Adhesive Composition for Use in an Immunosensor

• US 20110073493A1
• Filed: 09/30/2009
• Published: 03/31/2011
• Est. Priority Date: 09/30/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Rylatt, Dennis, Chatelier, Ronald C.
• Granted Patent: US 8,221,994 B2
• Time in Patent Office: Days
• US Class Current: 205/777.5
• CPC Class Codes: G01N 33/54326 Magnetic particles
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

An adhesive composition for use in devices and methods for measuring a presence or a concentration of a particular component, such as an antigen, in a sample, such as blood, are provided. In one exemplary embodiment of an adhesive composition, the composition includes an adhesive, water, a poloxamer, and an anticoagulant. The adhesive can include particular properties, such as being hydrophilic, pressure-sensitive, heat-activated, and/or water soluble. The adhesive is particularly useful because it can help improve the flow of sample a device. For example, when the device is an immunosensor, the adhesive can help prevent the blood from clotting in chambers of the immunosensor. This results in a more efficient and accurate determination of the concentration of the sample. Methods of making the composition and device in which the composition can be used are provided, as are methods of using the same.

Claims

1. An adhesive composition for use in an immunosensor, comprising:

an adhesive;

water;

a poloxamer; and

an anticoagulant.

2. The adhesive composition of claim 1, wherein the anticoagulant is selected from the group consisting of:

heparin, citrate, ethylenediaminetetraacetic acid, and oxalate.

3. The adhesive composition of claim 1, wherein the poloxamer comprises units derived from ethylene oxide and propylene oxide.

4. The adhesive composition of claim 3, wherein ethylene oxide and propylene oxide serve as the monomers in block copolymers.

5. The adhesive composition of claim 1, wherein the adhesive is pressure-sensitive.

6. The adhesive composition of claim 1, wherein the adhesive is heat-activated.

7. The adhesive composition of claim 1, wherein the adhesive is water soluble.

8. The adhesive composition of claim 1, wherein the adhesive is a sulfopolyester.

9. The adhesive composition of claim 1, wherein a concentration of the poloxamer with respect to the adhesive is approximately in the range of about 0.05 to about 0.5 percent.

10. The adhesive composition of claim 2, wherein a concentration of the heparin with respect to the adhesive is approximately in the range of about 0.1 to about 10 milligrams per milliliter.

11. The adhesive composition of claim 1, wherein the adhesive and the water are combined to form a mixture prior to being included with the poloxamer and the anticoagulant.

12. An immunosensor, comprising:

a lower electrode having a first liquid reagent comprising an antibody conjugated to an enzyme in a buffer, and a second liquid reagent comprising ferricyanide, a substrate for the enzyme, and an electrochemical mediator in a dilute acid solution, the first and second liquid reagents being striped on the lower electrode and then dried;

an upper electrode having magnetic beads conjugated to an antigen striped and dried thereon;

a separator disposed between the lower and upper electrodes;

a reaction chamber formed in the separator and having the first reagent and the magnetic beads conjugated to the antigen disposed therein;

a detection chamber formed in the separator and having the second reagent disposed therein;

a fill chamber formed at least partially in the separator and one of the lower and upper electrodes, spaced a distance apart from the detection chamber, and overlapping at least a portion of the reaction chamber;

a vent formed at least partially in each of the separator, the lower electrode, and the upper electrode, spaced a distance apart from the reaction chamber, and overlapping at least a portion of the detection chamber;

a hydrophilic adhesive tape having an incorporated anticoagulant coupled to one of the lower and upper electrodes, disposed over the vent, and configured to form a wall of the fill chamber and seal the vent; and

a sealing component coupled to the other of the lower and upper electrodes, disposed over the vent, and configured to seal the vent.

13. The immunosensor of claim 12, wherein the first liquid reagent comprises an antibody conjugated to glucose dehydrogenase-PQQ, and the buffer comprises citraconate, sucrose, poloxamers, and calcium ions.

14. The immunosensor of claim 12, wherein the anticoagulant comprises heparin.

15. The immunosensor of claim 14, wherein a concentration of the heparin with respect to a concentration of the hydrophilic adhesive is approximately in the range of about 0.1 to about 10 milligrams per milliliter.

16. The immunosensor of claim 12, wherein the second liquid reagent comprises ferricyanide, glucose, and phenazine ethosulfate in a dilute citraconic acid solution.

17. The immunosensor of claim 12, further comprising a meter containing a magnet disposed below the reaction chamber, the meter being configured to apply a potential between the lower and upper electrodes and to measure a resulting current.

18. The immunosensor of claim 17, further comprising a heating element associated with the meter.

19. The immunosensor of claim 17, further comprising a piercing component configured to pierce at least one of the hydrophilic tape and the sealing component disposed over the vent.

20. A method for measuring a blood sample, comprising:

providing;

a reaction chamber and a detection chamber formed in a separator disposed between two electrodes;

a fill chamber at least partially formed in the separator and one of the two electrodes, spaced a distance apart from the detection chamber, and overlapping at least a portion of the reaction chamber; and

a vent at least partially formed in the separator and the two electrodes, spaced a distance apart from the reaction chamber, and overlapping at least a portion of the detection chamber;

providing;

an antibody-enzyme conjugate in a first buffer and magnetic beads linked to an antigen in a second buffer in the reaction chamber;

ferricyanide, glucose, and a mediator in a dilute acid in the detection chamber;

a first seal over a first side of the vent by way of a hydrophilic adhesive tape, wherein the hydrophilic adhesive tape also forms a wall of the fill chamber; and

a second seal over a second side of the vent by way of a sealing component;

providing a blood sample to the fill chamber, wherein at least a portion of the blood sample moves from the fill chamber to the reaction chamber;

opening the vent after a pre-determined time by piercing at least one of the hydrophilic adhesive tape and the sealing component, thereby allowing portions of the blood sample containing the antibody-enzyme conjugate that is not bound to the magnetic beads to move to the detection chamber;

catalyzing oxidation of the glucose in the detection chamber, which results in the formation of ferrocyanide;

applying a potential between the two electrodes;

electrochemically detecting a current from the ferrocyanide; and

calculating a concentration of the antigen in the blood sample based on the signal detected.

21. The method of claim 20, further comprising heating the two electrodes.

22. The method of claim 20, wherein the hydrophilic adhesive further comprises heparin.

23. The method of claim 22, wherein a concentration of the heparin with respect to a concentration of the hydrophilic adhesive is approximately 1 milligram per milliliter.

24. The method of claim 20, wherein the hydrophilic adhesive further comprises a poloxamer.