WO1999012021A1 - Analyte detection systems - Google Patents
Analyte detection systems Download PDFInfo
- Publication number
- WO1999012021A1 WO1999012021A1 PCT/US1998/016980 US9816980W WO9912021A1 WO 1999012021 A1 WO1999012021 A1 WO 1999012021A1 US 9816980 W US9816980 W US 9816980W WO 9912021 A1 WO9912021 A1 WO 9912021A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- analyte
- signal
- glucose
- analytes
- sample
- Prior art date
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
- G01N21/274—Calibration, base line adjustment, drift correction
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/11—Automated chemical analysis
- Y10T436/112499—Automated chemical analysis with sample on test slide
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
- Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
- Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
- Y10T436/143333—Saccharide [e.g., DNA, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
- Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
- Y10T436/143333—Saccharide [e.g., DNA, etc.]
- Y10T436/144444—Glucose
Definitions
- This invention relates generally to analyte detection systems, and in particular to
- the invention is particularly useful in detecting
- aqueous fluids in particular biological fluids, such as, whole blood and urine and
- biological fluid derivatives such as, blood serum and blood plasma, is of ever-increasing
- the amount of materials being determined are either so small or so
- dye forms a chromophore when reacted with an analyte such as, for example, glucose.
- This dye absorbs at approximately 635 nm but does not absorb to any significant extent at
- this method requires that a relationship between absorbants at 635 nm and 700 nm
- This patent is similar to Phillips' earlier issued '005 patent because
- readings are taken at two different wavelengths. The reading at
- one wavelength e.g. 700 nm, is used to subtract out the background interference caused
- the NBTH-ANS dye couple exhibits strong and flat spectral absorption at about
- glucose and other analytes that react with an oxidase enzyme to produce the
- the absorbance of a colored reaction product is determined by subtracting an
- one or more analytes or interfering substances happen to absorb at the same wavelength
- Non-glucose analyte detection systems are also well known in the art. For example,
- interfering component absorbs at the detection wavelength, i.e., 546 nm.
- Patent No. 5,527,684 to Mabile et al. describes a method of measuring the luminescence
- This method includes forming a reaction mixture by
- the tracer is detected by measuring the emitted
- the internal reference is detected by measuring
- contaminating component of a sample happens to absorb at the detection wavelength.
- the present invention is a method for determining whether one or more analytes in a system.
- This method includes reacting the multi-component medium with one or more
- This method further includes detecting at least a first and second
- an analyte detection surface thereon, wherein the presence and/or concentration of glucose
- This system includes a means for introducing the blood
- the detection surface includes a glucose-specific reagent and indicator disposed thereon.
- the sample is then stimulated with one or more stimuli used to correct for
- interference-correcting stimuli do not overlap each other.
- concentration of the glucose is determined by applying mathematical formulas as further described herein to the produced signal(s).
- This process includes forming a signal
- composition by reacting an analyte with a reagent. The system is then excited
- concentration of one or more of the analytes is determined by applying mathematical
- Aa' is a measurable signal produced in response to a single
- interfering component (Bb) at the second detection point Hs a constant and is also the ratio between Bb and Ba, and c is the ratio between Aa and Ab.
- This device includes a hydrophilic porous
- the substrate with a blood application surface and an analyte detection surface.
- the pores of the polymeric matrix are sufficiently large to allow red blood cells in the
- An analyte-specific reagent and an indicator are dispersed on the analyte detection
- this signal producing composition produces at least two interference-correcting
- interfering signals produced by other analytes or interfering components in the sample are interfering signals produced by other analytes or interfering components in the sample.
- excitation means can be, for example, a laser, a visible light source, etc.
- detection means are also provided for detecting at least two signals.
- the interference-correcting signals are different from a
- the device further includes a means for determining the
- Aa' is a measurable signal produced at ⁇ a by the signal producing
- Bb' is a measurable signal produced at ⁇ b by the signal producing composition (Ab) and no
- a display means is also
- the present invention is directed to a method for indirectly determining the
- one or more analytes to be detected are proportional to the magnitude of a signal (Aa) as
- an "analyte” is any composition found in a
- the analytes of the present invention can be any medically significant
- composition for which the presence or quantity thereof in a body is important to ascertain is important to ascertain.
- Non-limiting examples of such analytes include glucose, creatinine, cholesterol, uric acid,
- the analyte or analytes of the present invention are detected in a multi-component
- multi-component medium refers to both
- aqueous and non-aqueous solutions containing at least one analyte to be detected.
- multi-component medium can also contain other analytes or interfering components which
- the analyte of interest may or may not interfere with the detection of the analyte of interest.
- the alyte of interest may or may not interfere with the detection of the analyte of interest.
- multi-component medium of the present invention refers to biological fluid samples
- the multi-component medium is reacted with one or more
- signal producing reagents to form one or more signal producing molecules.
