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US4788153A Expired / Lapsed US ⏱️ 0.0 years remaining

Method for the determination of bilirubin and an element useful therein

Assignee: Clinical Diagnostic Systems Inc
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Filing: 1987-10-08
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Granted: 1988-11-29
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Expires: 2007-10-08
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Abstract

Abstract A colorimetric assay for the determination of conjugated, unconjugated or total bilirubin in biological fluids can be carried out with an improved analytical element. This element comprises a support having thereon a substantially gelatin-free mordant layer comprising a positively-charged interactive mordant having at least one binding site for bilirubin, a radiation-blocking layer, and a porous spreading layer. This element does not contain any colorimetric or fluorometric interactive compositions for bilirubin other than the mordant.

Inventors

  • 👤 Richard L. Detwiler
  • 👤 David M. Taylor

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-29 13:21
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525; G01N33/526; Y; Y10; Y10T; Y10T436/00; Y10T436/14; Y10T436/145555; Y10T436/146666

Claims Analysis

Total Claims: 16
Claim 1
Independent Claim 165 words
A method for the determination of conjugated, unconjugated or total bilirubin comprising the steps of: A. contacting a sample of a liquid suspected of containing conjugated or unconjugated bilirubin with an analytical element comprising a support having thereon, in order, a gelatin-free mordant layer comprising a positively-charged interactive mordant having at least one binding site for bilirubin, said mordant being dispersed in a hydrophilic binder material other than gelatin or its derivatives, said hydrophilic binder material being present in an amount of from about 2 to about 20 g/m 2 , and being selected from the group consisting of copolymers of acrylamide or methacrylamide and N-vinyl pyrrolidone and terpolymers of an N-vinyl pyrrolidone, a carboxy-containing vinyl monomer and an acrylamide or methacrylamide, a radiation-blocking layer, and a porous spreading layer, provided that said element is free of colorimetric and fluorometric interactive compositions for bilirubin other than said mordant, and B. measuring the amount of conjugated or unconjugated or total bilirubin bound to said interactive mordant.
Claim 2
Independent Claim 165 words
A method for the determination of conjugated, unconjugated or total bilirubin comprising the steps of: A. contacting a sample of a liquid suspected of containing conjugated or unconjugated bilirubin with an analytical element comprising a support having thereon, in order, a gelatin-free mordant layer comprising a positively-charged interactive mordant having at least one binding site for bilirubin, said mordant being dispersed in a hydrophilic binder material other than gelatin or its derivatives, said hydrophilic binder material being present in an amount of from about 2 to about 20 g/m 2 , and being selected from the group consisting of copolymers of acrylamide or methacrylamide and N-vinyl pyrrolidone and terpolymers of an N-vinyl pyrrolidone, a carboxy-containing vinyl monomer and an acrylamide or methacrylamide, a radiation-blocking layer, and a porous spreading layer, provided that said element is free of colorimetric and fluorometric interactive compositions for bilirubin other than said mordant, and B. measuring the amount of conjugated or unconjugated or total bilirubin bound to said interactive mordant.
Claim 3
Dependent Claim 10 words
The method of claim 1 wherein total bilirubin is determined.
Claim 4
Dependent Claim 23 words
The method of claim 1 wherein either or both conjugated or unconjugated bilirubin is determined by spectrophotometric measurements at more than one wavelength.
Claim 5
Dependent Claim 128 words
An analytical element for the determination of conjugated, unconjugated or total bilirubin comprising a support having thereon, in order, a substantially gelatin-free mordant layer comprising a positively-charged interactive mordant having at least one binding site for bilirubin, said mordant being dispersed in a hydrophilic binder material other than gelatin or its derivatives, said hydrophilic binder material being present in an amount of from about 2 to about 20 g/m 2 , and being selected from the group consisting of copolymers of acrylamide or methacrylamide and N-vinyl pyrrolidone and terpolymers of an N-vinyl pyrrolidone, a carboxy-containing vinyl monomer and an acrylamide or methacrylamide, a radiation-blocking layer, and a porous spreading layer, provided that said element is free of colorimetric and fluorometric interactive compositions for bilirubin other than said mordant.
Claim 6
Dependent Claim 128 words
