Device for sampling and analysing a biological fluid

Abstract

Device for sampling and analysing a biological fluid; the device (1) comprises a sensor (2), which is configured to detect and / or quantify an analyte present in the sample and / or a property of the sample; the device (1) further comprises a transport system (3), which is configured to transport the sample from the external environment (in particular, from a living being) to the sensor (2) and comprises a fibrous material, configured to enable the diffusion of the biological fluid through itself and having an analysis portion (4) arranged in the area of the sensor (2) and a transport portion (5) provided with a first end which projects out of the device and a second end in contact with the analysis portion (4).

Description

[0001] "DEVICE FOR SAMPLING AND ANALYSING A BIOLOGICAL FLUID"

[0002] Cross-Reference to Related Applications

[0003] This Patent Application claims priority from Italian Patent Application No. 102024000018073 filed on August 1, 2024, the entire disclosure of which is incorporated herein by reference.

[0004] Technical Field

[0005] The present invention relates to a device for sampling and analysing a biological fluid. The present invention further relates to uses of such a device.

[0006] Background of the Invention

[0007] The detection and quantification of analytes (e.g. cytokines, uric acid, a viral agent, a bacterial agent) or other properties (such as pH and osmolarity) in biological fluids (e.g. tears, sweat, wound exudate, saliva, blood, urine, crevicular fluid, nose liquid) for diagnostic purposes normally requires, to date, the transfer of a sample of such fluids to the laboratory, with potential negative impacts on the measurement / quantif ication thereof (e.g. the possibility of contaminating the sample and / or, also considering the instability of some analytes such as cytokines, the possibility of losing part of the sample itself) . [Adv. Sci. 2021, 8, 2004433] . In addition, the analysis of a few microliters ( ,L) of matrix / biological fluid greatly complicates the sampling step of the fluid itsel f , as the problems related to evaporation and potential loss of material / inf ormation are ampli fied under these conditions .

[0008] Moreover, the procedures currently used are relatively slow and expensive ( since the sample is to be trans ferred to the laboratory, it is not possible to give the result to the patient within a few minutes ) , which does not allow the doctor to deal with the patient immediately and ef ficiently .

[0009] Aim of the present invention is to provide a device for sampling and analysing a biological fluid and uses thereof , which allow to overcome , at least partially, the drawbacks of the prior art and are , at the same time , easy and economical to implement .

[0010] Summary

[0011] According to the present invention there is provided a device for sampling and analysing a biological fluid and uses thereof as recited in the fol lowing independent claims and, preferably, in any of the claims directly or indirectly dependent on the independent claims .

[0012] Brief Description of the Drawings

[0013] The invention wi ll now be described with reference to the accompanying drawings , which show some non-limiting embodiments , wherein :

[0014] - Figure 1 is a schematic view, in plan and with some details removed for clarity of a device in accordance with the present invention;

[0015] - Figure 2 is a perspective and schematic view with some details removed for clarity of the device of Figure 1 ;

[0016] - Figure 3 is a schematic plan view, in plan and with some details removed for clarity of a device in accordance with the present invention;

[0017] - Figure 4 is a perspective and schematic view with some details removed for clarity of the device of Figure 3 ;

[0018] - Figure 5 is a side , schematic view with some details removed for clarity of the device of Figures 3 and 4 ; and

[0019] - Figure 6 is a graph obtained experimentally using a device in accordance with the present invention; the transconductance ( in mS ) is shown in the ordinate and the potential of the gate electrode is shown in the abscissa ( in V - the gate electrode is described in more detail below) .

[0020] Detailed Description

[0021] In accordance with a first aspect of the present invention, in Figure 1 , 1 denotes as a whole a device for sampling and analysing a biological fluid ( a liquid) ( in particular, a human or veterinary biological fluid; more in particular, a human biological liquid; for example , tears , sweat , wound exudate , saliva, blood, urine , crevicular fluid and / or nose liquid) . The device 1 comprises a sensor 2 , which is configured to detect ( and / or quanti fy) at least one characteristic of a sample of the biological fluid chosen from the group consisting of : at least one analyte present in the sample , at least one property of the sample ( and a combination thereof ) .

