Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
451 words
A method for calibrating a chemical analyzer useful in the determination of an analyte in an aqueous liquid, said analyzer comprising (a) spectrophotometric means for detecting "n" spectrophotometric responses A 1 , A 2 , . . . A n resulting when a sample of said liquid is contacted with an interactive composition for said analyte, and (b) means for calculating the concentration or activity C of said analyte in said sample using the equation (I): C=a.sub.0 +a.sub.1 [A.sub.1 +α.sub.1 A.sub.2 +. . . +α.sub.n-1 A.sub.n ] wherein a 0 , a 1 , α 1 , α 2 , . . . α n-1 are defined hereinafter, said method comprising the steps of: (A) from a multiplicity of patient test samples of unknown analyte concentration or activity, identifying first and second patient test samples having substantially the same analyte concentration or activity, said first sample exhibiting a significant bias in analyte concentration or activity and said second sample exhibiting no significant bias in analyte concentration or activity measured at a primary wavelength λ 1 ; (B) making a spectral absorption scan of each of said samples identified in step A; (C) identifying absorption bands from said spectral scans where differences in absorbance between said scans can be observed, and selecting at least one secondary wavelength from the group of secondary wavelengths λ 2 , λ 3 , . . . λ n representative of said absorption bands of both said first and second patient samples, respectively, wherein n represents the number of absorption bands; (D) using a multiplicity of patient test samples of known analyte concentration or activity, determining a linear regression line and its intercept and slopes using the equation (II): C=a.sub.0 +a.sub.1 A.sub.1 +a.sub.2 A.sub.2 + . . . +a.sub.n A.sub.n wherein C is analyte concentration or activity; a 0 is the intercept of said line; A 1 , A 2 , . . . A n are the spectrophotometric responses measured at λ 1 , λ 2 , . . . λ n respectively; and a 1 , a 2 , . . . a n are the slopes of said line relating said spectrophotometric responses at λ 1 , λ 2 , . . . λ n , respectively, to said analyte concentration or activity; (E) using the results of step D to determine constants α 1 , α 2 , . . . α n-1 for said equation (I) above using the equation (III): α.sub.i =(a.sub.i+1)/a.sub.1 wherein i=1 to (n-1); and (F) recording in said analyzer the values of said constants a 0 , a 1 , and α 1 , α 2 , . . . α n-1 for use in equation I above.
Claim 2
Independent Claim
451 words
A method for calibrating a chemical analyzer useful in the determination of an analyte in an aqueous liquid, said analyzer comprising (a) spectrophotometric means for detecting "n" spectrophotometric responses A 1 , A 2 , . . . A n resulting when a sample of said liquid is contacted with an interactive composition for said analyte, and (b) means for calculating the concentration or activity C of said analyte in said sample using the equation (I): C=a.sub.0 +a.sub.1 [A.sub.1 +α.sub.1 A.sub.2 +. . . +α.sub.n-1 A.sub.n ] wherein a 0 , a 1 , α 1 , α 2 , . . . α n-1 are defined hereinafter, said method comprising the steps of: (A) from a multiplicity of patient test samples of unknown analyte concentration or activity, identifying first and second patient test samples having substantially the same analyte concentration or activity, said first sample exhibiting a significant bias in analyte concentration or activity and said second sample exhibiting no significant bias in analyte concentration or activity measured at a primary wavelength λ 1 ; (B) making a spectral absorption scan of each of said samples identified in step A; (C) identifying absorption bands from said spectral scans where differences in absorbance between said scans can be observed, and selecting at least one secondary wavelength from the group of secondary wavelengths λ 2 , λ 3 , . . . λ n representative of said absorption bands of both said first and second patient samples, respectively, wherein n represents the number of absorption bands; (D) using a multiplicity of patient test samples of known analyte concentration or activity, determining a linear regression line and its intercept and slopes using the equation (II): C=a.sub.0 +a.sub.1 A.sub.1 +a.sub.2 A.sub.2 + . . . +a.sub.n A.sub.n wherein C is analyte concentration or activity; a 0 is the intercept of said line; A 1 , A 2 , . . . A n are the spectrophotometric responses measured at λ 1 , λ 2 , . . . λ n respectively; and a 1 , a 2 , . . . a n are the slopes of said line relating said spectrophotometric responses at λ 1 , λ 2 , . . . λ n , respectively, to said analyte concentration or activity; (E) using the results of step D to determine constants α 1 , α 2 , . . . α n-1 for said equation (I) above using the equation (III): α.sub.i =(a.sub.i+1)/a.sub.1 wherein i=1 to (n-1); and (F) recording in said analyzer the values of said constants a 0 , a 1 , and α 1 , α 2 , . . . α n-1 for use in equation I above.
