Amelioration of heterophile antibody immunosensor interference
AssigneeAbbott Point of Care Inc.
InventorsJohn Lewis Emerson Campbell, John Emegbero Omakor
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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.
Claims23
A device for performing an immunoassay of an analyte in a blood sample which is configured to reduce interference from heterophile antibodies, comprising a housing, an electrochemical immunosensor, a sample entry port, a conduit which permits a metered amount of blood sample to pass from the entry port to said immunosensor, and a dry reagent coated on at least one of said housing, said entry port, and said conduit comprising non-human IgM or fragments thereof in an amount sufficient to yield an IgM concentration of at least about 20 μg/mL or equivalent fragment concentration thereof in the metered blood sample in order to provide an amended sample having substantially sequestered heterophile antibodies therein.
A device for performing an immunoassay of an analyte in a blood sample which is configured to reduce interference from heterophile antibodies, comprising a housing, an electrochemical immunosensor, a sample entry port, a conduit which permits a metered amount of blood sample to pass from the entry port to said immunosensor, and a dry reagent coated on at least one of said housing, said entry port, and said conduit comprising non-human IgM or fragments thereof and non-human IgG or fragments thereof at a weight ratio from 0.004 to 4 and in an amount sufficient to yield an IgM concentration of at least about 20 μg/mL or equivalent fragment concentration thereof in the metered blood sample in order to provide an amended sample having substantially sequestered heterophile antibodies therein.
Dependencies are inferred from the claim text.