Positive calibrator/control composition for an IgM serology assay and an IgM serology assay
AssigneePB Diagnostic Systems, Inc.
InventorsT. Philip Wong, Russell A. Hammond
Life of this patent
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Abstract
There is described a positive calibrator/control composition for use in assays for the detection of antibodies to infectious disease agents. The composition includes a composite antibody of a nonspecific IgM immunoglobulin moiety covalently linked to a specific, non-IgM antibody moiety. Also described is an assay method which utilizes the positive calibrator or control composition.
Claims18
A positive calibrator or control composition for an IgM serology assay comprising a solution of a composite antibody of a nonspecific IgM immunoglobulin covalently bound to a specific, non-IgM antibody, said specific, non-IgM antibody being directed against a specific infectious disease agent.
A method for carrying out an assay with a positive calibrator or control composition for the presence of IgM antibodies to an infectious disease comprising the steps of:
- (a) applying to a solid carrier (i) a positive calibrator or control composition which comprises composite antibodies, said composite antibodies comprising a nonspecific IgM immunoglobulin covalently bound to a specific, non-IgM, antibody directed against a specific infectious disease agent, and (ii) a labeled detector material
- said solid carrier having immobilized thereto a binding material which binds to said composite antibodies and wherein the detector material of said labeled detector material binds to said composite antibodies
- whereby there is formed a ternary complex of said immobilized binding material, said composite antibodies and said labeled detector material;
- (b) removing free labeled detector material from said solid carrier;
- and
- (c) obtaining a readout signal by detecting the bound or free labeled detector material.
A method for determining a reference signal cutoff value for an assay for the presence of antibodies to an infectious disease agent comprising the steps of:
- (a) applying to a solid carrier (i) a positive calibrator or control composition which comprises composite antibodies, said composite antibodies comprising a nonspecific IgM immunoglobulin covalently bound to a specific, non-IgM, antibody directed against a specific infectious disease agent, and (ii) a labeled detector material
- said solid carrier having immobilized thereto a binding material which binds to said composite antibodies and wherein the detector material of said labeled detector material binds to said composite antibodies
- whereby there is formed a ternary complex of said immobilized binding material, said composite antibodies and said labeled detector material;
- (b) removing free labeled detector material from said solid carrier;
- (c) obtaining a readout signal by detecting the bound or free labeled detector material;
- and
- (d) utilizing said readout signal in the determination of a reference signal cutoff value.
Dependencies are inferred from the claim text.