COVID antigen tests approved
新冠抗原测试试剂获批
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.
国家药监局日前批准了两个新冠肺炎病毒抗原测试试剂，商品测试时间在20分钟之内，可用于对疑似人群进行迅速管理，提升测试能力。
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.
抗原测试的工作原理是测试病毒表面的蛋白质，比现在广泛应用的核酸测试价格要实惠、出结果更快，但准确度不如核酸测试。核酸测试的工作原理是在样本中测试病毒的基因痕迹。
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测试试剂由广州万孚生物技术股份公司和北京金沃夫生物工程科技公司生产，这是国内初次批准新冠肺炎病毒抗原测试试剂。
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，抗原测试不可以单独用于新型冠状病毒感染的诊断，应结合核酸测试、影像学、时尚病学史来判断感染状况。
