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US 5,965,375 AGranted
Diagnostic tests and kits for Clostridium difficile
AssigneeBiosite Diagnostics, Inc.
InventorGunars E. Valkirs
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AssigneeBiosite Diagnostics, Inc.
InventorGunars E. Valkirs
Estimating the term…
This invention provides methods, compositions, and kits for detecting the presence of toxigenic strains of C. difficile in a biological sample. One embodiment provides methods for C. difficile detection that involve assaying for both C. difficile glutamate dehydrogenase and C. difficile toxin A or toxin B. In another embodiment, the invention provides a highly sensitive assay for C. difficile toxin A that is useful for determining whether a C. difficile strain is toxigenic. This embodiment involves binding of toxin A to a moiety that reversibly binds to a capture moiety present on a magnetic bead. A magnetic field is applied to the sample to concentrate the toxin A, after which the magnetic beads are dissociated and removed from the solution to obtain a highly concentrated preparation of toxin A, thus making possible a very sensitive assay.
A kit for use as an aid in the diagnosis of infection by toxigenic C. difficile, wherein the kit comprises an assay for C. difficile glutamate dehydrogenase that comprises:
A kit for detection of C. difficile in a test sample, which kit comprises an assay for detecting C. difficile glutamate dehydrogenase, wherein the assay comprises:
A method to aid in the diagnosis of infection by toxigenic C. difficile, the method comprising:
A method to aid in diagnosing infection by toxigenic C. difficile, the method comprising performing on a test sample an immunoassay for C. difficile glutamate dehydrogenase which has greater clinical sensitivity for detecting infection by toxigenic C. difficile than a cytotoxicity assay for detecting C. difficile toxin B, wherein the presence of glutamate dehydrogenase in the test sample is indicative of infection by toxigenic C. difficile.
A method for detecting C. difficile in a test sample, the method comprising performing an immunoassay for C. difficile glutamate dehydrogenase, wherein the immunoassay can detect about 100 ng or less glutamate dehydrogenase per ml of sample.
Dependencies are inferred from the claim text.