Clinical chemistry therapeutic drug monitoring IVDs

Intended purpose

An enzyme-linked immunosorbent assay (ELISA) or its assayed quality control for the quantitative determination of drug levels in human serum samples. The amount of drug, when considered in conjunction with the anti-drug antibodies and clinical findings, like disease activity, contributes valuable information to the physician to assess the efficacy of therapies with the drugs, predict infusion-related reactions and loss of clinical response by the patient.