- the term "signal producing reagents" refers to compositions
- reaction products are selected with reference to the analyte or analytes to be detected, the composition of the multi-component medium and
- reagents of the present invention can include for example, chromogens, such as 3,3', 5,5'-
- Tetramethylbenzidine and Trinder reagents Tetramethylbenzidine and Trinder reagents, glucose oxidase, peroxidase, and oxygen
- acceptors such as, O-dianisidine, O-toluidine, O-tolidine, benzidine, 2,2'-azinodi-(3-
- the present invention contemplates the use of single or multi-signal-
- present invention also contemplates the use of systems of signal producing reagents which
- signal producing molecule or “signal
- producing molecules refers to the reaction product produced from reacting one or more
- measurable event that is used in the present invention to detect or quantitate the analyte or analytes of interested.
- This measurable event is typically, for example, a signal which is detectable using conventional methods including, absorbance,
- the present invention also encompasses signal producing molecules which
- the signal produced by these signal producing reagents may be self-produced or
- these signals usually produce a
- the number of stimuli must be one or
- component is any composition present in the multi-component medium which is capable
- At least a first and a second signal are detected in response to the signal generated by the signal producing molecules when the stimulus or stimuli are
- spectrophotometers such as for example, spectrophotometers, fluorescence spectrophotometers,
- composition of the multi-component medium is a composition of the multi-component medium.
- analytes is determined by applying mathematical formulas to at least the first and second
- value for the analyte Aa' is a measurable signal produced in response to a stimulus by the
- the present invention includes a signal producing
- Compound A reacts with an analyte (Compound A) to produce a signal, such as for
- a chromophore which absorbs at a specific wavelength ( ⁇ a ).
- absorbance at this wavelength is measured and is then related to the concentration of the
- Compound B also absorb at the same wavelength as the chromophore, an
- absorbance measurement is taken at a second wavelength ( ⁇ b ), even if the chromophore
- Aa is the absorbance of compound A at wavelength ⁇ a ;
- Ab is the
- measured at wavelength ⁇ b is the sum of the absorbances of compounds A and B at
- Aa Aa' - fcc(Bb'-Ab), which is the same as formula (V):
- Aa Aa' -
- k is a constant and represents the ratio between Bb and Ba, and Bb'
- the present invention is based on the observation that the signal producing
- wavelengths is the basis for the existence of the constants k and c, respectively, and for the
- the present method is able to detect and/or quantitate the
- interfering signals Ba and Ca can be accomplished by measuring Bb'and Cc' at two
- Aa Aa' - Ba - Ca
- Aa (Aa' - &bxBb' - cxCc')/(l-/tbxM - kcxke)
- the present method is effective at determining the presence and/or quantity of
- an analyte in a sample provided that there are no interfering components overlapping at a
- an analyte' s presence may be detected with a percent coefficient of variance of about 30%> to about 50%>.
- an analyte can be quantified, i.e., its concentration may be determined, with a percent coefficient of
- the stimulus or stimuli used to excite the multi-component is the stimulus or stimuli used to excite the multi-component
- medium can be derived from any source provided that such stimuli are able to induce the
- Such stimuli may include for
- ⁇ a and ⁇ b are 630 nm and 700 nm
- an analyte detection system for determining the presence and/or concentration of glucose in a blood sample
- the pores are sufficiently large to allow red blood cells in the blood sample to freely
- a blood sample is introduced onto a blood application surface as set
- the present system only requires a drop of blood from a patient.
- the volume of such a drop of blood can range from about 10 ⁇ l to about 100 ⁇ l.
- blood application surface of the present system can be any porous surface which is adapted
- the analyte detection surface of the present invention contains a glucose specific
- the reagent and indicator may be any suitable reagent and indicator.
- analyte detection surface itself or may be impregnated within the pores of
- glucose contained within the blood sample.
- a signal producing composition is formed through the reaction of the glucose-
- the indicator i.e., glucose
- the presence and/or concentration of glucose in the blood sample can be any suitable substance.
- one or more signals can be detected by
- ⁇ a and ⁇ b described in Formula I are 630 nm and 700 nm, respectively.
- Other wavelengths, however, are also contemplated by the
- the signal producing composition as set forth above, may
- composition which includes absorbance, voltage, radioactivity, temperature, current and
- the glucose-specific reagent may include a chromogen, such as for
- This process includes forming a signal producing composition by reacting an analyte with
- the process further includes exciting the system with more
- a device for detecting the presence and/or concentration of one or more analytes in a blood sample when the analyte cannot be directly detected.
- This device includes a hydrophilic porous substrate
- this signal producing composition When excited, this signal producing composition produces at
- detection surface detection means are also provided for detecting at least two
- the excitation and detection means can include spectrophotometers, fluorescent
- the device further includes a means for determining the presence and/or
- concentration of the analyte by applying mathematical formulas to at least the first and
- a display means is also provided for displaying the presence and/or concentration of the analyte. Such display
- means can be, for example, in the form of a monitor, a computer printout including tables
- Such display is not limited to the presence and/or concentration of a particular analyte and the like.
