中美COVID-19体外诊断产品对比分析

Comparative analysis of COVID-19 in vitro diagnostic products between China and USA

本文梳理了2020年中美两国批准上市的新型冠状病毒肺炎(COVID-19)体外诊断产品情况,对比分析了两国产品在上市趋势、来源、类别、检测样本、检测靶标和检测方法方面的异同,并据此展望了COVID-19体外诊断技术未来的发展方向,旨在为我国体外诊断产品的发展提供有益参考。

This paper reviews COVID-19 in vitro diagnosis products approved by China and the United States in 2020,analyzes the similarities and differences between the two countries in marketing trends,sources,categories,test samples,detection targets and detection methods,and looks forward to the future development direction of COVID-19 in vitro diagnosis technology.The purpose of this paper is to provide a useful reference for the development of epidemic prevention and control and in vitro diagnosis in China.