Claim 3
Dependent Claim
15 words
The calibration method of claim 1 wherein said analyte is bilirubin and n is 2.
Claim 4
Dependent Claim
28 words
The calibration method of claim 2 wherein λ 1 is from about 500 to about 580 nm and λ 2 is from about 420 to about 490 nm.
Claim 5
Dependent Claim
43 words
The calibration method of claim 1 wherein said spectrophotometric responses A 1 , A 2 , . . . A n are transformed transmission densities (D T ) determined at λ 1 , λ 2 , . . . λ n , respectively.
Claim 6
Dependent Claim
43 words
The calibration method of claim 1 wherein said absorption bands are identified in step C by subtracting said spectral scan of said second patient test sample from said spectral scan of said first patient test sample, and making a spectral absorption difference scan.
Claim 7
Independent Claim
505 words
A method for the determination of an analyte in an aqueous liquid, said method comprising the steps of: (A*) physically contacting a sample of said liquid with an interactive composition for said analyte; (B*) measuring the spectrophotometric responses A 1 , A 2 , . . . A n resulting from said contact at, respectively, a primary wavelength λ 1 and at n secondary wavelengths selected from secondary wavelengths λ 2 , λ 3 , . . . λ n ; and (C*) determining the concentration or activity C of said analyte using the equation (I): C=a.sub.0 +a.sub.1 (A.sub.1 +α.sub.1 A.sub.2 + . . . +α.sub.n-1 A.sub.n) wherein the constants a 0 , a 1 and α 1 , α 2 , . . . α n-1 and said secondary wavelengths λ 2 , λ 3 , . . . λ n are determined according to a calibration method for as many n secondary wavelengths as are used in said step (B*), said calibration method comprising the steps: (A) from a multiplicity of patient test samples of unknown analyte concentration or activity, identifying first and second patient test samples having substantially the same analyte concentration or activity, said first sample exhibiting a significant bias in analyte concentration or activity and said second sample exhibiting no significant bias in analyte concentration or activity measured at a primary wavelength λ 1 ; (B) making a spectral absorption scan of each of said samples identified in step A; (C) identifying absorption bands from said spectral scans where differences in absorbance between said scans can be observed, and selecting at least one secondary wavelength from the group of secondary wavelengths λ 2 , λ 3 , . . . λ n representative of said absorption bands of both said first and second patient samples, respectively, wherein n represents the number of absorption bands; (D) using a multiplicity of patient test samples of known analyte concentration or activity, determining a linear regression line and its intercept and slopes using the equation (II): C=a.sub.0 +a.sub.1 A.sub.1 +a.sub.2 A.sub.2 + . . . +a.sub.n A.sub.n wherein C is analyte concentration or activity; a 0 is the intercept of said line; A 1 , A 2 , . . . A n are the spectrophotometric responses measured at λ 1 , λ 2 , . . . λ n respectively; and a 1 , a 2 , . . . a n are the slopes of said line relating said spectrophotometric responses at λ 1 , λ 2 , . . . λ n , respectively, to said analyte concentration or activity; (E) using the results of step D to determine constants α 1 , α 2 , . . . α n-1 for said equation (I) above using the equation (III): α.sub.i =(a.sub.i+1)/a.sub.1 wherein i=1 to (n-1); and (F) recording in said analyzer the values of said constants a 0 , a 1 , and α 1 , α 2 , . . . α n-1 for use in equation I above.
