Diagnostic device

Abstract

A diagnostic device comprising a lateral flow strip, at least one radiation emitter positioned on a first side of the lateral flow strip and configured to transmit radiation through the lateral flow strip, and at least one radiation detector positioned on a second side of the lateral flow strip, wherein the radiation detector is configured to detect radiation transmitted by the radiation emitter through the lateral flow strip.

Description

[0001] DIAGNOSTIC DEVICE

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a diagnostic device, and a method of manufacturing a diagnostic device.

[0004] BACKGROUND TO THE INVENTION

[0005] Diagnostic devices which use a lateral flow strip are widely known. In general, a sample is applied to the lateral flow strip, and the lateral flow strip is used to detect the presence or absence of a specific target substance in a sample fluid. The target substance may be, for example, an antigen, a hormone (including but not limited to a hormone indicating pregnancy), another biological substance, or any other detectable substance.

[0006] In such lateral flow strips, when the target substance is detected, a line appears on the lateral flow test, to provide a visual indication that the target substance has been detected. Such a line is typically known as a “test line”. Lateral flow strips also typically include a control line, which appears when the reporter particles for visual indication are not captured by the test line and are instead captured by the control line, and is used to indicate that the test has worked correctly. That is, the control line does not indicate the presence of the substance to be detected, but rather serves as an indicator that the strip is functional.

[0007] Typically, in conventional arrangements, a lateral flow strip is typically enclosed inside a housing. This allows the lateral flow strip (which is a typically a thin piece of material (to be held robustly, and for other functions of the diagnostic device to be integrated into the housing.

[0008] In some known arrangements, the lateral flow strip is visible through an aperture in the housing, which allows the user to observe whether the control and or test lines have appeared on the lateral flow strip or not. However, these devices have the drawback they require manual observation from the user, and may provide results which are ambiguous to the user. In other known arrangements, a light and detector are integrated into the housing of the diagnostic device. In particular, the light and detector are positioned on one side of the lateral flow strip, so that the light emits light towards a lateral flow strip, and the light is reflected off the lateral flow strip towards the detector. Depending on whether the control and or test lines have appeared or not, different amounts of light are reflected, which allows the detector to process the result of the test, and output a result on a display to the user which is unambiguous. However, such arrangements may have the disadvantage that a complex arrangement of baffles and / or housing is required to enable the light to be reflected in a manner which provides a reliable result.

[0009] Further, the above conventional devices are typically time consuming and expensive to manufacture, because they are manufactured by producing the lateral flow strip and housing separately, with an upper and lower portion of the housings. The lateral flow strip is then manually placed in the correct position inside the bottom half of the housing, and the top half of the housing is positioned on top so as to form the rest of the device. Such housings are typically formed by injection mouldings. Such manufacturing methods may be time consuming and expensive.

[0010] It is an object of the present invention to at least partially address the problems noted above.

[0011] SUMMARY OF THE INVENTION

[0012] According to the present disclosure, there is provided a diagnostic device comprising a lateral flow strip, at least one radiation emitter positioned on a first side of the lateral flow strip and configured to transmit radiation through the lateral flow strip, and at least one radiation detector positioned on a second side of the lateral flow strip, wherein the radiation detector is configured to detect radiation transmitted by the radiation emitter through the lateral flow strip.

[0013] Optionally, the diagnostic device comprises a plurality of radiation emitters.

[0014] Optionally, the diagnostic device comprises a plurality of radiation detectors. Optionally, the number of radiation emitters is equal to the number of radiation detectors.

[0015] Optionally, the lateral flow strip has a plurality of lines, the lines being test lines and / or control lines, and the number of radiation emitters and / or the number of radiation detectors is equal to the number of lines.

[0016] Optionally, each line is aligned with a respective radiation emitter and radiation detector.

[0017] Optionally, at least one radiation emitter and radiation detector are aligned in an area of the lateral flow strip where no control or test line is present.

[0018] Optionally, the radiation emitter is configured to emit electromagnetic radiation.

[0019] Optionally, the radiation emitter is configured to emit one or more of visible light, infrared light, and ultraviolet light.

[0020] Optionally, the radiation emitters are light emitting diodes.

[0021] Optionally, the radiation emitter is a controllable display.

[0022] Optionally, the radiation emitter is configured to emit radiation having a wavelength corresponding to a wavelength absorbed or attenuated by a line on the lateral flow strip, the line being a control line and / or a test line.

[0023] Optionally, the radiation detectors are photodiodes and / or phototransistors.

[0024] Optionally, the diagnostic device further comprises a controller configured to receive an output from the radiation detector and determine a test result.

[0025] Optionally, the controller is configured to determine a detection result based on a threshold quantity detected or difference value measured by the radiation detector.

[0026] Optionally, the device further comprises a radiation filter configured to prevent radiation from the emitter from reaching at least a part of the lateral flow strip. Optionally, the radiation filter is on the same side of the lateral flow strip as the emitter.

