INTEGRATED SAMPLING AND ANALYSIS DEVICE

Abstract

The field of the invention generally relates to sample collection, for example of a sample being an exhaled breath. In particular, an integrated device is disclosed herein comprising a silicon chip for sampling particulate matter from a sample and for analysis, preferably by a protocol using thermocycling, of the particulate matter as collected from the sample. Further, point-of-care (PoC) and self-use analysis systems compatible with the integrated device, and methods related to sample collection and/or analysis using the same, are also disclosed.

Claims

1. A collecting device for sampling particulate matter from a sample, the collecting device comprising: a base structure; a monolithic silicon chip supported by said base structure, the chip comprising at least two opposite sides and a top surface and an opposite thereto bottom surface, wherein the bottom surface is closed allowing contacting with a heating source and wherein the top surface comprises a plurality of patterned impaction channels for capturing particulate matter present in the sample, and extending between the at least two opposite sides of the chip, each one of the impaction channels comprising at least one impaction channel inlet and at least one impaction channel outlet and comprising one or more T-junctions between the at least one impaction channel inlet and the at least one impaction channel outlet; a cover in contact with the base structure and comprising a chip-contacting layer that is in contact with the chip's top surface and is at least partially covering the impaction channels, wherein the cover is configured to define at least one sample inlet opening and at least one sample outlet opening, and further together with the chip's top surface to define an at least one sample inlet channel that is in fluidic connection with the at least one impaction channel inlet and that is arranged for guiding at least a part of the sample into the one or more T-junctions, and an at least one sample outlet channel that is in fluidic connection with the at least one impaction channel outlet and that is positioned downstream of the one or more T-junctions, wherein the cover is arranged such that fluidic connection between the at least one sample inlet channel and the at least one sample outlet channel is established by the one or more T-junctions; and a transparent zone that covers an area of the top surface of the chip, which area comprises the one or more of T-junctions for presenting said area to light-based detection of an analyte possibly captured in said one or more of T-junctions.

2. The collecting device according to claim 1, wherein at least one of the layers of the cover comprises one or more openings comprising at least a first opening corresponding to the at least one sample inlet opening.

3. The collecting device according to claim 2, wherein the one or more openings further comprises a second opening corresponding to the at least one sample outlet opening.

4. The collecting device according to claim 2, wherein the at least one of the layers of the cover is the chip-contacting layer.

5. The collecting device according to claim 1, wherein at least one of the layers of the cover is sticky on at least one side and/or is made from a foil.

6. The collecting device according to claim 5, wherein the foil is a transparent and/or flexible foil.

7. The collecting device according to claim 5, wherein at least one of said layers comprises one or more through-holes that at least partially defines any one of the at least one sample inlet channel or the at least one sample outlet channel.

8. The collecting device according to claim 1, wherein the cover comprises a further one or more ports for introducing and/or removing liquids into and/or from the impaction channels.

9. The collecting device according to claim 1, wherein the cover and the base structure comprise a further one or more ports for introducing and/or removing liquids into and/or from the impaction channels.

10. The collecting device according to claim 1, wherein the base structure further comprises one or more subcompartments for reagents or other liquids.

11. The collecting device according to claim 10, wherein one or more of said subcompartments is formed as a blister or as an ampoule.

12. The collecting device according to claim 10, wherein at least one of the subcompartments comprises a PCR mastermix.

13. The collecting device according to claim 1, wherein the base structure further comprises one or more sample guiding conduits, and a sample inlet, the sample inlet arranged to be in fluid communication with the at least one sample inlet opening.

14. The collecting device according to claim 13, wherein a sample outlet is arranged to be in fluid communication with the at least one sample outlet opening.

15. The collecting device according to claim 1, the collecting device further comprising a lid for at least partially covering the base structure.

16. The collecting device according to claim 15, wherein the lid forms a part of a wall defining one or more breath guiding conduits.

17. The collecting device according to claim 15, wherein the lid covers the area of the chip that comprises the one or more of T-junctions and is transparent at least over said area.

18. The collecting device according to claim 1, wherein the base structure further comprises or is connectable to a removable mouthpiece or a fitting arrangement for connecting further to the removable mouthpiece, wherein the removable mouthpiece when connected to the base structure is arranged to open from one side into the sample inlet.

