GB2613579A

GB2613579A - Apparatus and method

Info

Publication number: GB2613579A
Application number: GB2117603.7A
Authority: GB
Inventors: Cowan David; West David; Ballantine Dykes Hugh
Original assignee: Clarity Biosolutions Ltd
Current assignee: Clarity Biosolutions Ltd
Priority date: 2021-12-06
Filing date: 2021-12-06
Publication date: 2023-06-14
Also published as: GB202117603D0

Abstract

A reader [Fig. 2, 10] for a lateral flow device 2. The reader has a housing 22, 24 comprising a LFD support 16 configured to support the lateral flow device in a defined position, an insertion slot [Fig 2, 14] for the LFD into the housing, an image sensor with a support 18 and a light source configured to illuminate the reading window. The image sensor configured such that the reading window of an LFD is in its field of view; and one or more positioning elements to position the lateral flow device at the defined position. There may be a shroud 38 that shields the image sensor from ambient light. The reader may have means to read the identification mark on the LFD. The reader may comprise a communication means for sending/receiving data to an auxiliary device. The device may have an electronic controller that is configured to wait the incubation time before capturing data.

Description

APPARATUS AND METHOD

TECHNICAL FIELD

This invention relates to a reader for a lateral flow device, a system for reading a lateral flow device, an apparatus comprising multiple readers and a method for reading a lateral flow device.

BACKGROUND

Lateral flow tests, also known as lateral flow immunochromatographic assays are devices designed to detect the present of a target substance in a sample. These tests are widely used in medicine, for example in pregnancy tests and tests bacteria and viruses. Lateral flow tests are widely used to detect SARS-CoV-2 (COVID-19).

Lateral flow tests can typically be carried out in under 30 minutes and have the advantage that they can be carried out home, due to their simplicity.

A type of lateral flow device typically used for a lateral flow test is illustrated in Fig 1. The lateral flow device 2 is in the form of a cartridge 4 with a sample port 6 and a reading window 8. An absorbent strip, which is treated with reagents extends between the sample port and the reading window. In use, a liquid sample, or solution containing the sample is dispensed into the sample port. The sample moves along the absorbent strip by capillary action, interacting with the reagents, to the reading window. An incubation period is allowed to elapse before the test is read. A successful test (i.e. in which the sample has moved from the sample port to the reading window) causes a control line to show at C. A test line displayed at T indicates positive detection of the target substance in the sample, whereas absence of a line at T indicates no detection of the target substance.

Lateral flow devices for home use are typically read by eye. However, interpretation of lateral flow test by a home user can lead to inaccurate diagnosis, for example if there is uncertainty over the presence or absence of a faint result line. In the case of infectious diseases, such as Covid-19, this can lead to the unnecessary spread of infection.

Readers for lateral flow devices are available but are not typically used in the home environment due to their cost and/or complexity.

It is known to use smart phones to read a lateral flow device, making use of the in-built camera. The applicants have discovered that the use of smart phones to read lateral flow devices is inaccurate due to inconsistencies such as the variation in smart phone models (including different optics and operating systems), the lack of control over lighting conditions and user error (including positioning of the smart phone).

The present invention aims to overcome the problems of the prior art. SUMMARY OF THE INVENTION An aspect of the present invention provides a reader for a lateral flow device having a reading window in which one or more of a control line and a test line may be displayed, the reader comprising: a housing comprising a LFD support configured, in use, to support the lateral flow device in a defined position and an insertion slot through which the lateral flow device is inserted into the housing; a light source configured to illuminate the reading window of a LFD when located at the defined position; an image sensor configured such that at least a section of the reading window of an LFD when positioned in the defined position is in its field of view; one or more positioning elements configured, in use, to position the lateral flow device at the defined position.

The section of the reading window may correspond to the location of a control line and/or test line, when displayed, of an LFD when positioned in the defined position. The image sensor may be configured such that the entire reading window of an LFD when positioned in the defined position is in its field of view.

The light source may be configured to illuminate the entire reading window of the LFD when located at the defined position. The light source may be configured to simultaneously illuminate the entire reading window of the LFD when located at the desired position. In an embodiment, the light source is configured to illuminate the section of the reading window.

The reader has the advantage that the position of the LFD relative to the image sensor is defined. The defined position may comprise at least one of the relative distance between the image sensor and the LFD, and the position of the LFD in the plane of the LFD support.