[0027] Optionally, the radiation filter includes one or more openings configured to allow the passage of radiation and one or more blocking portions configured to block radiation.

[0028] Optionally, the radiation filter is configured to reduce the divergence angle of the radiation from the emitter relative to at least one plane perpendicular to the lateral flow strip.

[0029] Optionally, the radiation filter includes a respective region allowing transmission of the radiation wavelengths emitted by each of the one or more emitters.

[0030] Optionally, the radiation filter includes a first layer with at least one opening and a first blocking portion, a second layer with at least one opening and a second blocking portion, and a third layer intermediate the first and second layers, the third layer allowing the passage of radiation therethrough.

[0031] Optionally, the device further comprises a liquid sensor configured to trigger activation of the radiation emitter and / or the radiation detector upon detection of a liquid.

[0032] Optionally, the device further comprises a housing, wherein the lateral flow strip, at least one radiation emitter and at least one radiation detector are positioned inside the housing.

[0033] Optionally, the first and second sides of the lateral flow strip are opposed planar surfaces of the lateral flow strip.

[0034] Optionally, the lateral flow strip comprises a desiccant.

[0035] Optionally, the device further comprises one or more of a sample collection material or structure, a formable light barrier material, a material with conductive traces, a battery; a liquid detection sensor, a non electrically conducting pull tab positioned over at least one conductive track and / or between at least two conductive tracks, an adhesive layer, at least one antenna for wireless transfer of data, and a display configured to visually communicate the operational status and result of the test. According to the present disclosure, there is also provided a method of manufacturing a diagnostic device, the method comprising providing a housing template, positioning a lateral flow strip, at least one radiation emitter and at least one radiation detector on the housing template, and folding and / or selectively joining and / or and cutting parts of the housing template so as to form a housing enclosing the lateral flow strip, the radiation emitter and the radiation detector, such that radiation emitter is positioned on a first side of the lateral flow strip and configured to transmit radiation through the lateral flow strip, the radiation detector is positioned on a second side of the lateral flow strip, and the radiation detector is configured to detect radiation transmitted by the radiation emitter through the lateral flow strip.

[0036] Optionally, the housing template is initially flat.

[0037] Optionally, the method further comprises forming the housing template using a forming process, to thereby change the shape of the housing template.

[0038] Optionally, the radiation emitter and / or the radiation detector are positioned on the housing template before the forming step.

[0039] Optionally, the lateral flow strip is positioned on the housing template after the forming step.

[0040] Optionally, the method further comprises positioning further components on the housing template before the forming step.

[0041] Optionally, the further components include at least one conductive track.

[0042] Optionally, the method further comprises positioning further components on the housing template after the forming step.

[0043] Optionally, the forming step includes forming one or more cavities in which one or more components are disposed. Optionally, the further components include one or more of a sample collection material or structure, a formable light barrier material, a material with conductive traces, a battery, a liquid detection sensor, a non electrically conducting pull tab position over at least one conductive track and / or between at least two conductive tracks, a pressure sensitive adhesive on at least one surface, a controller configured to process radiation detector outputs and controlling radiation emitters, at least one antenna for wireless transfer of data, and a display configured to visually communicate the operational status and result of the diagnostic test.

[0044] Optionally, the forming process is vacuum forming and / or thermoforming and / or high pressure forming.

[0045] Optionally, the method further comprises forming a hinge on the housing template to allow said folding of the housing template.

[0046] Optionally, the housing template comprises a first portion and a second portion, and the housing template is folded at a junction between the first portion and the second portion, wherein after the housing template is folded to form the housing, the first portion is disposed adjacent the first side of the lateral flow strip, and the second portion is disposed adjacent to the second side of the lateral flow strip.

[0047] BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The present invention will now be described, by way of non-limitative example only, with reference to the accompanying drawings, in which:

[0049] Figure 1 shows a section view of a diagnostic device;

[0050] Figure 2 shows a view of the device of figure 1, with a test line visible on the lateral flow strip;

[0051] Figure 3 shows a section view of a further arrangement of diagnostic device;

[0052] Figure 4 shows a section view of a further arrangement of diagnostic device; Figure 5a shows a first step of a method of manufacture;

[0053] Figure 5b shows a second step of a method of manufacture;

[0054] Figure 5c shows a third step of a method of manufacture;

[0055] Figure 5d shows a fourth step of a method of manufacture;

[0056] Figure 6a shows a first step of a further method of manufacture;

[0057] Figure 6b shows a second step of a further method of manufacture;

[0058] Figure 6c shows a third step of a further method of manufacture;

[0059] Figure 6d shows a fourth step of a further method of manufacture;

[0060] Figure 7 shows a variation on figure 5c; and

[0061] Figure 8 shows a variation on figure 5d.

