generally includes a holder within a cartridge. It is capable of handling a plurality of analytical test elements, including individual test elements that allow multiple tests to be conducted. It has a sample dispenser through an infusion pump that has a rotor and each target subject to analysis is in a different cassette. It also comprises a separate reader, which uses fluorometry or reflectometry to measure test results, and also has an actuator to force test operation. This reduces the portability of the equipment, as it is of greater complexity and dimensions.

CN 103480438 discloses a lateral flow device for use in a mainframe or point-of-care clinical analyzer, wherein the lateral flow device includes a flat holder having at least one sample addition area and at least one reaction area. The sample addition area and reaction area are fluidly interconnected and form at least one lateral fluid flow path. The side flow device is sized for retention within an analyzer storage cartridge defined by a hollow interior and having a plurality of retained and stacked side flow test devices. The device disclosed is not point-of-care diagnostic equipment.

WO2010021873 discloses an analysis system that includes an optical imager for obtaining high resolution images of test strips (e.g., lateral flow test strips, or immunochromatographic test strips) and performs the processing. to identify individual assay strips and determine the results for each test strip by quantifying the presence or absence of the test line signal and the control signal. The assay system in this document automatically records all results and data in a database that stores a high-resolution image of the original immunochromatographic analysis, test line values and control lines, and test result. The user interface addresses an end user through operation.

EP2120048 discloses an immunochromatographic test strip plate assembled for various detections. The plate comprises a base, an upper lid engaged with the base and a drainage portion disposed between the strips on the base and the upper lid, wherein an opening for addition of the sample disposed on the upper lid is in front of the drainage piece. Said sample connects with a drainage groove in the lower part of the upper lid. The drainage groove is formed by several drainage channels. The immunochromatographic strips may have a radial or parallel arrangement. The edge of the drainage channel overlaps the adjacent sample pads. The lid and base closure is symmetrical.

The invention described by EP2120048 also provides a method for multiple detection by immunochromatography, for performing detection of multiple target analytes in a sample from a simultaneous assay, that is, one-to-many detection mode. This occurs by sample insertion and direct analysis. This allows many immunochromatographic test strips to be used and can perform synchronous and uniform reactions for multiple target analytes in a sample.

WO2015200246 A1 discloses a point-of-care immunization system based on a variety of detection methods for rapidly testing a patient to verify an immunization profile so that vaccines can be administered from according to the identified gaps. The system consists of sample and test strips / cartridges, configured to meet the health needs of national administrations.

In light of the above, it is clear that the state of the art lacks an integrated point-of-care system that simultaneously performs multiple separate tests that are effectively analyzed by equipment optimized for such activity.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a lateral flow testing device that allows multiple diagnostics of interest to be made in a single device, making the already known technique more efficient, effective and compact, and substantially reducing manufacturing costs.

A second object of the present invention is to provide a modular, low-cost, image-integrated, simultaneous point-of-care multi-diagnostics system that is capable of optimally capturing, storing, processing , analysis and / or interpretation of test images obtained by a lateral flow test device.

In order to achieve the above objectives, the present invention provides a lateral flow type radial symmetry diagnostic device comprising a base and a lid, wherein the lid comprises at least one sample inlet opening and at least least two observation windows, and the base comprises at least one sample acquisition element and at least two test strip beds, wherein each lid observation opening corresponds to a base test strip bed, and each bed may a test strip is set up, where the number of observation windows is equal to or greater than the number of test strips, and the number of beds is equal to or greater than the number of test strips, where at least one sample acquisition element is in communication with at least two test strips.

The invention also provides a reading system of a lateral flow type radial symmetry diagnostic device comprising: an optical image acquisition module, an illumination module, a processing and control module, and a storage unit, wherein: the optical image acquisition module is adapted to perform image acquisition of a lateral flow type radial symmetry diagnostic device; and the processing and control module is adapted to manage and extract information from other system modules. BRIEF DESCRIPTION OF THE FIGURES

The detailed description given below makes reference to the accompanying figures and their respective reference numbers.

