Process for obtaining delta antigen of hepatitis D virus and use of said antigen as a diagnostic agent
OwnerAlan G. Shattock, Bridget M. Morganinventors
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Abstract
A process for `unmasking` delta antigen in the blood of an animal, known or caused to be infected with the antigen. The process involves treating serum from the animal with a surfactant and optionally with an antibody--antigen dissociating agent. The blood derived delta antigen is used as a diagnostic agent in the detection and determination of different classes of antibodies to hepatitis D. virus (delta agent) by enzyme-immunoassay and radio-immunoassay.
Claims41
A process for obtaining delta antigen from an animal, known or caused to be infected with the antigen, for use as a source of delta antigen for diagnostic assays, said process comprising treating blood serum from the animal with a predetermined amount of a surfactant selected from the group consisting of condensates of ethylene oxide with fatty alcohols, condensates of ethylene oxide with aromatic alcohols, cetrimonium bromide and sodium N-lauroyl sarcosinate.
An immunoassay method for the detection and determination of the delta antigen component or the anti-delta component of a delta antigen-anti-delta reaction in a body fluid, wherein the delta antigen is derived solely from blood, which comprises:
- (a) adding a sample of the body fluid containing the component to be determined to an amount of the other component of said delta antigen-anti-delta reaction in an insolubilized form;
- (b) allowing an immunochemical reaction to take place between said components to form a delta antigen-anti-delta reaction product;
- (c) adding a predetermined amount of labelled antibody which is anti-delta antibody covalently linked to an enzyme or radio label;
- and
- (d) determining the enzymatic or radiometric activity of the reaction medium, which is a measure of the amount of said component present in said sample of the body fluid.
A test pack for the detection and determination of delta antigen in serum by immunoassay comprising:
- (a) a bottle or vial containing a buffered surfactant solution for unmasking or releasing the delta antigen in the serum, the surfactant being selected from the group consisting of condensates of ethylene oxide with fatty alcohols, condensates of ethylene oxide with aromatic alcohols, cetrimonium bromide and sodium N-lauroyl sarcosinate;
- (b) one or more microtitration plate(s) or strip(s) coated with a given quantity of insolubilized anti-delta antibody;
- and
- (c) a bottle or vial containing a corresponding coupling product of an enzyme or radio label with anti-delta antibody.
A test pack for the detection and determination of delta antigen in serum by immunoassay comprising:
- (a) a bottle or vial containing a buffered surfactant solution for unmasking or releasing the delta antigen in the serum, the surfactant being selected from the group consisting of condensates of ethylene oxide with fatty alcohols, condensates of ethylene oxide with aromatic alcohols, cetrimonium bromide and sodium N-lauroyl sarcosinate;
- (b) one or more microtitration plate(s) or strip(s) coated with a given quantity of insolubilized anti-delta antibody;
- (c) a bottle or vial containing an antibody-antigen dissociating agent selected from the group consisting of potassium thiocyanate, potassium bromide, potassium iodide, guanidine hydrochloride and urea, any of said dissociating agents being suitable for use with any one of said surfactants;
- and
- (d) a bottle or vial containing a corresponding given quantity of the coupling product of an enzyme or radio label with anti-delta antibody.
A test pack for the detection and determination of anti-delta antibodies in serum by immunoassay which comprises:
- (a) one or more microtitration plate(s) or strip(s) coated with a given quantity of insolubilized delta antigen, the delta antigen having been derived solely from blood;
- and
- (b) a bottle or vial containing a corresponding quantity of the coupling product of an enzyme or radio label with anti-delta antibody.
A test pack for the detection and determination of anti-delta antibodies in serum by immunoassay which comprises:
- (a) one or more microtitration plate(s) or strip(s) coated with a given quantity of insolubilized anti-delta antibody;
- (b) a bottle or vial containing serum delta antigen;
- (c) a bottle or vial containing a buffered surfactant solution for unmasking or releasing the delta antigen in the serum, the surfactant being selected from the group consisting of condensates of ethylene oxide with fatty alcohols, condensates of ethylene oxide with aromatic alcohols, cetrimonium bromide and sodium N-lauroyl sarcosinate;
- and
- (d) a bottle or vial of a corresponding quantity of the coupling product of an enzyme or radio label with anti-delta antibody.
A test pack for the detection and determination of anti-delta antibodies in serum by immunoassay which comprises:
- (a) one or more microtitration plate(s) or strip(s) coated with a given quantity of insolubilized anti-delta antibody;
- (b) a bottle or vial containing serum delta antigen;
- (c) a bottle or vial containing a buffered surfactant solution for unmasking or releasing the delta antigen in the serum, the surfactant being selected from the group consisting of condensates of ethylene oxide with fatty alcohols, condensates of ethylene oxide with aromatic alcohols, cetrimonium bromide and sodium N-lauroyl sarcosinate;
- and
- (d) a bottle or vial containing an antibody-antigen dissociating agent selected from the group consisting of potassium thiocyanate, potassium bromide, potassium iodide, quanidine hydrochloride and urea, any of said dissociating agents being suitable for use with any one of said surfactants.
Dependencies are inferred from the claim text.