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1. EP0967484 - METHODS FOR DETECTING OR ASSAYING VIRUS

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Claims

1. A method for measuring a hepatitis C virus (HCV) or Hepatitis B virus (HBV) or a HCV- or HBV- related virus in a sample by obtaining a sample suitable for detection of virus comprising the step of

(1) treating a virus-containing sample with a treatment solution containing (a) an anionic surfactant and (b) at least one agent selected from the group consisting of an amphoteric surfactant, a nonionic surfactant and a protein denaturant; such that the virus particle is disrupted, the virus antigen is exposed or released; and antibodies against the virus antigen, if present in the sample, are inactivated; and

(2) detecting the virus antigen by immunoassay.


  2. A method for measuring a hepatitis C virus (HCV) or Hepatitis B virus (HBV) or a HCV- or HBV- related virus in a sample by obtaining a sample suitable for detection of virus comprising the step of

(1) treating a virus-containing sample with a treatment solution containing (a) an anionic surfactant, (b) an amphoteric surfactant (c) at least one agent selected from the group consisting of a nonionic surfactant and a protein denaturant; such that virus particle is disrupted, the virus antigen is exposed or released; and antibodies against the virus antigen, if present in the sample, are inactivated; and

(2) detecting the virus antigen by immunoassay.


  3. A method for measuring a hepatitis C virus (HCV) or Hepatitis B virus (HBV) or a HCV- or HBV- related virus in a sample by obtaining a sample suitable for detection of virus comprising the step of

(1) treating a virus-containing sample with a treatment solution containing (a) an anionic surfactant, (b) an amphoteric surfactant (c) a nonionic surfactant and (d) a protein denaturant; such that virus particle is disrupted, the virus antigen is exposed or released; and antibodies against the virus antigen, if present in the sample, are inactivated; and

(2) detecting the virus antigen by immunoassay.


  4. A method according to any one of claims 1 to 3, wherein said treatment solution further contains urea, an imidazole ring-containing compound or an indole ring-containing compound.
  5. A method according to claim 4, wherein said imidazole ring-containing compound is imidazole, histidine, imidazoleacrylic acid, imidazolecarboxyaldehyde, imidazolecarboxamide, imidazoledione, imidazoledithiocarboxylic acid, imidazoledicarboxylic acid, imidazolemethanol, imidazolidinethione, imidazolidone, histamine or imidazopyridine.
  6. A method according to claim 4, wherein said indole ring-containing compound is tryptophan, indoleacrylic acid, indole, indoleacetic acid, indoleacetic hydrazide, methyl indoleacetate, indolebutyric acid, indoleacetonitrile, indolecarbinol, indolecarboxyaldehyde, indolecarboxylic acid, indoleethanol, indolelactic acid, indolemethanol, indolepropionic acid, indolepyruvic acid, indolyl methyl ketone, indomycin, indoleacetone, indomethacin, indoprofen or indolamine.
  7. A method for measuring a hepatitis C virus (HCV) or Hepatitis B virus (HBV) or a HCV - or HBV-related virus in a sample by obtaining a sample suitable for detection of virus comprising the step of

(1) treating a virus-containing sample with a treatment solution containing (a) a caotropic ion and (b) an acidifying agent; such that the virus particle is disrupted, the virus antigen is exposed or released; and antibodies against the virus antigen, if present in the sample, are inactivated; and

(2) detecting the virus antigen by immunoassay.


  8. A method for measuring a hepatitis C virus (HCV) or Hepatitis B virus (HBV) or a HCV - or HBV-related virus in a sample by obtaining a sample suitable for detection of virus comprising the step of

(1) treating a virus-containing sample with a treatment solution containing (a) a caotropic ion, (b) an acidifying agent and (c) a nonionic surfactant; such that virus particle is disrupted, the virus antigen is exposed or released; and antibodies against the virus antigen, if present in the sample, are inactivated; and

(2) detecting the virus antigen by immunoassay.


  9. A method according to any one of claims 1 to 8 wherein said immunoassay is immunoassay using a monoclonal antibody.
  10. A diagnostic kit for determining the presence or absence of a hepatitis C virus (HCV) or hepatitis B virus (HBV) or a HCV - or HBV-related virus in a sample, which is for use in an immunoassay method according to any one of claims 1-9, comprising (1) (a) an anionic surfactant and (b) at least one agent selected from the group consisting of an amphoteric surfactant, a nonionic surfactant and a protein denaturant or (2)(a) caotropic agent and (b) an acidifying agent and a nonionic surfactant.
  11. A diagnostic kit according to claim 10 which further includes urea, an imidazole ring-containing compound or an indole ring-containing compound.
  12. A diagnostic kit according to claim 11, wherein said imidazole ring-containing compound is imidazole, histidine, imidazoleacrylic acid, imidazolecarboxyaldehyde, imidazolecarboxamide, imidazoledione, imidazoledithiocarboxylic acid, imidazoledicarboxylic acid, imidazolemethanol, imidazolidinethione, imidazolidone, histamine or imidazopyridine.
  13. A diagnostic kit according to claim 11, wherein said indole ring-containing compound is tryptophan, indoleacrylic acid, indole, indoleacetic acid, indoleacetic hydrazide, methyl indoleacetate, indolebutyric acid, indoleacetonitrile, indolecarbinol, indolecarboxyaldehyde, indolecarboxylic acid, indoleethanol, indolelactic acid, indolemethanol, indolepropionic acid, indolepyruvic acid, indolyl methyl ketone, indomycin, indoleacetone, indomethacin, indoprofen or indolamine.