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The ARK Voriconazole II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of voriconazole in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of voriconazole to help ensure appropriate therapy. The assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures. ARK Voriconazole II Calibrator is intended for use in calibration of the ARK Voriconazole II Assay. ARK Voriconazole II Control is an assayed quality control material intended for use in quality control of the ARK Voriconazole II Assay.

The ARK Voriconazole II Assay Test System consists of the ARK Voriconazole II Assay, the ARK Voriconazole II Calibrator, and the ARK Voriconazole II Control. The ARK Voriconazole II Assay consists of: - Reagent R1: rabbit polyclonal antibodies to voriconazole, glucose-6-phosphate, nicotinamide adenine dinucleotide, bovine serum albumin, sodium azide, and stabilizers. - Reagent R2: voriconazole labeled with bacterial G6PDH buffer, bovine serum albumin, sodium azide, and stabilizers. The ARK Voriconazole II Calibrator has six levels and consists of voriconazole, buffer, bovine serum albumin, and sodium azide. The ARK Voriconazole II Control has three levels and consists of voriconazole, buffer, bovine serum albumin, and sodium azide.