19. The collecting device according to claim 15, wherein the lid further comprises or is connectable to a removable mouthpiece or a fitting arrangement for connecting further to the removable mouthpiece, wherein the removable mouthpiece when connected to the base structure is arranged to open from one side into the sample inlet.

20. The collecting device according to claim 1, wherein the base structure further comprises a filter arranged to capture air exiting through the sample outlet.

21. The collecting device according to claim 1, further comprising an external casing for fitting the base structure with a removable mouthpiece and/or a filter arranged to capture air exiting through the sample outlet and/or for providing firm grasp for the user.

22. The collecting device according to claim 21, wherein the external casing comprises handles for providing firm grasp for the user

23. The collecting device according to claim 1, further comprising sensors or connections for sensors for monitoring during a sample collection process.

24. The collecting device according to claim 23, wherein the sample collection process is a breath collection process for collection of any one or more of the following parameters: pressure, temperature, humidity, and flow rate.

25. A breath analyser comprising the collecting device according to claim 1, and a mouthpiece wherein the cross-section of the part of the mouthpiece designed to engage with the user's lips is defined by two wider rims and two perpendicular thereto shorter rims defining the positioning of the mouthpiece with respect to the lips of the user, wherein the collecting device is positioned such that the chip is positioned horizontally with respect to the wider rims of the mouthpiece such that the chip is positioned horizontally with respect to the flow of air that the user exhales into the card/collecting device via the mouthpiece.

26. A diagnostic system comprising the collecting device according to claim 1, wherein the system further comprises a heating module and a reader, wherein the system is engageable with the collecting device and adapted to perform thermocycling on and reading output signals from the chip directly.

27. Use of the collecting device according to claim 1, for testing a user for a presence of a metabolic condition or a disease, the disease being an infectious disease caused by an infectious agent, or an infectious disease caused by an infectious agent that undergoes shedding into material exhaled by a user, or a virus such as SARS-CoV-2 virus.

28. Use of the diagnostic system according to claim 26, for testing a user for a presence of a metabolic condition or a disease, the disease being an infectious disease caused by an infectious agent, or an infectious disease caused by an infectious agent that undergoes shedding into material exhaled by a user, or a virus such as SARS-CoV-2 virus.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0041] For a fuller understanding, reference is made to the following detailed description taken in conjunction with the accompanying drawings in which:

[0042] FIG. 1 schematically shows a possible embodiment of the disclosed herein collection device (1) wherein the base structure (10) comprises two sample guiding conduits (11), the first conduit (11) extending from the sample inlet (12) and positioned upstream of the chip (2) with the impaction channels, and the second conduit (11) positioned downstream of the chip (2) and leading to a sample outlet (13);

[0043] FIG. 2 shows an exploded view of the embodiment of the collection device shown in FIG. 1, which clearly shows two layers of the cover (3), being an outer layer covering the base structure (10) and the chip-contacting layer (30) comprising two openings, one of said openings contacting the first sample guiding conduit (11) extending from the sample inlet (12) and therefore defining together with the structures of the chip the sample inlet opening (32), and the second opening contacting the second sample guiding conduit (11) leading to a sample outlet (13), and therefore defining together with the structures of the chip the sample outlet opening (33). The top (2T) and the bottom (2B) surfaces of the chip are also indicated;

[0044] FIG. 3 shows a simplified schematic representation of a chip shown as part of the embodiment of the collection device shown in FIG. 1, the representation of the chip comprising two impaction channels symbolized as two adjacent T-junctions (211) in the top surface (2T) of the chip;

[0045] FIG. 4 shows a chip-contacting layer (30) of the cover (3) from the embodiment of the collection device shown in FIG. 1, the chip-contacting layer (3) comprising two openings that when laid on the chip (2) define the sample inlet opening (32) and the sample outlet opening (33);

[0046] FIG. 5 shows a top-view alignment of the chip (2) and the chip-contacting layer (30) of the embodiment of the collection device from FIG. 1., which view shows that fluidic connection between the sample inlet opening (32) and the sample outlet opening (33) is made through T-junctions (211);

[0047] FIG. 6 shows a schematic top-view of the embodiment of the collection device from FIG. 1 with a schematic indication by dashed arrows of a path made by a sample, such as a breath sample from the sample inlet (12) via a first sample guiding conduit (11) made within the base structure (10) to sample inlet opening (32) for entering the impaction channels within the chip (2) where the collection of the particulate matter happens by impaction within the T-junctions (211), after which the reminder of the sample (symbolically represented by a dashed arrow that is thinner than the dashed arrow entering the T-junctions) exists the grooves of the chip (2) through the sample outlet opening (33) and proceeds by the second sample guiding conduit (11) to the sample outlet (13) leading outside of the collection device (1);