Figure 1 illustrates an exploded view of a lateral flow type radial symmetry diagnostic device for ten simultaneous tests according to a first optional embodiment of the present invention.

Figure 2 illustrates an exploded view of a lateral flow type radial symmetry diagnostic device for eight simultaneous tests according to a second optional embodiment of the present invention.

Figure 3 shows an exploded view of a lateral flow type radial symmetry diagnostic device for nine simultaneous tests according to an optional third embodiment of the present invention.

Figure 4 shows a top view of a lateral flow type radial symmetry diagnostic device for six simultaneous tests according to an optional fourth embodiment of the present invention.

Figure 5 illustrates a perspective view of a reading system of a lateral flow type radial symmetry diagnostic device in accordance with an optional embodiment of the present invention.

Figure 6 illustrates a front view of a reading system of a lateral flow type radial symmetry diagnostic device in accordance with an optional embodiment of the present invention.

Figure 7 illustrates a side view of a reading system of a lateral flow type radial symmetry diagnostic device in accordance with an optional embodiment of the present invention.

Figure 8 illustrates a top view of a reading system of a lateral flow type radial symmetry diagnostic device in accordance with an optional embodiment of the present invention.

Figure 9 illustrates a block diagram representative of the actuation of the reading system of a lateral flow type radial symmetry diagnostic device according to an optional embodiment of the present invention.

Figure 10 illustrates a conceptual arrangement of the reading system of a lateral flow type radial symmetry diagnostic device illustrated in Figures 5 to 8.

DETAILED DESCRIPTION OF THE INVENTION

First of all, it is emphasized that the following description will start from a preferred embodiment of the invention. As will be apparent to any person skilled in the art, however, the invention is not limited to that particular embodiment.

Figure 1 illustrates an exploded view of a lateral flow type radial symmetry diagnostic device according to a first optional embodiment of the present invention, wherein the lateral flow type radial symmetry diagnostic device is capable of performing ten tests. simultaneously.

As can be seen, the radial symmetry diagnostic device comprises a base B and a lid T, wherein the lid T comprises at least two sample inlets 1 and at least two observation windows 2, and the The base B comprises at least one sample acquisition element 3 and at least two test strips 4. The at least one sample acquisition element 3 is common to all adopted test strips 4.

It is emphasized that each observation opening 2 of lid T corresponds to a test strip bed 5 of base B, and to each bed 5 a test strip 4 can be seated.

Alternatively, the test strip bed 5 may have no seated elements. In such cases, it will not be possible to perform any reading from the corresponding observation window 2. As As shown in Figure 1, in an alternative embodiment wherein a T-cap and a B-base with respectively ten observation openings 2 and ten test strip beds 5 are adopted, only five beds 5 may comprise seated test strips 4. Thus, the optional configuration of the lateral flow type radial symmetry diagnostic device illustrated in this figure will be able to take five distinct readings through five observation windows 2, while five other observation windows will not be used.

Therefore, optionally, the number of observation windows 2 adopted and / or number of beds 5 is equal to or greater than the number of test strips 4 adopted. If the number of observation windows 2 is greater than the number of test strips 4, it will be noted that some windows 2 are not used for reading as they will not have test strips 4 to be read. In such cases, a buffer (not shown) may be applied to each of the observation windows 2 which does not comprise associated test strips 4. The tampon would have a purely aesthetic function and is not an essential component of the device.

In addition, cover T and base B comprise a plurality of pins and holes adapted to be engaged such that when cover T and base B are assembled, the lateral flow type radial symmetry diagnostic device is formed. , the pins are inserted into holes preventing relative movement between cover T and base B.

Figure 2 illustrates an exploded view of a lateral flow type radial symmetry diagnostic device for eight simultaneous tests according to a second optional embodiment of the present invention. In this configuration, the cover T comprises eight windows 2 and the base B comprises eight test strips 4 beds 4. In this case, eight test strips 4 are also adopted, one for each bed 5.

