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 labelled.
Claims29
A method of screening an undiluted sample of serum or plasma obtained from an animal subject for analyte autoantibodies reactive with the antigenic molecule 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 of the one or more first sources are capable of interacting with analyte autoantibodies in a sample of serum or plasma from said subject or in a calibrator and comprises molecules of IA-2;
- (b) contacting said immobilized antigenic molecules of the one or more first sources with:
- (1) an undiluted sample of serum or plasma from said subject, or said calibrator;
- and
- (2) antigenic molecules of a one or more second sources comprising a direct or indirect label, wherein said antigenic molecules of one or more second sources are capable of interacting with analyte autoantibodies in a sample of serum or plasma from said subject or in said calibrator, and comprises molecules of IA-2,
- whereby analyte autoantibodies when present in said sample of serum or plasma interact with said antigenic molecules of the 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.
A method of screening a diluted sample of serum or plasma obtained from an animal subject for analyte autoantibodies reactive with the antigenic molecule 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 the second source, wherein said first source of antigenic molecule is capable of interacting with analyte autoantibodies in a sample of serum or plasma from said subject, or a calibrator and comprises molecules of IA-2;
- (b) contacting said immobilized one or more first sources of antigenic molecules 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 of one or more second sources comprising a direct or indirect label, wherein said antigenic molecules of the one of 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 of IA-2,
- whereby analyte autoantibodies when present in said sample of serum or plasma interact with said antigenic molecules of the 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.
Dependencies are inferred from the claim text.