[0022] The device 1 further comprises a transport system 3 , which is configured to transport the sample from the external environment ( in particular, from a living being; more in particular, from an animal ; even more in particular , from a human being) to the sensor 2 and comprises a fibrous material , configured to enable the di f fusion of the biological fluid ( through the fibrous material itsel f ) and having an analysis portion 4 arranged in the area of the sensor 2 and a transport portion 5 provided with a first end 6 which proj ects out of the device 1 and a second end 7 in contact with the analysis portion 4 .

[0023] In particular, the fibrous material is configured to enable the di f fusion of the biological fluid ( through the fibrous material itsel f ) by hygroscopicity .

[0024] In particular, the first end 6 is configured so that it can come (more in particular, the device 1 is configured so that the first end 6 can come ) into contact with a tissue and / or a fluid o f a human being and / or an animal (more in particular, a human being - patient ) , more in particular so that the sample is absorbed by the first end 6 and trans ferred into the fibrous material up to the analysis portion 4 . According to some non-limiting embodiments , the first end 6 is exposed outwards ( it is not covered by anything) . In particular, the first end 6 is exposed outwards (not covered by anything) laterally ( and in its terminal portion - in its tip ) .

[0025] More precisely but not necessarily, the first end 6 is connected to the device only by means of its own proximal portion) .

[0026] Advantageously but not necessarily, the fibrous material comprises ( consists substantially of ) a material chosen from the group consisting o f : cotton, cellulose ( and a combination thereof ) .

[0027] In addition or alternatively, the fibrous material has one or more of the following characteristics :

[0028] • substantial absence of residual ash (<0 . 007 % by weight with respect to the total weight of the fibrous material ) ;

[0029] • pore dimensions higher than 10pm ( in particular measured by scanning electron microscopy) ;

[0030] • di f fusion of the isotropic fluid, evaluating the geometry and structure of the pores by scanning electron microscopy; and

[0031] • high filtration speed ( less than 100 s / ml Herzberg) .

[0032] In particular, the filtration speed is measured with a water reference solution for hydrophilic membranes . For example , the weight of water that is absorbed over a certain period of time in a membrane sample of known dimens ion ( for example 4cm2) is measured and defined as = Permeate flux

[0033] Then this formula is used .

[0034] Membrane flux = ( Permeate flux ) / (Membrane Area ) .

[0035] In particular, the fibrous material has one or more of the following characteristics :

[0036] • pore dimensions higher than 10pm ( in particular measured by scanning electron microscopy) ; and

[0037] • high filtration speed ( less than 100 s / ml Herzberg) .

[0038] In particular, the filtration speed is up to 500 s / ml .

[0039] Advantageously but not necessarily, the fibrous material has filtration speed of less than 100 s / ml ( in particular, up to 500 s / ml ) .

[0040] In particular, the filtration speed is measured as described in https / / www . rotec- com / news / how-to- c a 1 c u late-ro - e mb r a n e - f 1 u x / .

[0041] Alternatively or in addition, the fibrous material has pore dimensions higher than 10pm ( in particular measured by scanning electron microscopy)

[0042] In use , the first end 6 is placed in contact with the tissue / fluid to be examined ( for example with the eye or with the inner part of the mouth or a wound) and passively transports ( it is assumed by hygroscopicity) this fluid ( liquid) to the sensor 2 (where , in use , the analysis takes place ) .

[0043] The device 1 has proven to be a rapid, quantitative and low-cost instrument capable of detecting / quanti f ying presence of analytes (molecules of various types such as proteins and uric acid) or other properties .