[0062] DETAILED DESCRIPTION

[0063] The present invention relates to a diagnostic device 10. The diagnostic device may be any device which is used to detect the presence or absence of a particular target substance in a sample. For example, the substance may be, for example, a protein, a substance indicative of the presence of a disease or disorder, or a hormone. It will be understood that any other biological substances or non-biological substance may also be identified by the diagnostic device.

[0064] An example of such a diagnostic device is shown in figures 1 and 2. The diagnostic device includes a lateral flow strip 11. The lateral flow strip may be of any suitable type, and may be chosen depending on the desired type of detection. It will be understood that figures 1 and 2 are a schematic side view of the device, and is not drawn to scale. In particular, the thickness of the lateral flow strip (i.e. the vertical direction when shown in side view) is exaggerated. The thickness of the lateral flow strip may be, for example (but is not limited to), 200-250pm.

[0065] As shown in figures 1 and 2, the diagnostic device 10 further includes a radiation emitter 12, and a radiation detector 13. The device may further comprise a housing 14 in which the lateral flow strip 11, the radiation emitter 12, and the radiation detector 13 are positioned.

[0066] As depicted in figures 1 and 2, the radiation emitter 12 is positioned on a first side of a lateral flow strip. The radiation emitter 12 is also configured to transmit radiation through the lateral flow strip 11.

[0067] The radiation detector 13 is positioned on a second side of the lateral flow strip. That is, the radiation detector is positioned on an opposite side of the lateral flow strip to the radiation emitter. It will be understood that, in this context, the term “side” refers to the planar faces of a thin strip.

[0068] Thus, the radiation detector 13 is configured to detect radiation which is emitted by the radiation emitter 12 and transmitted through the lateral flow strip 11. That is, radiation is emitted by the radiation emitter 12, passes through the lateral flow strip, and is detected by the radiation detector 13 after it has passed through (i.e. been transmitted through) the lateral flow strip.

[0069] In some arrangements, the radiation emitted by the radiation emitter is electromagnetic radiation, and may be, for example, visible light, infrared light, or ultraviolet light, or any combination thereof. Examples of suitable radiation emitters are light emitting diodes (LEDs), including inorganic LEDs, micro LEDs, and arrays of organic LEDs. In some arrangements, the radiation emitter may be coupled to phosphors.

[0070] The radiation detector may be any suitable detector configured to detect the type of radiation which is emitted by the radiation emitter. For example, in the case of the radiation being visible light, infrared light or ultraviolet light, the radiation detector may be a photodiode and / or a phototransistor. The wavelength of the emitted radiation may be chosen such that substantially all of, or the majority of, the radiation emitted by the radiation emitter 12 is transmitted thought the lateral flow strip when the lateral flow strip is in its unused state (or has been used but has not provided a positive indication by virtue of a line appearing on the strip). That is, the wavelength may be chosen such that the lateral flow strip, when unused or not showing a positive indication, is substantially transparent to the radiation. This is shown by arrow A in figure 1.

[0071] The wavelength of the emitted radiation may also be chosen such that when the lateral flow strip has been used and absorbent reporter particles, which absorb at the wavelength or wavelengths emitted, are tethered in the test / control line position, the absorption (and / or attenuation) of the radiation in the region(s) of the strip where a line is present is higher than the strip in its unused state (or has been used but has not provided a positive indication by virtue of a line appearing on the strip). This is shown in figure 2, where a test line 15 is has tethered reporter particles (and is thus visible in the figure), and, as indicated by arrow B, a portion of the radiation has been absorbed by the line on lateral flow strip 11. In order to provide this functionality, the radiation emitter 12 and the radiation detector 13 may be positioned such that the radiation detector intercepts the transmitted beam from the radiation emitter, where the beam has travelled through a line on the strip (which may be a test line and / or a control line), as shown in figure 2. This may be done by aligning the detector and transmitter with a line on the lateral flow strip, or by other suitable positioning.

[0072] As shown in figures 1 and 2, the change in the amount of radiation transmitted through the lateral flow strip when a control and or test line is present, may allow the result of the lateral flow strip to be detected by the radiation detector 13. That is, the result of the lateral flow strip is determined with reference to the amount of radiation detected by the radiation detector 13.

[0073] Although not depicted in figures 1 and 2, the diagnostic device 10 may further comprise a controller. The controller may be configured to process outputs of the radiation detectors and to control the radiation emitters. In particular, the controller may be configured to receive an output signal from the radiation detector. The signal output from the radiation detector to the controller may be processed by the controller, which may in turn allow the result of the test to be determined. This may be done, for example, by judging the output of the radiation detector relative to a threshold quantity. In other words, when the radiation detector detects a result which is higher than a threshold (because no line has appeared on the lateral flow strip and thus no increase in absorption / attenuation has occurred), a negative or failed result may be determined, and when the radiation detector detects a result which is lower than the threshold (because a line has appeared on the lateral flow strip and thus an increase in absorption / attenuation has occurred), a positive result may be determined. It will be understood that the detection result may be determined either by a change in absolute value of detected radiation, or by a change in relative value of detected radiation (e.g. relative to the value detected by a radiation detector positioned and operated to measure the absorption of an area of the lateral flow strip which is not a test line or control line). The threshold quantity may be pre-determined, depending on the properties of the lateral flow strip and the radiation emitters used.

