초록 ▼

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

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.

대표청구항 ▼

We claim: 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 im

We claim: 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. 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. 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. 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.