[0048] FIG. 7 shows a different schematic and simplified representation of another embodiment of a chip (2) that comprises differently arranged impaction channels (21) and better visible and longer than in the embodiment of FIG. 3 patterned grooves that together with chip-contacting cover define a sample inlet channel (22) and a sample outlet channel (23). On the right-hand-side, a panel shows an enlarged section of the chip containing a T-junction (211) with arrows symbolically indicating the path a sample makes within T-junction while being subject to collection of particulate matter via impaction;

[0049] FIG. 8 shows another and a similar to the one of FIG. 1 embodiment of the collection device (1) wherein the base structure (10) also comprises two sample guiding conduits (11), one extending from the sample inlet (12) to the chip (2) and the second one leading therefrom to a sample outlet (13). As in FIG. 6, direction in which a fluid sample enters and exits the collection device is represented by dashed arrows. In this embodiment, the chip-contacting layer (30) of the cover comprises a branched through-hole defining the sample inlet opening (32) and also participates with the chip (2) in creating sharp bends for more efficient impaction. In this embodiment, the sharp bends are created using the cover (3) and the chip (2). The transparent zone (3211) for presenting to light-based detection the contents of the T-junctions with the possibly captured particulate matter is indicated in the enlarged section of the collection device (1) shown in the right-hand-side, together with the schematic indication of the path as made by the sample during the particulate matter collection process;

[0050] FIG. 9 shows an exploded view of the embodiment of the collection device shown in FIG. 8, which comprises the cover (3) that contains a chip-contacting layer (30) that together with the structures of the chip (2) creates sharp bends for enhancing impaction. The top (2T) and the bottom (2B) surfaces of the chip are indicated;

[0051] FIG. 10 shows another possible embodiment of the collection device (1) wherein the base structure (10) is made from a transparent rigid material and the cover (3) comprises 3 layers, wherein the chip-contacting layer (30) of the cover comprises a plurality of parallel through-holes that interchangeably define a plurality of parallel sample inlet channels (322) that connect with a sample inlet opening (32) made as a through-hole in another layer of the cover (3), and a plurality of parallel sample outlet channel (323) that connect with a sample outlet opening (33) made a second through-hole the other layer of the cover (3);

[0052] FIG. 11 shows an exploded view of the embodiment of the collection device shown in FIG. 10. In this exploded view, the transparent base structure (10) is positioned on the top of the scheme. Below, the three exemplary layers of the cover (3) are represented, showing distinct structure as manufactured therewith as through holes, for example being the parallel sample inlet and outlet channels (322, 323) in the chip-contacting layer (30), or the through-holes corresponding to the sample inlet opening (32) or the sample outlet opening (33) in the layer underneath the chip-contacting layer (30). On the bottom of the scheme, the chip (2) is shown with an indication of its patterned top surface (2T) and its side exposed to the direction from which the sample is provided into the chip, i.e. the proximal side (2a);

[0053] FIG. 12 shows a schematic representation of another embodiment of a chip (2) that is the chip shown in FIGS. 10 and 11 and comprises multiple parallel impaction channels (21), wherein each impaction channel (21) comprises a series of multiple T-junctions (211) that are arranged along the length of each impaction channel (21);

[0054] FIG. 13 shows the bottom side of the embodiment of the collection device (1) shown in FIGS. 10 and 11, wherein the bottom side (2B) of the chip (2) that is arranged to contact a heating source like a thermoelectric cooler (TEC);

[0055] FIG. 14 shows the embodiment of the collection device (1) shown in FIG. 10 and a bottom panel that zooms in on the top-view alignment of the chip (2) and the part of the multi-layer cover (3) comprising the plurality of parallel sample inlet channels (322) that connect with a sample inlet opening (32) and are interchangeably arranged with respect to the plurality of parallel sample outlet channel (323) that connect with a sample outlet opening (33);

[0056] FIG. 15 shows the zoomed-in in FIG. 14 top-view alignment from of the chip (2) with the part of the multi-layer cover (3) comprising the functional through-holes in the appropriate cover layers that define the path along which the sample enters the impaction zone of the chip (2) thus allowing collection of the particulate matter potentially comprising the analyte of interested to be collected and then detected within the grooves patterned on the top surface of the chip (2). The path made by the sample is schematically indicated by dashed arrows. The bottom pane shows a further zoomed-in top-view of a part of the chip (2) and the cover (3) clearly indicating the entry and exit points from the T-junctions (211) where the impaction happens. The entry path is represented by relatively thicker dashed arrows while the exit path is represented by relatively thinner dashed arrows.

