| 摘要 |
A method for determining the presence or level of an autoantibody to a therapeutic antibody for treating an autoimmune disease in a sample comprises (a) contacting a labelled therapeutic antibody with the sample to form a labelled complex with the autoantibody; (b) subjecting the labelled complex to size exclusion chromatography to separate the labelled complex from free labelled therapeutic antibody and to detect an amount of the labelled complex and an amount of the free labelled therapeutic antibody; and (c) comparing the amount of the labelled complex and the amount of the free labelled therapeutic antibody detected in step (b) to a standard curve of known amounts of the autoantibody, thereby determining the presence or level of the autoantibody. |