Claim 8
Independent Claim
505 words
A method for the determination of an analyte in an aqueous liquid, said method comprising the steps of: (A*) physically contacting a sample of said liquid with an interactive composition for said analyte; (B*) measuring the spectrophotometric responses A 1 , A 2 , . . . A n resulting from said contact at, respectively, a primary wavelength λ 1 and at n secondary wavelengths selected from secondary wavelengths λ 2 , λ 3 , . . . λ n ; and (C*) determining the concentration or activity C of said analyte using the equation (I): C=a.sub.0 +a.sub.1 (A.sub.1 +α.sub.1 A.sub.2 + . . . +α.sub.n-1 A.sub.n) wherein the constants a 0 , a 1 and α 1 , α 2 , . . . α n-1 and said secondary wavelengths λ 2 , λ 3 , . . . λ n are determined according to a calibration method for as many n secondary wavelengths as are used in said step (B*), said calibration method comprising the steps: (A) from a multiplicity of patient test samples of unknown analyte concentration or activity, identifying first and second patient test samples having substantially the same analyte concentration or activity, said first sample exhibiting a significant bias in analyte concentration or activity and said second sample exhibiting no significant bias in analyte concentration or activity measured at a primary wavelength λ 1 ; (B) making a spectral absorption scan of each of said samples identified in step A; (C) identifying absorption bands from said spectral scans where differences in absorbance between said scans can be observed, and selecting at least one secondary wavelength from the group of secondary wavelengths λ 2 , λ 3 , . . . λ n representative of said absorption bands of both said first and second patient samples, respectively, wherein n represents the number of absorption bands; (D) using a multiplicity of patient test samples of known analyte concentration or activity, determining a linear regression line and its intercept and slopes using the equation (II): C=a.sub.0 +a.sub.1 A.sub.1 +a.sub.2 A.sub.2 + . . . +a.sub.n A.sub.n wherein C is analyte concentration or activity; a 0 is the intercept of said line; A 1 , A 2 , . . . A n are the spectrophotometric responses measured at λ 1 , λ 2 , . . . λ n respectively; and a 1 , a 2 , . . . a n are the slopes of said line relating said spectrophotometric responses at λ 1 , λ 2 , . . . λ n , respectively, to said analyte concentration or activity; (E) using the results of step D to determine constants α 1 , α 2 , . . . α n-1 for said equation (I) above using the equation (III): α.sub.i =(a.sub.i+1)/a.sub.1 wherein i=1 to (n-1); and (F) recording in said analyzer the values of said constants a 0 , a 1 , and α 1 , α 2 , . . . α n-1 for use in equation I above.
Claim 9
Dependent Claim
26 words
The method of claim 6 wherein said interactive composition is in a dry analytical element which comprises a support having thereon an isotropically porous spreading zone.
Claim 10
Dependent Claim
28 words
The method of claim 7 wherein said element comprises a support having thereon, in order and in fluid contact, a hydrophilic zone and an isotropically porous spreading zone.
Claim 11
Dependent Claim
10 words
The method of claim 6 wherein said analyte is bilirubin.
Claim 12
Dependent Claim
68 words
The method of claim 9 wherein n is 2 and the concentration of total bilirubin (B T ) in said liquid is determined using the equation: B.sub.T =a.sub.0 +a.sub.1 [A.sub.1 +α.sub.1 A.sub.2 ] wherein a 0 , a 1 and α 1 are constants determined according to said calibration method, and A 1 and A 2 are spectrophotometric responses detected at λ 1 and λ 2 , respectively.
Claim 13
Dependent Claim
27 words
The method of claim 10 wherein λ 1 is from about 500 to about 580 nm and λ 2 is from about 420 to about 490 nm.
Claim 14
Dependent Claim
101 words
The method of claim 9 wherein said interactive composition comprises a diazonium salt which is represented by the structure: ##STR2## wherein X - is a stabilizing anion; Y is --CO-- or --SO 2 --; R 1 and R 2 are independently selected from hydrogen, alkyl, alkaryl, aryl, carboxyalkyl and hydroxyalkyl; and R 3 and R 4 are independently selected from groups such that the sum of the Hammett sigma values for R 3 and R 4 does not exceed +0.4 or R 3 and R 4 , taken together, represent the carbon atoms necessary to complete a fused carbocyclic arylene moiety.
Claim 15
Dependent Claim
35 words
The method of claim 12 wherein X - is an anion of a Lewis acid coordinatively saturated by a hydrogen halide, Y is --SO 2 --, R 1 is hydrogen and R 2 is carboxymethyl.
Claim 16
Dependent Claim
42 words
The method of claim 6 wherein said spectrophotometric responses A 1 , A 2 , . . . A n are transformed transmission densities (D T ) determined at λ 1 , λ 2 , . . . λ n , respectively.
