Diagnostic test
First Claim
1. In a diagnostic test method suitable for the detection of physiological conditions characterized by the presence of a polypeptide or glycoprotein antigen selected from chorionic gonadotropin, human chorionic gonadotropin, pregnant mare'"'"'s serum gonadotropin, carcino embryonic antigen, luteinizing hormone, follicle stimulating hormone, human menopausal gonadotropin and thyroid stimulating hormone in urine including:
- (a) clarifying a sample of the urine to be tested;
(b) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane backed by a layer of absorbent capable of sorbing urine serum passing through the membrane, and said membrane having a molecular weight with cut-off from about 5,000 to about 200,000, whereby said polypeptide or glycoprotein antigen is retained in the sample;
(c) continuing the ultrafiltration until the retentate sample is one-tenth to one-five hundredth its original volume;
(d) diluting the retentate with sufficient water to provide a retentate sample of about 0.5 ml; and
(e) contacting the retentate sample with the appropriate amount of an immunologic reagent for detecting the presence of said polypeptide or glycoprotein antigen in the retentate sample, with the proviso that when said antigen is human chorionic gonadotropin, then the immunologic reagent comprises other than pyruvic aldehyde stabilized erythrocytes sensitized to human chorionic gonadotropin with a bifunctional molecule;
the improvement which comprises contacting said membrane with a dilute solution of polyvinylpyrrolidone prior to or concurrent with ultrafiltration, wherein said polyvinylpyrrolidone has an average molecular weight greater than about 9,000 and less than about 40,000.
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Accused Products
Abstract
A simple, sensitive, reliable and safe method and device for detecting a polypeptide or glycoprotein antigen. The test involves concentration in the presence of polyvinylpyrrolidone by ultrafiltration of a sample of urine or serum from a subject; followed by determining the presence of said polypeptide or glycoprotein antigen or a particular subunit thereof in the concentrated sample.
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Citations
20 Claims
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1. In a diagnostic test method suitable for the detection of physiological conditions characterized by the presence of a polypeptide or glycoprotein antigen selected from chorionic gonadotropin, human chorionic gonadotropin, pregnant mare'"'"'s serum gonadotropin, carcino embryonic antigen, luteinizing hormone, follicle stimulating hormone, human menopausal gonadotropin and thyroid stimulating hormone in urine including:
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(a) clarifying a sample of the urine to be tested; (b) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane backed by a layer of absorbent capable of sorbing urine serum passing through the membrane, and said membrane having a molecular weight with cut-off from about 5,000 to about 200,000, whereby said polypeptide or glycoprotein antigen is retained in the sample; (c) continuing the ultrafiltration until the retentate sample is one-tenth to one-five hundredth its original volume; (d) diluting the retentate with sufficient water to provide a retentate sample of about 0.5 ml; and (e) contacting the retentate sample with the appropriate amount of an immunologic reagent for detecting the presence of said polypeptide or glycoprotein antigen in the retentate sample, with the proviso that when said antigen is human chorionic gonadotropin, then the immunologic reagent comprises other than pyruvic aldehyde stabilized erythrocytes sensitized to human chorionic gonadotropin with a bifunctional molecule; the improvement which comprises contacting said membrane with a dilute solution of polyvinylpyrrolidone prior to or concurrent with ultrafiltration, wherein said polyvinylpyrrolidone has an average molecular weight greater than about 9,000 and less than about 40,000. - View Dependent Claims (5, 6, 7, 8, 11, 12, 13, 14, 17, 18, 19)
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2. In a diagnostic test method suitable for the detection of physiological conditions characterized by the presence of a polypeptide or glycoprotein antigen selected from chorionic gonadotropin, human chorionic gonadotropin, pregnant mare'"'"'s serum gonadotropin, carcino embryonic antigen, luteinizing hormone, follicle stimulating hormone, human menopausal gonadotropin and thyroid stimulating hormone in urine including:
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(a) clarifying a sample of the urine to be tested; (b) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane backed by a layer of absorbent capable or sorbing urine passing through the membrane, and said membrane having a molecular weight cut-off from about 5,000 to about 50,000, whereby said polypeptide or glycoprotein antigen is retained in the sample; (c) continuing the ultrafiltration until the retentate sample is one-tenth to one-five hundredth its original volume (d) diluting the retentate with sufficient water to provide a retentate sample of about 0.5 ml; and (e) contacting the retentate sample with the appropriate amount of an immunologic reagent for detecting the presence of said polypeptide or glycoprotein antigen in the retentate sample, with the proviso that when said antigen is human chorionic gonadotropin, then the immunologic reagent comprises other than pyruvic aldehyde stabilized erythrocytes sensitized to human chorionic gonadotropin with a bifunctional molecule; the improvement which comprises pre-washing said membrane with about 0.5% to about 4.0% solution of polyvinylpyrrolidone prior to ultrafiltration, wherein said polyvinylpyrrolidone has an average molecular weight greater than about 9,000 and less than about 40,000.
