新冠抗原檢測試劑獲批大綱

COVID antigen tests approved
新冠抗原檢測試劑獲批

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.
國家藥監局近日批准了兩個新冠病毒抗原檢測試劑，產品檢測時間在20分鐘之內，可用於對疑似人羣進行快速管理，提高檢測能力。

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.
抗原檢測的工作原理是檢測病毒表面的蛋白質，比目前廣泛應用的核酸檢測價格要便宜、出結果更快，但準確度不如核酸檢測。核酸檢測的工作原理是在樣本中檢測病毒的基因痕跡。

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.
國家藥監局11月5日在聲明中表示，新批准的這兩個抗原檢測試劑由廣州萬孚生物技術股份有限公司和北京金沃夫生物工程科技有限公司生產，這是我國首次批准新冠病毒抗原檢測試劑。

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.
但國家藥監局提示，抗原檢測不能單獨用於新型冠狀病毒感染的診斷，應結合核酸檢測、影像學、流行病學史來判斷感染狀態。