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Diagnostic test

  • US 4,208,187 A
  • Filed: 10/06/1978
  • Issued: 06/17/1980
  • Est. Priority Date: 12/19/1977
  • Status: Expired due to Term
First Claim
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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:

  • (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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