ASSAY FOR DIAGNOSIS OF CARDIAC MYOCYTE DAMAGE
First Claim
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1. An immunoassay for detecting cardiac myocyte damage in a subject from a test sample, the immunoassay comprising the steps of:
- a) contacting a test sample from a subject suspected of having cardiac myocyte damage with n antibodies (Aan′
n) that bind to at least n epitopes on n′
cardiac myocyte antigens (an′
) to form n′
(n-antibody;
antigen) immuno-complexes (Aa11)(Aa12) . . . (Aa1n)(a1), (Aa12)(Aa22) . . . (Aa2n)(a2), . . . (Aan′
1)(Aan′
2) . . . (Aan′
n)(an′
) wherein n is an integer from 1 to 10; and
n′
is an integer from 2 to 10;
b) contacting said mixture comprising n′
(n-antibody;
antigen) immuno-complexes with n″
antibodies (Ban′
n″
) that bind to n″
epitopes on n′
cardiac myocyte antigens (an′
) to form n′
((n+n″
) antibody;
antigen) measurable assemblies ((Aa11)(Aa12) . . . (Aa1n)((Ba11)(Ba12) . . . (Ba1n)(a1), ((Aa21)(Aa22) . . . (Aa2n))((Ba21)(Ba22) . . . (Aa2n))(a2), . . . ((Aan′
1)(Aan′
2) . . . (Aan′
n)(Ban″
1)(Ban′
2) . . . (Ban″
n))(an′
) wherein n and n″
are independently an integer from 1 to 10, and n′
is an integer from 2 to 10, and antibodies A and B bind to (n+n″
) different epitopes of a cardiac myocyte antigen;
c) measuring an optical, electrical, or change-of-state signal of the measurable assembly; and
d) detecting cardiac myocyte damage by determining whether the measurement in step (c) exceeds a predetermined level.
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Abstract
Assays are disclosed for diagnosing a clinical condition, assessing risk or predicting an outcome as a result of cardiac myocyte damage. Immunoassay methods and kits provide for the assessment of cardiac myocyte damage by determining the presence of multiple cardiac myocyte antigens in a test sample, and combining the multiple determinations in a single assay result.
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Citations
54 Claims
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1. An immunoassay for detecting cardiac myocyte damage in a subject from a test sample, the immunoassay comprising the steps of:
-
a) contacting a test sample from a subject suspected of having cardiac myocyte damage with n antibodies (Aa n′ n) that bind to at least n epitopes on n′
cardiac myocyte antigens (an′
) to form n′
(n-antibody;
antigen) immuno-complexes (Aa1 1)(Aa1 2) . . . (Aa1 n)(a1), (Aa1 2)(Aa2 2) . . . (Aa2 n)(a2), . . . (Aan′ 1)(Aan′ 2) . . . (Aan′ n)(an′
) wherein n is an integer from 1 to 10; and
n′
is an integer from 2 to 10;b) contacting said mixture comprising n′
(n-antibody;
antigen) immuno-complexes with n″
antibodies (Ban′ n″
) that bind to n″
epitopes on n′
cardiac myocyte antigens (an′
) to form n′
((n+n″
) antibody;
antigen) measurable assemblies ((Aa1 1)(Aa1 2) . . . (Aa1 n)((Ba1 1)(Ba1 2) . . . (Ba1 n)(a1), ((Aa2 1)(Aa2 2) . . . (Aa2 n))((Ba2 1)(Ba2 2) . . . (Aa2 n))(a2), . . . ((Aan′ 1)(Aan′ 2) . . . (Aan′ n)(Ban″ 1)(Ban′ 2) . . . (Ban″ n))(an′
) wherein n and n″
are independently an integer from 1 to 10, and n′
is an integer from 2 to 10, and antibodies A and B bind to (n+n″
) different epitopes of a cardiac myocyte antigen;c) measuring an optical, electrical, or change-of-state signal of the measurable assembly; and d) detecting cardiac myocyte damage by determining whether the measurement in step (c) exceeds a predetermined level. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. An immunoassay for detecting cardiac myocyte damage in a subject from a test sample, the immunoassay comprising the steps of:
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a) contacting a test sample from a subject suspected of having cardiac myocyte damage with n antibodies (Aa n′ n) that bind to at least n epitopes on n′
cardiac myocyte antigens (an′
) to form n′
(n-antibody;
antigen) immuno-complexes (Aa1 1)(Aa1 2) . . . (Aa1 n)(a1), (Aa2 1)(Aa2 2) . . . (Aa1 n)(a2), . . . (Aan′ 1)(Aan′ 2) . . . (Aan′ n)(an′
) wherein n is an integer from 1 to 10; and
n′
is an integer from 2 to 10;b) contacting said mixture comprising n′
(n-antibody;
antigen) immuno-complexes with n″
antibodies (Ban′ n″
) that bind to n″
epitopes on n′
cardiac myocyte antigens (an′
) to form n′
((n+n″
) antibody;
antigen) measurable assemblies ((Aa1 1)(Aa1 2) . . . (Aa1 n)((Ba1 1)(Ba1 2) . . . (Ba1 n)(a1), ((Aa2 1)(Aa2 2) . . . (Aa2 n))((Ba2 1)(Ba2 2) . . . (Ba2 n))(a2), . . . ((Aan′ 1)(Aan′ 2) . . . (Aan′ n))((Ban″ 1)(Ban″ 2) . . . (Ban″ n)(an′
) wherein n and n″
are independently an integer from 1 to 10, and n′
is an integer from 2 to 10, and antibodies A and B bind to (n+n″
) different epitopes of a cardiac myocyte antigen, wherein antibodies B are labeled with a detectable label comprising at least one acridinium compound;c) generating or providing a source of hydrogen peroxide to the mixture of step (b); d) adding a basic solution to the mixture of step (c) to generate a light signal; e) measuring the light signal generated by or emitted in step (d); and f) detecting cardiac myocyte damage by determining whether the measurement in step (e) exceeds a predetermined level. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. A kit for detecting cardiac myocyte damage from a test sample, the kit comprising:
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a) n antibodies (Aa n′ n) that bind to at least n epitopes on n′
cardiac myocyte antigens (an′
) to form n′
(n-antibody;
antigen) immuno-complexes (Aa1 1)(Aa1 2) . . . (Aa1 n)(a1), (Aa2 1)(Aa2 2) . . . (Aa2 n)(a2), . . . (Aan′ 1)(Aan 2) . . . (Aan′ n)(an′
) wherein n is an integer from 1 to 10; and
n′
is an integer from 2 to 10;b) n″
antibodies (Ban′ n″
) that bind to n″
epitopes on n′
cardiac myocyte antigens (an′
) to form n′
((n+n″
) antibody;
antigen) measurable assemblies ((Aa1 1)(Aa1 2) . . . (Aa1 n))((Ba1 1)(Ba1 2) . . . (Ba1 n))(a1), ((Aa2 1)(Aa2 2) . . . (Aa2 n))((Ba2 1)(Ba2 2) . . . (Ba2 n)(a2), . . . ((Aan′ 1)(Aan′ 2) . . . (Aan′ n))((Ban″ 1)(Ban″ 2) . . . (Ban″ n))(an′
), wherein n and n″
are independently an integer from 1 to 10, and n′
is an integer from 2 to 10, and antibodies A and B bind to (n+n″
) different epitopes of a cardiac myocyte antigen; andc) instructions for determining whether the total amount of cardiac myocyte antigens (an′
) in the test sample exceeds a predetermined - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54)
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Specification