[0057] FIG. 16 shows a 3D representation of the parallel sample inlet and outlet channels (322, 323) extending from the sample inlet opening (32) or the sample outlet opening (33), respectively. The bottom panel zooms in on the dead-ends of two sample outlet channels (323) that are positioned between three sample inlet channels (322). The zoomed-in section shows that there is no fluidic communication between the inlet and the outlet channels (322, 323) other than by the impaction zone of the chip (for clarity the chip is not shown but the path the sample makes is indicated by dashed arrows as in FIG. 15);

[0058] FIG. 17 shows an example of a possible diagnostic system comprising an instrument (4) adapted to accept by an entry slot (41) any one of two exemplary embodiments of the collecting device (1) shown (out of scale due to being enlarged for clarity) on the right-hand-side of the instrument (4) and facing the entry slot (41) with their parts exposing the bottom side of their respective chips. The embodiment of the instrument (4) comprises a heating module for contacting the exposed closed bottom parts of the chips in order to execute a thermocycling programme within their grooves; and further comprise an optic reader for detecting e.g. light signals originating from the structures on top surface of the chip (facing bottom in this schematic representation).

DETAILED DESCRIPTION

[0059] In a first general aspect, a collecting device (1) is hereby disclosed for sampling particulate matter from a sample, the sample for example being breath exhaled by a human subject, the collecting device comprising [0060] a base structure (10), a monolithic silicon chip (2) supported by said base structure (10), the chip (2) comprising at least two opposite sides and a top surface (2T) and an opposite thereto bottom surface (2B), wherein the bottom surface (2B) is closed allowing contacting with a heating source and wherein the top surface (2T) comprises a plurality of patterned impaction channels (21) for capturing particulate matter present in the sample, for example the exhaled breath, and extending between the at least two opposite sides of the chip, each one of the impaction channels (21) comprising at least one impaction channel inlet (212) and at least one impaction channel outlet (213) and comprising one or more T-junctions (211) between the at least one impaction channel inlet (212) and the at least one impaction channel outlet (213); [0061] the collecting device further comprising a cover (3) in contact with the base structure (10) and comprising a chip-contacting layer (30) that is in contact with the chip's top surface (2T) and is at least partially covering the impaction channels (21), [0062] wherein the cover (3) is configured to define at least one sample inlet opening (32) and at least one sample outlet opening (33), and further to define together with the chip's top (2T) surface an at least one sample inlet channel (22, 322) that is in fluidic connection with the at least one impaction channel inlet (212) and that is arranged for guiding at least a part of the sample into the one or more T-junctions, and an at least one sample outlet channel (23, 323) that is in fluidic connection with the at least one impaction channel outlet (213) and that is positioned downstream of the one or more T-junctions, [0063] wherein the cover (3) is arranged such that fluidic connection between the at least one sample inlet channel (22, 322) and the at least one sample outlet channel (23, 323) is established by the one or more one or more of T-junctions (211), and [0064] wherein the collecting device (1) further comprises a transparent zone (3211) that covers, and optionally is in contact with, an area of the top surface (2T) of the chip (2), which area comprises the one or more of T-junctions (211) for presenting said area to light-based detection of an analyte possibly captured in said one or more of T-junctions (211).

[0065] In other words, an advantageously integrated sample collection and analysis device is hereby provided comprising a chip patterned with impaction channels (21) serving for both the sample collection by impaction and their subsequent analysis within the same chip's structures, wherein the above-described at least one sample inlet channel (22, 322) and the at least one sample outlet channel (23, 323) are in fluidic connection exclusively made through the one or more one or more of T-junctions (211) patterned in the chip and closed by the cover (3).

