Amelioration of Heterophile Antibody Immunosensor Interference
AssigneeAbbott Point of Care Inc.
InventorsJohn Lewis Emerson Campbell, John Emegbero Omakor
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AssigneeAbbott Point of Care Inc.
InventorsJohn Lewis Emerson Campbell, John Emegbero Omakor
Estimating the term…
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.
1-29. (canceled)
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 μg/mL or equivalent fragment concentration and substantially sequestering any heterophile antibodies in said sample.
50-66. (canceled)
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.
Dependencies are inferred from the claim text.