Methods and systems for point of care bodily fluid analysis

• US 20050158866A1
• Filed: 01/16/2004
• Published: 07/21/2005
• Est. Priority Date: 01/16/2004
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Metrika, Inc. (Bayer AG)
• Inventors: Stivers, Carole R., Pierce, Jeffrey A., Xie, Zongcen Charles
• Granted Patent: US 7,150,995 B2
• Time in Patent Office: Days
• 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; and

a device adapted for receiving at least a portion of diluted blood solution, for contacting the blood solution with a dry immunoassay reagent system for detecting a change in the reagent system and for providing an indication of the analytical result to the user;

wherein the blood dilution solution comprises a first surfactant for hemolysis and a second surfactant for stability.

2. A system according to claim 1 wherein the first surfactant is a zwitterionic surfactant.

3. A system according to claim 1 wherein the second surfactant is a nonionic surfactant.

4. A system according to claim 2 wherein the second surfactant is a nonionic surfactant.

5. A system according to claim 4 wherein the dry reagent system comprises a microparticulate label.

6. A system according to claim 5 wherein the dry reagent system comprises latex particles.

7. A composition for providing an analytical indication of an analyte in a diluted body fluid comprising a body fluid diluted with a mixture comprising a first surfactant for modification of an analyte in the fluid and a second surfactant for stability of the system, and a dry immunoassay reagent comprising a microparticulate label.

8. A composition according to claim 7 wherein the first surfactant is a zwitterionic surfactant.

9. A composition according to claim 7 wherein the second surfactant is a nonionic surfactant.

10. A composition according to claim 8 wherein the second surfactant is a nonionic surfactant.

11. A composition according to claim 7 wherein the dry reagent system comprises latex particles.

12. A method of making an analytical system or kit comprising providing a first part by forming a composition for dilution of a body fluid for analysis comprising mixing a first surfactant for modification of an analyte in the fluid and a second surfactant for stability and providing a second part by forming a dry immunoassay reagent system whereby the dry immunoassay reagent system is adapted for receiving a portion of the body fluid diluted with the surfactant composition.

13. A method according to claim 12 wherein first surfactant is a zwitterionic surfactant.

14. A method according to claim 12 wherein second surfactant is a nonionic surfactant.

15. A method according to claim 13 wherein second surfactant is a nonionic surfactant.

16. A method of preparing a whole blood sample for analysis comprising diluting the blood sample with a solution comprising a first surfactant for hemolysis and a second surfactant for stability and contacting the diluted blood sample with a dry immunoassay reagent system.

17. A method according to claim 16 wherein first surfactant is a zwitterionic surfactant.

18. A method according to claim 16 wherein second surfactant is a nonionic surfactant.

19. A method according to claim 17 wherein second surfactant is a nonionic surfactant.

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

a sample dilution solution; and

a device adapted for receiving at least a portion of diluted sample solution, for contacting the sample solution with a dry non-enzymatic binding assay reagent system adapted for indicating a change in the reagent system and for providing an indication of the analytical result to the user;

wherein the sample dilution solution comprises a first surfactant for modification of the analyte and a second surfactant for stability.

21. A system according to claim 20 wherein the first surfactant is a zwitterionic surfactant.

22. A system according to claim 20 wherein the second surfactant is a nonionic surfactant.

23. A system according to claim 21 wherein the second surfactant is a nonionic surfactant.

24. A system according to claim 20 wherein the dry reagent system comprises a microparticulate label.

25. A system according to claim 24 wherein the dry reagent system comprises latex particles.