Test system for analyzing a sample of a bodily fluid

Patent metadata

Field	Value
Publication number	US-11215577-B2
Application number	US-201816185210-A
Country	US
Kind code	B2
Filing date	Nov 9, 2018
Priority date	Jun 17, 2016
Publication date	Jan 4, 2022
Grant date	Jan 4, 2022

Abstract

A test system for analyzing a sample of a bodily fluid is provided and comprises: at least one test strip comprising at least one capillary channel comprising an inlet opening configured to receive the sample; a vent opening configured to provide an air vent to the capillary channel; and at least one zone consisting of a detection zone and a reagent zone; at least one measuring device configured for interacting with the test strip, the measuring device comprising at least one sealing element for hermetically sealing the vent opening from an ambient atmosphere; and at least one suction device adapted to provide an underpressure to the vent opening; wherein the measuring device further comprises at least one valve or is connectable to the valve, wherein the valve is configured to vent the vent opening of the test strip when the measuring device interacts with the test strip.

First claim

What is claimed is:

1. A test system for analyzing a sample of a bodily fluid comprising:
at least one test strip comprising at least one capillary channel, the capillary channel comprising
an inlet opening configured to receive the sample of the bodily fluid;
a vent opening configured to provide an air vent to the capillary channel; and
at least one zone selected from the group consisting of a detection zone and a reagent zone;

at least one measuring device configured for interacting with the test strip, the measuring device comprising
at least one sealing element configured for hermetically sealing the vent opening of the test strip from an ambient atmosphere; and
at least one suction device adapted to provide an underpressure to the vent opening;

wherein the measuring device further comprises at least one valve or is connectable to the at least one valve, and
wherein the sealing element comprises at least one suction spout configured to reversibly connect the vent opening of the capillary channel to the suction device,
wherein the suction spout is configured to fully or partially surround the vent opening and to seal the vent opening from the ambient atmosphere.

2. The test system according to claim 1 , wherein the valve comprises a three-way valve, and wherein the vent opening is connected to a vent port or to the suction device.

3. The test system according to claim 1 , wherein the valve is configured to vent the vent opening of the test strip when the measuring device interacts with the test strip.

4. The test system according to claim 1 , wherein the valve is configured to vent the vent opening of the test strip when the test strip is inserted in the measuring device.

5. The test system according to claim 1 , wherein the suction spout comprises the at least one valve or is connectable to the at least one valve, wherein the at least one valve is configured to vent the vent opening when the suction spout is connected to the vent opening.

6. The test system according to claim 5 , wherein the valve is configured to vent an interior of the suction spout.

7. The test system according to claim 1 , wherein the capillary channel further comprises at least one hydrophilic section and/or at least one hydrophobic section configured to control a movement of the sample of bodily fluid.

8. The test system according to claim 7 , wherein the capillary channel comprises at least one hydrophobic section spaced apart from the inlet opening, wherein the hydrophobic section is adapted to stop a flow of the bodily fluid, wherein the measuring device is adapted to overcome the stop of the flow of the bodily fluid by applying the underpressure to the vent opening, thereby fully or partially moving the sample of the bodily fluid over the hydrophobic section.

9. The test system according to claim 8 , wherein the measuring device is adapted to allow for a movement of the sample of the bodily fluid from the inlet opening to the hydrophobic section by capillary force, without applying an underpressure and, consequently, to apply the underpressure to overcome the stopping of the movement of the sample by applying the underpressure to the vent opening.

10. A method for controlling a transport of a sample of bodily fluid within a test strip, the method comprising using a test system according to claim 1 , the method comprising the following steps:
a) connecting the test strip to the measuring device;
b) connecting the vent opening to an ambient atmosphere;
c) applying the sample of bodily fluid to the inlet opening of the capillary channel;
d) generating an initial flow of the sample of the bodily fluid by capillary force; and
e) generating an underpressure in the capillary channel and achieving a subsequent flow of the sample of the bodily fluid, thereby transporting the sample of bodily fluid to the at least one zone selected from the group consisting of a detection zone and a reagent zone.

11. The method according to claim 10 , wherein the valve of the measuring device is configured to be moved to at least one open position and to at least one closed position, wherein in the open position the vent opening is connected to the ambient atmosphere and in the closed position the vent opening is connected to the suction device, wherein during one or more of step a), step b), step c) and step d) the valve is in the open position and wherein during step e) the valve is in the closed position.

12. A method for analyzing a sample of a bodily fluid, the method comprising transporting the sample of the bodily fluid by using the method according to claim 11 , wherein the method further comprising conducting an analysis of the sample of the bodily fluid by using the test strip and at least one analysis device of the measuring device.

13. A test system for analyzing a sample of a bodily fluid comprising:
at least one test strip comprising at least one capillary channel, the capillary channel comprising
an inlet opening configured to receive the sample of the bodily fluid;
a vent opening configured to provide an air vent to the capillary channel; and
at least one zone selected from the group consisting of a detection zone and a reagent zone;

at least one measuring device configured for interacting with the test strip, the measuring device comprising
at least one sealing element configured for hermetically sealing the vent opening of the test strip from an ambient atmosphere; and
at least one suction device adapted to provide an underpressure to the vent opening;

wherein the measuring device further comprises at least one valve or is connectable to the at least one valve, and
wherein the sealing element comprises at least one housing configured to surround the vent opening of the capillary channel, wherein the housing comprises a test strip slot through which the test strip is at least partially introduced into the housing, and wherein the housing is configured to provide a circumferential seal around the test strip at the test strip slot such that an interior space of the housing is sealed against the ambient atmosphere.

14. The test system according to claim 13 , wherein the housing comprises the at least one valve or is connected to the at least one valve, wherein the valve is configured to vent the vent opening of the test strip when the test strip is at least partially introduced into the housing.

15. The test system according to claim 14 , wherein the valve is configured to vent the interior space of the housing.

16. The test system according to claim 13 , wherein the valve comprises a three-way valve, and wherein the vent opening is connected to a vent port or to the suction device.

17. The test system according to claim 13 , wherein the valve is configured to vent the vent opening of the test strip when the measuring device interacts with the test strip.

18. The test system according to claim 13 , wherein the valve is configured to vent the vent opening of the test strip when the test strip is inserted in the measuring device.

19. The test system according to claim 13 , wherein the capillary channel further comprises at least one hydrophilic section and/or at least one hydrophobic section configured to control a movement of the sample of bodily fluid.

20. The test system according to claim 19 , wherein the capillary channel comprises at least one hydrophobic section spaced apart from the inlet opening, wherein the hydrophobic section is adapted to stop a flow of the bodily fluid, wherein the measuring device is adapted to

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Goebbert Uwe
• Lopez-Calle Eloísa
• Marquant Michael
• Nortmeyer Christine
• Reiter Katja
• Stein Reiner

Classifications

• B01L3/502738

  characterised by integrated valves (throttle valves in microfluidic sample containers B01L3/502746) · CPC title

• B01L2400/0688

  surface tension valves, capillary stop, capillary break · CPC title

• B01L2400/049

  vacuum · CPC title

• B01L2300/0645

  Electrodes · CPC title

• B01L3/50273

  characterised by the means or forces applied to move the fluids · CPC title