Control solution for photometric analysis

• US 20040180444A1
• Filed: 03/11/2003
• Published: 09/16/2004
• Est. Priority Date: 03/11/2003
• Status: Active Grant

• Current Assignee: Ferraris Group, Inc.
• Original Assignee: Bionostics, Inc. (Bio-Techne Corporation)
• Inventors: Rannikko, Minna A., Murray, Donna M., Rafferty, Donna M.
• Granted Patent: US 6,900,058 B2
• Time in Patent Office: Days
• US Class Current: 436/14
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2496/15 containing dyes to mimic optical absorption of, e.g. hemoglobin
• CPC Class Codes: G01N 2496/25 containing added polymers to stabilise biological material against degradation or maintain viscosity or density, e.g. gelatin, polyacrylamides or polyvinyl alcohol
• CPC Class Codes: G01N 2496/35 Polyvinylpyrrolidone, e.g. PVP
• CPC Class Codes: G01N 2496/80 Multi-analyte reference solutions containing cholesterol, glucose and the like
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

An aqueous control solution is disclosed for use with a spectrophotometer or photometric test strip that includes a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant. In one embodiment, the aqueous control solution is applied to a photometric test strip having a chemical that oxidizes glucose and consequently forms hydrogen peroxide which reacts with an indicator dye that is also present on the strip. In this embodiment, the control solution includes a predetermined amount of glucose, an infrared reference dye, sodium dodecyl sulfate, and the indicator dye, such as sulforhodamine B.

Claims

1. An aqueous control solution, comprising a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant.

2. The solution of claim 1, further comprising an indicator dye.

3. The solution of claim 2, wherein the indicator dye is selected from the group consisting of sulforhodamine B, rose bengal, amaranth and 8-(anilino)-1-naphthalenesulfonate (ANS).

4. The solution of claim 2, wherein the indicator dye or reaction product thereof and the hydrophobic reference dye absorb light at different wavelengths.

5. The solution of claim 1, wherein the hydrophobic reference dye absorbs infrared light.

6. The solution of claim 5, wherein the hydrophobic reference dye is selected from the group consisting of C₆₂H₉₆N₆SbF₆ (ADS905AM), C₆₂H₉₂Cl₂N₆O₈ (SDA8080), and C₆₂H₉₂N₆SbF₆ (SDA5324).

7. The solution of claim 1, wherein the analyte is selected from the group consisting of glucose, cholesterol, tryglycerides, fructosamine, amino acids, electrolytes, urea, uric acid, lactate, ketones, hemoglobin, glycosylated hemoglobin, microalbumin, creatinine, an antigen, a hapten, an antibody, and a drug or drug metabolite.

8. The solution of claim 7, wherein the analyte is glucose.

9. The solution of claim 1, wherein the surfactant is selected from the group consisting of sodium alkyl sulfate, bile acid surfactants, sulfobetaines, alkylglucosides, salts thereof and mixtures thereof.

10. The solution of claim 1, wherein the surfactant is an anionic surfactant.

11. The solution of claim 10, wherein the anionic surfactant is selected from the group consisting of sodium dodecyl sulfate, ammonium perfluoralkyl carboxylate, sodium lauroyl myristoyl lactylate, glycocholic acid, cholic acid, taurocholic acid, deoxycholic acid, glycodeoxycholic acid, taurodeoxycholic acid, amine alkylbenzene sulfonate, sodium dioctylsulfosuccinate, sodium olefin sulfonate, sodium polyoxyethylene(1) lauryl sulfate, salts thereof, and mixtures thereof.

12. The solution of claim 1, wherein the surfactant is a non-ionic surfactant.

13. The solution of claim 12, wherein the non-ionic surfactant is selected from the group consisting of dodecyl-β

-D-maltoside, N,N-bis(3-D-glucon-amidopropyl) cholamide, polyoxypropylene-polyoxyethylene block copolymer, N-tetradecyl-β

-D-maltoside, daconyl-N-methyl-glucamide, hexyl-β

-D-glucopyranoside, heptyl-β

-D-glucopyranoside, octyl-β

-D-glucopyranoside, nonyl-β

-D-glucopyranoside, decyl-β

-D-glucopyranoside, dodecyl-β

-D-glucopyranoside, octyl-β

-D-thioglucopyranoside, polyethylene glycol ester of stearic acid, ethoxylated cocomonoglyceride, octyphenoxypoly (ethyleneoxy) ethanol, ethoxylated octylphenol, polyoxyethylene alkyl ethers, and mixtures thereof.

