Single channel cartridge device for coagulation assays in fluid samples

• US 10,598,675 B2
• Filed: 10/03/2018
• Issued: 03/24/2020
• Est. Priority Date: 09/26/2014
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Di Tullio, Katrina Petronilla, Taylor, Jay Kendall, Lee-Yow, Niko Daniel, Ball, Sheila Diane
• Primary Examiner(s): Kwak, Dean
• Application Number:
  US16/150,818
• Publication Number:
  US 20190033331A1
• Time in Patent Office: 538 Days
• Field of Search: 435 13, 436 8, 436 10, 436 69, 422 73
• 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, C12Q1/54
• 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 method of analyzing a biological sample within a sample analysis cartridge, the method comprising:

receiving a biological sample in an inlet chamber of the sample analysis cartridge;

moving, using a pump, the biological sample from the inlet chamber to a conduit of the sample analysis cartridge; and

pushing, using the pump, the biological sample in the conduit to a fluidic lock valve, such that at least a portion of the biological sample is positioned in the conduit over a portion of a sensor chip comprising a first micro-environment sensor and a second micro-environment sensor, each of the first micro-environment sensor and the second micro-environment sensor comprising at least one transducer coated with a polymer layer,

wherein the conduit comprises a first reagent integrated within, coated over, positioned adjacent, or a combination thereof to the polymer layer of the first micro-environment sensor, and a second reagent integrated within, coated over, positioned adjacent, or a combination thereof to the polymer layer of the second micro-environment sensor, and

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.

2. The method of claim 1, wherein the first reagent comprises a first enzyme substrate and the second reagent comprises a second enzyme substrate.

3. The method of claim 1, wherein the polymer layer is porous.

4. The method of claim 3, wherein the polymer layer comprises the first enzyme substrate and the second enzyme substrate that are immobilized in the polymer layer.

5. The method of claim 1, wherein the method further comprises triggering an extrinsic pathway of coagulation in the biological sample in the conduit by one or more components of the first reagent, and triggering an intrinsic pathway of coagulation in the biological sample in the conduit by one or more components of the second reagent.

6. The method of claim 5, wherein the first reagent comprises a first thrombin-cleavable peptide with a detectable moiety, and the second reagent comprises a second thrombin-cleavable peptide with a detectable moiety.

7. The method of claim 6, wherein the first thrombin-cleavable peptide is different from the second thrombin-cleavable peptide.

8. The method of claim 6, wherein the first detectable moiety is different from the second detectable moiety.

9. The method of claim 6, further comprising detecting a first cleavage product of the first thrombin-cleavable peptide and detecting a second cleavage product of the second thrombin-cleavable peptide.

10. The method of claim 9, wherein the detecting comprises one or both of optical detection and electrochemical detection.

11. The method of claim 1, further comprising a flow restrictor diverting flow of the biological sample to the first micro-environment sensor and the second micro-environment sensor, wherein the flow restrictor is located in an overflow conduit fluidically connected to the conduit at a junction.