Figure 3 illustrates an exploded view of a device lateral flow type radial symmetry diagnostics for nine simultaneous tests according to an optional third embodiment of the present invention. Also in such configuration, the device comprises a base B and a lid T, wherein the lid T comprises two sample inlet openings, a central opening 6 and a peripheral opening 7, and the base B comprises a sample acquisition element. 3, and a channel 8 connecting the peripheral aperture 7 to the central aperture 6.

In the illustrated embodiment, base B comprises nine test strips 4, one associated with each observation window 2 of lid T. However, it is noted that any number of test strips 4 may be adopted, wherein the number of test strips 4 may be equal to or less than the number of observation windows 2.

Figure 4 shows a top view of a lateral flow type radial symmetry diagnostic device for six simultaneous tests according to an optional fourth embodiment of the present invention. In this configuration, at least one labeling region 11, preferably two labeling regions 11, is also provided in cap T. If two labeling regions 11 are adopted, they may be arranged symmetrically.

The lateral flow type radial symmetry diagnostic device described in Figures 1 to 4 is based on the chromatography methodology, in which targets are preferably deposited on nitrocellulose membranes. The test strips are composed of a sample pad 3 region, a preferably glass wool region containing biologically or chemically activated nanoparticles, a membrane containing one or more targets, and a region at the end of the fluidic path with material. sink pad.

As noted, the diagnostic device described herein comprises radial symmetry and can be made with various formats. In addition, the cover T and base B may be manufactured in one piece or multiple parts which, in assembled configuration, form a single diagnostic device.

Optionally, the cover T and base B of the device are made of polymeric material, preferably by some method of 3D prototyping, or injection molding. As already described, both cover T and base B have structures that provide fittings and geometries for holding at least two test strips 4, wherein all test strip beds 5, as well as the test strips 4 themselves, are arranged in a manner. preferably radial within the device.

For mounting the lateral flow type radial symmetry diagnostic device of the invention, a sample acquisition element 3 (sample pad) is placed in the central region of the base B, then the test strips are positioned in the respective beds. Lastly, cap T is snapped and locked onto the base so that the sample inlet opening 1 of cap T is positioned over the sample acquisition element 3.

Optionally thereafter bar code labels 1 and identification label 11 may be affixed to the device cover.

The lateral flow type radial symmetry diagnostic device presented herein was developed to operate in two steps. In a first step, the buffer solution and the antibody and / or antigen (from the positive venous whole blood, serum or human plasma sample) are contacted with a colloidal metal chemically conjugated protein A complex. These are attached to the capture antigen and / or antibody, allowing their chemical binding. This protein complex may be deposited on a glass fiber located a priori on the nitrocellulose strip (test strip), conjugate membrane and conjugate. This device also allows chemical analysis to be performed and / or physical and / or biological, such as diagnostics of pH levels, presence or absence of metals, identification of specific molecular chains, radioactive elements, magnetic or magnetizable materials, and other analytes that can be analyzed simultaneously.

In a second step, and in the case of biological analysis, the running buffer solution is added to the test, allowing the mixture contained in the fluidic system to migrate through the nitrocellulose membrane and pass through the adsorbed antigen or antibody thereon.

Disclosure of the antigen-antibody complex occurs when it is captured by recognition of the antigen or antibody deposited on nitrocellulose, with the immunocomplex formed by the serum antibody and protein A with metal formed in the first step. As recognition occurs over and over again, nanoparticles accumulate on the deposited antigens, generating color and the appearance of banding at the given location.

At the end of or simultaneously with the test, the lateral flow type radial symmetry diagnostic device may be read. Such reading can be done by the naked eye, by a skilled user, with technicians, nurses, doctors, scientist, etc., or by a reading system of a lateral flow type radial symmetry diagnostic device.

Therefore, the invention also provides a reading system for a lateral flow type radial symmetry diagnostic device which performs image acquisition, upon which it will analyze the result. Using fiducial marks on the diagnostic device, the reading system guides the acquired image. This is also corrected to prevent any distortion caused by the optical system. Thus, from the obtained image, the regions containing the information of interest are separated for computational analysis.

