Analyte detection systems
First Claim
1. An analyte detection system for determining the presence and/or concentration of glucose in a blood sample having two or more interfering components masking the presence and/or concentration of glucose in contact with a substrate having a blood application surface and an analyte detection surface wherein the presence and/or concentration of glucose cannot be directly determined comprising:
- a) means for introducing said blood sample onto said blood application surface;
b) means for allowing said sample to migrate through said porous substrate to said analyte detection surface, wherein said detection surface includes a glucose-specific reagent and an indicator disposed thereon;
c) means for forming a signal producing composition through the reaction of said glucose-specific reagent, said indicator and said glucose present in said blood sample;
d) means for stimulating said sample with one or more stimuli;
e) means for detecting one or more signals produced in response to d, and for correcting for any interfering signals produced by other analytes and/or two or more interfering components, wherein the number of stimuli required is equal to or greater than the sum of the number of analytes in said sample and any interfering components therein, provided that said stimuli for said interfering components are different from a stimulus for measuring said glucose and the interfering components must not simultaneously overlap at at least one correction point and further provided that said signal producing composition produces a measurable response having a characteristic ratio of signals at two different stimuli; and
f) means for determining the presence and/or concentration of said glucose by applying a mathematical formula to said one or more signals.
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Abstract
The present invention is directed to an improved analyte systems which are able to compensate for interfering signals and to provide accurate detection and/or quantification of analytes in a sample. In particular, the invention describes new methods, systems, and devices for indirectly determining the presence of one or more analytes in a multi-component medium.
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Citations
33 Claims
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1. An analyte detection system for determining the presence and/or concentration of glucose in a blood sample having two or more interfering components masking the presence and/or concentration of glucose in contact with a substrate having a blood application surface and an analyte detection surface wherein the presence and/or concentration of glucose cannot be directly determined comprising:
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a) means for introducing said blood sample onto said blood application surface; b) means for allowing said sample to migrate through said porous substrate to said analyte detection surface, wherein said detection surface includes a glucose-specific reagent and an indicator disposed thereon; c) means for forming a signal producing composition through the reaction of said glucose-specific reagent, said indicator and said glucose present in said blood sample; d) means for stimulating said sample with one or more stimuli; e) means for detecting one or more signals produced in response to d, and for correcting for any interfering signals produced by other analytes and/or two or more interfering components, wherein the number of stimuli required is equal to or greater than the sum of the number of analytes in said sample and any interfering components therein, provided that said stimuli for said interfering components are different from a stimulus for measuring said glucose and the interfering components must not simultaneously overlap at at least one correction point and further provided that said signal producing composition produces a measurable response having a characteristic ratio of signals at two different stimuli; and f) means for determining the presence and/or concentration of said glucose by applying a mathematical formula to said one or more signals. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A process for detecting one or more analytes in a multi-component system wherein the ability to directly detect said one or more analytes in a signal producing composition is masked by two or more interfering components of said multi-component system comprising:
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a) exciting said system with one or more stimuli to produce an interference-correction signal from said signal producing composition, whereby the number of stimuli provided is equal to or greater than the sum of the number of said analytes in said multi-component medium and any interfering components therein, provided that said stimuli for said interfering components are different from a stimulus for measuring said analyte, and the interfering components must not overlap at least one interfering correction stimulus that is used for said corrections; b) measuring said signal or signals at detection points; and c) determining the presence and/or concentration of said one or more analytes by applying a correction to said signal or signals, wherein said signal or signals are proportional to said analyte or analytes to be detected said correction being;
space="preserve" listing-type="equation">Concentration and/or Presence of Analyte=E·
Aawherein Aa=(Aa'"'"'-kb·
Bb'"'"'-kc·
Cc'"'"')/(1-kb·
kd-kc·