[0044] According to some non-limiting embodiments , the fibrous material can be of a single type or of more types . For example , the fibrous material may consist of several layers ( e . g . , two ) , each of which is of a respective type di f ferent from that of the others .

[0045] In particular, the transport portion 5 (more precisely, the second end 7 thereof ) and the analysis portion 4 are one the continuation of the other . In other words , the fibrous material extends from the transport portion 5 to the analysis portion 4 seamlessly .

[0046] Advantageously but not necessarily, the transport portion 5 has a width of less than about 6 mm ( in particular, less than about 5 mm; more in particular, less than about 4 mm) . In particular, the transport portion 5 has a width higher than about 0 . 4 mm, more in particular equal to or higher than about 1 mm, even more in particular higher than about 2 mm .

[0047] Alternatively or additionally, the transport portion 5 has a length of less than about 25 mm ( in particular, less than about 20 mm; more in particular, less than about 15 mm) . In particular, the transport portion 5 has a length higher than about 1 mm, more in particular higher than about 5 mm, even more in particular higher than about 10 mm .

[0048] Alternatively or additionally, the transport portion 5 has a thickness of less than about 3 mm ( in particular, less than about 2 mm; more in particular, less than about 1 mm) . In particular, the transport portion 5 has a length higher than about 0 . 1 mm, more in particular higher than about 0 . 5 mm, even more in particular higher than about 0 . 9 mm .

[0049] It has been experimentally observed that thanks to one or more of these dimensions of the transport portion 5 in combination with the other characteristics described above , the device 1 was surprisingly able to detect ( and / or quanti fy) at least one characteristic of a sample of the biological fluid ( liquid) of extremely small volumes ( even less than 10 ,L ) .

[0050] Advantageously but not necessarily, the first end 6 has ( at least one terminal portion with) a width of less than about 2 mm ( in particular, less than or equal to about 1 mm; in particular, higher than about 0 . 1 mm) .

[0051] In this way, it has been experimentally observed that the use of the device allows the sample to be taken more easily and substantially non-invasively ( in a way that is more bearable by the patient ) .

[0052] According to some non-limiting embodiments , the first end 6 has a length of less than about 10 mm (in particular, less than about 5 mm; more in particular, less than about 2 mm) .

[0053] Advantageously but not necessarily, the sensor 2 comprises (in particular, is) an organic electrochemical transistor (OECT) .

[0054] According to some non-limiting embodiments, the sensor 2 comprises (in particular, consists of) a source electrode 8, a drain electrode 9, a gate electrode 10 and a semiconductor material 11 (commonly called channel) connected to the source electrode 8, to the drain electrode 9 (to the gate electrode 10) and to said analysis portion 4.

[0055] In other words, in particular, the semiconductor material 11 (commonly called channel) connects the source electrode 8 to the drain electrode 9 and, through said analysis portion 4, to the gate electrode 10.

[0056] According to some non-limiting embodiments, the semiconductor material 11 comprises (consists of) at least one (organic) polymer. In particular, the polymer is chosen from the group consisting of: poly (3, 4- ethylenedioxythiophene ) : poly ( styrene ) (PEDOT:PSS) , selfdoped poly ( 3 , 4-ethylenedioxythiophene ) (S-PEDOT) , iron ( I I I ) -doped poly ( 3 , 4-ethylenedioxythiophene ) p- toluenesulfonate (PEDOT:TOS) , hydroxymethyl poly (3,4- ethylenedioxythiophene ) :perchlorate ( PEDOTOH : C1O4 ) , poly ( 3 , 4-ethylenedioxythiophene-poly (3,4- ethylenedioxythiophene : perchlorate copolymer (PEDOT-co- PEDOTOH : C1O4 ) , Poly ( 3-hexyl thiophene-2 , 5-diyl ) (P3HT) , PTHS, ( Poly (benzimidazobenzophenanthroline ) ) (BBL) , poly (2- (3,3'-bis (2- (2- ( 2 -met hoxy ethoxy ) ethoxy) ethoxy) —[2,2’— bithiophene] -5-yl) thieno [3, 2-b] thiophene) (p(g2T- TT) ) , poly(2- (3, 3 '-bis ( tetrade cyl oxy ) -[2,2' -bit iophene ] -5- yl) thieno [3, 2-b] thiophene) (p(a2T-TT) ) , (poly ( 6- ( thiophene- 3-yl) hexane-l-sulfonate) ) -tetramethylammonium<+>-co-Poly (3- hexylthiophene ) PTHS-TMA<+>-co-P3HT, p(gNDI-g2T) , p(gOT2- g6T2) , Polyaniline (PANI) , Polypyrrole (PPy) , P-90] .