Claim 17
Dependent Claim
492 words
A chemical analyzer for the determination of an analyte in an aqueous liquid in contact with an interactive composition for said analyte; said analyzer comprising means for measuring the spectrophotometric responses A 1 , A 2 , . . . A n at, respectively, a primary wavelength λ 1 and at n secondary wavelengths selected from the secondary wavelengths λ 2 , λ 3 , . . . λ n ; and means for determining the concentration or activity C of said analyte using the equation (I): C=a.sub.0 +a.sub.1 (A.sub.1 +α.sub.1 A.sub.2 + . . . +α.sub.n-1 A.sub.n) wherein the constants a 0 , a 1 and α 1 , α 2 , . . . α n-1 and said secondary wavelengths λ 2 , λ 3 , . . . λ n are determined according to a calibration method for as many n secondary wavelengths as are used, said calibration method comprising the steps: (A) from a multiplicity of patient test samples of unknown analyte concentration or activity, identifying first and second patient test samples having substantially the same analyte concentration or activity, said first sample exhibiting a significant bias in analyte concentration or activity and said second sample exhibiting no significant bias in analyte concentration or activity measured at a primary wavelength λ 1 ; (B) making a spectral absorption scan of each of said samples identified in step A; (C) identifying absorption bands from said spectral scans where differences in absorbance between said scans can be observed, and selecting at least one secondary wavelength from the group of secondary wavelengths λ 2 , λ 3 , . . . λ n representative of said absorption bands of both said first and second patient samples, respectively, wherein n represents the number of absorption bands; (D) using a multiplicity of patient test samples of known analyte concentration or activity, determining a linear regression line and its intercept and slopes using the equation (II): C=a.sub.0 +a.sub.1 A.sub.1 +a.sub.2 A.sub.2 + . . . +a.sub.n A.sub.n wherein C is analyte concentration or activity; a 0 is the intercept of said line; A 1 , A 2 , . . . A n are the spectrophotometric responses measured at λ 1 , λ 2 , . . . λ n respectively; and a 1 , a 2 , . . . a n are the slopes of said line relating said spectrophotometric responses at λ 1 , λ 2 , . . . λ n , respectively, to said analyte concentration or activity; (E) using the results of step D to determine constants α 1 , α 2 , . . . α n-1 for said equation (I) above using the equation (III): α.sub.i =(a.sub.i+1)/a.sub.1 wherein i=1 to (n-1); and (F) recording in said analyzer the values of said constants a 0 , a 1 , and α 1 , α 2 , . . . α n-1 for use in equation I above.
Claim 18
Dependent Claim
492 words
A chemical analyzer for the determination of an analyte in an aqueous liquid in contact with an interactive composition for said analyte; said analyzer comprising means for measuring the spectrophotometric responses A 1 , A 2 , . . . A n at, respectively, a primary wavelength λ 1 and at n secondary wavelengths selected from the secondary wavelengths λ 2 , λ 3 , . . . λ n ; and means for determining the concentration or activity C of said analyte using the equation (I): C=a.sub.0 +a.sub.1 (A.sub.1 +α.sub.1 A.sub.2 + . . . +α.sub.n-1 A.sub.n) wherein the constants a 0 , a 1 and α 1 , α 2 , . . . α n-1 and said secondary wavelengths λ 2 , λ 3 , . . . λ n are determined according to a calibration method for as many n secondary wavelengths as are used, said calibration method comprising the steps: (A) from a multiplicity of patient test samples of unknown analyte concentration or activity, identifying first and second patient test samples having substantially the same analyte concentration or activity, said first sample exhibiting a significant bias in analyte concentration or activity and said second sample exhibiting no significant bias in analyte concentration or activity measured at a primary wavelength λ 1 ; (B) making a spectral absorption scan of each of said samples identified in step A; (C) identifying absorption bands from said spectral scans where differences in absorbance between said scans can be observed, and selecting at least one secondary wavelength from the group of secondary wavelengths λ 2 , λ 3 , . . . λ n representative of said absorption bands of both said first and second patient samples, respectively, wherein n represents the number of absorption bands; (D) using a multiplicity of patient test samples of known analyte concentration or activity, determining a linear regression line and its intercept and slopes using the equation (II): C=a.sub.0 +a.sub.1 A.sub.1 +a.sub.2 A.sub.2 + . . . +a.sub.n A.sub.n wherein C is analyte concentration or activity; a 0 is the intercept of said line; A 1 , A 2 , . . . A n are the spectrophotometric responses measured at λ 1 , λ 2 , . . . λ n respectively; and a 1 , a 2 , . . . a n are the slopes of said line relating said spectrophotometric responses at λ 1 , λ 2 , . . . λ n , respectively, to said analyte concentration or activity; (E) using the results of step D to determine constants α 1 , α 2 , . . . α n-1 for said equation (I) above using the equation (III): α.sub.i =(a.sub.i+1)/a.sub.1 wherein i=1 to (n-1); and (F) recording in said analyzer the values of said constants a 0 , a 1 , and α 1 , α 2 , . . . α n-1 for use in equation I above.
Claim 19
Dependent Claim
13 words
The analyzer of claim 15 wherein said determining means comprises a computing means.
Claim 20
Dependent Claim
13 words
The analyzer of claim 15 wherein said computing means comprises a programmable microprocessor.
Claim 21
Dependent Claim
15 words
The analyzer of claim 15 adapted to determine said analyte with a dry analytical element.