[0066] An example of how the sample inlet channels (22) can be connected with the sample outlet channels (23) via a T-junction is shown in FIG. 5 as well as in FIG. 6 schematically showing by dashed arrows the path a sample makes after entering into the showed therein embodiment of the disclosed herein collection device via a sample inlet (12) through the T-junctions of the chip, where the collection of the particulate matter takes place by impaction, till the sample outlet (13) leading the remainder of the sample after the impaction to the outside of the collection device.

[0067] In a preferred embodiment, the base structure (10) will be made of a rigid material, preferably resistant to being exposed to temperatures typical of thermocycling conditions, e.g. resistant to temperatures of at least 80° C. or 90° C., preferably higher. Advantageously, the collecting device will be disposable and consequently the base structure can be made of a thermoplastic material; for example from polycarbonate, like black (medical grade) polycarbonate. Black, generally dark, or even opaque, and/or generally non-reflective materials have the advantage of reducing reflection when light-based detection is considered, and consequently may be preferred in certain embodiments. In possible embodiments, the chip can be made from silicon, the cover can be made from polymer laminate like PET, polyester with adhesives and/or the base structure can be made in polycarbonate, PMMA, etc.

[0068] The base structure will support or enclose the chip that can be e.g. glued thereto or stably positioned therewith thanks to the presence of the cover (3), preferably being a multi-layer cover.

[0069] When the base structure (10) is provided in a form of a baseplate, alternatively termed as a test-card, i.e. appearing to have two major planes, the chip (1) may preferably be positioned horizontally with respect to the major planes of such visibly flat base structure.

[0070] In an alternative embodiment, the chip can possibly be positioned vertically, which can be achieved by e.g. changing the routing in the base structure (10). Horizontal positioning of the chip (1) with respect to the base structure is however preferred for its compactness, advantages during assembly, as well as final collection device geometry.

[0071] Exemplary embodiments of collection devices comprising such substantially flat or card-shaped base structures (1) and chips horizontally positioned therewith are shown as assembled entities in FIGS. 1, 8, 10 and 13, and in exploded view in FIGS. 2, 9, and 11.

[0072] Depending on the side from which a sample will be directed into the impaction channels (21) of the chip (2), regardless of the shape (square, rectangular, or even oval or round) of the chip it will be possible to say that the chip (2) is defined by a proximal side (2a), i.e. the side from which the sample enters the chip, possibly being the side from which air or breath is blown into the collecting device, and by a distal side (2b) opposite to the proximal side (2a), i.e. being the side from which the sample, e.g. air, exits the collecting device, and by two lateral sides (2c, 2d) connecting the proximal side (2a) and the distal side (2b), in addition to the top surface (2T) and the opposite thereto bottom surface (2B).

[0073] The above explained indication of different sides of possible, though simplified and schematic embodiments of chips for the collecting device as disclosed herein are shown in FIGS. 3, 7, and 12.

[0074] In case of such defined sides of the chip, in a possible embodiment, a collecting device can be provided wherein the plurality of the patterned impaction channels (21) the top surface (2T) of the chip (2) are extending between the two lateral sides of the chip (2c, 2d), and wherein each one of the impaction channels (21) comprising at least one impaction channel inlet (212) are positioned closer to the first lateral side (2c) than to the second lateral side (2d), and wherein the at least one impaction channel outlet (213) is positioned closer to the second lateral side (2d) than to the first lateral side (2c).

[0075] In a related embodiment, a collecting device can be provided, wherein the cover (3) comprises one or more openings comprising an opening positioned entirely or at least partially (as shown in enlarged panel of FIG. 8) in the proximity of the chip's proximal side (2a) for defining the at least one sample inlet opening (32). Analogously, in a further embodiment the collecting device is provided comprising a second opening positioned in the proximity of the chip's distal side (2b) for defining the at least one sample outlet opening (33).

[0076] As it will be seen from the exemplary embodiments of the collection devices in FIGS. 1, 8, 10 and 13 in view of the indication of sides of chips as indicated in FIGS. 3, 7, and 12, the orientation of the T-junctions (211) is shown as perpendicular to the direction in which a sample, such as air blown by a user, is directed into the chips for collection of the particulate. This orientation of the T-junctions is merely exemplary and other orientations are possible For example, the orientation of the T-junctions can be rotated with respect to how they are shown in said Figures; to do so, the chip-contacting layer (30) may also be rotated. For example, to have the T-junctions rotated 90°, an extra bend or extra bends can be added on e.g. channel 22 or 212 resulting in a similar result as shown in the schematic representation of the chip of FIG. 7.