[0056] These regions are related and / or compared with the information contained in the bar code or any other graphical representation of numeric or alphanumeric data and provide information regarding the tests contained in the diagnostic device. The information consists of parameters that determine the absence and / or presence of the bands on the test strips, and determine whether this is a valid assay or not.

Figures 5 to 8 illustrate, respectively, perspective, front, side and top views of an optional configuration of a reading system of a lateral flow type radial symmetry diagnostic device as described in the previous paragraph. This system as well as its elements will be described in detail below.

The reading system of a lateral flow type radial symmetry diagnostic device of the invention comprises a variety of operating modules, which: processing and control module 15; communication module 16; storage module (fixed and / or removable); human interface module 12; acquisition optical module 13; georeferencing module 17; and power module 14.

Figure 9 illustrates a block diagram depicting the actuation of the reading system of a lateral flow type radial symmetry diagnostic device according to an optional embodiment of the present invention, and Figure 10 illustrates a conceptual arrangement of the reading system. reading a lateral flow type radial symmetry diagnostic device illustrated in Figures 5 to 8. These figures will aid in understanding the following description.

It is noteworthy that the system may or may not contain each of the listed modules, which may be integral parts of the equipment, extra functionality of the same equipment, or specific or non-removable modules.

Optionally, a system configuration of reading a The lateral flow type radial symmetry diagnostic device of the present invention comprises an optical image acquisition module (such as a camera), an illumination module, a processing and control module 15, and a storage unit, wherein the optical module An image acquisition device 13 acquires an image of a lateral flow type radial symmetry diagnostic device as described above, wherein the image is optionally archived in a storage module.

At a later time, the image is optionally processed and analyzed by hardware or digital logic, and then interpreted by the same software or by the user. The result (interpretation) is obtained from an optical analysis performed by the system itself, or performed by a skilled user.

Additionally, the result may be: qualitative, as "positive" or "negative" for the presence of a particular reagent in the sample; or quantitative, by determining a concentration of a particular reagent in the sample.

Optionally, georeferencing data can be associated with the result. For this, the system can make use of a georeferencing module 17, responsible for generating georeferencing information, such as location and time of the test performed.

More specifically, the processing and control module

15 is responsible for extracting data from the information obtained by other modules, whether or not processing the data, measuring or not the results, administration and integration of one or more other modules. To this end, the processing and control module 15 may be responsible for executing embedded software if required.

In a more essential configuration, in the absence of embedded software, the processing and control module 15 is responsible for interpreting commands sent from an external interface. In this In this case, it acts as an integrator of the other modules.

It is emphasized that different modes of module operation can be obtained with different combinations of different processing, control or processing and control modules.

[0068] Communication module 16 is responsible for importing and exporting data and information from / to other devices via interfaces. These interfaces may employ any known prior art data transfer standards, media and protocols such as Wi-Fi, Bluetooth, electromagnetic waves, USB, ethernet, fiber optics, communication cables, or standards created specifically for this module. . One skilled in the art will appreciate that the choice of data transfer standards, media and protocols used in communication module 16 is not a limiting factor of the present invention, so that any known or further developed technology may be adopted for this purpose.

Optionally, the communication module 16 may be used to assist the processing module in the integration of other modules such as by establishing a wireless communication path between the optical module 13 and the processing module and control 15.

The storage module is responsible for storing the operating system and system-generated data through the various modules, such as equipment operation records for future reference.

The storage module may be fixed and / or removable in nature, whereby removable storage may perform the function of communication module 16, as in some cases it may be used for data transport between devices. and / or modules. By way of illustration only, a removable memory (such as a flash drive) could be used to collect data from the device so that it is only transported to a benchtop computer where this data could be processed and analyzed.

The human interface module 12 aims to promote interaction between a user and the system so that the user can send commands to other modules, view data of interest and perform a plurality of non-automated actions. Thus, the human interface module 12 can enable, for example, a user to start the device, view data or images, access results, among others.

The human interface module 12 can therefore optionally comprise power buttons, command keys, optical display screens, sounders, switches, fingerprint scanners, iris scanners and light emitters, among other elements.