The reader has the advantage that consistent light levels are used for each LFD. Furthermore, the same image sensor is used for each LFD, ensuring consistency of images.

The one or more positioning elements may define the position of the LFD in one, two or three dimensions.

The base may comprise a longitudinal axis which defines the direction of travel of the lateral flow device in and out of the housing, and wherein the one or more positioning element is configured to define the position of the LFD parallel with the longitudinal axis.

The base may comprise a longitudinal axis which defines the direction of travel of the lateral flow device in and out of the housing, and wherein the one or more positioning element is configured to define the position of the LFD transverse to the longitudinal axis.

The one or more positioning element may be configured to act as a stop and thereby limit the extent to which the LFD can be inserted in the housing.

In one embodiment, the base is configured to form a channel to receive the LFD, wherein the one or more positioning elements comprises a first positioning element forming an end of the channel and/or second and third positioning elements forming opposite sides of the channel.

The reader may comprise a second set of one or more positioning elements to define a second position of the LFD. In this second position, an identification mark on the LFD is located within the field of view of the image sensor.

The base may comprise a longitudinal axis which defines the direction of travel of the lateral flow device in and out of the housing, and wherein the second set of one or more positioning element may be configured to define the second position of the LFD parallel with the longitudinal axis. The second set of one or more positioning elements may be configured to act as a stop and thereby limit the extent to which the LED can be inserted into the housing.

The second set of one or more positioning elements may be configured to act as a stop when a pressure below a threshold is applied to the LFD but to allow movement of the LFD when a pressure above a threshold is applied to the LFD.

The second set of one or more positioning elements may, for example, comprise a region of increased friction, deflectable tabs, and/or a raised or angled surface.

The image sensor may be mounted on an image sensor support. The image sensor support may be configured to be parallel to the LFD support.

The image sensor may comprise a pixelated sensor, for example a two-dimensional pixelated sensor. The image sensor may be selected from a charge-coupled device (CCD) and complementary metal-oxide-semiconductor (CMOS) sensor. Suitable mage sensors may be of the type found in cameras typically used in smart phones and similar devices.

The light source may be mounted on the image sensor support. The light source may comprise two light sources, optionally with one positioned on either side of the image sensor. The light source may be adjacent the image sensor. At least one baffle may be provided between the light source and the image sensor. The light source may comprise a light emitting diode.

The image sensor support may comprise a printed circuit board.

The housing may be configured to shield the image sensor, the reading window of the lateral flow device when positioned in the defined position, and the area extending between them from ambient light.

The housing may define an interior space, in which the LFD support, one or more positioning elements, light source and image sensor are located. The housing may be configured to shield the interior space from ambient light when the LFD is inserted into the housing. The housing may be configured to fully surround the interior space, with the exception of the insertion slot and optionally a window for the communications module.

The housing may comprise a material which prevents the penetration of light. The housing may comprise a bottom surface, a top surface and at least one wall extending between the top and bottom surfaces.

The insertion slot comprises an opening in the housing. In one embodiment, the insertion slot is substantially rectangular, although may be of other shapes. The insertion slot is configured to match the size and shape of the LFD being read, so that when the LFD is inserted into the insertion slot, the LFD fills the insertion slot and prevents ambient light from penetrating the interior space of the housing via the insertion slot.

The reader may comprise a shroud, configured to shield the image sensor, the reading window of the lateral flow device when positioned in the defined position and the area extending between them from ambient light. The shroud may be located within the interior space of the housing.

The shroud may comprise at least one wall extending downwards from the image sensor support, the shroud having a lower surface located adjacent to the upper surface of the LFD, when in the defined position. This arrangement ensures that the shroud protects the region between the image sensor and the reading window from ambient light.

The shroud may comprise a material which prevents the penetration of light.

The shroud may comprise a single wall which forms a continuous curtain around the light source and reading window.

The housing may comprise a base section, configured to receive a lateral flow device, and a cover section, wherein the base section comprises the LFD support and the cover section comprises the image sensor.

The first and second sections may be connected together using any suitable means. In one embodiment, the first section and second section are each provided with cooperating connection means, for example a snap-fit or push-fit arrangement. Alternatively, the first and second means may be connected by known mechanical fixing means, such as screws, nuts and bolts, or bonding means, such as adhesive.

