Device and method for measuring properties of a sample

• US 7,674,616 B2
• Filed: 09/14/2006
• Issued: 03/09/2010
• Est. Priority Date: 09/14/2006
• Status: Expired due to Fees

• Current Assignee: Alere San Diego Incorporated (Abbott Laboratories)
• Original Assignee: Hemosense Incorporated (Abbott Laboratories)
• Inventors: Farnam, W. Edward III, Navarro, Maria C.
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US11/532,072
• Publication Number:
  US 20080124749A1
• Time in Patent Office: 1,272 Days
• Field of Search: 435/7.1, 435/7.21, 435/91.1, 435/91.2, 435/810, 422/68.1, 422/50, 422/55, 422/58, 436/527, 436/538, 436/807
• US Class Current: 435/287.1
• 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 degree of the ability of a sample to coagulate 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, and further wherein at least one of said delaying branch channels is fluidly connected to a control reaction chamber, wherein at least one of said non-delaying branch channels is fluidly connected to an assay reaction chamber, and wherein the control reaction chamber comprises an electrode pair for measuring an electrical property of the sample.

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 said delaying branch channel is longer than said non-delaying branch channel.

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

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

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

7. The test strip of claim 6, wherein said obstacle is less wettable than said branch channel.

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

9. 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.

10. 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).

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

12. The test strip of claim 1, wherein said assay and control reaction chambers comprise reagent compositions for measuring prothrombin time (PT).

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

14. 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.