Method and device for detecting and quantifying glucose in body fluids
First Claim
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1. A method of quantifying glucose in a body fluid sample, comprising the steps of:
- a) contacting the body fluid with a specific binding pair comprising a first member which is a glucose-binding ligand labelled with a first light-absorbing material and a second member which is a glycoconjugate labelled with a second light-absorbing material, the excited state energy level of the first light-absorbing material overlapping with the excited state energy level of the second light-absorbing material,said ligand and said glycoconjugate being chosen such that over the range of physiological concentrations of glucose found in body fluids ranging from 0.05 mg.mL to 5.0 mg/mL they reversibly bind to each other such that glucose present in said body fluid sample can displace said glycoconjugate and reversibly bind to said ligand;
b) determining the extent to which non-radiative fluorescence resonance energy transfer occurs between the first light-absorbing and the second light-absorbing material in the presence of the glycoconjugate displaced by glucose and the ligand reversibly bound to glucose; and
c) comparing the result of step (b) with the relationship between the extent of non-radiative energy transfer between the first light-absorbing material and the second light-absorbing material and glucose concentration in the body fluid determined in a calibration step.
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Abstract
A method for quantifying glucose concentration in blood, body fluids, and other samples within, below and above the normal physiological range, which relies on non-radiative fluorescence resonance energy transfer, as well as devices useful in quantifying blood glucose concentration using the present method.
882 Citations
28 Claims
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1. A method of quantifying glucose in a body fluid sample, comprising the steps of:
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a) contacting the body fluid with a specific binding pair comprising a first member which is a glucose-binding ligand labelled with a first light-absorbing material and a second member which is a glycoconjugate labelled with a second light-absorbing material, the excited state energy level of the first light-absorbing material overlapping with the excited state energy level of the second light-absorbing material, said ligand and said glycoconjugate being chosen such that over the range of physiological concentrations of glucose found in body fluids ranging from 0.05 mg.mL to 5.0 mg/mL they reversibly bind to each other such that glucose present in said body fluid sample can displace said glycoconjugate and reversibly bind to said ligand; b) determining the extent to which non-radiative fluorescence resonance energy transfer occurs between the first light-absorbing and the second light-absorbing material in the presence of the glycoconjugate displaced by glucose and the ligand reversibly bound to glucose; and c) comparing the result of step (b) with the relationship between the extent of non-radiative energy transfer between the first light-absorbing material and the second light-absorbing material and glucose concentration in the body fluid determined in a calibration step. - View Dependent Claims (2, 3, 4, 10)
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5. An in vivo method for determining glucose concentration in an individual, comprising the steps of:
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a) placing a sensor in communication with glucose present in the body fluids of the individual in such a way that once in place said sensor does not exit the skin of the individual, thereby permitting non-invasive monitoring of the glucose concentration in the body fluids of the individual, said sensor comprising a specific binding pair which comprises a first member which is a glucose-binding ligand labelled with a first light-absorbing material and a second member which is a glycoconjugate labelled with a second light-absorbing material, the excited state energy level of the first light-absorbing material overlapping with the excited state energy level of the second light-absorbing material, said ligand and said glycoconjugate being chosen such that over the range of physiological concentrations of glucose found in body fluids ranging from 0.05 mg/mL to 5.0 mg/mL they reversibly bind to each other such that glucose present in the individual'"'"'s body fluid can displace said glycoconjugate and reversibly bind to said ligand; b) non-invasively monitoring the extent to which non-radiative fluorescence energy transfer occurs between the first light-absorbing material and the second light absorbing material in the presence of the glycoconjugate displaced by glucose and the ligand reversibly bound to glucose; and c) comparing the result of step (b) with the relationship between the extent of non-radiative energy transfer and glucose concentration in the individual'"'"'s body fluids determined in a calibration step. - View Dependent Claims (6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A sensor for non-invasively monitoring glucose concentration in an individual comprising a specific binding pair which comprises a first member which is a glucose-binding ligand labelled with a first light-absorbing material and a second member which is a glycoconjugate labelled with a second light-absorbing material,
the excited state energy level of the first light-absorbing material overlapping with the excited state energy level of the second light-absorbing material, said ligand and said glycoconjugate being chosen such that they reversibly bind to each other over the physiological range of glucose concentrations found in the body fluid of the individual ranging from 0.05 mg/mL to 5.0 mg/mL to enable glucose present in the individual'"'"'s body fluid to displace said glycoconjugate and reversibly bind to said ligand, the components of said sensor being configured such that once implanted in the individual said sensor does not exit the skin of the individual, thereby permitting non-invasive monitoring of the glucose concentration in the body fluids of the individual in the presence of the glycoconjugate displaced by glucose and the ligand reversibly bound to glucose.
Specification