[0074] In addition, during the operation of the, test the amount of absorption can change. For test lines and control line regions, an initial increase in absorption level can occur as the reporter particles flow through the test and control lines. For a positive result, where the number of absorption particles is tethered at the test and control line, the density of particles may increase over time, which may result in increased absorption over time, leading to a reducing level of detected radiation at the radiation detector over time. Such a gradual reduction may be used to detect a positive test result. For a negative test, the absorption of the radiation (due to the density of reporter particles in the vicinity of the test line) may initially increase due to flow-through, but as the test progresses the absorption amount may reduce. Thus, within a certain time period, there may be a reduction in absorption at the test line (leading to an increasing level of detection at the radiation detector over time). This may signify (and be used to detect) a negative test, as long as there is an increase in absorption at the control line. If there is a reduction in absorption at control line at a certain time period after the start of the test, this test may be deemed to have failed.

[0075] Although the arrangement of figures 1 and 2 depict a lateral flow test with a single line, and a corresponding device with a single radiation emitter 12 and radiation detector 13, arrangements are also possible in which multiple lines are provided on the lateral flow strip. For example, the lateral flow strip may comprise two lines, namely one control line and one test line, as described above. Further arrangements are possible in which the lateral flow light test includes a plurality of test lines along with, optionally, a control line.

[0076] In such arrangements, a plurality of radiation emitters and a plurality of radiation detectors may be used. In some arrangements, the number of radiation emitters may be equal to the number of radiation detectors. Further, in such arrangements, the number of radiation detector and emitter pairs may correspond to (i.e. be equal to) the number of lines on the lateral flow strip. That is, each test and or control line of the lateral flow strip may be associated with and / or aligned with a respective radiation emitter and radiation detector. This may allow for example, a lateral flow strip which tests for a plurality of different substances to be used. In other arrangements, the number radiation detector and emitter pairs may be greater than the number of lines on the lateral flow strip.

[0077] Figure 3 illustrates an example of such an arrangement. The arrangement of figure 3 is similar to that of figures 1 and 2, but includes a plurality of radiation emitters and a plurality of radiation detectors, as well as other components, as will be described below. It will be understood that components from figure 3 may also be incorporated into the arrangement of figures 1 and 2, and that components from figure 3 may also be omitted.

[0078] In the arrangement of figure 3, diagnostic device includes a first radiation emitter 32a and a second radiation emitter 32b, and a first radiation detector 33a and second radiation detector emitter 33b.

[0079] As shown in figure 3, the lateral flow strip 31, when used, has two lines. The first line 35a may be, for example, a test line, and the second line 35b may be, for example, a control line. As will be seen from figure 3, the first radiation emitter 32a and the first radiation detector 33a are aligned with the first line 35a, and the second radiation emitter 32b and the second radiation detector 33b are aligned with the second line 35b.

[0080] In the arrangement of figure 3, the device also includes a radiation filter 36 configured to prevent radiation from the radiation emitters from reaching at least a part of the lateral flow strip. This may reduce the divergence of the beam of radiation passing through the test and / or control lines. That is, the radiation filter 36 allows regions of the lateral flow strip (e.g. the regions at which a line can appear) to be selectively illuminated, rather than radiation from the emitters illuminating larger portions of the strip (which may result in erroneous detection from scattered or reflected radiation reaching the active radiation detector).

[0081] In the arrangement shown in figure 3, the radiation filter 36 includes openings 37 configured to allow the passage of radiation, and one or more blocking portions 38 (or barriers) configured to block radiation. This may reduce the divergence of the radiation from the emitter in at least one plane parallel to the lateral flow strip. That is, the radiation filter 36 may act as a collimator, slit or aperture.

[0082] In the arrangement of figure 3, the radiation filter is on the same side of the lateral flow strip as the radiation emitters. This may provide improved reduction in unwanted scattering and reflections. However, other arrangements are possible in which a radiation filter is additionally or alternatively provided on the same side of the lateral flow strip as the radiation detectors.

[0083] In the arrangement of figure 3, the radiation filter 36 includes a first layer 36a with openings and blocking portions, a second layer 36b with openings and blocking portions, and a third layer intermediate the first and second layers. The third layer allows the passage of radiation therethrough. Such an arrangement, with three layers, may provide improved reduction in unwanted scattered and reflected light reaching the radiation detector.

[0084] As well as providing selective blocking (i.e. selectively allowing passage) of radiation, the radiation filter may also include regions which allow or block transmission of the radiation wavelengths emitted by each of the one or more emitters. For example, rather than openings (which may allow substantially all wavelengths to pass), the radiation filter may include regions which allow only certain wavelength to pass.