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3. In a diagnostic test method suitable for the detection of physiological conditions characterized by the presence of a polypeptide or glycoprotein antigen selected from chorionic gonadotropin, human chorionic gonadotropin, pregnant mare'"'"'s serum gonadotropin, carcino embryonic antigen, luteinizing hormone, follicle stimulating hormone, human menopausal gonadotropin and thyroid stimulating hormone in urine including:
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(a) clarifying a sample of the urine to be tested through a filter; (b) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane backed by a layer of absorbent capable of sorbing urine serum passing through the membrane, and said membrane having a molecular weight cut-off from about 5,000 to about 50,000, whereby said polypeptide or glycoprotein antigen is retained the sample; (c) continuing the ultrafiltration until the retentate sample is one-tenth to one-five hundredth its original volume; (d) diluting the retentate with sufficient water to provide a retentate sample of about 0.5 ml; and (e) contacting the retentate sample with the appropriate amount of an immunologic reagent for detecting the presence of said polypeptide or glycoprotein antigen in the retentate sample, with the proviso that when said antigen is human chorionic gonadotropin, then the immunologic reagent comprises other than pyruvic aldehyde stabilized erythrocytes sensitized to human chorionic gonadotropin with a bifunctional molecule; the improvement which comprises pretreating said filter with about a 0.5% to about 4.0% solution of polyvinylpyrrolidone prior to ultrafiltration, wherein said polyvinylpyrrolidone has an average molecular weight greater than about 9,000 and less than about 40,000.
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4. In a diagnostic test method suitable for the detection of physiological conditions characterized by the presence of a polypeptide or glycoprotein antigen selected from chorionic gonadotropin, human chorionic gonadotropin, pregnant mare'"'"'s serum gonadotropin, carcino embryonic antigen, luteinizing hormone, follicle stimulating hormone, human menopausal gonadotropin and thyriod stimulating hormone in urine including:
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(a) clarifying a sample of the urine to be tested through a filter; (b) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane backed by a layer of absorbent capable of sorbing urine serum passing through the membrane and said membrane having a molecular weight cut-off from about 5,000 to about 50,000, whereby said polypeptide or glycoprotein antigen is retained in the sample; (c) continuing the ultrafiltration until the retentate sample is one-tength to one-five hundredth is original volume; (d) diluting the retentate with sufficient water to provide a retenate sample of about 0.5 ml; and (e) contacting the retentate sample with the appropriate amount of an immunologic reagent for detecting the presence of said polypeptide or glycoprotein antigen in the retentate sample, with the proviso that when said antigen is human chorionic gonadotropin, then the immunologic reagent comprises other than pyruvic aldehyde stabilized erythrocytes sensitized to human chorionic gonadotropin with a bifunctional molecule; the improvement which comprises contacting said urine sample before of after clarification with a sufficient amount of polyvinylpyrrolidone to give a concentration of the polyvinylpyrrolidone in the urine of from about 0.01% to about 2.0%, wherein said polyvinylpyrrolidone has an average molecular weight greater than about 9,000 and less than about 40,000. - View Dependent Claims (9, 10, 15, 16, 20)
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Specification