The cover section may comprise a top surface and side walls extending downwards from the top surface. The base section may comprise the one or more positioning means. The base section may optionally comprise the second one or more positioning means..

The insertion slot comprises top, bottom and side edges, and wherein the bottom and side edges are located in the base section. The top edge may be defined by either the base section or the cover section.

This arrangement has the advantage that different designs of base section and cover can be combined together to form a range of housing configurations.

The modular nature of the reader and interchangeable components allow the reader to accommodate and securely retain lateral flow devices of different sizes and shapes, with different models of base sections being designed to accommodate different lateral flow device shapes and sizes. This increases the versatility of the reader, reduces the costs and materials used for manufacture of the reader. The modular nature of the reader provides ease of assembly.

The reader may comprise a communication means for sending/receiving data to an auxiliary device. The communication means may comprise a wired or wireless connection with the auxiliary device. For example, the communication means may comprise a USB connection, Bluetoothm or Wifi connectons.

The auxiliary device may comprise a personal computer (PC), laptop, server, smart phone, table, smart watch, smart glasses or other suitable device.

An electronic controller may be provided on the reader or external to the reader, for example as part of the auxiliary device. The electronic controller may be configured to receive image data from the image sensor. The electronic controller may be configured to send instructions to the light source and image sensor to illuminate and capture an image.

The image sensor and light source may be powered by an internal or external power source.

For example, a battery may be provided in the reader and electrically connected to the image sensor and light source. Alternatively, the reader may be in electrical connection with an external power source, such as a mains power source or the power source of the auxiliary device.

In one embodiment, a reference marking is located on the LED support, in the field of view of the image sensor. The reference marking may be configured for calibration of the image sensor. The reference marking may be configured to be in the location of the LED support on which the reading window is positioned when the LED is inserted in the defined position. The electronic controller may be configured to receive image data relating to the reference marking from the image sensor and use the image data to calibrate the reader. For example, the electronic controller may compare the image data relating to the reference marking with calibration data and/or a calibration algorithm, and use the results of the comparison to calibrate the image sensor and/or image data captured from the image sensor.

An aspect of the present invention provides a system for reading a lateral flow device having a reading window in which one or more of a control line and a test line may be displayed, the system comprising: a housing comprising a LED support configured, in use, to support the lateral flow device in a defined position and an insertion slot through which the lateral flow device is inserted into the housing; a light source configured to illuminate the reading window of a LED when located at the defined position; an image sensor configured such that at least a section of the reading window of an LED when positioned in the defined position is in its field of view; one or more positioning elements configured, in use, to position the lateral flow device at the defined position; a processing module configured to run on at least one processor and further configured to process data from the image sensor, the processing module comprising: an analysing module configured to analyse image data derived from the image sensor; and a display module configured to output analysed data to a display.

The section of the reading window may correspond to the location of a control line and/or the test line when displayed on the LED. The image sensor may be configured such that the entire reading window of an LED, when positioned in the defined position, is in its field of view.

The processing module may be located in the housing or in an accessory electronic device. The display may be located on an accessory electronic device.

The analysing module may be configured to receive incubation data corresponding to the incubation time (time between the lateral flow test being carried out and the capture of image data), and optionally the test time (time that the sample was applied to the LFD), and output a signal to the image sensor to capture an image when the incubation time has elapsed.

Incubation data may be embedded in the LFD, or may be entered via the accessory electronic device.

The reader may comprise a data capture device for capturing data embedded on the lateral flow device, optionally wherein the data capture device comprises an RFID detector or the image sensor.

For example, the data capture device may comprise an RFID detector configured to read an RFID device on the LFD. The data capture device may be configured to capture data relating to the incubation time required for the lateral flow device, and optionally the test time. The data capture device may be configured to export the data relating to the incubation time to an electronic controller. The electronic controller may be configured to send a command to the image sensor to capture an image when the incubation time has elapsed. This may use a combination of the incubation time and the test time (for example, which may be established from the data embedded in the lateral device, the time the LFD is inserted into the reader, or manually input by the user). Alternatively, the electronic controller may be configured to output a signal to an indicator when the incubation time has elapsed. The indicator may be located on the reader. The signal may comprise a visual or audible signal. For example, the reader may comprise a visual or sound indicator, such as an LED or buzzer.

The analysing module may be configured to receive and analyse data from the data capture device, such as an identification code. Data from the data capture device may be image data (i.e. from the image sensor) or other formats of data (i.e. from an RFID reader).

