Assay kit
AssigneeNovartis AG
InventorsFrançois Legay, Roland Wenger
Life of this patent
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Abstract
A new method of measuring blood levels of immunophilin-binding pharmaceuticals, e.g., cyclosporins, rapamycins, and FK506 compounds is provided, comprising the novel step of displacing the pharmaceutical from its immunophilin by using a binding competitor, thereby eliminating the need for an extraction step and enhancing the simplicity and accuracy of the assay. Assay kits comprising a binding competitor and a receptor, e.g., a monoclonal antibody, which binds to the pharmaceutical but not significantly to the binding competitor are also provided, as are new uses of immunophilin-binding compounds as binding competitors in such assays.
Claims20
A method of determining blood levels of a pharmaceutical compound, at least a portion of which is complexed with an immunophilin to form a pharmaceutical-immunophilin complex, said method comprising:
- a. providing to a sample of the blood a binding competitor which displaces the pharmaceutical compound from the pharmaceutical-immunophilin complex by binding to the immunophilin in said sample,
- b. further providing to the blood sample a receptor which binds the pharmaceutical compound but is unable to significantly bind the binding competitor, whereby the pharmaceutical compound is released from the pharmaceutical-immunophilin complex to form a pharmaceutical-receptor complex capable of detection, and
- c. determining the amount of the pharmaceutical compound in said sample.
An assay kit suitable for detecting the blood level of a pharmaceutical compound at least a portion of which is complexed with an immunophilin to form a pharmaceutical-immunophilin complex, said kit comprising a binding competitor capable of displacing the pharmaceutical from the pharmaceutical-immunophilin complex by binding to the immunophilin in said sample, and a receptor capable of binding the pharmaceutical to cause the pharmaceutical to be released from the pharmaceutical-immunophilin complex and to form a pharmaceutical-receptor complex capable of detection, said receptor being unable to significantly bind the binding competitor.
Dependencies are inferred from the claim text.