[0057] To obtain the semiconductor material 11 in its position as described above, a solution can be deposited (on textile, plastic or fibrous substrate) to make a thin film (e.g. deposited by screen printing, blade covering, spin covering, inkjet printing) .

[0058] The gate electrode 10 may be made of both the organic polymer (see what is described above) and inorganic material (e.g., gold, silver / silver chloride, and / or platinum) .

[0059] For the elements made by means of organic polymer, secondary additives may be advantageously but not necessarily added to the commercial product that is dispersed in solution to improve the conductivity, adhesion and structure thereof. Examples of additives are ethylene glycol (EG) , dodecylbenzene sulfonate acid (DBSA) and glycidoxypropyl trimethoxylane (GOPS) or Dimethylsulfoxide (DMSO) .

[0060] An example of formulation to obtain the semiconductor material 11 is PEDOT:PSS 93.75%, EG 5%, GOPS 1%, DBSA 0.25% (by weight with respect to the total weight of the formulation) .

[0061] Advantageously but not necessarily, the semiconductor material 11 has dimensions (length and width) that can vary from tens of micrometres (in particular from about 10 pm; more in particular, from about 20 m) to tens of millimetres (in particular to about 80 mm; more in particular, to about 50 mm; even more in particular, to about 10 mm) . In addition or alternatively, the semiconductor material 11 has a thickness that can vary from 100 nm (e.g. for devices printed on plastic substrates) to 2-3 mm (e.g. for devices printed on textile or paper substrates) .

[0062] In accordance with a specific and non-limiting example, the geometry of the semiconductor material 11 is as follows: 200 pm wide, 100 pm long, 150 nm thick.

[0063] Advantageously but not necessarily, the gate electrode 10 has dimensions ranging from tens of micrometres (in particular from about 10 pm; more in particular from about 20 pm) to tens of millimetres (in particular to about 80 mm; more in particular to about 50 mm; even more in particular to about 10 mm) in length and width (for example 50 pm x 50 pm) and has a thickness from about 150 nm to about 2-3 mm (when the gate electrode 10 is in PEDOT:PSS) or to about 50 nm (when the gate electrode 10 is in gold or platinum) .

[0064] In particular, the source electrode 8, the drain electrode 9, the gate electrode 10 and the semiconductor material 11 are arranged in contact with the analysis portion 4 (wherein the fluid is "guided" by hygroscopicity or absorption gradient - as mentioned above) .

[0065] According to some non-limiting embodiments (Figures 1 and 2) , the source electrode 8, the drain electrode 9 and the gate electrode 10 (and the semiconductor material 11) are arranged (lie) substantially on a same plane.

[0066] According to some non-limiting embodiments (Figures 3, 4 and 5) , the analysis portion 4 is arranged (in contact) between the semiconductor material 11 and the gate electrode 10 (in a "sandwich"-like configuration) .

[0067] In particular, the source electrode 8 and the drain electrode 9 (and the semiconductor material 11) are arranged (lie) substantially on a same plane and the gate electrode 10 is arranged on a different plane (as best seen in Figure 5) . More precisely, the gate electrode 10 lies on the same vertical as (orthogonally to) the semiconductor material 11.