The processing module may comprise a memory module configured to store analysed image data derived from the image sensor and/or data from the data capture device. The memory module may be configured to link the data from the data capture device (e.g. derived from the identification code of a LFD) to the image data captured from the reading window of that LFD. Data from the identification code may comprise, for example, type of test, the ID number, the expiry date, required incubation time for test and, for read-writable identification codes, time of test. The memory module may be located separately from the analysing module. For example, the analysing module may be located on a smart phone, whereas the memory module is in the cloud.

Another aspect of the present invention provides an apparatus comprising a plurality of readers according to the present invention. This apparatus may be configured to communicate to a single or multiple auxiliary devices.

An aspect of the invention provides a system comprising a reader according to the invention and an electronic controller, wherein the electronic controller is operatively connected to the image sensor in such a way that the electronic controller can initiate image capture by the image sensor and/or receive images from the image sensor.

The electronic controller may be configured to receive an incubation time of the LFD, and optionally the test time (time that the sample was added to the LFD), and wherein the electronic controller is configured to initiate image capture by the image sensor when the incubation time has elapsed. The electronic controller may be operatively connected to the light source.

The electronic controller may be operatively connected to the data capture device in such a way that data from the data capture device can be received by the electronic control system, and wherein the electronic controller is configured to receive incubation time data, and optionally the test time, from the data capture device.

An aspect of the present invention provides a method for reading a lateral flow device having a reading window in which one or more of a control line and a test line may be displayed, the method comprising the step of: (a) inserting a lateral flow device into an insertion slot of a housing, the housing comprising an LFD support configured, in use, to support the lateral flow device; (b) positioning the lateral flow device into a defined position within the housing, the defined position being defined by one or more positioning elements; (c) illuminating the reading window of the lateral flow device with a light source; (d) capturing an image of at least a section of the reading window of the LFD with an image sensor.

The method may further comprise the steps of: outputting image data from the image sensor to an electronic controller, processing the image data to determine if a test line is present or absent, and displaying the result on a display.

The method may comprise the steps of: capturing data embedded on the LFD relating to the required incubation time; determining when the incubation time has elapsed; carrying out step (d) at the end of the incubation time.

The method may comprise the step of: capturing data embedded on the LFD relating to test identification; storing the test identification data for an LFD; storing the test result for said LFD; and linking the stored test identification data and said test result for said LFD.

Throughout the description and claims of this specification, the words "comprise" and "contain" and variations of the words, for example "comprising" and "comprises", mean "including but not limited to", and do not exclude other components, integers or steps.

Moreover, the singular encompasses the plural unless the context otherwise requires: in particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

Preferred features of each aspect of the invention may be as described in connection with any of the other aspects. Within the scope of this application, it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and/or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination, unless such features are incompatible.

BRIEF DESCRIPTION OF THE DRAWINGS

One or more embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a plan view of a prior art lateral flow device; Figure 2 is a first perspective view of a reader according to an embodiment; Figure 3 is a second perspective view of the reader of Fig 2; Figure 4 is a cross section of the reader of Fig 2; Figure 5 shows the base section of the reader of Fig 2; Figure 6 shows the base section and shroud of the reader of Fig 2; Figure 7 shows the reader of Fig 2 and an auxiliary device; Figure 8 is a flow diagram showing the method according to an embodiment; Figure 9 is a simplified plan view of a base of a reader according to an embodiment; Figure 10 is a simplified cross-sectional side view of a reader and LFD according to an embodiment; and Figures 11A and 11B are simplified plan views of a base of a reader and inserted LFD in two different positions according to an embodiment.

DETAILED DESCRIPTION First embodiment

A reader 10 according to a first embodiment of the invention is illustrated in Figs 2 to 7.

The reader 10 comprises a housing 12 with an insertion slot 14 into which a lateral flow device (LFD) 2 may be inserted.

The housing defines an interior space, in which is located an LFD support 16 for receiving an LFD and an image sensor support 18 onto which is mounted an image sensor and light source (not shown).

A communication means, in the form of a USB connection 20, is provided in the house to export data from the image sensor to an auxiliary device and to receive signals from the auxiliary device.

Housing The housing defines the interior space and minimises ambient light from entering the interior space. The housing is made from a light-proof material, such as a plastics material.

