Micro mechanical methods and systems for performing assays

• US 20050136551A1
• Filed: 10/29/2004
• Published: 06/23/2005
• Est. Priority Date: 10/29/2003
• Status: Active Grant

• Current Assignee: Mec Dynamics Corporation
• Original Assignee: Mec Dynamics Corporation
• Inventors: Mpock, Emmanuel C.
• Granted Patent: US 7,939,030 B2
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/721 Haemoglobin

Abstract

The present invention provides a micro mechanical system for performing assays for determining the presence of one or more selected analytes in a sample. The device comprises of a base and a disposable strip with at least one reaction well and at least one moveable member capable of moving fluids and parts through the fluids in a defined reaction well. Reagents in the reaction chambers and or the moveable members, react with the sample to yield a physically detectable change. The moveable parts are capable of executing motions that either mix, move reaction components, exchange or systematically deliver reagents to targets in the cartridge. Sensors in the base are configured to detect and or quantify the presence of a sample in the reaction well and of analytes in the sample. The signal is converted to an output on a visual display window on the external part of the base.

Claims

1. A disposable strip comprising:

a first solid substrate comprising a sample collection well, a reference well, and a reaction well, wherein the wells are in fluidic communication via a first capillary channels; and

a second solid substrate comprising holes wherein the first solid substrate and the second solid substrate are joined and the holes communicate with the wells.

2. The disposable strip of claim 1, wherein the first substrate and the second substrate are rectangular.

3. The disposable strip of claim 1, wherein the substrate is selected from the group consisting of plastic, glass, nylon, metal, and combinations thereof.

4. The disposable strip of claim 3, wherein the substrate is plastic.

5. The disposable strip of claim 1, further comprising a stir bar in the reaction well.

6. The disposable strip of claim 1, further comprising an antibody deposited in the reaction well.

7. The disposable strip of claim 6, wherein the antibody is specific for HbA1c.

8. The disposable strip of claim 1, wherein the reference well and the reaction well comprise a lysing agent.

9. The disposable strip of claim 1, wherein the lysing agent is a nonionic surfactant.

10. The disposable strip of claim 1, further comprising a membrane having a capture zone wherein the membrane is connected to the reaction well via a second capillary channel.

11. The disposable strip of claim 10, wherein the membrane is interposed between an absorbent pad and the reaction well.

14. The disposable strip of claim 1, wherein the substrate is selected from the group consisting of plastic, glass, nylon, metal, and combinations thereof.

15. The disposable strip of claim 14, wherein the substrate is plastic.

12. A disposable strip comprising:

a first solid substrate comprising a sample application well, a reference well, and a reaction well, wherein the wells are in fluidic communication via capillary channels, and wherein the reference well comprises a first lysing agent and the reaction well comprises a second lysing agent, an antibody, and a stir bar;

a second solid substrate comprising holes wherein the first solid substrate and the second solid substrate are joined and the holes communicate with the wells; and

a membrane having a capture zone wherein the membrane is connected to the reaction well via a second capillary channel.

13. The disposable strip of claim 12, wherein the first substrate and the second substrate are rectangular.

16. The disposable strip of claim 12, wherein the first and the second lysing agents are nonionic surfactant.

17. The disposable strip of claim 12, wherein the antibody is specific for HbA1c.

18. A method for determining the percentage of hemoglobin that is HbA1c, the method comprising:

providing a disposable strip comprising a first solid substrate comprising a sample well, a reference well, and a reaction well, wherein the wells are in fluidic communication via a first capillary channel, and wherein the reference well comprises a first lysing agent and the reaction well comprises a second lysing agent, a HbA1c specific antibody, and a stir bar;

a second solid substrate comprising holes wherein the first solid substrate and the second solid substrate are joined and the holes communicate with the wells; and

a membrane having a capture zone wherein the membrane is connected to the reaction well via a second capillary channel;

placing a sample in the sample application well;

adding a diluent to the sample application well;

determining the total hemoglobin from the reference cell and the total HbA1c from the capture zone; and

dividing the total HbA1c by total hemoglobin to obtain the percentage of hemoglobin that is HbA1c.

19. The method of claim 18, wherein the first substrate and the second substrate are rectangular.

20. The method of claim 18, wherein the substrate is selected from the group consisting of plastic, glass, nylon, metal, and combinations thereof.

21. The method of claim 20, wherein the substrate is plastic.

22. The method of claim 18, wherein the first and second lysing agents are nonionic surfactant.

23. The method of claim 18, wherein the membrane comprises two or more capture zones.

24. The method of claim 23, wherein one capture zone comprises antigens that specifically bind to antibody-HbA1c complex, and another capture zone comprises antigens that bind to the antibody.

25. The method of claim 24, wherein the total HbA1c is determined by UV measurements.

26. The method of claim 18, wherein the total hemoglobin is determined by UV, IR or combinations thereof.

27. The method of claim 18, wherein the total hemoglobin is spectrophotometrically determined using 580 nm and 880 nm light.