[0068] As regards the production and operation of the device 1 in relation to the detection / quantif ication (sensing) of the analytes and of the properties of the sample, the simplest strategy consists in the oxidation / reduction of the analytes on the gate electrode 10 or on the semiconductor material 11. Depending on the molecule to be investigated, the potentials to be applied to the source electrode 8, to the drain electrode 9 and to the gate electrode 10 must be used and calibrated, in order to have the potential necessary for the required oxidation-reduction.

[0069] Similarly, it is useful to define the geometry of the device, falling within the ranges shown above.

[0070] For example, with regard to the potentials, VdS=-0.3V (potential of the drain electrode 9 with respect to the source electrode 8) and Vgs=0.4V (potential of the gate electrode 10 with respect to the source electrode 8) were used to monitor the uric acid as described in a previous work by some of the inventors of the present application (Isacco Gualandi et al. , J. Mater. Chem. B, 2015, 3, 6753- 6762) , having "grounded" the source electrode 8. The oxidation-reduction reaction modifies the current of the gate electrode 10 (gate current) and results in a change in the current to the drain electrode 9 (drain current) (with signal amplification, given the transistor geometry) , which can be used as a monitorable signal correlatable to the concentration of the molecule in solution, as described for example for the oxygen in the article by some of the inventors of the present application: Decataldo et al. , 2020, APL Mater. 8, 091103.

[0071] The gate potential (potential at the gate electrode 10 with respect to the source electrode 8) and the drain potential (potential at the drain electrode 9 with respect to the source electrode 8) can be kept static or the gate potential can be varied cyclically, quantifying the analyte in a potentiostatic or potentiodynamic way, respectively. In the second case, different scanning speeds can be used, in the range from 0.5 mV / s to 500 mV / s, impacting the monitoring process differently, as detailed in the article by some of the inventors of the present application Isacco Gualandi et al. , 2016, Scientific Reports volume 6, 35419. An example of quantification of uric acid (molecule that undergoes oxidation on the gate terminal of the device) with a potentiodynamic analysis method is represented in Figure 6. Typically but not in a limiting manner, referring to Figure 6, the figure of merit of the transistor, transconductance, which manifests the amplification of the transistor, is studied. The transconductance is calculated from the first derivative of the drain current with respect to the gate potential Vgs; then the derivative of a transcharacteristic curve is carried out, which monitors the current in the channel Ids by varying the potential applied to the gate electrode 10. The transconductance shows how the signal in input to OECT Vgsis "transformed" into the output signal Ids. The presence of the analyte is given by the appearance of a peak at its oxidation / reduction potential, as occurs in Figure 6 for the uric acid at Vgs= 0.3V.

[0072] In Figure 6 the points relate to measurements made on a phosphate buffered saline (PBS) solution in the absence of the analyte; the asterisks relate to measurements made on a PBS solution with uric acid (analyte) having a concentration of 100 M. The appearance of the oxidation peak shows the detection of the analyte by the device.

[0073] Alternatively, the gate electrode 10 can be functionalized with strategies depending on the type of analyte to be monitored. To make biomarker sensors (such as for example proteins) , functionalization strategies may provide to deposit antibodies on the surface of the gate electrode 10. During the detection operations, the occurrence of protein ( analyte ) -antibody binding (functionalization of the gate electrode 10 - gate) alters the signal response, allowing the analyte to be monitored. An example of functionalization for biomarkers is obtained through the subsequent deposition of AminopropylTriethoxylan (APTES) , Biotin, Streptavidin and the antibody capable of binding to the analyte of interest, as described in the following work: Francesco Decataldo et al. 2019, Flex. Print. Electron. , 4 044006, DOI 10.1088 / 2058-8585 / ab5bfc.