In the current embodiment, the housing has two sections, a base section 22 and a cover section 24. The base section 22 and cover section 24 are connected together via snap fit connections 26. The LFD support 16 is provided in the base section 22, whilst the image sensor support 18 and its associated components are provided in the cover section 24.

LFD support The LFD support 16 is provided with positioning elements in the form of channel 28 to define the position of the LFD when inserted in the housing. The channel has a bottom surface 30, end surface 32 and first and second side surfaces 34,36. The channel has a longitudinal axis A. In use, the LFD is inserted into the housing via the insertion slot, with a lower surface of the LFD placed on the bottom surface 30 of LFD support 16 and the LFD positioned between first and second side surfaces 34,36. The LFD is pushed into the housing, until an end of the LFD abuts the end surface 32 and the LFD is in a fully inserted position.

Once the LFD is fully inserted, its position is defined by the bottom surface 30 which defines its height relative to image sensor support 18, the end surface 32 which defines its position parallel to the longitudinal axis and the side surfaces 34,36, which define its position transverse to the longitudinal axis.

Imaqe sensor support The image sensor support 18 is mounted towards the top of the housing. In this embodiment, the image sensor support is a printed circuit board (PCB). Alternatively, circuitry for the light source and image sensor may be located separately, for example mounted on the image sensor support. On the image sensor support is mounted an image sensor, of the type typically used in a smart phone, such as a CCD, and a light source, such as LED. The camera has a field of view which is configured to include the reading window of the LFD, when the LFD is fully inserted into the housing. The entire reading window of the LFD may be within the field of view of the image sensor. Alternatively, sections of the reading window may fall within the field of view of the image sensor, such as sections corresponding to the locations of the control and test lines (when present). In this embodiment, a LED is mounted on either side of and adjacent to the CCD.

Shroud A shroud 38 extends from the image sensor support 18 towards the base 16 and fully surrounds the light source, image sensor and space directly below. The bottom of the shroud extends to the top of the LFD, when inserted in the housing, allowing sufficient clearance space for movement of the LFD in and out of the housing. In this embodiment, the shroud has four walls, which form a rectangular cross section. The shroud is made from a light-proof material, such as a plastics material. When the LFD is fully inserted in the housing, the top surface of the LFD abuts the bottom surface of the shroud, ensuring that no light penetrates the interior of the housing. Furthermore, the LFD fills the insertion slot, preventing ambient light from entering via this aperture.

Communication A communication means is included to allow transfer of data to an auxiliary device, such as a personal computer, smart phone, tablet etc. In this embodiment, the communication means is a USB connection 20 mounted in the housing, with an electrical connection to the image sensor and optionally the light source. A window 40 in the housing allows access to the USB device. A baffle 42 is located behind the USB connection, to shield the image sensor support and shroud from any light leaking through window 40. The USB connection also provides an electrical connection to the reader, to either power the light source and image sensor and/or power a rechargeable battery in the reader. The USB connection may provide electricity from the auxiliary device or an alternative power source, such as mains power or a battery. Use of the USB connection to provide power has the advantage that an on-board power source, such as a battery, is not required. This allows the reader to be smaller and more cost effective. In addition, the lack of on-board power source has the added advantage of improved safety and improved storage, as the risk of battery degradation and water damage is eliminated.

Auxiliary device Figure 7 shows the reader 10 connected to an auxiliary device in the form of a smart phone 44. A cable 46 connects the smart phone 44 to the reader 10 via the USB device 20. An electronic controller, in the form of the processor of the smart phone, receives image sensor data from the reader and sends signals to the light source and image sensor to initiate image capture. An app on the smart phone may be used to provide an interface for the user. The app may be configured to analyse the image data and display the test results. The results may be stored on the auxiliary device. Alternatively, or additionally, the results may be stored on a server or in the cloud.

Calibration An interior reference mark is provided on the base plate, positioned such that it is in the field of view of the image sensor. This interior reference mark is a QR code, but could alternatively comprise other reference marks such as a bar code etc. The interior reference mark is used to calibrate the image sensor, when the LFD is not inserted in the housing. Fig 9 is a simplified plan view of the base section 22, showing the interior reference mark 70.

LFD identification The LFD is provided with an identification mark (72 in Figs 11A8(11B; 76 in Fig 10), such as a QR code or bar code. This identification mark may contain information about the test, such as the type of test, the ID number, the expiry date, and required incubation time for test. The identification mark may be read by the image sensor of the reader or by a camera on a separate device, such as a smart phone.