[0085] Although the arrangement of figure 3 includes a radiation filter, it will be understood that in other arrangements, the radiation filter may be omitted. Likewise, although a particular structure has been described above and is depicted in figure 3, it will be understood that any suitable arrangement which prevents radiation from the radiation emitters from reaching at least a part of the lateral flow strip. For example, a single layer with one or more openings may be used.

[0086] The device may include further components. A battery 39 may be provided, to provide electrical power to the components of the device. The battery 39 may be connected to other components of the device by one or more conductive tracks or traces. In order to prevent inadvertent activation of the device, at least one of the conductive tracks may be covered by a pull tab formed of an electrically non-conductive material. The device may also include an antenna for transferring data (e.g. the detected result of the test) wirelessly to another device and / or a display to visually communicate the operational status and result of the test to the user. A label 39 may also be provided on the top surface of the device, which may be attached using a pressure sensitive adhesive 41. It will be understood that any subset of the above further components may be provided in the device.

[0087] Although the arrangements describe above use light emitting diodes as radiation emitters, other arrangements of radiation emitter are possible. For example, rather than a plurality of individual radiation emitters, there may be a single radiation emitter taking the form of a controllable display or linear array of organic light emitting diodes. In other words, regions of the controllable display can be readable or unreadable (e.g. lit or unlit). This may allow selective control over the location at which the radiation (e.g. light) is emitted, so as to selectively illuminate particular lines on the lateral flow strip.

[0088] In the arrangement described above, the activation of the radiation emitter and or radiation detector may be triggered by a liquid sensor provided in the device. That is, when the liquid sensor detects the presence of a liquid (i.e. the analyte), the emitters and detectors may be activated so as to be able to detect the result of the test. This may result in reduced power consumption because the device is powered off when not needed.

[0089] As an alternative mechanism for triggering activation of the radiation emitter and or radiation detector, there may be a further radiation emitter and detector which are not aligned with a position at which the lateral flow strip shows a line. In such regions, when the analyte liquid reaches the respective region of the lateral flow strip, there may be a change in the transmissivity of the lateral flow strip, which can be detected by the change in the amount of radiation transmitted through the lateral flow strip. Thus, this change in transmissivity may be used as a liquid detection mechanism. In turn, this liquid detection mechanism may trigger the activation of the remaining radiation emitters and or detectors. Again, in such an arrangement, the radiation emitters and detectors which are not used until the analyte is provided on the lateral flow strip can be maintained in a switched off state until they are required.

[0090] Figure 4 depicts an example of such an arrangement. The arrangement of figure 4 is similar to that of figure 3, and description of features which are common to both arrangements will not be repeated. Unlike the arrangement of figure 3, the arrangement of figure 4 includes four radiation emitters 32a-d and four radiation detectors 33a-d. The lateral flow strip is configured to show three lines 35a-c (which may be any combination of test and control lines).

[0091] As shown in figure 4, each of lines 35a, 35b and 35c is aligned with a respective radiation emitter and radiation detector. In other words, emitter 32a and detector 33a are aligned with line 35a, emitter 32b and detector 33b are aligned with line 35b, and emitter 32c and detector 33c are aligned with line 35c. However, emitter 32d and detector 33d are not aligned or associated with a line on the lateral flow strip. As described above, this may be used as a wet detection mechanism, which may in turn be used to trigger activation of the other emitters and detectors and / or other components of the device.

[0092] In the arrangements described above, the number of radiation emitters and radiation detects is equal. That is, for each radiation emitter, there is a single corresponding radiation detector, and vice versa. However, arrangements are also possible in which a radiation detector is configured to detect radiation from more than one radiation emitter. For example, different emitters may emit light of different wavelengths, and the wavelengths may be used by the radiation detector to distinguish between radiation from different sources. Arrangements are also possible in which a radiation emitter emits radiation which is detected by more than one detector. For example, radiation from one emitter may be guided to more than one line on the lateral flow strip, and detected by a respective detector corresponding to a respective line.

[0093] The diagnostic devices of the present disclosure may be manufactured by any suitable method. However, a particularly advantageous method uses a housing template, which is used to provide part or all of the housing of the device. In such a method, in order to assemble the device, various components of the device can be placed on the housing template. For example, a lateral flow strip, at least one radiation emitter, and at least one radiation detector may be positioned on the housing template.

[0094] Then, the housing template may be manoeuvred so as to produce the housing, with the components enclosed by the housing. The manoeuvring may include at least one of folding the housing template, selectively joining parts of the housing template, and cutting parts of the housing template. In some arrangements, a hinge portion may be formed on the housing template to allow folding of the housing template. It will be understood that any combination of these processes may be used in order to provide the housing. This may provide a diagnostic device as described above, namely with a housing enclosing the lateral flow strip, a radiation emitter and a radiation detector, with the radiation emitter positioned on a first side of the lateral flow strip and configured to transmit radiation through the lateral flow strip, the radiation detector positioned on a second side of the lateral flow strip, and the radiation detector being configured to detect radiation transmitted by the radiation emitter through the lateral flow strip. It will be understood that the term “fold” may mean a sharp angular fold to align the left part of the template to the right part of the substrate with high precision, or may encompass other types of fold.

