DEVICE AND METHOD FOR MEASURING PROPERTIES OF A SAMPLE

• US 20080124749A1
• Filed: 09/14/2006
• Published: 05/29/2008
• Est. Priority Date: 09/14/2006
• Status: Active Grant

• Current Assignee: Alere San Diego Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Hemosense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Farnam, W. Edward, Navarro, Maria C.
• Granted Patent: US 7,674,616 B2
• Time in Patent Office: Days
• US Class Current: 435/13
• CPC Class Codes: C12Q 1/56 involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10T 29/494 Fluidic or fluid actuated device making

Abstract

Test strips designed to prevent or reduce false results when measuring the condition of a sample are provided. The test strips can be used for analysis of samples by methods including electrical and optical measurements. The reagent test strips and methods are particularly suited for use in the detection of blood coagulation.

Claims

1. A test strip for determining the condition of a sample comprising at least two branch channels each fluidly connected to a different reaction chamber, wherein at least one of said branch channels is a delaying branch channel and at least one of said branch channels is a non-delaying branch channel, wherein the delaying branch channel is adapted to delay arrival of a portion of the sample to its reaction chamber with respect to arrival of a second portion of the sample to said non-delaying branch channel reaction chamber.

2. The test strip of claim 1, wherein the reaction chamber of the delaying channel detects an error in the test strip.

3. The test strip of claim 1, wherein the condition is the quantity and/or presence or absence of an analyte.

4. The test strip of claim 1, wherein the condition is the degree of the ability of a sample to coagulate or lyse.

5. The test strip of claim 1, wherein said delaying branch channel is longer than said non-delaying branch channel.

6. The test strip of claim 1, wherein said delaying branch channel is narrower than said non-delaying branch channel.

7. The test strip of claim 1, wherein said delaying branch channel is longer and narrower than said non-delaying branch channel.

8. The test strip of claim 1, wherein said delaying branch channel is are partially occluded by an obstacle.

9. The test strip of claim 8, wherein said obstacle is less wettable than said branch channel.

10. The test strip of claim 1, wherein said reaction chambers are configured for the detection of coagulation or lysis time of a fluid sample.

11. The test strip of claim 1, wherein said delaying branch channel prolongs the time it takes a sample to fill a reaction chamber coupled to said delaying branch channel.

12. The test strip of claim 1, wherein at least one reaction chamber of said non-delaying branch channel comprises a reagent that activates the coagulation of said fluid sample for determining one of prothrombin time (PT), activated clotting time (ACT), activated partial prothrombin time (APTT), or thrombin clotting time (TCT).

13. The test strip of claim 1, wherein at least one reaction chamber comprises tissue factor.

14. The test strip of claim 1, wherein at least one of said delaying branch channels is fluidly connected to a control reaction chamber, and wherein at least one of said non-delaying branch channels is fluidly connected to an assay reaction chamber.

15. The test strip of claim 14, wherein said assay and control reaction chambers comprise reagent compositions for measuring prothrombin time (PT).

16. The test strip of claim 1, wherein the condition is determined as an electrical or optical property of said sample.

17. The test strip of claim 1 wherein each of said reaction chambers comprises an electrode pair measuring a parameter of coagulation of sample in said reaction chamber.

18. A system for measuring a parameter of coagulation or lysis of a sample, said system comprising:

(a) a test strip comprising at least two branch channels, wherein each of said branch channels is fluidly connected to a different reaction chamber, wherein at least one of said branch channels is a delaying branch channel fluidly connected to a delaying reaction chamber and at least one of said branch channels is a non-delaying branch channel, wherein the delaying branch channel is adapted to delay arrival of a portion of the sample to its reaction chamber with respect to arrival of a second portion of the sample to the non-delaying branch channel reaction chamber; and

(b) a measuring device comprising an inlet port for receiving said test strip and measuring a parameter of coagulation or lysis in said non-delayed chamber.

19. The system of claim 18, wherein said device is configured to signal an error message when at least one of said delaying reaction chambers is not filled with said sample.

20. The system of claim 18, wherein at least one of said delaying reaction chambers comprises reagents formulated to coagulate said sample within a predetermined normal range.

21. The system of claim 18, wherein at least one of said delaying reaction chambers comprises reagents formulated to coagulate said sample within a predetermined therapeutic range.

22. The system of claim 18, wherein said device is further configured to signal an error message when said sample does not coagulate within said predetermined range.

24. The method of claim 21, wherein said delaying detects an error in said test strip.

25. The method of claim 21, wherein said determining said condition of a sample comprises detecting an electrical or an optical characteristic of said sample.

27. The method of claim 19, wherein each of said reaction chambers comprises a formulation adapted to coagulate or lyse said sample.

28. The method of claim 19, wherein at least one of said delaying branch channels comprises a control formulation.

23. A method for determining the condition of a sample comprising:

(a) applying a sample to a sample well of a test strip

(b) conveying a first portion of said sample from said sample well to an assay chamber;

(c) conveying a second portion of said sample from said sample well to a control chamber, wherein said second portion is delayed in reaching said control chamber with respect to arrival of said first portion in said assay chamber.

26. A method of fabricating a test strip for measuring a parameter of coagulation or lysis of a fluid sample comprising:

providing a laminate having three layers; and

microfabricating on one of said three layers a fluidic path comprising a feeder channel coupled to at least two branch channels, each of said channels being coupled to a different reaction chamber, wherein one or more delaying branch channels are adapted to delay a fluid sample from reaching said reaction chamber.