Second embodiment In a second embodiment, illustrated in Figs 11A and 11B, the LFD is provided with an identification mark 72, such as a QR code or bar code, which can be detected by the image sensor of the reader. The base section 22 is provided with a second set of one or more positioning elements, in the form of a pair of deflectable tabs 74, to define a second position of the LFD within the housing. In this second position, at least a part of the identification mark 72 is located within the field of view of the image sensor. The deflectable tabs 74 are configured to define the position of the LFD when light pressure is applied but deflect to allow the LFD to pass through when firmer pressure is applied. In the second position, the position of the LFD is defined by the bottom surface 30 which defines its height relative to image sensor support 18, side surfaces 34,36, which define its position transverse to the longitudinal axis, and deflectable tabs 74 which defines its position parallel to the longitudinal axis.

In use, the LFD is inserted through the slot in the housing and into the channel with a light pressure until its end abuts the deflectable tabs 74. At this second position, an image is captured of the identification mark. A larger pressure is then applied to the LFD, so that it causes the deflectable tabs 74 to deflect and the LFD moves along the channel until it abuts the end surface 32, at which position the image sensor captures an image of at least a section of the reading window.

Third embodiment In a third embodiment of the invention, the reader includes a data capture device in the form of an RFID reader. This is configured to capture data from an RFID tag on the LFD.

Use of an RID reader and tag has the advantage that the RFID tag is read-writeable, allowing it to include more data than a read-only code, such as a QR code. The data includes the required incubation time for the test, i.e. the time between dispensing the sample into the LFD and the test being ready for reading the results. In addition, the data can include writeable information, such as the test time, i.e. the time the sample was applied to the test.

Fig 10 illustrates a simplified cross section of the reader showing an LFD with RFID tag 76 and an RFID reader 78 in the housing. Data from the RFID reader is sent to an electronic controller (not shown) which will determine when the LFD test is ready for reading. The electronic controller may be located within the reader or externally, for example in the auxiliary device. Once the incubation time has elapsed, the electronic control will either send a command to the reader to capture an image of the LFD or output a signal to an indicator, in the form of an LED, that the incubation time has elapsed. The data from the RFID reader may include the incubation time and optionally the test time.

Fourth embodiment In a third embodiment of the invention, a LTD reading system enables multiple LFDs to be read. In this system, an apparatus is made up of multiple readers. Each reader having the components as described in the first and/or second embodiments.

Method The method according to the invention is shown in Fig 8. In a first step 50, the LFD is inserted into the housing. The position of the LFD is determined in three dimensions by the one or more positioning means. In step 52 data relating to the LFD is input into the electronic controller. This could be manually input by the user or embedded data in the LFD could be captured by the reader or by the auxiliary device. If the data contains incubation data, the electronic controller determines time for capturing image (step 54), i.e. when the incubation time has elapsed. Image capture is then initiated (step 56) either manually by the user or automatically by the electronic controller. In the image capture step, the light source illuminates the LFD reading window and the image sensor captures an image. In step 58, the image data is output to the electronic controller which analyses the data to determine if a test line is present or absent. The electronic controller uses known image processing methods to determine whether a test line is positive or absent. In step 60, the electronic controller outputs the results data to a display to display a negative or positive result.

In an alternative embodiment, suitable for home use purposes, a user will carry out the LFD test according to user instructions. The reader is then used to record and, if required, upload the results data to a remote database.