[0095] In some arrangements, the housing template may be initially flat. If a very simple housing design is required, the housing may be produced merely by folding the flat housing template so as to form the desired housing shape (with the components of the device enclosed therein), and joining parts of the housing as required.

[0096] However, in other arrangements, a more complex housing shape may be desirable. In such arrangements, an initially flat housing template may first have some components, such as conductive tracks, added, before having its shape changed by a forming process (such as a high pressure forming, vacuum forming or thermoforming process) so that it is no longer flat. Additional components may then be positioned on the housing template. This may allow a more complex shape of housing to be provided using a simple manufacturing step. A further advantage of this arrangement is that the shape of the housing can be made to any desired shape before certain components (which may be sensitive to pressure and / or heat) are positioned on the template. It will also be understood that in some arrangements, of the components may be added after the forming process.

[0097] In some arrangements, the housing template can be considered to comprise a first portion and a second portion, with the housing template being folded at a junction between the first portion and the second portion. The junction may be, for example, a fold line or a hinge portion. Thus, after the housing template is folded to form the housing, the first portion is disposed adjacent the first side of the lateral flow strip, and the second portion is disposed adjacent the second side of the lateral flow strip.

[0098] In some arrangements, the method may comprise positioning further components on the housing template, prior to the step of folding. These components may correspond to any of the components described above in relation to figures 1-4. For example, a sample collection material or structure may be provided. Alternatively or additionally, one or more of a formable light barrier material, a material with conductive traces, a battery, conductive tracks or traces, a pull tab formed of an electrically non-conductive material, a liquid detection sensor, a controller, an antenna, a display and / or indicator, a label, and a pressure sensitive adhesive may be provided. It will be understood that any subset of the above further components may be provided in the device.

[0099] Figures 5a-5d schematically depict an example method of manufacturing a device similar to that depicted in figures 1 and 2. It will be understood that these figures are not to scale, and are intended merely to illustrate the principle used in the method of manufacture.

[0100] As shown in figure 5a, a housing template 51 (or substrate) is first provided. The housing template may be a piece of material which is initially substantially flat, which is used to produce the housing.

[0101] As shown in figure 5b, the housing template is then subjected to a forming process (e.g. high pressure forming, vacuum forming, or thermoforming) to change its shape. After the forming step, as shown in figure 5c, components (in this example, a radiation detector, a radiation transmitter, and a lateral flow strip) are positioned on the housing template. The components may be positioned using, for example, pick and place, or peel bar applicators. The position of the components in the finished housing may be determined by their position on the housing template. For example, components which are desired to be on opposite walls of the housing may be positioned on opposite sides of the region which is folded.

[0102] Finally, as shown in figure 5d, the housing template is folded so as to provide the housing, with the components positioned as described above in relation to figures 1 and 2. The parts of the housing which come into contact with each other may be joined using a range of methods, including but not limited to ultrasonic welding, application of a pressure sensitive adhesive, laser welding, RF welding, and heat sealing.

[0103] Figures 6a-6d schematically depict a further example method of manufacturing a device similar to that depicted in figure 4.

[0104] As shown in figure 6a, a housing template 61 (or substrate) is first provided. The housing template 61 may be a piece of material which is initially substantially flat, which is used to produce the housing. As shown in figure 6b, the housing template is then subjected to a forming process (e.g. high pressure forming or thermoforming) to change its shape. It will be noted that a hinge portion 62 is provided, which may allow (or ease) accurate folding of the housing template. The hinge portion may be produced as part of the forming process, or by scoring the housing template, or by otherwise removing some material from the housing template. In some arrangements, the hinge portion may be scored such that the entire thickness of the material is cut through in some regions, and only partially through the thickness of the material in other regions. This may provide improved folding properties.

[0105] After the forming step, as shown in figure 6c, components (in this example, the components shown in figure 4 and described above) are positioned on the housing template. The components may be positioned using, for example, pick and place, or peel bar applicators. The position of the components in the finished housing may be determined by their position on the housing template. For example, components which are desired to be on opposite walls of the housing may be positioned on opposite sides of the region which is folded. Finally, as shown in figure 6d, the housing template is folded so as to provide the housing, with the components positioned as described above in relation to figure 4. The parts of the housing which come into contact with each other may be joined using a range of methods, including but not limited to ultrasonic welding, application of a pressure sensitive adhesive, laser welding, RF welding, and heat sealing.

