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US 8,574,855 B2Granted
Assays for the detection of anti-TNF drugs and autoantibodies
AssigneeNestec S.A.
InventorsSharat Singh, Shui Long Wang, Linda Ohrmund
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Abstract
The present invention provides assays for detecting and measuring the presence or level of anti-TNFα drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNFα drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.
Claims20
A method for determining the presence or level of an anti-TNFα drug in a sample, the method comprising:
- (a) contacting a labeled TNFα with a sample having an anti-TNFα drug to form a labeled complex with the anti-TNFα drug;
- (b) subjecting the labeled complex to size exclusion chromatography to separate the labeled complex from free labeled TNFα and to detect an amount of the labeled complex and an amount of the free labeled TNFα;
- and
- (c) comparing the amount of the labeled complex and the amount of the free labeled TNFα detected in step (b) to a standard curve of known amounts of the anti-TNFα drug, thereby determining the presence or level of the anti-TNFα drug.
1 more element
A method for determining the presence or level of an autoantibody to an anti-TNFα drug in a sample, the method comprising:
- (a) contacting a labeled anti-TNFα drug with the sample to form a labeled complex with the autoantibody;
- (b) subjecting the labeled complex to size exclusion chromatography to separate the labeled complex from free labeled anti-TNFα drug and to detect an amount of the labeled complex and an amount of the free labeled anti-TNFα drug;
- and
- (c) comparing the amount of the labeled complex and the amount of the free labeled anti-TNFα drug detected in step (b) to a standard curve of known amounts of the autoantibody, thereby determining the presence or level of the autoantibody.
1 more element
Dependencies are inferred from the claim text.