Patent ID: 6025141
Filing Date: 2000-02-15
Classification: A61K,C07K,C12N,G01N,Y10S

Abstract:
A method for detection of a disease state which comprises utilizing an insoluble form of at least one recombinant protein in a flow cytometric immunofluorescence assay, said method comprising:(i) obtaining a sample of biological fluid within which the disease state is to be detected;(ii) adding a predetermined amount of said insoluble form of at least one recombinant protein to said sample to form a mixture, wherein said insoluble form being produced in particle form by expression in baculovirus or in an expression system producing a particle form, and wherein said insoluble form is the carrier and the antigen;(iii) incubating said mixture for a period of time sufficient to permit association between said insoluble form of at least one recombinant protein and antibodies within said sample to form an incubated mixture;(iv) washing said incubated mixture;(v) adding a labelled antibody to the mixture of step (iv) and incubating for a period of time sufficient for said labeled antibody to bind with antibodies within said incubated mixture to form a labeled mixture;(vi) washing said labeled mixture;(vii) detecting IgM complexes formed in said washed labeled mixture using flow cytometric immunofluorescence; and(viii) correlating detection of IgM complexes with a disease state, wherein an increase level of IgM over the control level is indicative of the disease state.