Amelioration of heterophile antibody immunosensor interference
First Claim
1. A method of reducing interference from heterophile antibodies in an analyte immunoassay, comprising:
- (a) contacting a whole blood sample with a dry reagent comprising non-human IgM or fragments thereof to yield an amended sample having a non-human IgM concentration of at least 20 μ
g/mL or equivalent fragment concentration; and
(b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample, wherein the amended sample has sufficiently sequestered heterophile antibodies therein.
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Accused Products
Abstract
The invention is directed to methods and devices for reducing interference from heterophile antibodies in an analyte immunoassay. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with non-human IgM or fragments thereof by dissolving into said sample a dry reagent to yield a non-human IgM concentration of at least about 20 μg/mL or equivalent fragment concentration; and (b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG or fragments thereof in addition to the IgM of fragments thereof.
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Citations
46 Claims
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1. A method of reducing interference from heterophile antibodies in an analyte immunoassay, comprising:
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(a) contacting a whole blood sample with a dry reagent comprising non-human IgM or fragments thereof to yield an amended sample having a non-human IgM concentration of at least 20 μ
g/mL or equivalent fragment concentration; and(b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample, wherein the amended sample has sufficiently sequestered heterophile antibodies therein. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method of reducing interference from heterophile antibodies in a cardiac troponin I immunoassay, comprising:
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(a) contacting a whole blood sample with a mixture comprising;
(i) non-human IgG or IgG fragments, and (ii) non-human IgM or IgM fragments, to yield an amended sample having a non-human IgM concentration of at least about 20 μ
g/mL or equivalent IgM fragment concentration; and(b) performing an electrochemical immunoassay on the amended sample wherein the amended sample has sufficiently sequestered antibodies therein.
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29. A method of reducing interference from heterophile antibodies in a brain natriuretic peptide immunoassay, comprising:
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(a) contacting a sample with a mixture comprising;
(i) non-human IgG or IgG fragments, and (ii) non-human IgM or IgM fragments to yield an amended sample having a non-human IgM concentration of at least about 20 ug/mL or equivalent IgM fragment concentration; and(b) performing an electrochemical immunoassay on the amended sample, wherein the amended sample has sufficiently sequestered heterophile antibodies therein.
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30. A method of reducing interference from heterophile antibodies in an analyte immunoassay comprising:
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(a) contacting a biological sample with IgM or fragments thereof and optionally IgG or fragments thereof to yield an amended sample having a non-human IgM concentration of at least about 20 μ
g/mL or equivalent fragment concentration; and(b) performing an immunoassay on the amended sample to determine the concentration of said analyte in said sample, the amended sample having sufficiently sequestered heterophile antibodies therein. - View Dependent Claims (31, 32, 33, 34, 35, 36)
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37. A method of reducing heterophile antibody interference in an analyte immunoassay device, comprising:
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(a) adding IgM or fragments thereof and IgG or fragments thereof to a biological sample in an amount sufficient to substantially sequester any heterophile antibodies in said sample and forming an amended sample, wherein the IgM or fragments thereof and the IgG or fragments thereof are added at a weight ratio greater than 0.004; and (b) performing an electrochemical immunoassay on said amended sample to determine the concentration of the analyte in said amended sample. - View Dependent Claims (38, 39, 40, 41, 42, 43, 44, 45, 46)
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Specification