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The MyCare Psychiatry Clozapine Assay Kit is intended for the in vitro quantitative measurement of clozapine in adult human serum using automated clinical chemistry analyzers. Measurements obtained can be used to aid in the management of individuals prescribed clozapine for treatment-resistant schizophrenia. This assay should be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make treatment decisions.

The MyCare Psychiatry Clozapine Assay Kit is a homogenous two reagent nanoparticle agglutination assay used for detection of clozapine in human serum. It is based on competition between drug and drug-conjugates for binding to drug-specific antibodies covalently bound to nanoparticles. The extent of particle aggregation can be followed spectrophotometrically on clinical chemistry analyzers. This aggregation is measured at a wavelength of around (b)(4) by automated clinical chemistry analyzers. The assay contains: - Reagent 1 (R1) reaction buffer that contains drug-conjugate in a buffered protein . solution - . Reagent 2 (R2) - nanoparticle reagent that contains clozapine-specific monoclonal antibody bound to nanoparticles in a buffered solution