Applications and regulatory of nanotechnology‐based innovative <i>in vitro</i> diagnostics
Kuan Chen, Houyu Han, Ruslan G. Tuguntaev, Peirong Wang, Weisheng Guo, Jiayu Huang, Xiaoqun Gong, Xing‐Jie Liang
Abstract
Abstract Nanotechnology‐based in vitro diagnostics (nanoIVDs) are widely studied for disease diagnostics with promising sensitivity, specificity, and convenience. However, it is still a major challenge for both regulatory authorities and scientific researchers to accelerate the clinical translation of such an innovative technology. Herein, this perspective discussed the benefits and challenges of nanoIVDs as well as the administration considerations on the distinguish features of nanoIVDs by regulatory authorities, so as to further achieve the evaluation, translation, and application of nanoIVD products.
Topics & Concepts
NanotechnologyRegulatory scienceRisk analysis (engineering)Engineering ethicsComputer scienceEngineeringBusinessMedicineMaterials sciencePathologyAdvanced biosensing and bioanalysis techniquesBiosensors and Analytical DetectionGold and Silver Nanoparticles Synthesis and Applications