SINGLE CHANNEL CARTRIDGE DEVICE FOR COAGULATION ASSAYS IN FLUID SAMPLES

• US 20160091511A1
• Filed: 09/25/2015
• Published: 03/31/2016
• Est. Priority Date: 09/26/2014
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Di Tullio, Katrina Petronilla, Taylor, Jay Kendall, Lee-Yow, Niko Daniel, Ball, Sheila Diane
• Granted Patent: US 10,114,031 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0672 Swellable plugs
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: G01N 2333/745 Assays involving non-enzymic blood coagulation factors
• CPC Class Codes: G01N 2333/96463 Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups
• CPC Class Codes: G01N 27/403 Cells and electrode assemblies
• CPC Class Codes: G01N 27/4166 measuring a particular property of an electrolyte
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

The present invention relates to analytical testing devices comprising a single channel with micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, to performing coagulation assays using a single channel with micro-environment sensors in a point of care test cartridge. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber configured to receive a biological sample and a conduit fluidically connected to the inlet chamber. The conduit includes a sensor chip including a first micro-environment sensor and a second microenvironment sensor, and a fluid lock valve. The sample analysis cartridge further includes a pump configured to push the biological sample over the first micro-environment sensor and the second microenvironment sensor to the fluidic lock valve such that the biological sample is positioned over the first micro-environment sensor and the second micro-environment sensor.

Claims

1. A sample analysis cartridge comprising:

an inlet chamber configured to receive a biological sample;

a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber, the conduit comprising;

a sensor chip including a first micro-environment sensor and a second microenvironment sensor, and

a fluidic lock valve; and

a pump configured to push the biological sample over the first micro-environment sensor and the second microenvironment sensor to the fluidic lock valve such that the biological sample is positioned over the first micro-environment sensor and the second micro-environment sensor.

2. The sample analysis cartridge of claim 1, wherein the first micro-environment sensor is a prothrombin time (PT) sensor, and the second micro-environment sensor is an activated partial thromboplastin time (aPTT) sensor.

3. The sample analysis cartridge of claim 1, wherein the fluidic lock valve is a membrane sponge valve, a microchannel capillary, a micro-array valve, or a capillary burst valve.

4. The sample analysis cartridge of claim 1, further comprising an overflow conduit fluidically connected to the conduit at a junction, the overflow conduit comprises a flow restrictor region configured to divert flow of the biological sample to the first micro-environment sensor and the second microenvironment sensor.

5. The sample analysis cartridge of claim 1, wherein the conduit further comprises a first reagent formed on or adjacent to the first micro-environment sensor and a second reagent formed on or adjacent to the second micro-environment sensor.

6. The sample analysis cartridge of claim 5, wherein

the first reagent comprises a first thrombin-cleavable peptide with a detectable moiety;

the second reagent comprises a second thrombin-cleavable peptide with a detectable moiety; and

the first thrombin-cleavable peptide is different from the second thrombin-cleavable peptide.

7. The sample analysis cartridge of claim 1, wherein the first micro-environment sensor is configured to analyze an extrinsic pathway of coagulation in the biological sample, and the second micro-environment sensor is configured to analyze an intrinsic pathway of coagulation in the same biological sample.

8. A method of analyzing a biological sample within a sample analysis cartridge, the method comprising:

receiving a biological sample in an inlet chamber;

moving the biological sample from the inlet chamber to a conduit using a pump; and

pushing the biological sample over at least a portion of a sensor chip in the conduit to a fluidic lock valve such that the biological sample is positioned over the portion of the sensor,

wherein the sensor includes a first micro-environment sensor and a second microenvironment sensor.

9. The method of claim 8, wherein the first micro-environment sensor is a prothrombin time (PT) sensor, and the second micro-environment sensor is an activated partial thromboplastin time (aPTT) sensor.

10. The method of claim 8, wherein the fluidic lock valve is a membrane sponge valve, a microchannel capillary, a micro-array valve, or a capillary burst valve.

11. The method of claim 8, further comprising contacting the biological sample with a first reagent formed on or adjacent to the first micro-environment sensor and a second reagent formed on or adjacent to the second micro-environment sensor.

12. The method of claim 11, wherein

the first reagent comprises a first thrombin-cleavable peptide with a detectable moiety;

the second reagent comprises a second thrombin-cleavable peptide with a detectable moiety; and

the first thrombin-cleavable peptide is different from the second thrombin-cleavable peptide.

13. A sensing device comprising:

a conduit configured to receive a fluid sample;

at least one analyte sensor positioned within the conduit;

at least one conductivity sensor positioned within the conduit, the at least one conductivity sensor comprising a first portion upstream of a midpoint of the at least one analyte sensor and a second portion downstream of a midpoint of the at least one analyte sensor; and

a pump for moving the fluid sample in the conduit.

14. A sensing device comprising a single planar substrate that comprises a first analyte sensor, a second analyte sensor, and at least one conductivity sensor, wherein the at least one conductivity sensor comprises a first portion upstream of a midpoint of the first analyte sensor and a second portion downstream of a midpoint of the second analyte sensor.

15. The sensing device of claim 14, wherein the first analyte sensor is for determining prothrombin time and the second analyte sensor is for determining activated partial thromboplastin time.

16. A sensing device of claim 14, wherein the at least one conductivity sensor comprises a ground electrode and the first analyte sensor comprises a counter-reference electrode, and the ground electrode and the counter-reference electrode are a combined common electrode.

17. A method for determining a position of a fluid in a conduit of a sensing device, the method comprising:

receiving a fluid in an inlet chamber;

moving the fluid from the inlet chamber to a conduit using a pump;

determining arrival of the fluid at a position upstream of an analyte sensor with a first portion of a conductivity sensor based on a first change in measured conductivity; and

determining arrival of the fluid at a position downstream of the analyte sensor with a second portion of the conductivity sensor based on a second change in measured conductivity.

18. The method of claim 17, wherein:

the conductivity sensor comprises a conductivity electrode and a ground electrode;

a first portion of the conductivity electrode and a first portion of the ground electrode are positioned upstream of the analyte sensor; and

a second portion of the conductivity electrode and a second portion of the ground electrode are positioned downstream of the analyte sensor.

19. The method of claim 17, wherein the at least one analyte sensor comprises a first amperometric electrode for determining prothrombin time and a second amperometric electrode for determining activated partial thromboplastin time.

20. The method of claim 17, wherein both the analyte sensor and the conductivity sensor are fabricated on a single silicon chip.