[0074] The detection (sensing) of analytes and ions, such as for example the pH level or the amount of chlorine ions, can be carried out through PEDOT functionalizations that exploit electrochemical techniques to deposit electrochemically active nanoparticles on the surface of the organic polymer, as described in Federica Mariani et al. , ACS Sens. 2021, 6, 2366-2311 , [pH] and Scientific Reports, 2020, 10:11180, [Cl], or through functionalizations with other polymeric compounds, as described in Federica Mariani et al. , Electrochemistry Communications 116 (2020) 106163. In the reported works it is observed that the Limit of Detection (LCD) and the linearity range were significant and useful in reference to the expected analyte levels.

[0075] With particular reference to the embodiment of Figures 1 and 2, the sensor 2, for example made through any of these functionalization strategies, can be printed on a plastic and flexible substrate, such as for example Polyethylene Naphthalate (PEN) and / or Polyethylene Terephthalate (PET) and / or Polyimide (PI) films and / or paper and / or textile material (in particular, PEN and / or PET and / or PI) .

[0076] With reference to the embodiment of Figures 3-5, the connection between the semiconductor material 11 and the gate electrode 10 can be obtained through the analysis portion 4 (in particular, of paper, fabric - for example in cotton - and / or gauze) properly positioned and with a well- defined shape. It is advantageous that the transport system 3 (paper, tissue or gauze ) is able to absorb electrolytes ( e . g . tears , sweat , wound exudate , saliva, blood, urine , crevicular fluid, nose liquid . . . ) that allow the connection between semiconductor material 11 and gate electrode 10 . It was observed experimentally that the ability of transporting paper / fabric / gauze allows to bring the analytes of interest to the point of interaction analyte / gate electrode 10 .

[0077] Alternatively, the sensor 2 can be printed directly on this material ( the transport system 3 ) which acts as a sampler of the liquid to be studied .

[0078] Advantageously but not necessarily, the device 1 comprises at least one covering casing (not shown) for the sensor 2 and the fibrous material . In particular, the covering casing encapsulates the sensor 2 and the fibrous material ( except for the first end 6 or at least of the terminal portion thereof ) .

[0079] According to some non-limiting embodiments , the covering casing is made of a hydrophobic, electrically insulating and possibly flexible material .

[0080] In particular, the covering casing comprises several superimposed layers ( thin; in particular with thickness less than 1 mm, for example about 125 m) . In these cases , the di f ferent layers are fixed with a brief exposure to the oxygen plasma of the plastic materials that act as an encapsulant (as, for example, made in our previous work: Francesco Decataldo et al., Scientific Reports, 2019, 9:10598, https: / / doi.org / 10.1038 / s41598-019-46967-2) , or using a chemical functionalization or even with a biocompatible glue in silicone material (e.g. PDMS) and a short (<lh) heat treatment.

[0081] According to some non-limiting embodiments, the device 1 comprises electrical contacts (not shown in the figures) with external electronics (but portable - also not shown in the figures) . Such electrical contacts may consist of magnetic pads, located on one side of the disposable device.

[0082] Typically but not necessarily, the external electronics is a compact external electronics, maximum 10cm x 10cm x 7cm, to which the electrical contacts of the device are connected to measure the analyte. The electronics allows the measurement of the analyte under examination, polarizing and monitoring the current of the three OECT terminals. Depending on the selected analyte, the electronics measures, for example :

[0083] - 4 transcharacteristic curves (current in the channel measured as a function of the voltage variation on the gate from -0.2V to 0.8V) , keeping the latter (more stable) as a reference. Of this, the integrated firmware performs the derivative and returns the value of the concentration of the analyte of interest, converting the value of the oxidation / reduction peak, compared to a "blank" inserted earlier (for example, even at the beginning of the working day) with saline solution.

[0084] - alternating current transconductance in the frequency range IHz-lOOkHz, polarizing the gate electrode 10 and the semiconductor material 11 with constant voltages and sending a signal with sinusoidal amplitude (i.e. 10 mV) from the gate electrode 10 and sampling it from the source electrode 8 of the device. Also in this case, the integrated firmware returns the concentration of the protein given the variation in transconductance compared to a "blank" made with saline solution .