An analytical element for the determination of conjugated, unconjugated or total bilirubin comprising a support having thereon, in order, a substantially gelatin-free mordant layer comprising a positively-charged interactive mordant having at least one binding site for bilirubin, said mordant being dispersed in a hydrophilic binder material other than gelatin or its derivatives, said hydrophilic binder material being present in an amount of from about 2 to about 20 g/m 2 , and being selected from the group consisting of copolymers of acrylamide or methacrylamide and N-vinyl pyrrolidone and terpolymers of an N-vinyl pyrrolidone, a carboxy-containing vinyl monomer and an acrylamide or methacrylamide, a radiation-blocking layer, and a porous spreading layer, provided that said element is free of colorimetric and fluorometric interactive compositions for bilirubin other than said mordant.
Claim 7
Dependent Claim 17 words
The element of claim 4 wherein said binder material is a copolymer of acrylamide and N-vinyl 2-pyrrolidone.
Claim 8
Dependent Claim 29 words
The element of claim 4 wherein said interactive mordant is selected from the group consisting of poly(N,N,N-trimethyl-N-vinyl-benzylammonium chloride), poly[styrene-co-benzyl(dimethyl)p-vinyl-benzylammonium chloride], poly(styrene-co-N-vinylbenzyl-N,N-dimethylammonium chloride-co-divinylbenzene), poly(N,N,N-trimethyl-N-vinylbenzylammonium chloride-co-styrene), poly(N,N,N-trioctyl-N-vinylbenzylphosphonium chloride) and poly[styrene-co-(vinylbenzyl)-(trihexyl)ammonium chloride].
Claim 9
Dependent Claim 13 words
The element of claim 4 wherein said spreading layer contains a bilirubin effector.
Claim 10
Dependent Claim 20 words
The element of claim 4 wherein said radiation-blocking layer comprises inorganic pigment particles dispersed in a second hydrophilic binder material.
Claim 11
Dependent Claim 40 words
The element of claim 4 wherein said interactive mordant is a polymer having repeating units of the formula: ##STR2## wherein A represents an organo group, Q represents a quaternary ammonium or phosphonium group and X - represents an acid anion.
Claim 12
Dependent Claim 13 words
The element of claim 9 wherein M + represents a quaternary ammonium group.
Claim 13
Dependent Claim 184 words
An analytical element for the determination of conjugated, unconjugated or total bilirubin comprising a nonporous support having thereon, in order, a substantially gelatin-free mordant layer comprising a positively-charged, polymeric interactive mordant having at least one binding site for bilirubin and having recurring units represented by the formula ##STR3## wherein A represents an organo group, Q represents a chemical bond or linking group, M + represents a quaternary ammonium or phosphonium group and X - represents an acid anion, said mordant being dispersed in a first hydrophilic binder material other than gelatin or its derivatives, said first hydrophilic binder material being present in an amount of from about 2 to about 20 g/m 2 , and being selected from the group consisting of copolymers of acrylamide or methacrylamide and N-vinyl pyrrolidone and terpolymers of an N-vinyl pyrrolidone, a carboxy-containing vinyl monomer and an acrylamide or methacrylamide, a radiation-blocking layer comprising an inorganic pigment dispersed in a second hydrophilic binder material, and a porous blushed polymer spreading layer, provided that said element is free of colorimetric and fluorometric interactive compositions for bilirubin other than said mordant.
Claim 14
Dependent Claim 184 words
An analytical element for the determination of conjugated, unconjugated or total bilirubin comprising a nonporous support having thereon, in order, a substantially gelatin-free mordant layer comprising a positively-charged, polymeric interactive mordant having at least one binding site for bilirubin and having recurring units represented by the formula ##STR3## wherein A represents an organo group, Q represents a chemical bond or linking group, M + represents a quaternary ammonium or phosphonium group and X - represents an acid anion, said mordant being dispersed in a first hydrophilic binder material other than gelatin or its derivatives, said first hydrophilic binder material being present in an amount of from about 2 to about 20 g/m 2 , and being selected from the group consisting of copolymers of acrylamide or methacrylamide and N-vinyl pyrrolidone and terpolymers of an N-vinyl pyrrolidone, a carboxy-containing vinyl monomer and an acrylamide or methacrylamide, a radiation-blocking layer comprising an inorganic pigment dispersed in a second hydrophilic binder material, and a porous blushed polymer spreading layer, provided that said element is free of colorimetric and fluorometric interactive compositions for bilirubin other than said mordant.
Claim 15
Dependent Claim 13 words
The element of claim 11 wherein said second hydrophilic binder material is gelatin.
Claim 16
Dependent Claim 19 words
The element of claim 11 wherein said first hydrophilic binder material is poly(acrylamide-co-N-vinyl-2-pyrrolidone) and said mordant is poly(styrene-co-N-vinylbenzyl-N,N-dimethylammonium chloride-co-divinylbenzene).

References Cited (Backward Citations)

US4069016A Cited
US4069017A Cited
US4311665A Cited
US4412005A Cited
US4338095A Cited
GB2085581A Cited
JPS59230160A Cited
US4548905A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1991-11-29 1992-05-30 1992-11-29 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1995-11-29 1996-05-30 1996-11-29 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1999-11-29 2000-05-30 2000-11-29 $7700.00 Window Closed / Lapsed

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