A component for use in a diagnostic testing device

Abstract

A component 10 for use in a diagnostic testing device comprises a first body portion 12 having a test strip holding portion 46 for receiving a lateral flow test strip 48; and a second body portion 14

Description

The present invention relates to a component for use in a diagnostic testing device and relates particularly, but not exclusively, to the packaging for containing a lateral flow test strip . Diagnostic self-test kits are simple and easy-to-use devices that can be performed at home to diagnose a patient's health. One of the most common self-test kits are the lateral flow test strips. These are used for a variety of medical analysis such as blood glucose levels, urinalysis and coronavirus, with the most commonly known type of lateral flow test being the pregnancy test. Furthermore, due to their adaptability, lateral flow tests are also used across a number of other industry sectors including pharma, environmental testing and animal health. These devices function by detecting either the presence or absence of specific hormones, viral antigens, pathogens or biomarkers within a small amount of liquid. The liquid added to the test is typically in the form of the persons saliva, blood or urine. The lateral flow test strips typically contain a control line to confirm that the test is working properly, along with one or more target or test lines which indicate the persons diagnosis, such as a positive pregnancy result. As a result of the COVID-19 pandemic, the number of lateral flow tests required for diagnosis has risen dramatically. This increase in the number of people using lateral flow tests has resulted in the production and manufacturing of the tests to also increase considerably. With more and more tests being produced there has been a significant increase in the number of single-use plastics being sent to landfill. Preferred embodiments of the present invention seek to overcome or alleviate the above-described disadvantages of the prior art. According to an aspect of the present invention there is provided a component for use in a diagnostic testing device, the component comprising: a first body portion and a second body portion, the body portions being formed from fibre material; a test strip holding portion located on said first body portion for receiving a lateral flow test strip; at least one aperture in said second body portion for allowing liquid to be applied to a first portion of said test strip and for allowing a second portion of said test strip to be viewed; and an engagement portion for closing said first and second body portions together. Having two body portions enables a user to open the component and expose the test strip after a test, such as the lateral flow test. This allows the user to easily remove the test strip from the component and discard the non-recyclable testing strip into an appropriate disposal unit. As the body portions are formed from a fibre material this allows for the component of the diagnostic testing device to be recycled in recycling centres and also in the household. The fibre materials also provide sufficient strength and stiffness for use in self-test kits. The test body is suitably strong and water resistant to withstand bending and therefore being accidentally opened whilst being delivered or transported to the user. This further ensures that the test strip will stay secured within the component and not become contaminated if opened prematurely or exposed to a humid environment. By removing all plastic from the housing component and forming the component form fibre reduces the use of virgin plastics entering landfill. Currently each test kit on the market presently contains a plastic housing of around 8-9g of plastic. Unfortunately, the test-kits are a single use product and are disposed of immediately after its use. Replacing the plastic housing with fibre has a positive effect on the environment by reducing waste, increasing the recyclability of the product and therefore reducing the use of landfill sites. In a preferred embodiment said test strip holding portion comprises a first recess. In another preferred embodiment said aperture comprises at least one first aperture for allowing liquid to be applied to said first portion of said test strip and at least one second aperture for allowing said second portion of said test strip to be viewed. In a further preferred embodiment said engagement portion comprises at least one second recess located on said first body portion and at least first protrusion located on said second body portion wherein said first protrusion engages with said second recess. This provides secure and water resistant closure mechanism for the housing component and keeps the testing strip inside safe from contamination. In an additional preferred embodiment said second recces and first protrusion encircle said test strip holding portion. In a preferred embodiment said engagement portion comprises an adhesive layer. In an additional preferred embodiment said body portions further comprise a hinge therebetween, wherein said hinge is located along a first edge. In a further preferred embodiment said fibre material comprises plant fibre or paper pulp. In an additional preferred embodiment said first and second body portions comprise a weakened portion such that when opposing forces are applied to opposing ends of said body portions said weakened portion breaks. In a preferred embodiment said weakened portion comprises perforations . By including a weaken portion, such as perforations, on the body portion provides the advantage that the body portions can be broken, along the perforations. This will inevitably lead to the exposure of one end of the text strip making it easily accessible for extraction from the other part making it easier to recycle properly by removing all non-cardboard (plastic) materials. Alternatively, if the test strip is fixed to one (the smaller) of the now separate parts of the housing components, this small part can be used to hold the test strip without risk of touching the test strip. As a result, the risk of infection is reduced and the majority of the housing component can still be recycled. Removal of the test strip to enable recycling of at least some of the components of the lateral flow test improves the user experience for people who want to recycle as much as possible. In another preferred embodiment said body portions further comprise tabs and when said body portions are closed said tabs do not align. The first and second body portions preferably comprise a base and a lid for substantially covering said