The element has a chemical detection reagent comprising components such as polypeptide e.g. nicotinamide adenine dinucleotide or nicotinamide adenine dinucleotide phosphate-based glucose dehydrogenase or glucose-6-phosphate dehydrogenase, or coenzyme and optical indicator, which are sensitive against ionized radiation. The element is subjected to sterilization, and the components exist in a functional form after the sterilization at proportion of greater than or equal to 90 percentage with respect to complete quantity of the components in the element before the sterilization. An independent claim is also included for a method for manufacturing a diagnostic element.本発明は、診断用エレメントおよびその製造方法に関する。