Method and device for immunoassay using nucleotide conjugates
AssigneeAbbott Point of Care Inc.
InventorsGordon Bruce Collier, Cary James Miller
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Abstract
A composition of matter for use in an immunoassay devices and method comprising a signal antibody, e.g., FAB fragment, covalently linked to a first nucleotide; and one or more signal elements, e.g., signal enzymes such as ALP or fluorescent dyes, each covalently linked to a second nucleotide, wherein the first nucleotide has one or more repeated sequences, and the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the signal antibody to the signal element is controlled by the number of repeated sequences.
Claims26
A single-use cartridge for performing an immunoassay, comprising:
- a sample entry port for receiving a biological sample suspected of containing a target analyte,
- a conduit containing an electrode,
- a region containing a wash fluid, and
- a waste chamber,
- wherein an immunoassay is formed on said electrode, the immunoassay comprising immobilized first antibody bound to said target analyte, second antibody to said target analyte, wherein the second antibody is attached to a first single stranded nucleotide;
- and
- one or more signal elements each attached to a second single stranded nucleotide having complimentary base pairs to the first single stranded nucleotide;
- wherein the wash fluid is capable of washing said biological sample from said electrode in said conduit into said waste chamber.
A composition of matter for use in an immunoassay comprising:
- a FAB fragment covalently linked to a first nucleotide;
- and
- one or more signal elements each covalently linked to a second nucleotide,
- wherein said first nucleotide has one or more repeated sequences, and wherein the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the FAB fragment to the signal element is controlled by the number of repeated sequences.
A method of determining the presence of analyte in a biological sample comprising:
- contacting the biological sample so that the analyte binds to an immobilized first antibody and a second antibody to form an immunoassay, wherein the second antibody is bounded to at least one signal enzyme via a synthetic nucleotide bridge;
- washing said biological sample from said immunoassay;
- and
- determining the presence of the analyte based on a signal generated by a reaction with the signal enzyme.
A method of determining whether a patient may suffer a myocardial infarction comprising:
- (a) applying a sample from a patient to a surface to which is bound a first antibody which is capable of binding to a first epitope on cTnI;
- (b) adding a second antibody that is capable of binding to a second epitope on cTnl, wherein the second antibody further comprises a first stranded polynucleotide sequence that is bound to one or more second stranded polynucleotides bound to a signal element;
- and
- (c) determining the extent of binding of the second antibodies.
A signal conjugate batch comprising signal conjugates in which at least 80 mol % of the signal conjugates have from about 2 to about 20 signal elements per signal conjugate.
A signal conjugate batch comprising signal conjugates in which at least 80 mol % of the signal conjugates have from about 1 to about 4 signal antibodies per signal conjugate.
A signal conjugate batch comprising signal conjugates in which at least 80 mol % of the signal conjugates have a molar ratio of signal elements to signal antibodies ranging from about 0.5 to about 20.
Dependencies are inferred from the claim text.