[0074] The acquisition optical module 13 is responsible for the acquisition of luminous data from the tests of interest. It can be composed of a single sensor (such as a photodiode) or sensor panel (such as CCD, CMOS, optical films, phosphor screens, transmission panels), capturing various kinds of optical signals (luminescence, reflection, diffraction and refraction phenomena). etc.) with or without the aid of filters and / or optical arrangements (focal lenses, mirror assemblies, interferometers, etc.) and, if necessary, a controlled lighting environment (darkroom and any light emitters).

The georeferencing module 17 is responsible for making the equipment coordinates known in a given reference system. Initially, we obtain the coordinates of the place to be georeferenced (known as control points), where these coordinates belong to the system in which it is intended to georeference. Control points are perfectly identifiable locations due to physical references, whether natural structures such as roads, rivers, mountains or airport runways.

Control point coordinates can be obtained in the field from topographic surveys, GNSS (Global Navigation Satellite System) or through georeferenced images or maps (paper or digital). Many devices today use georeferencing for various purposes, either for internal control or for safety reasons. Obtaining control points is most often performed using GPS. However, it is understood that a person skilled in the art will be able to define the best georeferencing equipment for the desired application.

Power module 14 is responsible for supplying power to the other integrated modules. The energy supplied can be obtained from external power (conventional sockets, solar panels, dynamos, etc.) or internal reserve, such as batteries, rechargeable or not. It is also responsible, if necessary, for voltage transformation and rectification, electric current filtering and signal stabilization. This module can be internal, partially internal or fully external.

Preferably, the processing and control module 15 is responsible for managing all other reading system modules of a lateral flow type radial symmetry diagnostic device of the system. To this end, the processing and control module 15 comprises busbars and sockets adapted to provide coupling of the other modules.

Optionally, the system provides power from an external power grid, wherein the power module 14 comprises means for performing the conversion and provision of power supply to the other modules. For this, the power module 14 is optionally in communication with the processing and control module 15 via bus and / or wiring suitable for the electrical current required by the processing and control module 15.

Optionally, communication between the processing and control module 15 and the power module 14 may include cables or data bus to inform the processing and control module 15 of power conditions such as battery level and any problems. of supply of electric current.

The power module 14 may optionally comprise means for performing filtration and electrical protection. With this, the other modules are protected from possible oscillations in the external power grid.

In addition, modules with a current requirement greater than the supply capacity of the processing and control module 15 must be connected directly to the power module 14. In this case, the human interface module 12, acquisition optical module 13 and, In exceptional cases, the communication module 16 may have suitable buses with this function, being connected directly to the power module 14.

The human interface module 12 may be connected to the processing and control module 15 directly via bus and / or cabling appropriate to the data traffic needs of the components or devices used for this purpose. Interfaces such as HDMI, VGA or DVI, among other possible graphical interfaces may be included in this module, as well as a display.

Additionally, human interface module 12 may comprise peripheral input devices such as keyboards, mice, touch membranes, among others. These peripheral input devices are optionally used for a user to send commands to the system, or to view and receive instructions. Peripheral devices of input can be connected by independent bus and / or cabling, or via the same display interface.

The acquisition optical module 13 may be connected to the processing and control module 15 directly via bus and / or cabling suitable for the data traffic needs of the components or devices used for this purpose. This module comprises, besides the electronic components, an optical arrangement suitable for the application, such as light cone, mirror arrangements, among others.

Optionally, the storage module is connected to the processing and control module 15 directly via bus and / or cabling appropriate to the data traffic needs of the components or devices used for this purpose. As already described, the storage module may or may not be used exclusively for the storage function, so that if the storage module is a mobile module, such as when a USB device is used for this purpose, this module It can also be used as a communication element, used to export or import data to the processing and control module 15.

Optionally, the communication and georeferencing modules 17 may be connected to the processing and control module 15 directly via buses and / or wiring suitable for the data traffic needs of the components or devices used for this purpose. Both communication and georeferencing modules 17 may comprise communication antennas or similar function structures to meet specific needs, which may or may not be shared with other modules.

