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1. (WO2017032632) DEVICE AND METHOD FOR ANALYSING LIQUID SAMPLES
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Claims

A device (1 ) for analysing liquid samples, wherein the device (1 ) comprises at least one sample layer (1 1 1 ) comprising a plurality of liquid permeable test sites (1 12) separated from each other by a liquid impermeable barrier region (1 13), wherein said device (1 ) comprises an inlet part (2), wherein said inlet part (2) comprises a plurality of inlet channels (21 1 ), and wherein said inlet channels (21 1 ) lead to respective test sites (1 12) of said at least one sample layer (1 1 1 ), such that a flow connection between said inlet channels (21 1 ) and said respective test sites (1 12) is established or can be established, wherein said inlet channels (21 1 ) comprise first openings (218), which are positioned in a first plane (p-i), wherein said first openings (218) are accessible from the outside of said inlet part (2), such that liquid samples are loadable into said inlet channels (21 1 ) by means of said first openings (218), and wherein said inlet channels (21 1 ) comprise second openings (219), which are positioned in a second plane (p2) adjacent to said test sites (1 12), such that liquid samples can flow from said inlet channels (21 1 ) to respective test sites (1 12) via said second openings (219), characterised in that

a first surface area is defined by the positions of the first openings (218) in said first plane (p-i), and a second surface area is defined by the positions of said second openings (219) in said second plane (p2), wherein said second surface area is smaller than said first surface area.

The device (1 ) according to claim 1 , wherein the device (1 ) comprises at least a top sample layer (1 15) and a second sample layer (1 16), and wherein said top sample layer (1 15) and said second sample layer (1 16) are positioned such that the test sites (1 12) of said top sample layer (1 15) overlap with respective test sites (1 12) of said second sample layer (1 16), such that a liquid permeable sample channel (1 14) extending through said top sample layer (1 15) and said second sample layer (1 16) is formed by the test sites (1 12).

The device (1 ) according to claim 1 or 2, wherein at least one of said inlet channels (21 1 ) comprises an angled section (220), wherein said angled section (220) is arranged at an angle (a) of 5° to 89° with respect to a plane (p) defined by said at least one sample layer (1 1 1 ).

The device (1 ) according to claim 3, wherein said angled section (220) is positioned at an angle (a) of 5° to 50°, particularly at an angle of 10° to 45°, with respect to the plane (p).

The device (1 ) according to one of the preceding claims, wherein said inlet channels (21 1 ) comprise a reservoir section (212) and a connecting section (213), wherein said connecting section (213) leads to a respective test site (1 12).

6. The device (1 ) according to claim 5, wherein said reservoir section (212) has a volume in the range of 10 μ I to 1000 μΙ, particularly in the range of 20 μΙ to 300 μΙ.

7. The device (1 ) according to claim 5, wherein said reservoir section (212) has a volume of 3 μΙ to 50 μΙ, particularly 3 μΙ to 25 μΙ, more particularly 3 μΙ to 12 μΙ.

8. The device (1 ) according to one of the claims 5 to 7, wherein said reservoir

section (212) comprises a first diameter (d-ι ), and said connecting section (213) comprises a second diameter (d2), wherein the ratio between said first diameter (d-i ) and said second diameter (d2) is at least 2 to 1 , particularly at least 4 to 1.

9. The device (1 ) according to one of the preceding claims, wherein neighbouring first openings (218) are arranged at a first centre-to-centre distance (D-i ) with respect to each other in the first plane (p-i ), and wherein neighbouring second openings (219) are arranged at a second centre-to-centre distance (D2) with respect to each other in the second plane (p2), and wherein the ratio between the minimal first centre-to-centre distance (D-i ) and the minimal second centre-to-centre distance (D2) is at least 3 to 2, particularly at least 2 to 1.

10. The device (1 ) according to one of the preceding claims, wherein said device (1 ) comprises a separation membrane (3), particularly a plasma separation membrane (3), wherein the separation membrane (3) is positioned in at least one of said inlet channels (21 1 ).