14. The solution of claim 1, wherein the surfactant is amphoteric.

15. The solution of claim 14, wherein the amphoteric surfactant is selected from the group consisting of N-dodecyl-N,N-dimethylglycine, lauramidopropyl betaine, N-tetradecyl-N,N-dimethyl-3-ammonio-1-propanesulfonate, N-dodecyl-N,N-dimethyl-3-ammonio-1-propanesulfonate, cocoamidopropylbetaine, cocoamidosulfobetaine, N-octyl-N,N-dimethyl-3-ammonio-1-propanesulfonate, N-tetradecyl-N,N-dimethyl-3-ammonio-1-propanesulfonate, salts thereof, and mixtures thereof.

16. The solution of claim 1, wherein the surfactant is a cationic surfactant.

17. The solution of claim 16, wherein the cationic surfactant is selected from the group consisting of coco hydroxyethyl imidazoline, lauryltrimethylammonium chloride, decyltrimethylammonium bromide, octyltrimethylammonium bromide, cetyl trimethyl ammonium bromide, salts thereof, and mixtures thereof.

18. The solution of claim 1, further comprising an antifoaming agent.

19. The solution of claim 18, wherein the antifoaming agent is selected from the group consisting of dimethyl siloxane, methyl cellulose, a hydrogenated tallow glyceride, a silicone polymer and mixtures thereof.

20. The solution of claim 1, further comprising a preservative.

21. The solution of claim 20, wherein the preservative is selected from the group consisting of diazolidinyl urea, sodium benzoate, potassium benzoate, benzalkonium chloride, chlorhexidine, imidazolidinyl urea, 5-chloro-2-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazolin-3-one, and mixtures thereof.

22. The solution of claim 1, further comprising a chelator.

23. The solution of claim 22, wherein the chelator is selected from the group consisting of ethylenediaminetetraacetic acid, citric acid, salts thereof, and hydrates thereof.

24. The solution of claim 1, further comprising a buffer.

25. The solution of claim 24, wherein the buffer is selected from the group consisting of a citrate buffer, an imidazole buffer, and a N-2-hydroxyethyl piperazine-N-2-ethanesulfonic acid buffer.

26. The solution of claim 1, further comprising a viscosity enhancer.

27. The solution of claim 26, wherein the viscosity enhancer is one or more compounds selected from the group consisting of glycerol, polyvinylpyrrolidone, starch, and combinations thereof.

28. An aqueous control solution, comprising a predetermined amount of glucose, C₆₂H₉₆N₆SbF₆ (ADS905AM), sodium dodecyl sulfate, and an indicator dye selected from the group consisting of sulforhodamine B and rose bengal.

29. The solution of claim 28, further comprising a preservative.

30. The solution of claim 29, wherein the preservative is selected from the group consisting of diazolidinyl urea, sodium benzoate, potassium benzoate, benzalkonium chloride, chlorhexidine, imidazolidinyl urea, 5-chloro-2-methyl-4-isothiazolinone, 2-methyl-4-isothiazoline-3-one and mixtures thereof.

31. The solution of claim 30, wherein the preservative is diazolidinyl urea or a mixture of 5-chloro-2-methyl-4-isothiazolin-one and 2-methyl-4-isothiazoline-3-one.

32. The solution of claim 28, further comprising a buffer.

33. The solution of claim 32, wherein the buffer is selected from the group consisting of a citrate buffer, an imidazole buffer and a N-2-hydroxyethyl piperazine-N-2-ethanesulfonic acid buffer.

34. The solution of claim 28, further comprising a viscosity enhancer.

35. The solution of claim 34, wherein the viscosity enhancer is glycerol, polyvinylpyrrolidone or a combination thereof.

36. The solution of claim 28, further comprising:

a) a citrate buffer or a N-2-hydroxyethyl piperazine-N-2-ethanesulfonic acid buffer;

b) glycerol, polyvinylpyrrolidone, or a combination thereof; and

c) diazolidinyl urea, or a combination of 5-chloro-2-methyl-4-isothiazolin-one and 2-methyl-4-isothiazoline-3-one.