AMELIORATION OF HETEROPHILE ANTIBODY IMMUNOSENSOR INTERFERENCE
First Claim
1. A method of reducing interference from heterophile antibodies in an analyte immunoassay, comprising:
- (a) amending 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 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.
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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
69 Claims
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1. A method of reducing interference from heterophile antibodies in an analyte immunoassay, comprising:
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(a) amending 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 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. - 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) amending a whole blood sample with a mixture comprising;
(i) non-human IgG or IgG fragments, and (ii) non-human IgM or IgM fragments, sufficient to substantially sequester any heterophile antibodies in said sample, wherein the non-human IgM concentration in the amended sample is at least about 20 μ
g/mL or equivalent IgM fragment concentration; and(b) performing an electrochemical immunoassay on the amended sample.
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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) amending a sample with a mixture comprising;
(i) non-human IgG or IgG fragments, and (ii) non-human IgM or IgM fragments, sufficient to substantially sequester any heterophile antibodies in said sample, wherein the non-human IgM concentration in the amended sample is at least about 20 μ
g/mL or equivalent IgM fragment concentration; and(b) performing an electrochemical immunoassay on the amended sample.
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30. A device for performing an immunoassay of an analyte in a blood sample with reduced interference from heterophile antibodies, comprising a housing, an electrochemical immunosensor, a conduit and a sample entry port, wherein said conduit permits a blood sample to pass from the entry port to said immunosensor, and wherein at least one of said housing, said entry port, and said conduit includes a dry reagent comprising non-human IgM or fragments thereof and optionally IgG or fragments thereof, said dry reagent being capable of dissolving into said blood sample to yield an IgM concentration of at least about 20 μ
- g/mL or equivalent fragment concentration and substantially sequestering any heterophile antibodies in said sample.
- View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. A method of reducing interference from heterophile antibodies in an analyte immunoassay comprising:
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(a) amending a biological sample with IgM or fragments thereof and optionally IgG or fragments thereof to yield 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. - View Dependent Claims (51, 52, 53, 54, 55, 56)
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57. 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 (58, 59, 60, 61, 62, 63, 64, 65, 66)
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- 67. A device for performing an immunoassay of an analyte in a blood sample with reduced interference from heterophile antibodies, comprising a housing, an electrochemical immunosensor, a conduit and a sample entry port, wherein said conduit permits a blood sample to pass from the entry port to said immunosensor, and wherein at least one of said housing, said entry port, and said conduit includes a dry reagent comprising non-human IgM or fragments thereof and IgG or fragments thereof at a weight ratio greater than 0.004.
Specification