base and for containing said test strip and wherein said engagement portion comprises sides of said base and lid. In a preferred embodiment said base and lid each comprise a pair of compression recesses extending from a bottom surface of said base and from a top surface of said lid respectively and extending into said component, the compression recesses for applying a compression force to said test strip. In another preferred embodiment said base further comprises a plurality of retaining recesses on either side of said compression recesses. In a further preferred embodiment each retaining recess comprises two planar portions and a curved portion connecting therebetween. The base preferably further comprises at least one support recess located between said compression recesses on said base. In a preferred embodiment said first and second body portions are tapered along their length. In another preferred embodiment said engagement portion comprises, on said base, a first substantially vertical side extending from a bottom surface of said base and having a substantially horizontal lip extending therefrom and terminating in a cut edge, whereas on said lid said engagement portion comprises a second substantially vertical side extending from an upper surface of said lid and a curved portion initially extending inwards of said second substantially vertical side and then extending outwards of said second substantially vertical side, wherein said cut edge engages an inner surface of said second substantially vertical side. Preferred embodiments of the present invention will now be described, by way of example only, and not in any limitative sense with reference to the accompanying drawings in which:- Figure 1 is a front view of a component of the present invention; Figure 2 is a perspective view of the component of figure 1 in an open condition; Figure 2 is a front view of an alternative component of the present invention; Figure 4 is a front view of another alternative component of the present invention; Figure 5 is a back view of the component of figure 4; Figure 6 is a perspective view of the component of figure 4; Figure 7 is a front view of an additional alternative component of the present invention; Figure 8 is a perspective view of the component of figure 7 in a separated condition; Figure 9 is a front view of another alternative component of the present invention; Figure 10 is an open perspective view of the component of figure 9; Figure 11 is a front view of a further alternative component of the present invention; Figure 12 is a front view of another alternative component of the present invention; Figure 13 is an perspective view of the component of figure 12 in an open condition; Figures 14 and 15 are front and rear views of an alternative component of the present invention; Figure 16 is another rear view of the component of figure 14 in an open condition; Figure 17 is a perspective view of a further alternative component of the present invention; Figure 18 is a series of orthogonal projection views of the component of figure 17; Figure 19 is an exploded perspective view of the component of figure 17; Figures 20 and 21 are sectional views along the lines A-A and B-B respectively of the component of figure 17; and Figure 22 is a side view of the component of figure 17 placed next to figure 23 which is a slight alternative embodiment to the component shown in figure 22. Referring initially to figure 1 and 2 there is shown a housing component 10 for use in a diagnostic testing device or kit such as a lateral flow test including a component 10 and additional parts such as reagents, swabs and sample pots. The housing component 10 includes first and second body portions 12 and 14, and a hinge 16 therebetween. The housing component 10 is formed from a plant-based fibre such as bamboo, bagasse, paper or wood. It also includes alternatives such as natural cellulose variants, bamboo fibres and starch variants. The first and second body portions 12 are substantially rectangular in shape and form the front and back of the component 10. The second body portion 14 forms the front of the component 10 and the first body portion 12 forms the back, with the front facing towards the user when in use. The second body portion 14 includes a first surface 18 located on the outside of the component 10 and a second surface 20 located on the inside of the component when closed. Extending through both the first and second surfaces 18 and 20 is a first aperture in the form of a sample port 22. The sample port 22 has a larger first opening 24 adjacent the first surface 18 relative to a second opening 26 adjacent the second surface 20. This provides an angled surface 28 around the aperture sides allowing liquid to naturally traverse towards the internal second surface 20 when the component 10 is place on a horizontal surface. Located in line and above the sample port 22 are a pair of second and third apertures in the form of first and second viewing windows 30 and 32. Located along the top shorter side (the top being relative to a user holding it with the sample port 18 closest to the user) of the second body portion 14 is a first edge 34a connected to the hinge 16. Located on the second surface 20 of the second body portion 14 is first protrusion in the form of a press-fit rib 36. Following the shape of the outside edge of the second body is rectangular in shape and forms a portion of an engagement portion 38a. Surrounding the first protrusion 36 are a series of second protrusions in the form of press fit bosses 40. The first body portion 12 includes a third surface 42 located on the inside of the component 10 and a fourth surface 44 located on the outside of the component when closed. Located on the third surface 42 is a first recess forming a test strip holding portion 46. The test strip holding portion 46 is an elongated recess substantially in the shape of the test strip 48 and includes a circular recessed pinch portion 50 near the base. The pinch portion 50 provides an area for the user the place their fingers around the test strip 48 and extract it from the test strip holding portion 46. Extending out from the edges of the test strip holding portion 46 are a series of test strip grips 52 used for holding the test strip 48 within the first recess 46 when being stored or transported. Encircling the test strip holding portion 46 is a second recess 54. The second recess 54 forms the other section of the engagement portion 38b and engages with the press-fit rib 36 when the component 10 is closed creating a partially sealed section around the test strip holding portion 46. Surrounding the second