- test strip according to the present invention was prepared as follows: a piece of
- nylon membrane (Magna, 1.2 ⁇ m from Micron Separations, Inc. Westborough, MA) was
- composition A An analyte detection composition, Composition A was prepared as follows: 0.6 g
- microcrystalline cellulose particles was added to 12.5 g of distilled water, and stirred for
- composition A of Example 2 was applied onto the dried nylon
- the coated substrate of Example was 1C cut into test strips which are compatible
- glucose meters such as, One TouchTM II or Basic glucose
- test strips were then placed in One TouchTM glucose meters and the glucose concentrations
- test strips of the present invention arc able to determine the level of glucose present over a wide range of concentrations. Furthermore, the results indicate that interference due to higher hematocrit levels can be easily
- Example 1 A A nylon membrane as described in Example 1 A was coated with a Trinder reagent
- Example lC. Composition B was prepared by combining the following reagents: 0.6 g
- Igepal CO-530 prepared by mixing 0.03 g of a
- the enzyme solution was prepared with 1949 ⁇ glucose oxidase, 1935 ⁇
- the Trinder reagent was prepared by adding 1 g of the 2,5 Furandione, polymer
- composition B Using composition B and the Trinder reagent solution and the nylon substrate
- Example 2 A the procedure set forth in Example ID was repeated.
- test strips of the present invention are able to determine the levels of glucose present over a wide range of concentrations. Furthermore, the results indicate that interference due to higher hematocrit levels can be easily compensated for using One TouchTM glucose meters.
- composition C as described in further detail below was
- Composition C was prepared by combining the following reagents: 2.4 g of a
- sulfobenzoate solution prepared by adding 2.4027g of 4-sulfobenzoic acid, potassium salt
- Trinder reagent solution To 1 g of 2,5 Furandione, polymer with methoxyethene
- Example 3 A the procedure set forth in Example ID was repeated. The results of the
- test strips of the present invention are able to determine the levels of glucose present over a wide range of concentrations. Furthermore, the results indicate that interference due to higher hematocrit levels can be easily compensated for using One TouchTM glucose meters.
- the oxidized TMB, MAOS and MAP products the oxidized TMB, MAOS and MAP products
- analytes i.e., glucose
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- Urology & Nephrology (AREA)
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- General Health & Medical Sciences (AREA)
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Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP98940924A EP1007950A1 (en) | 1997-08-29 | 1998-08-17 | Analyte detection systems |
AU89089/98A AU8908998A (en) | 1997-08-29 | 1998-08-17 | Analyte detection systems |
JP2000508974A JP2001516010A (en) | 1997-08-29 | 1998-08-17 | Analyte detection system |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/920,822 US6121050A (en) | 1997-08-29 | 1997-08-29 | Analyte detection systems |
US08/920,822 | 1997-08-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999012021A1 true WO1999012021A1 (en) | 1999-03-11 |
Family
ID=25444470
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/016980 WO1999012021A1 (en) | 1997-08-29 | 1998-08-17 | Analyte detection systems |
Country Status (5)
Country | Link |
---|---|
US (1) | US6121050A (en) |
EP (1) | EP1007950A1 (en) |
JP (1) | JP2001516010A (en) |
AU (1) | AU8908998A (en) |
WO (1) | WO1999012021A1 (en) |
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CN103808774A (en) * | 2014-02-26 | 2014-05-21 | 高磊 | Average red blood cell glucose concentration |
US9410915B2 (en) | 2004-06-18 | 2016-08-09 | Roche Operations Ltd. | System and method for quality assurance of a biosensor test strip |
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US20050037505A1 (en) * | 2000-05-11 | 2005-02-17 | James Samsoondar | Spectroscopic method and apparatus for analyte measurement |
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US6862534B2 (en) * | 2001-12-14 | 2005-03-01 | Optiscan Biomedical Corporation | Method of determining an analyte concentration in a sample from an absorption spectrum |
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US9410915B2 (en) | 2004-06-18 | 2016-08-09 | Roche Operations Ltd. | System and method for quality assurance of a biosensor test strip |
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US8373851B2 (en) | 2010-01-28 | 2013-02-12 | Roche Diagnostics Operations, Inc. | Measuring system and measuring method, in particular for determining blood glucose |
CN103808774A (en) * | 2014-02-26 | 2014-05-21 | 高磊 | Average red blood cell glucose concentration |
CN103808774B (en) * | 2014-02-26 | 2016-01-13 | 高磊 | Mean corpuscular concentration of glucose |
Also Published As
Publication number | Publication date |
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US6121050A (en) | 2000-09-19 |
JP2001516010A (en) | 2001-09-25 |
EP1007950A1 (en) | 2000-06-14 |
AU8908998A (en) | 1999-03-22 |
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