[0085] According to some non-limiting embodiments, the device 1 (in particular, the transport system 3) comprises lateral elements 12 arranged on opposite sides with respect to the transport portion 5 (and the analysis portion 4) made of hydrophobic and electrically insulating material, for example (thin) plastic such as PEN or Polydimethylsiloxylane (PDMS) , to guide the liquid on the fibrous material, while sealing laterally (making compact) the device 1.

[0086] Advantageously but not necessarily, the device 1 has a length of less than about 20 mm (in particular, less than about 17 mm; more in particular, about 15 mm) .

[0087] In this way, the device 1 can be easily handled by the clinician during the sampling step. Advantageously but not necessarily, the device 1 has a width of less than about 10 mm (in particular, less than about 7 mm; more in particular, about 5 mm) .

[0088] Advantageously but not necessarily, the sensor 2 has a width and length of less than about 15 mm (in particular, less than about 13 mm; more in particular about 10 mm) .

[0089] To obtain the embodiment of the device 1 shown in Figures 1 and 2, the sensor 2 is typically printed on a same substrate .

[0090] To obtain the embodiment of the device 1 shown in Figures 3, 4 and 5, the gate electrode 10 is typically printed on a different substrate than the semiconductor material 11 (channel) and is then turned "face down" towards the semiconductor material 11 (channel) (the gate electrode 10 "faces" the channel in this way, as shown in Figures 3, 4 and 5) . In this second hypothesis, the gate electrode 10 is printed on a different substrate with respect to the semiconductor material 11 (channel) , so as to be able to have the fibrous material and the gate electrode 10 as disposable layers of the device 1, exploiting the semiconductor material 11 (possibly functionalized) for repeated uses.

[0091] As a further alternative, the gate electrode 10 and the semiconductor material 11 can be printed on a same plastic substrate, which is rolled on itself in order to have them facing each other and to make a "cannula / straw" of reduced section in which the fibrous material can sample the biological fluid, in a similar way to what is observed in the work Leticia Ferro, 2021, Adv. Mater. , 33, 2101518.

[0092] In accordance with a second aspect of the present invention, there is provided a use of a device 11 (described above in accordance with the first aspect of the present invention) for taking a sample of biological fluid (a liquid) (in particular, a human or veterinary biological fluid; more in particular, a human biological liquid) from an animal (in particular, from a human being) and for analysing the sample.

[0093] Advantageously but not necessarily, the biological fluid is chosen from the group consisting of: tears, sweat, wound exudate, saliva, blood, urine, crevicular fluid, nose liquid (and a combination thereof) .

[0094] Advantageously but not necessarily, the use is for detecting (and / or quantifying) at least one characteristic of a sample of the biological fluid chosen from the group consisting of: an analyte present in the sample, a property of the sample and a combination thereof.

[0095] In particular, the use provides to determine at least one characteristic of the biological fluid chosen from the group consisting of: presence (and / or concentration) of at least one protein (e.g. a cytokine such as an interleukin and / or a chemokine) , presence (and / or concentration) of uric acid, pH, osmolarity, presence (and / or concentration) of at least one viral agent, presence (and / or concentration) of a bacterial agent (and a combination thereof) .

[0096] In some non-limiting cases, the use provides to determine at least one characteristic of the biological fluid chosen from the group consisting of: osmolarity, pH, presence (and / or concentration) of at least one protein (e.g., a cytokine and / or lactoferrin) (and a combination thereof) .

[0097] According to some examples of non-limiting embodiments, the protein is chosen from the group consisting of: lactoferrin, pepsin, lysozyme, interleukin- 6 (and a combination thereof) .

[0098] In particular, the use provides to quantify at least one characteristic of the biological fluid chosen from the group consisting of: concentration of uric acid, pH, concentration of interleukin-6, osmolarity, concentration of chlorine ions, concentration of lactoferrin, concentration of pepsin, concentration of lysozyme, concentration of at least one viral agent, concentration of at least one bacterial agent (and a combination thereof) .