Claims

CLAIMS1. A reader for a lateral flow device having a reading window in which one or more of a control line and a test line may be displayed, the reader comprising: a housing comprising an LFD support configured, in use, to support the lateral flow device in a defined position and an insertion slot through which the lateral flow device is inserted into the housing; a light source configured to illuminate the reading window of a LFD when located at the defined position; an image sensor configured such that at least a section of the reading window of an LFD when positioned in the defined position is in its field of view; one or more positioning elements configured, in use, to position the lateral flow device at the defined position.
2. A reader according to any preceding claim, wherein the defined position comprises a defined distance from the image sensor.
3. A reader according to any preceding claim, wherein the base comprises a longitudinal axis which defines the direction of travel of the lateral flow device in and out of the housing, and wherein the one or more positioning element is configured to define the position of the LFD parallel and/or transverse with the longitudinal axis.
4. A reader according to any preceding claim, wherein the LFD support is configured to form a channel to receive the LFD, wherein the one or more positioning elements comprises a first positioning element forming an end of the channel and second and third positioning elements forming opposite sides of the channel.
5. A reader according to any preceding claim, comprising a second set of one or more positioning elements to define a second position of the LFD in which an identification mark on the LFD is within the field of view of the image sensor.
6. A reader according to claim 5, wherein the second set of one or more positioning elements is configured to define the position the LFD at the second position when a first pressure is applied to the LFD but to allow the LFD to move past the second position when a second pressure greater then the first pressure is applied to the LFD.
7. A reader according to any preceding claim, wherein the image sensor comprises a pixelated sensor, optionally wherein the image sensor is selected from a charge-coupled device (CCD) and complementary metal-oxide-semiconductor (CMOS) sensor.
8. A reader according to any preceding claim, wherein the light source is adjacent the image sensor.
9. A reader according to any preceding claim, wherein the light source comprises a light emitting diode.
10. A reader according to any preceding claim, wherein the image sensor is mounted on an image sensor support, wherein the image sensor support optionally comprises a printed circuit board.
11. A reader according to any preceding claim, wherein the housing is configured to shield the image sensor, the reading window of the lateral flow device when positioned in the defined position, and the area extending between them from ambient light.
12. A reader according to any preceding claim, wherein the housing defines an interior space, in which light source and image sensor are located and wherein the housing is configured to ensure that no ambient light penetrates the interior space when the LFD is inserted into the housing.
13. A reader according to any preceding claim, comprising a shroud, configured to shield the image sensor and the reading window of the lateral flow device when positioned in the defined position and the area extending between them from ambient light.
14. A reader according to any preceding claim, wherein the housing comprise a base section configured to receive a lateral flow device and a cover section, wherein the base section comprises the LFD support and the cover section comprises the image sensor.
15. A reader according to claim 14, wherein the base section and cover section comprise cooperating connecting means.
16. A reader according to any of claims 14-15, wherein the base section comprises the one or more positioning means.
17. A reader according to any of claims 14-16, wherein the insertion slot comprises top, bottom and side edges, and wherein the bottom and side edges are located in the base section.
18. A reader according to any preceding claim, comprising a communication means for sending/receiving data to an auxiliary device.
19. A reader according to any preceding claim, comprising a reference marking located on the LFD support, in the field of view of the image sensor, wherein the reference marking is configured for calibration of the image sensor.
20. A reader according to any preceding claim, comprising a data capture device for capturing data embedded on the lateral flow device, optionally wherein the data capture device comprises an RFID detector or the image sensor.
21. A reader according to claim 20, wherein the data capture device is configured to capture data relating to the incubation time required for the lateral flow device.
22. A system comprising a reader according to any of claims 1-21 and an electronic controller, wherein the electronic controller is operatively connected to the image sensor in such a way that the electronic controller can initiate image capture by the image sensor and/or receive images from the image sensor.
23. A system according to claim 22, wherein the electronic controller is configured to receive an incubation time of the LFD and wherein the electronic controller is configured to initiate image capture by the image sensor when the incubation time has elapsed.
24. A system according to claim 23 in combination with claim 20, wherein the electronic controller is operatively connected to the data capture device in such a way that data from the data capture device can be received by the electronic control system, and wherein the electronic controller is configured to receive incubation time data from the data capture device.
25. An apparatus comprising a plurality of readers according to any of claims 1-24.
26. A method for reading a lateral flow device having a reading window in which one or more of a control line and a test line may be displayed, the method comprising the step of: (a) inserting a lateral flow device into an insertion slot of a housing, the housing comprising an LFD support configured, in use, to support the lateral flow device; (b) positioning the lateral flow device into a defined position within the housing, the defined position being defined by one or more positioning elements; (c) illuminating the reading window of the lateral flow device with a light source; (d) capturing an image of at least a section of the reading window of the LFD with an image sensor.
27. A method according to claim 26, comprising the steps of: outputting image data from the image sensor to an electronic controller, processing the image data to determine if a test line is present or absent, and displaying the result on a display.
28. A method according to any of claims 26-27, comprising the steps of: capturing data embedded on the LFD relating to the required incubation time; determining when the incubation time has elapsed; carrying out step (d) at the end of the incubation time.