China's top drug regulator has recently 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 supplies of testing kits.
The two new products, developed by Guangzhou Wondfo Biotech Co Ltd and Beijing Jinwofu Bioengineering Technology Co Ltd, received the approval via an emergency, accelerated track from the National Medical Products Administration on Tuesday, the administration said in a statement released on Thursday.
"It is the first time that China has approved antigen tests for COVID-19," the administration said. "They can rapidly detect positive cases during acute infection periods with high viral loads, and will facilitate early and rapid management of patients."
The antigen tests can deliver results in less than 20 minutes, according to the statement. By comparison, the turnaround time for processing a nucleic acid test sample takes two to four hours.
"Their entry into the market will broaden the types of available COVID testing kits and increase their supplies to better meet demands of disease control," the administration said.
However, it also noted that antigen tests alone cannot be used to confirm diagnoses of COVID-19 infection. "Antigen test results should be evaluated along with nucleic acid test results, CT imaging, epidemiologic history before making a diagnosis," the administration said.
All people who have taken antigen tests should also receive nucleic acid tests later regardless of their antigen test results, the administration added.
As of recently, the administration has granted market approvals to 24 nucleic acid tests, 25 antibody tests and two antigen tests.