新冠抗原检测试剂获批

COVID antigen tests approved

新冠抗原检测试剂获批

China's top drug regulator has approved two antigen tests for COVID-19 that can produce results within 20 minutes, aimed at expediting management of suspected cases of the virus and boosting testing capacity.

国家药监局近日批准了两个新冠病毒抗原检测试剂，产品检测时间在20分钟之内，可用于对疑似人群进行快速管理，提高检测能力。

Antigen tests, which detect proteins on the surface of the virus, are considered cheaper and faster, but less accurate than the widely used nucleic acid tests, which look for genetic traces of the virus in samples.

抗原检测的工作原理是检测病毒表面的蛋白质，比目前广泛应用的核酸检测价格要便宜、出结果更快，但准确度不如核酸检测。核酸检测的工作原理是在样本中检测病毒的基因痕迹。

The newly approved tests, developed by Guangzhou Wondfo Biotech Co and Beijing Jinwofu Bioengineering Technology Co, are the first antigen tests for COVID-19 to be approved by the National Medical Products Administration, it said in a statement released on Thursday.

国家药监局11月5日在声明中表示，新批准的这两个抗原检测试剂由广州万孚生物技术股份有限公司和北京金沃夫生物工程科技有限公司生产，这是我国首次批准新冠病毒抗原检测试剂。

The administration noted, however, that antigen tests alone cannot be used to confirm COVID-19 infection. "Antigen test results should be evaluated along with nucleic acid test results, CT imaging and epidemiologic history before making a diagnosis," it said.

但国家药监局提示，抗原检测不能单独用于新型冠状病毒感染的诊断，应结合核酸检测、影像学、流行病学史来判断感染状态。