[0077] In particularly preferred from manufacturing-perspective embodiments of the disclosed herein collection devices, the cover (3) will be a multi-layer cover (3) or a composite cover (3) comprising two or more layers. Examples of such layers in possible embodiments of such multi-layer cover (3) can be seen in the exploded view FIGS. 2, 9, and 11. Alternatively, the cover can be manufactured as monobloc that is 3D printed or appropriately moulded. In such case the monobloc constitutes a single layer cover (3) embodiment wherein the chip-contacting layer (30) is the single layer of the monobloc.

[0078] As already mentioned, in a preferred embodiment, a collecting device (1) is provided wherein at least one of the layers of the cover (3) comprises one or more openings comprising at least a first opening corresponding to the at least one sample inlet opening (32), and possibly further comprises a second opening corresponding to the at least one sample outlet opening (33), possibly wherein the at least one of the layers of the cover (3) is the chip-contacting layer (30) such as the examples of the chip contacting layers seen in in the exploded view FIGS. 2, 9, and 11 as well as in FIG. 4.

[0079] In possible advantageous embodiments of the collection device, any one of the cover (3) or the base structure (10) or both can be transparent.

[0080] In another embodiment, a collecting device is provided, wherein at least one of the layers of the cover (3) is sticky on at least one side and/or is made from a foil, preferably being a transparent and/or flexible foil. For example, when looking at the exploded view in FIG. 11 the layer of the cover (3) that is the closest to the rigid base structure (10) can be made from a double-sided tape for connecting additional layers and/or parts of a surface of the chip. In such case, the chip-contacting layer (30) can be made of a foil that is not sticky from any side while the final layer containing the sample inlet and outlet openings (32 and 33) can then be made by a foil that is sticky from at least one side. Alternatively, the layer of the cover (3) that is the closest to the rigid base structure (10) can be entirely eliminated in case the chip-contacting layer (30) is made sticky on its side facing the transparent rigid base structure (10). Many alternative arrangement can be envisaged of connecting the layers of the cover (3), which consequently will not be discussed further herein.

[0081] In another possible embodiment, a collecting device can be provided, wherein at least one of the layers of the cover comprises one or more through-holes that at least partially define any one of the at least one sample inlet channel (322) or the at least one sample outlet channel (323). Examples of such embodiment of the collecting device are shown in FIGS. 10, 11, and 13, with a more detailed schematic views shown in FIGS. 14, 15 and 16 detailing how such created multiple sample inlet channels (322) and multiple sample outlet channels (323) can be arranged and direct samples to and outside an impaction zone created within a chip (to e.g. exemplary impaction channels (21) as shown in a schematic chip example of FIG. 12).

[0082] In a further embodiment, a collecting device can be provided wherein the cover (3) and optionally the base structure (10) comprises a further one or more ports for introducing and/or removing liquids such as reagents into and/or from the impaction channels (21). An example of such structure can be an opening within the cover (3) or in the base structure (10), or even a removable part positioned in the vicinity of the chip for pipetting thereto e.g. a PCR mastermix or appropriate buffers.

[0083] In a further embodiment, a collecting device can be provided, wherein the base structure (10) further comprises one or more subcompartments for reagents or other liquids, preferably wherein one or more of said subcompartments is formed as a blister or as an ampoule, more preferably wherein at least one of the subcompartments comprises a PCR mastermix.

[0084] In another possible embodiment, a collecting device is provided, wherein the base structure (10) further comprises one or more sample guiding conduits (11), such as the ones shown or partially shown in FIGS. 1, 2, 5, 6, 8, and 9, possibly and preferably being guiding conduits, and a sample inlet (12), the sample inlet (12) arranged to be in fluid communication with the at least one sample inlet opening (32), and optionally a sample outlet (13), optionally arranged to be in fluid communication with the at least one sample outlet opening (33).

[0085] In a further possible embodiment, a collecting device can be provided further comprising a lid for at least partially covering the base structure (10), possibly wherein the lid forms a part of a wall defining the one or more breath guiding conduits (11), e.g. in case the cover (3) is not involved in this, possibly wherein such additional lid provides an additional protection and covers the area of the chip (2) that comprises the one or more of T-junctions (211) and is transparent at least over said area.

[0086] In a particularly preferred embodiment, the disclosed herein collecting devices will be adapted to collecting a sample being a breath sample.