ke) and Aa is said true value for said analyte, Aa'"'"' is a measurable signal produced in response to a single stimulus by said signal producing composition (Aa) and said no more than two interfering components (Ba and Ca) at said first detection point, Bb'"'"' is a measurable signal produced in response to said stimulus by said signal producing composition (Ab) and said no more than one interfering component (Bb) at said second detection point, Cc'"'"' is a measurable signal produced in response to said stimulus by said signal producing composition (Ac) and said no more than one interfering component (Cc) at said third detection point, kb is a constant and is a ratio between Ba and Bb, kc is a constant and is a ratio between Ca and Cc, kd is a constant and is a ratio between Ab and Aa, and ke is a constant and is a ratio between Ac and Aa. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A device for detecting the presence and/or concentration of one or more analytes in a blood sample when said analyte cannot be directly detected comprising:
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a) a hydrophilic porous substrate with a blood application surface and an analyte detection surface, said substrate comprising a polymeric matrix having pores dispersed throughout said matrix and in communication with said blood application and analyte detection surfaces, wherein the diameter of said pores is sufficiently large to allow at least a portion of said sample to freely migrate therebetween; b) an analyte-specific reagent and an indicator dispersed on said analyte detection surface for reacting with said analyte to produce a signal producing composition which, when excited, produces at least three signals at wavelengths (λ
a), (λ
b) and (λ
c), respectively to correct for any interfering signal or signals produced by other analytes or interfering components in said sample;c) excitation means for exciting said sample on said analyte detection surface; d) detection means for detecting said at least three signals, whereby the number of signals produced must be equal to or greater than the sum of the number of said analytes in said blood sample and any interfering components therein, provided that said signals for said interfering compounds are different from a signal for measuring said analyte, and the interfering components must not overlap at at least one interfering correction stimulus that is used for said corrections and further provided that said signal producing composition produces a measurable response having a characteristic ratio of signals at the two different wavelengths; e) means for determining the presence and/or concentration of said analyte by applying said corrections to said at least first and second signals, said corrections being;
space="preserve" listing-type="equation">Concentration and/or Presence of Glucose=E·
Aawherein Aa=(Aa'"'"'-kb·
Bb'"'"'-kc·
Cc'"'"')/(1-kb·
kd-kc·
ke) and Aa is said true value for said analyte, Aa'"'"' is a measurable signal produced λ
a, in response to a single stimulus by said signal producing composition (Aa) and said no more than two interfering components (Ba and Ca), Bb'"'"' is a measurable signal produced at λ
b in response to said stimulus by said signal producing composition (Ab) and said no more than one interfering component (Bb), Cc'"'"' is a measurable signal produced at λ
c in response to said stimulus by said signal producing composition (Ac) and said no more than one interfering component (Cc), kb is a constant and is a ratio between Ba and Bb, kc is a constant and is a ratio between Ca and Cc, kd is a constant and is a ratio between Ab and Aa, and ke is a constant and is a ratio between Ac and Aa and;f) display means for displaying said presence and/or concentration of said analyte.
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23. A method for determining the presence and/or concentration of glucose in a blood sample in contact with a porous substrate having a blood application surface and an analyte detection surface wherein the presence and/or concentration of glucose cannot be directly determined comprising:
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a) introducing said blood sample onto said blood application surface; b) allowing a portion of said sample to migrate through said porous substrate to said analyte detection surface, wherein said detection surface includes a glucose-specific reagent and an indicator disposed thereon; c) forming a signal producing composition through the reaction of said glucose-specific reagent, said indicator and said glucose present in said blood sample; d) stimulating said sample with one or more stimuli; e) detecting one or more signals produced in response to d, and for correcting for at least two or more interfering signals produced by other analytes and/or interfering components, wherein the number of stimuli required is equal to or greater than the sum of the number of analytes in said sample and any interfering components therein, provided that said stimuli for said interfering compounds are different from a stimulus for measuring said glucose and the interfering components must not overlap at at least one interfering correction stimulus that is used for said corrections and further provided that said signal producing composition produces a measurable response having a characteristic ratio of signals at two different stimuli; and f) determining the presence and/or concentration of said glucose by applying said corrections based on said characteristic ratio to said one or more signals. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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Specification