Methods and systems for point of care bodily fluid analysis

• US 7,150,995 B2
• Filed: 01/16/2004
• Issued: 12/19/2006
• Est. Priority Date: 01/16/2004
• Status: Expired due to Fees

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Metrika, Inc. (Bayer AG)
• Inventors: Xie, Zongcen Charles, Stivers, Carole R., Pierce, Jeffrey A.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): LEVKOVICH, NATALIA A
• Application Number:
  US10/759,547
• Publication Number:
  US 20050158866A1
• Time in Patent Office: 1,068 Days
• Field of Search: 422/61, 436/518, 436/67
• US Class Current: 436/67
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/723 Glycosylated haemoglobin

Abstract

The invention provides a system for quantitative measurement of percent glycated hemoglobin as hemoglobin A1c in whole blood having extended shelf life at room temperature. The system comprising a blood dilution solution and a device adapted for receiving at least a portion of diluted blood solution, for contacting the blood solution with a dry reagent system, for detecting a change in the reagent system and for providing an indication of the analytical result to the user, and the extended shelf life and the elimination of a requirement for refrigeration for storage is achieved by having the blood dilution solution which comprises a first surfactant for hemolysis and a second surfactant for stability. The system of this invention is useful in other analysis kits and systems as well.

Claims

1. A system for quantitative measurement of percent glycated hemoglobin in whole blood, comprising:

a blood dilution solution;

a dry immunoassay reagent system; and

a device adapted for;

receiving at least a portion of diluted blood solution;

contacting the blood solution with the dry immunoassay reagent system for detecting a change in the reagent system; and

providing an indication of the analytical result to the user;

wherein the blood dilution solution comprises N-tetradecyl-N,N-dimetyl-3 -ammonio-1-propanesulfonate, and a nonionic surfactant selected from the group consisting of an ethoxylated acetylenic glycol polymer, and a block copolymer of ethylene oxide and propylene oxide;

wherein the blood dilution solution is not in contact with the dry immunoassay reagent system during storage.

2. A system according to claim 1, wherein the dry immunoassay reagent system comprises microparticulate labels.

3. A system according to claim 2, wherein the microparticulates are latex particles.

7. The system according to claim 1, wherein the ethoxylated acetylenic glycol polymer is ethoxylated-2,4,7,9-tetramethyl-5-decyne-4,7-diol.

8. The system according to claim 7, wherein the ethoxylated-2,4,7,9-tetramethyl-5-decyne-4,7-diol has an ethylene oxide content of from about 40 to about 85% by weight.

9. The system according to claim 1, wherein the block copolymer of ethylene oxide and propylene oxide is a polyethylene oxide-polypropylene oxide-polyethylene oxide triblock copolymer or a polypropylene oxide-polyethylene oxide-polypropylene oxide triblock copolymer.

4. A system for detection of an analyte in a liquid sample comprising:

a sample dilution solution;

a dry non-enzymatic binding assay reagent system; and

a device adapted for;

receiving at least a portion of diluted sample solution;

contacting the sample solution with the dry non-enzymatic binding assay reagent system adapted for indicating a change in the reagent system; and

providing an indication of the analytical result to the user;

wherein the blood dilution solution comprises N-hexadecyl-N, N-dimethyl-3-amino-1-propanesulfonate, and a nonionic surfactant selected from the group consisting of an ethoxylated acetylenic glycol polymer, and a block copolymer of ethylene oxide and propylene oxide;

wherein the sample dilution solution is not in contact with the dry non-enzymatic binding assay reagent system during storage.

5. A system according to claim 4, wherein the dry non-enzymatic binding assay reagent system comprises microparticulate labels.

6. A system according to claim 5, wherein the microparticulates are latex particles.

10. The system according to claim 4, wherein the ethoxylated acetylenic glycol polymer is ethoxylated-2,4,7,9-tetramethyl-5-decyne-4,7-diol.

11. The system according to claim 10, wherein the ethoxylated-2,4,7,9-tetramethyl-5-decyne-4,7-diol has an ethylene oxide content of from about 40 to about 85% by weight.

12. The system according to claim 4, wherein the block copolymer of ethylene oxide and propylene oxide is a polyethylene oxide-polypropylene oxide-polyethylene oxide triblock copolymer or a polypropylene oxide-polyethylene oxide-polypropylene oxide triblock copolymer.