[0106] In some methods, certain components may be disposed on the housing template before the forming process (i.e. between the arrangements shown in figures 5a and 5b, or figures 6a and 6b). For example, conductive traces may be printed on the housing template, and other components (in particular heat-resistant components) may be attached using conductive pastes, anisotropic conductive pastes or anisotropic conductive tapes. Likewise, the radiation detectors and radiation emitters may be placed on the housing template either before the forming process, or after the forming process.

[0107] Although in figures 5 and 6, the components are shown as being mounted on the surface of the housing template, and protruding into the cavity in the housing, in some arrangements, certain components may be recessed so that they are flush with, or below (i.e. do not protrude beyond) the surface of the housing template. For example, as depicted in figure 7 (which is a variant of figure 5), the radiation emitter 12 and radiation detector 13 may be recessed in a cavity. The cavity may be produced as part of the forming process set out above, and (depending on the type of electronic component), the component may be placed on the housing template before or after the forming process. The positioning of such components in a cavity may aid in preventing those components from pressing on, or coming into contact with, the lateral flow strip, which may cause the lateral flow strip to malfunction. Although this arrangement has been depicted as a variation to figure 5c, it will be understood that the principle of producing a cavity, in which a component is disposed, as part of the forming process, may be applied to any of the arrangements and components set out above.

[0108] In some arrangements (including those described above), the housing template may be provided with alignment or retention features, which aid in the positioning and / or retention of components when the housing is in the folded state. An example of this is pillar 64, which, as shown in figure 6c, protrudes from the housing template. The pillar 64 is positioned so that when the housing is folded, the pillar holds a component (in this example, a battery) in place (and thus acts as a retention feature).

[0109] It will also be understood that alignment features may also be used to keep the upper and lower surfaces of the housing in position (i.e. alignment) relative to each other (e.g. by a pillar spanning between the upper and lower surfaces, to thereby maintain the spacing between the surfaces). An example of this is illustrated in figure 8 (which is a variant of figure 5d), with a pillar 81, which spans the cavity and maintains the spacing between the surfaces of the housing. It will be understood that such a pillar may be integrally formed (or attached to) only one of the upper and lower surfaces, or may be formed of two smaller pillars each attached to a respective surface and are arranged to come into contact with each other when the housing template is folded.

[0110] Although the methods above have been described in general terms, the methods may be advantageously combined with a reel-to-reel manufacturing process. In particular, the various components (or combinations thereof) may be placed onto a roll, and may be brought together using a reel-to-reel process. For example, a plurality of housing templates may be produced on a first roll, and the components which are placed on the housing template may be produced on one or more different rolls. These may then be brought together using a reel-to-reel process so as to position the components on the housing template. The housing template may then be folded (or otherwise manoeuvred to produce the housing), either on the roll, or separately from the roll. This may allow a large number of devices to be manufactured quickly and accurately.

[0111] It should be understood by those skilled in the art that while the present invention has been described with reference to exemplary embodiments, it is not limited to the disclosed exemplary embodiments. Various modifications, combinations, sub-combinations and alterations may occur depending on design requirements and other factors insofar as they are within the scope of the appended claims or the equivalents thereof. Features from any example or embodiment of the present disclosure can be combined with features from any other example or embodiment of the present disclosure.

Claims

CLAIMS1. A diagnostic device comprising: a lateral flow strip; at least one radiation emitter positioned on a first side of the lateral flow strip and configured to transmit radiation through the lateral flow strip; and at least one radiation detector positioned on a second side of the lateral flow strip; wherein the radiation detector is configured to detect radiation transmitted by the radiation emitter through the lateral flow strip.

2. The diagnostic device of claim 1, wherein the diagnostic device comprises a plurality of radiation emitters.

3. The diagnostic device of claim 1 or 2, wherein the diagnostic device comprises a plurality of radiation detectors.

4. The diagnostic device of claim 1, 2 or 3, wherein the number of radiation emitters is equal to the number of radiation detectors.

5. The diagnostic device of any preceding claim, wherein the lateral flow strip has a plurality of lines, the lines being test lines and / or control lines, and the number of radiation emitters and / or the number of radiation detectors is equal to the number of lines.

6. The diagnostic device of claim 5, wherein each line is aligned with a respective radiation emitter and radiation detector.

7. The diagnostic device of any preceding claim, wherein at least one radiation emitter and radiation detector are aligned in an area of the lateral flow strip where no control or test line is present.

8. The diagnostic device of any preceding claim, wherein the radiation emitter is configured to emit electromagnetic radiation.

9. The diagnostic device of any preceding claim, wherein the radiation emitter is configured to emit one or more of visible light, infrared light, and ultraviolet light.

10. The diagnostic device of any preceding claim, wherein the radiation emitters are light emitting diodes.

11. The diagnostic device of any preceding claim, wherein the radiation emitter is a controllable display.

12. The diagnostic device of any preceding claim, wherein the radiation emitter is configured to emit radiation having a wavelength corresponding to a wavelength absorbed or attenuated by a line on the lateral flow strip, the line being a control line and / or a test line.