[0099] Advantageously but not necessarily, the use comprises a sampling step, during which an operator places the first end 6 in contact with the tissue and / or a fluid of a human being and / or an animal (in particular, a human being - patient) , in particular so that the sample is absorbed by the first end 6 and transferred into the fibrous material up to the analysis portion 4. In other words, during the sampling step the operator places the first end 6 in direct contact with the human being and / or animal (in particular, human being - patient) .

[0100] Unless explicitly stated otherwise, the content of the references (articles, books, patent applications, etc.) cited in this text is fully referred to herein. In particular, the aforementioned references are incorporated herein by reference.

Claims

CLAIMS1. A device for sampling and analysing a biological fluid (for example, a human or veterinary biological fluid) ; the device (1) comprises a sensor (2) , which is configured to detect at least one characteristic of a sample of the biological fluid chosen from the group consisting of: at least one analyte present in the sample, at least one property of the sample and a combination thereof; the device (1) further comprises a transport system (3) , which is configured to transport the sample from the external environment (in particular, from a living being) to the sensor (2) and comprises a fibrous material, configured to enable the diffusion of the biological fluid and having an analysis portion (4) arranged in the area of the sensor (2) and a transport portion (5) provided with a first end(6) , which projects out of the device (1) , and a second end(7) in contact with the analysis portion (4) .

2. The device according to claim 1, wherein the transport portion (5) has a width of less than about 5 mm, a length of less than about 20 mm and a thickness of less than about 2 mm.

3. The device according to claim 1 or 2, wherein the sensor (2) comprises an organic electrochemical transistor.

4. The device according to claim 3, wherein the sensor (2) comprises a source electrode (8) , a drain electrode (9) ,a gate electrode (10) and a semiconductor material (11) connected to the source electrode (8) , to the drain electrode(9) and to said analysis portion (4) .

5. The device according to claim 4, wherein the source electrode (8) , the drain electrode (9) , the gate electrode(10) and the semiconductor material (11) are arranged on said analysis portion (4) .

6. The device according to claim 4, wherein the analysis portion (4) is arranged in contact between the semiconductor material (11) and the gate electrode (10) .

7. The device according to any one of the preceding claims, wherein the first end (6) has at least one terminal portion with a width of less than about 2 mm; in particular, the first end (6) has a length of less than about 10 mm (in particular, less than about 5 mm; more in particular, less than about 2 mm) .

8. The device according to any one of the preceding claims and comprising at least one covering casing for the sensor (2) and the fibrous material.

9. The device according to any one of the preceding claims, wherein the fibrous material has a filtration speed of less than 100 s / ml (Herzberg) .

10. The device according to any one of the preceding claims, wherein the fibrous material is chosen from the group consisting of: paper, fabric, gauze and a combinationthereof .

11. A use of a device (1) according to any one of the preceding claims for taking a biological fluid sample from an animal (in particular, from a human being) and for analysing the sample.

12. The use according to claim 11, wherein the biological fluid is chosen from the group consisting of: tears, sweat, wound exudate, saliva, urine, blood, crevicular fluid, nose liquid and a combination thereof; in particular, the use provides to determine at least one characteristic of the biological fluid chosen from the group consisting of: presence of at least one protein (for example, pepsin, lactoferrin and / or lysozyme) , presence of uric acid, pH, osmolarity, presence of at least one viral agent, presence of a bacterial agent and a combination thereof; more in particular, the use provides to quantify at least one characteristic of the biological fluid chosen from the group consisting of: concentration of uric acid, pH, concentration of interleukin-6, osmolarity, concentration of chlorine ions, concentration of lactoferrin, concentration of pepsin, concentration of lysozyme, presence of at least one viral agent, presence of a bacterial agent and a combination thereof.

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