ISOLATED HUMAN AUTOANTIBODIES TO NATRIURETIC PEPTIDES AND METHODS AND KITS FOR DETECTING HUMAN AUTOANTIBODIES TO NATRIURETIC PEPTIDES
First Claim
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1. A method for detecting one or more autoantibodies reactive with at least one natriuretic peptide or natriuretic peptide fragment in a test sample, the method comprising the steps of:
- (a) preparing a mixture comprising a test sample being assessed for the presence of one or more autoantibodies to at least one natriuretic peptide or natriuretic peptide fragment, and a first specific binding partner labeled with a detectable label, wherein the first specific binding partner is a natriuretic peptide or a natriuretic peptide fragment and further wherein the one or more autoantibodies and the first specific binding partner form a first specific binding partner-autoantibody complex; and
(b) measuring the signal generated by or emitted from the detectable label.
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Abstract
The present disclosure relates to isolated human autoantibodies and assays and kits for detecting human autoantibodies reactive with at least one natriuretic peptide or natriuretic peptide fragment in a test sample.
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Citations
30 Claims
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1. A method for detecting one or more autoantibodies reactive with at least one natriuretic peptide or natriuretic peptide fragment in a test sample, the method comprising the steps of:
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(a) preparing a mixture comprising a test sample being assessed for the presence of one or more autoantibodies to at least one natriuretic peptide or natriuretic peptide fragment, and a first specific binding partner labeled with a detectable label, wherein the first specific binding partner is a natriuretic peptide or a natriuretic peptide fragment and further wherein the one or more autoantibodies and the first specific binding partner form a first specific binding partner-autoantibody complex; and (b) measuring the signal generated by or emitted from the detectable label. - View Dependent Claims (2)
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3. A method for detecting one or more autoantibodies reactive with at least one natriuretic peptide or natriuretic peptide fragment in a test sample, the method comprising the steps of:
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(a) preparing a mixture comprising a test sample being assessed for the presence of one or more autoantibodies to at least one natriuretic peptide or natriuretic peptide fragment and a first specific binding partner that is immobilized on a solid phase, wherein the first specific binding partner is a natriuretic peptide or a natriuretic peptide fragment and further wherein the one or more autoantibodies and the first specific binding partner form a solid phase first specific binding partner-autoantibody complex; (b) adding a second specific binding partner labeled with a detectable label to the mixture to form a first specific binding partner-one or more autoantibodies-second specific binding partner complex, wherein the second specific binding partner is an anti-human antibody; and (c) measuring the signal generated by or emitted from the detectable label. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10)
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11. A kit for detecting one or more autoantibodies reactive with at least one natriuretic peptide or a natriuretic peptide fragment in a test sample, the kit comprising:
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(a) at least one natriuretic peptide or natriuretic peptide fragment; (b) at least one detectable label; and (c) instructions for detecting said one or more autoantibodies. - View Dependent Claims (12, 13, 14, 15, 16, 17)
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18. An isolated human natriuretic peptide autoantibody, wherein the autoantibody is obtained by a process comprising the steps of:
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(a) preparing a mixture comprising a human natriuretic peptide autoantibody; and (b) isolating the human natriuretic peptide autoantibody from the mixture. - View Dependent Claims (19, 20, 21)
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22. A method of screening for at least one agent useful in inhibiting the binding of at least one human natriuretic peptide or natriuretic peptide fragment to at least one human natriuretic peptide autoantibody, the method comprising the steps of:
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(a) preparing a mixture comprising an isolated human natriuretic peptide autoantibody; (b) adding to the mixture at least one human natriuretic peptide or natriuretic peptide fragment and at least one agent to be tested; and (c) determining whether the agent inhibits the binding of the at least one human natriuretic peptide or natriuretic peptide fragment to the human natriuretic peptide autoantibody.
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23. A method of determining the reliability of a human natriuretic peptide assay result, the method comprising the steps of:
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(a) assaying a test sample for one or more autoantibodies reactive with a human natriuretic peptide; and (b) determining the reliability of a human natriuretic peptide assay result, wherein the presence of an elevated level in the test sample of one or more autoantibodies reactive with a human natriuretic peptide indicates that the human natriuretic peptide result is not reliable.
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24. A method of assessing whether a subject has or is at risk of developing cardiovascular disease, the method comprising the steps of:
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(a) determining the concentration or amount in a test sample from a subject of one or more autoantibodies reactive with human natriuretic peptide; and (b) comparing the concentration or amount of the one or more autoantibodies reactive with human natriuretic peptide determined in step (a) with a predetermined level, wherein if the concentration or amount of the one or more autoantibodies reactive with human natriuretic peptide determined in step (a) is favorable with respect to a predetermined level, then the subject is determined not to have or be at risk for a cardiovascular disease; and
further wherein if the concentration or amount of the one or more autoantibodies reactive with human natriuretic peptide determined in step (a) is unfavorable with respect to the predetermined level then the subject is determined to have or be at risk for a cardiovascular disease. - View Dependent Claims (25)
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26. A method of monitoring the progression of disease in a subject, the method comprising the steps of:
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(a) determining the concentration or amount in a first test sample from a subject of one or more autoantibodies reactive with human natriuretic peptide; (b) determining the concentration or amount in a second or subsequent test sample from the subject of one or more autoantibodies reactive with human natriuretic peptide; and (c) comparing the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (b) with the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (a), wherein if the concentration or amount determined in step (b) is unchanged or is unfavorable when compared to the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (a), then the disease in the subject is determined to have continued, progressed or worsened, further wherein, if the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (b) is favorable when compared to the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (a), then the disease in the subject is determined to have discontinued, regressed or improved. - View Dependent Claims (27, 28)
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29. A method of monitoring the treatment of disease in a subject, the method comprising the steps of:
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(a) determining the concentration or amount in a first test sample from a subject of one or more autoantibodies reactive with human natriuretic peptide; (b) treating the subject with one or more pharmaceutical compositions for a period of time; (c) determining the concentration or amount in a second or subsequent test sample obtained from the subject following treatment in step (b) of one or more autoantibodies reactive with human natriuretic peptide; and (d) comparing the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (c) with the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (a), wherein if the concentration or amount determined in step (c) is unchanged or is unfavorable when compared to the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (a), then the subject should be treated with a higher concentration of the one or more pharmaceutical compositions administered to the subject in step (b) or the subject should be treated with one or more pharmaceutical compositions that are different then the one or more pharmaceutical compositions administered to the subject in step (b). further wherein, if the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (c) is favorable when compared to the concentration or amount of one or more autoantibodies reactive with human natriuretic peptide determined in step (a), then the subject should continue to be administered the one or pharmaceutical compositions of step (b). - View Dependent Claims (30)
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Specification