Ideas about Registration for Prenatal Diagnosis of Chromosome Aneuploidy by Next Generation Sequencing Technology / 中国医疗器械杂志

To review the registration and technical data for prenatal diagnosis of chromosome aneuploidy by next generation sequencing technology. On the basis of introducing declarations of the reagents, analysis registration dossier common problems. And analysis the requirement of performance evaluation, reference intervals and clinical evaluation study.

Discussion on Current Registration Situation and Problems of in Vitro Diagnostic Device of Tumor Marker / 中国医疗器械杂志

This paper aims to analysis of the general problem in the registration dossier and make recommendations on in vitro diagnostic device of tumor markers. On the basis of introducing declarations of the reagents, analysis registration dossier common problems occurs in the products intend to detect novel tumor markers and the combined detection product for multiple tumor markers, and analysis the special requirements for such products.

Achievement and progress of dynamic culture conditions on the construction of engineered blood vessel substitutes / 生物医学工程学杂志

Dynamic culture conditions serve as a critical factor in constructing physiologically functional blood vessel substitutes. With the development of tissue engineering, many experiments have verified the hypothesis that proper dynamic conditions are important for cells' behaving ways such as attachment, proliferation, differentiation and the remodeling of the extracellular matrix. By means of simulating the physiological dynamic conditions, one can enhance cell growth and extracellular matrix remodeling, and further improve the function of engineered vessel. In this paper is reviewed the current state of dynamic culture conditions provided for tissue engineering vessel graft, including the effects of different dynamic culture conditions on the proliferation of vascular cells and the remodeling of extracellular matrix. The use of bioreactor in constructing tissue engineering blood vessels and the effects of dynamic culture environments are also discussed with respect to the biological properties of vascular grafts.