[0087] Consequently, in a preferred embodiment, a collecting device is provided wherein the base structure (10) or the lid further comprises or is connectable to a removable mouthpiece or a fitting arrangement for connecting further to the removable mouthpiece, wherein the removable mouthpiece when connected to the base structure (10) is arranged to open from one side into the sample inlet (12).

[0088] In case of monitoring of infectious diseases, an advantageous embodiment can be envisaged wherein a collecting device is provided comprising a filter arranged to capture air exiting through the sample outlet (13), preferably wherein it is the base structure (10) that comprises such filter arranged to capture air exiting through the sample outlet (13).

[0089] In another possible embodiment, a collecting device can be provided further comprising an external casing for fitting the base structure (10) with the removable mouthpiece and/or the filter and/or for proving firm grasp for the user, preferably comprising handles for proving firm grasp for the user.

[0090] In a further advantageous embodiment, a collecting device may be provided comprising sensors or connections for sensors for monitoring during the sample collection process, preferably during breath collection process anyone or more of the following parameters: pressure, temperature, humidity, flow rate e.g. airflow including its speed.

[0091] In a yet another embodiment, a collecting device can be provided, wherein the base structure (10) comprises an through-hole (14) for exposing the bottom surface (2B) of the chip (2) for allowing direct contacting of said bottom surface (2B) with the heating source such as a TEC, for example a TEC integrated inside of a an instrument such as the one shown in FIG. 17 for engaging and automated processing of possible embodiments of the disclosed herein collection devices.

[0092] In a further embodiment, a collecting device can be provided wherein the transparent zone (3211) of the cover (3), and optionally the lid (30) is protected by a removable element for protecting said transparent zone from dirt, for example a sticker or a liner.

[0093] In a practical embodiment, a collecting device can be provided formed as or comprised as part of a card, such as a test card.

[0094] In another practical embodiment, a collecting device can be provided further comprising a code such as a barcode, preferably provided on the base structure (10) or on the lid.

[0095] In a related aspect, the present disclosure also provides a breath analyser comprising the collecting device (1) as described above, and a mouthpiece wherein the cross-section of the part of the mouthpiece designed to engage with the user's lips is defined by two wider rims and two perpendicular thereto shorter rims defining the positioning of the mouthpiece with respect to the lips of the user, wherein the collecting device (1) is positioned such that the chip (2) is positioned horizontally with respect to the wider rims of the mouthpiece such that the chip (2) is positioned horizontally with respect to the ground level and/or to the base structure and to the flow of air that the user exhales into the card/collecting device via the mouthpiece.

[0096] To the knowledge of the inventors, no devices using such practical horizontal incorporation of the chip in collecting device are known, which geometrically advantageous arrangement has the benefit of allowing the collected particles to be readily detected directly using at least a part of the collecting device with the chip upon provision to an appropriate analysis system.

[0097] The breath analysers as discussed herein can be manufactured as many possible embodiments, including, just to name a few, addition of practical casings and/or arrangements making the embodiments connectable to disposable, standard and/or adjustable mouthpieces (e.g. smaller ones for children); including further mechanical additions such as handles for firm grasp by children or e.g. elderly; adjustment means to ensure steady airflow and comfort of breathing during sample collection; arrangements for connecting with filter such as standard filters; sensors; connection means to a device comprising a screen either via cable connection or wirelessly to e.g, a smartphone, possibly with a provision of an interface like an app for visualising airflow or monitoring if enough sample is being acquired during the collection process etc.

[0098] In a yet another aspect, a diagnostic system is further provided herein comprising the collecting device (1) of the disclosure, wherein the system further comprises a heating module and a reader, wherein the system is engageable with the collecting device and adapted to perform thermocycling on and reading output signals from the chip (2) directly.

[0099] In a preferred embodiment, such diagnostic system can be provided wherein the heating module and the reader form one integrated subsystem of the diagnostic system, such as in the form of an instrument as shown in FIG. 17.

[0100] Last but not least, provided herein are also uses of the collecting device or the system of the disclosure, for testing a human subject for a presence of a metabolic condition or a disease, the disease preferably being an infectious disease caused by an infectious agent, even more preferably being an infectious disease caused by an infectious agent that undergoes shedding into material exhaled by a user, most preferably being a virus such as SARS-CoV-2 virus.