Methods and systems for point of care bodily fluid analysis
View Patent ↗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.
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.