13. The diagnostic device of any preceding claim, wherein the radiation detectors are photodiodes and / or phototransistors.

14. The diagnostic device of any preceding claim, further comprising a controller configured to receive an output from the radiation detector and determine a test result.

15. The diagnostic device of claim 14, wherein the controller is configured to determine a detection result based on a threshold quantity detected or difference value measured by the radiation detector.

16. The diagnostic device of any preceding claim, wherein the device further comprises a radiation filter configured to prevent radiation from the emitter from reaching at least a part of the lateral flow strip.

17. The diagnostic device of claim 16, wherein the radiation filter is on the same side of the lateral flow strip as the emitter.

18. The diagnostic device of claim 16 or 17, wherein the radiation filter includes one or more openings configured to allow the passage of radiation and one or more blocking portions configured to block radiation.

19. The diagnostic device of claim 16, 17 or 18, wherein the radiation filter is configured to reduce the divergence angle of the radiation from the emitter relative to at least one plane perpendicular to the lateral flow strip.

20. The diagnostic device of any of claims 16-19, wherein the radiation filter includes a respective region allowing transmission of the radiation wavelengths emitted by each of the one or more emitters.

21. The diagnostic device of any of claims 16-20, wherein the radiation filter includes a first layer with at least one opening and a first blocking portion, a second layer with at least one opening and a second blocking portion, and a third layer intermediate the first and second layers, the third layer allowing the passage of radiation therethrough.

22. The diagnostic device of any preceding claim, wherein the device further comprises a liquid sensor configured to trigger activation of the radiation emitter and / or the radiation detector upon detection of a liquid.

23. The diagnostic device of any preceding claim, wherein the device further comprises a housing, wherein the lateral flow strip, at least one radiation emitter and at least one radiation detector are positioned inside the housing.

24. The diagnostic device of any preceding claim, wherein the first and second sides of the lateral flow strip are opposed planar surfaces of the lateral flow strip.

25. The diagnostic device of any preceding claim, wherein the lateral flow strip comprises a desiccant.

26. The diagnostic device of any preceding claim, further comprising one or more of: a sample collection material or structure; a formable light barrier material; a material with conductive traces; a battery; a liquid detection sensor; a non electrically conducting pull tab positioned over at least one conductive track and / or between at least two conductive tracks; an adhesive layer; at least one antenna for wireless transfer of data; and a display configured to visually communicate the operational status and result of the test.

27. A method of manufacturing a diagnostic device, the method comprising: providing a housing template; positioning a lateral flow strip, at least one radiation emitter and at least one radiation detector on the housing template; and folding and / or selectively joining and / or and cutting parts of the housing template so as to form a housing enclosing the lateral flow strip, the radiation emitter and the radiation detector, such that radiation emitter is positioned on a first side of the lateral flow strip and configured to transmit radiation through the lateral flow strip, the radiation detector is positioned on a second side of the lateral flow strip, and the radiation detector is configured to detect radiation transmitted by the radiation emitter through the lateral flow strip.

28. The method of claim 27, wherein the housing template is initially flat.

29. The method of claim 27 or 28, further comprising forming the housing template using a forming process, to thereby change the shape of the housing template.

30. The method of claim 29, wherein the radiation emitter and / or the radiation detector are positioned on the housing template before the forming step.

31. The method of claim 29 or 30, wherein the lateral flow strip is positioned on the housing template after the forming step.

32. The method of claim 29, 30 or 31, further comprising positioning further components on the housing template before the forming step.

33. The method of claim 32, wherein the further components include at least one conductive track.

34. The method of any of claims 29-33, further comprising positioning further components on the housing template after the forming step.

35. The method of any of claims 29-34, wherein the forming step includes forming one or more cavities in which one or more components are disposed.

36. The method of any of claims 32-35, wherein the further components include one or more of: a sample collection material or structure; a formable light barrier material; a material with conductive traces; a battery; a liquid detection sensor; a non electrically conducting pull tab position over at least one conductive track and / or between at least two conductive tracks; a pressure sensitive adhesive on at least one surface; a controller configured to process radiation detector outputs and controlling radiation emitters; at least one antenna for wireless transfer of data; anda display configured to visually communicate the operational status and result of the diagnostic test.

37. The method of any of claims 29-36, wherein the forming process is vacuum forming and / or thermoforming and / or high pressure forming.

38. The method of any of claims 27-37, further comprising forming a hinge on the housing template to allow said folding of the housing template.

39. The method of any of claims 27-38, wherein the housing template comprises a first portion and a second portion, and the housing template is folded at a junction between the first portion and the second portion, wherein after the housing template is folded to form the housing, the first portion is disposed adjacent the first side of the lateral flow strip, and the second portion is disposed adjacent to the second side of the lateral flow strip.

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