Detection of autoantibodies reactive with pancreatic islet cell antigenic molecules and/or insulin
AssigneeRSR Limited
InventorsBernard Rees Smith, Jadwiga Furmaniak, Michael Powell
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Abstract
A method of screening a sample of body fluid obtained from an animal subject for analyte autoantibodies reactive with one or more antigenic molecules selected from pancreatic islet cell antigenic molecules (GAD, 1A2) and insulin, or one or more variants, analogs, derivatives or fragments thereof, and a kit for use in such a method. After addition of the sample one or more complexes comprising [antigenic molecule of first source]-[analyte auto antibody]-[antigenic molecule of second source]. The antigenic molecule of first source is immobilized to a solid phase, the second is labeled.
Claims34
A method of screening a diluted sample of serum or plasma obtained from an animal subject for analyte autoantibodies reactive with one or more antigenic molecules selected from glutamic acid decarboxylase (GAD) antigens or the protein tyrosine phosphatase-like islet cell antigen (IA-2), said method comprising:
- (a) immobilizing antigenic molecules from one or more first sources to a solid support in an amount so as to form a monovalent intermediate complex comprising [antigenic molecule of said first source]-[analyte autoantibody] capable of forming a divalent complex with antigenic molecules of a second source, wherein said antigenic molecules from the one or more first sources are capable of interacting with analyte autoantibodies in a sample of serum or plasma from said subject, or a calibrator and comprises molecules selected from the group consisting of glutamic acid decarboxylase 65 (GAD65), glutamic acid decarboxylase 67 (GAD67), and IA-2;
- (b) contacting said immobilized antigenic molecules from the one or more first sources with:
- (1) a diluted sample of serum or plasma from said subject, wherein the sample is diluted 32-fold or less;
- or said calibrator;
- and
- (2) antigenic molecules from one or more second sources comprising a direct or indirect label, wherein said antigenic molecules from the one or more second sources are capable of interacting with analyte autoantibodies in a sample of serum or plasma from said subject, or said calibrator and comprises molecules selected from the group consisting of GAD65;
- GAD67;
- IA-2,
- whereby analyte autoantibodies when present in said sample or calibrator interact with said antigenic molecules from the one or more first and second sources to form one or more divalent complexes comprising [antigenic molecule of said first source]-[analyte autoantibody]-[antigenic molecule of said second source];
- and
- (c) detecting the presence of complexes formed in (b) to provide an indication of analyte autoantibodies present in said sample;
- wherein said antigenic molecules from the one or more first and second sources comprises at least one GAD antigenic molecule.
Dependencies are inferred from the claim text.