11. The device (1 ) according to one of the preceding claims, wherein said inlet channel (21 1 ) comprises at least one air passage (5), which connects said inlet channel (21 1 ) to the exterior.

12. The device (1 ) according to one of the preceding claims, wherein said device (1 ) comprises an optical unit (6) adapted to provide excitation light to a fluorophore and/or to measure light, particularly fluorescence, emitted by a fluorophore.

13. A method for analysing liquid samples by means of the device (1 ) according to one of the preceding claims, comprising the steps of:

• loading a liquid sample into a respective inlet channel (21 1 ) of said inlet part (2) in a loading step,

· passing said liquid sample through a respective test site (1 12) and/or sample channel (1 14), which is connected to said respective inlet channel (21 1 ), in an assay step,

• analysing substances bound to a sample layer (1 1 1 ) of the device (1 ) in an analysis step.

14. The method according to claim 13, wherein at least one of said liquid samples is a viscous sample having a dynamic viscosity of at least 3- 10 3 Pa s, and wherein said viscous sample is diluted by a dilution factor in a dilution step prior to the loading step.

The method according to claim 14, wherein said viscous sample comprises a first component and a second component, and wherein said first component is separated from said second component in a separation step after said dilution step and prior to said loading step.

A method for functionalising a sample layer (1 1 1 ), comprising the steps of:

• providing a sample layer (1 1 1 ), wherein said sample layer (1 1 1 ) comprises a plurality of liquid permeable test sites (1 12) separated by a liquid impermeable barrier region (1 13),

• providing a reagent, which is able to bind to said test sites (1 12),

• providing an inlet part (2) comprising a plurality of inlet channels (21 1 ), wherein said inlet channels (21 1 ) comprise first openings (218), which are positioned in a first plane (p-i ), wherein said first openings (218) are accessible from the outside of said inlet part (2), such that liquid samples are loadable into the inlet channels (21 1 ) by means of said first openings (218), and wherein said inlet channels (21 1 ) comprise second openings (219), which are positioned in a second plane (p2), wherein a first surface area is defined by the positions of said first openings (218) in said first plane (p-i ), and a second surface area is defined by the positions of said second openings (219) in said second plane (p2), wherein the second surface area is smaller than the first surface area,

• assembling said inlet part (2) and said sample layer (1 1 1 ), such that said test sites (1 12) of said sample layer (1 1 1 ) are aligned with respective second openings (219), such that liquid samples can flow from said inlet channels (21 1 ) of said inlet part (2) to said respective test sites (1 12) via said second openings (219),

• loading said reagent into at least one inlet channel (21 1 ), and

• passing said reagent through said respective test site (1 12), which is in flow connection with said at least one inlet channel (21 1 ).

A kit for performing the steps of the method according to claim 16 comprising:

• a sample layer (1 1 1 ), wherein the sample layer (1 1 1 ) comprises a plurality of liquid permeable test sites (1 12) separated by a liquid impermeable barrier region (1 13),

• a reagent, which is able to bind to said test sites (1 12) and

• an inlet part (2) comprising a plurality of inlet channels (21 1 ), wherein said inlet channels (21 1 ) lead to respective test sites (1 12) of said sample layer (1 1 1 ), such that a flow connection between said inlet channels (21 1 ) and said respective test sites (1 12) is established or can be established, wherein said inlet channels (21 1 ) comprise first openings (218), which are positioned in a first plane (p-i ), wherein said first openings (218) are accessible from the outside of said inlet part (2), such that liquid samples are loadable into the inlet channels (21 1 ) by means of said first openings (218), and wherein said inlet channels (21 1 ) comprise second openings (219), which are positioned in a second plane (p2), such that liquid samples can flow from said inlet channels (21 1 ) to respective test sites (1 12) via said second openings (219), wherein a first surface area is defined by the positions of said first openings (218) in said first plane (p-i), and a second surface area is defined by the positions of said second openings (219) in said second plane (p2), wherein said second surface area is smaller than said first surface area.