recess 54 are a series of third recesses 56 that engage with the press fit bosses 40 when the component 10 is closed. This engagement further decreases the chances of the component opening when being transported or handled and the test strip falling out or being contaminated. The testing strip is placed within the test strip holding portion 46 such that the sample port 22 is located at the bottom of the test strip and the first and second viewing windows 30 and 32 are located at the detection sites of the test strip, that is a parts of the strip that show the results, typically test and confirmation lines. Located along the top shorter side of the first body portion 12 is a first edge 34b connected to the hinge 16 and therefore the second body portion 14 . As seen in figure 1, the second body portion 14 further includes a tab 58 located at the base of a longer edge. The tab can could also be located on the first body portion 12 as shown in figure 2. The tabs 58 are used for holding and / or opening the component 10. The component 10 is manufactured using a dry-fibre moulding process. Other such manufacturing techniques could also be used including but not limited to, injection moulding, compressing moulding and wet-fibre moulding. Operation of the component 10 for use in a diagnostic testing device will now be described. When a user has received the test, they lay the component 10 down on a clean and flat surface with the first surface 18 of the second body portion 14 facing the user. The sample port 22 and viewing windows 30 and 32 should be free of any debris and clean. The user performs the test and squeezes a few drops of the liquid / sample from the test onto the sample port 22. As the liquid travels down the angled surface 28 and through the second opening 26 the liquid makes contact with the test strip 48. Once contact has occurred the liquid will begin to slowly travel up the test strip towards the detection areas below the first and second viewing windows 30 and 32. Once the test is finished and the user has seen their results as indicated through the view windows 30 and 32 the component 10 can be prepared for recycling. The user opens the component 10 by pinching one or both tabs 58 and pulling them gently apart. To extract the test strip 48 the user places a finger and thumb into the pinch portion 50, of the test strip holding portion 46, and grips the end of the test strip 48. Using a small amount of force the test strip 48 can be pulled from the test grips 52. Once the test strip 48 is in hand the user can throw the test strip in the bin. The component 10 however is now suitable to be recycled in a typical household bin. Referring now to figures 4 to 6, in which components equivalent to those in figures 1 to 3 have been identified with like reference numerals increased by 100, the housing component 110 includes first and second body portions 112 and 114 connected by a hinge 116 therebetween. Located on a first surface 118 of the second body portion 114 are a pair of first and second windows 130 and 132 and a sample port 122. The hinge 116 is connected to a first edge 134a located along one of the longer edges of the second body portion 114. Along the opposing longer edge is a tab 158 for opening and holding the component 110. Located on the second surface 120 of the second body portion 114 is an engagement portion 138a including a press fit rib 136 and a series of press fit bosses 140. Located on a third surface 142 of the first body portion 112 is a test strip holding portion 146 for securing a test strip 150. Also located on the third surface 142 is an engagement portion 138b including a second and third recess 154 and 156 for engaging the press fit-rib 136 and press-fit bosses 140 and enabling the component 110 to be closed. Referring now to figures 7 and 8, in which components equivalent to those in figures 1 to 3 have been identified with like reference numerals increased by 200, the housing component 210 includes first and second body portions 212 and 214 adhered together along their edges. Extending though both the first and second body portions are a series of elongated apertures forming first perforations 260 through the middle of the component 210. These elongated apertures 260 allow the component 210 to be snapped or torn in half exposing one end of a testing strip 250 located within. These perforations could instead be in the form of thinned areas of the material, such that the material would tear along these lines, exposing the test strip 248. Once the user has completed their test, such as the lateral flow test the component 210 is broken in half. This allows the user to pull the test strip 248 from the test strip holding portion (not shown) and discard, enabling the user to recycle the component 210 separately. In the example shown, the housing component 210 separates into two approximately equal parts for recycling. In an alternative example, the housing component can divide into two unequal parts and the test strip 248 attached, by gluing for example, to the smaller end. The test strip and small end are then disposed of thereby allowing the strip to be removed with reduced risk of a person touching the potentially infectious or dangerous test strip. Referring now to figures 9 to 13, in which components equivalent to those in figures 1 to 3 have been identified with like reference numerals increased by 300, the housing component 310 includes first and second body portions 312 and 314. Figure 9 shows a pair of first and second windows 330 and 332 located on a first surface of the second body portion 314 whilst figure 11 highlights only a single first viewing window 362. This elongated window 362 exposes both detection areas (control area and test area) of a test strip 348, to allow the user to view their result after performing a test. Located on the second surface 320 of the second body portion 314 is an engagement portion 338a including a series of press fit bosses 340. Located on a third surface 342 of the first body portion 112 is a test strip holding portion 346 for securing the test strip 348 and an engagement portion 138b for the press-fit bosses 140 enabling the closure of the component 310. Also included on the third surface 342 is a large fourth recess 364, this recesses the same shape and depth of the second body portion 314 and allows the second body portion to be inset within the first body portion. This engagement enables the closure of the component 310 and the securing of the test strip 348. Referring now to figures 14 to 16, in which components equivalent to those in figures 1 to 3 have been identified with like reference