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  • Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum, plasma) to measure levels of one or more immunosuppressive agents (i.e., agents that suppress immune function by one of several mechanisms of action) in the sample. These reagents are used to measure the immunosuppressant levels in patients undergoing treatment to determine the adequacy of drug treatment (i.e., therapeutic drug monitoring) or to diagnose a drug overdose or drug-related toxicity. Therapeutic drug monitoring plays a key role in helping clinicians maintain immunosuppressants within therapeutic ranges in blood due to the narrow therapeutic index unique to each patient and to the variable absorption, distribution, and elimination that is characteristic of these agents.
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