In view of the above, it is clear that the invention described solves the problems of the state of the art by providing a lateral flow type radial symmetry diagnostic device which allows perform multiple diagnostics of interest on a single device more efficiently, effectively and compactly.

In addition, the present invention also provides a reading system of a lateral flow type radial symmetry diagnostic device capable of performing simultaneous point-of-care, modular, low cost imaging integrated imaging and easy operation. Such a system can optimally perform the capture, storage, processing, analysis and / or interpretation of test images obtained by a lateral flow test device.

It is noteworthy that numerous variations on the scope of protection of this application are permitted. Accordingly, it is emphasized that the present invention is not limited to the particular embodiments / embodiments described above.

Claims

1. Side-flow type radial symmetry diagnostic device, characterized in that it comprises a base (B) and a cover (T) wherein

lid (T) comprises at least one sample inlet opening (1) and at least two observation windows (2), and

base (B) comprises at least one sample acquisition element (3) and at least two test strip beds (5),

wherein each observation opening (2) of the lid (T) corresponds to a test strip bed (5) of the base (B), and in each bed (5) a test strip (4) may be seated,

where the number of observation windows (2) is equal to or greater than the number of test strips (4), and the number of beds (5) is equal to or greater than the number of test strips (4),

wherein the at least one sample acquisition element (3) is in communication with the at least two test strips (4).

Device according to Claim 1, characterized in that at least one observation window (2) comprises at least one buffer.

Device according to claim 1 or 2, characterized in that the lid (T) and the base (B) comprise a plurality of pins and holes adapted to be engaged, wherein when the lid (T) and the base ( B) are in mounted position, the pins are inserted into holes preventing relative movement between the cover (T) and the base (B).

Device according to any one of claims 1 to 3, characterized in that the lid (T) comprises a central sample opening (6) and a peripheral sample opening (7), and the base B comprises an acquisition element. sample port (3), and a channel (8) connecting the peripheral sample port (7) to the sample port central (6).

Device according to any one of claims 1 to 4, characterized in that the lid (T) comprises at least one labeling region (11).

Device according to any one of claims 1 to 5, characterized in that the lid (T) and the base (B) are made of polymeric material.

Reading system of a lateral flow type radial symmetry diagnostic device comprising: an optical image acquisition module (13), an illumination module, a processing and control module (15), and a where:

the optical image acquisition module (13) is adapted to perform image acquisition of a lateral flow type radial symmetry diagnostic device as defined in one of claims 1 to 6; and the processing and control module (15) is adapted to manage and extract information from other system modules.

System according to claim 7, characterized in that it further comprises at least one of: a storage communication module (16); a human interface module (12); a georeferencing module (17); and a power module (14).

System according to claim 7 or 8, characterized in that the communication module (16) is adapted to: import and export data and information from / to other devices via interfaces; and integrate the other system modules.

System according to any one of claims 7 to 9, characterized in that the storage module is responsible for storing the operating system and the data generated by the system, wherein the storage module is fixed or removable in nature.

System according to any one of claims 7 10, characterized in that the human interface module (12) comprises means for providing interaction between a user and the system, wherein the human interface module (12) comprises at least one of: power buttons; command keys; screens for optical display; sound emitters; switches; fingerprint scanners; iris scanners; and light emitters.

System according to any one of claims 7 to 11, characterized in that the acquisition optical module (13) comprises at least one of: a single sensor; a sensor panel; optical filters; optical arrangements; focal lenses; mirror sets; interferometers; and a controlled lighting chamber.

System according to any one of claims 7 to 12, characterized in that the georeferencing module (17) is adapted to make the equipment coordinates known in a given reference system, wherein the coordinates of the control points are obtained by means of GPS

System according to any one of Claims 7 to 13, characterized in that the power supply module (14) is adapted to supply power to the other system modules, where power is obtained from one of: external network; an alternative energy source; and internal reserve.

System according to any one of claims 7 to 14, characterized in that the power module (14) comprises means for performing filtration and electrical protection.