numerals increased by 400, the housing component 410 includes first and second body portions 412 and 414. The second body portion 412 includes first and second viewing windows 430 and 432 and a sample port 422 on a first surface 418. Located on the opposing second surface are a series of press-fit bosses (not shown) that engage with a series of third recesses 456 located on a third surface (not shown) of the first body portion 412. Located between the first and second body portions is a test strip holding portion (not shown) that secures a test strip 448 within. Also located on the first body portion is a fourth surface 444. This fourth surface 466 forms the back exterior of the component 410 and includes a series of second perforations 466 that extend though a section of the first body portion 412. The second perforations follow a rectangular shape extending from a tab 158 the bottom of the component 410 toward the top. The width between the second perforations is such that when the tab is pulled the perforations tear along the length of the fourth surface 444 exposing the test strip 448 inside and the third surface 465 of the first body portion 312. With further reference to figures 17 to 23, the housing component 510 is formed from a first body portion in the form of a base 512 and a second body portion in the form of a lid 514. The lid has a sample port 522 and a viewing window 562 cut therein. The test strip 548 is contained within the volume defined by the base 512 on the lid 514. The test strip is maintained in the correct position within the housing component 510 by the use of a series of recesses formed into a bottom surface 570 of the base 512 and a pair of recesses formed into a top surface 572 of the lid 514. These recesses can be defined into two groups, namely compression recesses in both the base 512 and lid 514 and retaining recesses formed in the base. Looking firstly at the compression recesses in the lid 514, these recesses, labelled 574 and 576, are located on either side of the window 562. Interacting with the lid compression recesses 574 and 576 are the further compression recesses 578 and 580 which are formed in the base 512. When the lid and base are assembled the compression recesses 574 to 580 are aligned with each other. That is, the first lid compression recess 574 is aligned with the first base compression recess 578 and the second lid compression recess 574 is aligned with the second base compression recess 578. As a result of the retaining force of the lid on the base the compression recesses push towards each other and apply a compression force to portions of the test strip 548 . On either side of the compression recesses 578 and 580 are a series of four retaining recesses all labelled 582. These retaining recesses are significantly larger than the compression recesses and can be viewed as containing three parts. At either end of a retaining recess 582 are a pair of planar portions 584 which are connected by a curved surface 586. The retaining recesses 582 have an inner side wall 588 located adjacent the compression recesses 578 and 580 and it is this inner wall which engages the side edges of the test strip 548 and prevents it from moving from side to side. Test strip 548 is supported along its length by support bars 590 which are formed as recess ribs extending across the whole width of the base 512. As a result, the test strip 548 is supported from underneath at five points, these being the three support bars 590 and the compression recesses 578 and 580. Looking specifically at figures 20 and 21, the sides of the base 512 and lid 514 engage one another to act as the engagement portion. On the base 512 the engagement portion is formed from a substantially vertical part 592 which extends from the bottom surface 570. This substantially vertical part 592 extends into a horizontal part 594 which has a cut edge 596 which is the outermost edge of the base 512. On the lid 514, the engagement portion is formed from a substantially vertical portion 598, which extends from the top surface 572. Extending from the vertical portion 598 is a curved portion 600 which extends inwards, towards the base 512 before extending outwards away from the base and terminating in a cut edge 602. When the lid 514 is brought into engagement with the base 512, the bottom of the curved portion 600 engages the cut edge 596 which pushes the curved portion slightly outwards and pushes the cut edge slightly inwards. Continued movement of the lid downwards over the base results in the curved portion 600 passing the horizontal part 594 so that the cut edge 596 engages an inner surface 604 of the vertical portion 598. Once in this position the lid 514 is trapped in engagement with the base 512 and the correct compression is applied between the recesses 574 and 578 and between the recesses 576 and 580. It should be noted that the bottom surface 570 of the base 512 extends slightly lower than the bottommost edge 606 of the curved portion 600. Turning to look at figure 18, it can be seen on close inspection of the top and bottom views that the base 512 and lid 514 are slightly tapered along their length with the wider portion being located adjacent the sample port 522. As with the previous embodiments, the component 510 is manufactured using a dry-fibre moulding process although other similar manufacturing techniques could also be used including but not limited to, injection moulding, compressing moulding and wet-fibre moulding. The forming process using the dry-fibre moulding technique creates the two component parts of the lid and base. The edges and any apertures (window 562 and sample port 522) are then cut into the formed component parts before the test strip 548 is inserted into the base 512 and the lid placed into engagement therewith as described above. It will be appreciated by persons skilled in the art that the above embodiments have been described by way of example only and not in any limitative sense, and that various alterations and modifications are possible without departure from the scope of the protection which is defined by the appended claims. For example, the above components are formed of a plant based fibre however, any recyclable material could be used. A further variation is shown in figure 23 which contrasts with the embodiment shown in figure 22 which matches those in figures 17 to 21. In figure 22 it can be seen that the curved portion 600 at the outermost edge of the lid 514 extends around the entire edge. In contrast, in figure 23, the equivalent curved portion only extends along the linear sides of the component and not around the curved ends.

Claims

1. A component for use in a diagnostic testing device, saidcomponent comprising:a first body portion having a test strip holding portion forreceiving a lateral flow test strip; anda second body portion having at least one aperture in said second body portion for allowing liquid to be applied to a first portion of said test strip and for allowing a second portion of said test strip to be viewed, wherein said first and second body portions being formed from fibre material and together provide an engagement portion for closing said first and second body portions together.

2. A component according to claim 1 wherein said test strip holding portion comprises a first recess.

3. A component according to any preceding claim wherein said aperture comprises at least one first aperture for allowing liquid to be applied to said first portion of said test strip and at least one second aperture for allowing said second portion of said test strip to be viewed.

4. A component according to any preceding claim wherein saidengagement portion comprises atleast onesecond recesslocatedon said first body portion and at least one first protrusionlocated on said second body portion wherein said firstprotrusion engages with said second recess.

5. A component according to claim 4 wherein said second recess and said first protrusion encircle said test strip holding portion.

6. A component according to claims 1 to 3, wherein said engagement portion comprises an adhesive layer.

7. A component according to any preceding claim wherein said body portions further comprise a hinge therebetween, wherein said hinge is located along a first edge.

8. A component according to any preceding claim wherein said fibre material comprises plant fibre.

9. A component according to claim 8 wherein said plant fibre comprises paper pulp.

10. A component according to any preceding claim wherein said first and second body portions comprise a weakened portion such that when opposing forces are applied to opposing ends of said body portions said weakened portion breaks.

11. A component according to claim 10, wherein said weakened portion comprises perforations.

12. A component according to claims 1 to 9 wherein both of said body portions further comprise tabs and when said body portions are closed said tabs do not align.

13. A component according to any preceding claim wherein said first and second body portions comprise a base and a lid for substantially covering said base and for containing said test strip and wherein said engagement portion comprises sides of said base and lid.

14. A component according to claim 13 wherein said base and lid each comprise a pair of compression recesses extending from a bottom surface of said base and from a top surface of said lid respectively and extending into said component, the compression recesses for applying a compression force to said test strip.

15. A component according to claim 14 wherein said base further comprises a plurality of retaining recesses on either side of said compression recesses.

16. A component according to claim 15 wherein each retaining recess comprises two planar portions and a curved portion connecting therebetween.

17. A component according to claims 14 to 16 wherein said base further comprises at least one support recess located between said compression recesses on said base.

18. A component according to any preceding claim wherein said first and second body portions are tapered along their length.

19. A component according to claims 13 to 18 wherein said engagement portion comprises, on said base, a first substantially vertical side extending from a bottom surface of said base and having a substantially horizontal lip extending therefrom and terminating in a cut edge, whereas on said lid said engagement portion comprises a second substantially vertical side extending from an upper surface of said lid and a curved portion initially extending inwards of said second substantially vertical side and then extending outwards of said second substantially vertical side, wherein said cut edge engages an inner surface of said second substantially vertical side .

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