Germany grants special approval for first COVID-19 self-test kits
BERLIN - The German Federal Institute for Drugs and Medical Devices (BfArM) granted special approval for three antigen self-test kits for the detection of SARS-CoV-2 on Wednesday.
Minister of Health Jens Spahn announced the approval in an interview with the German public broadcaster ZDF. "Testing is an opportunity now even in this difficult phase of the pandemic," said Spahn.
The self-test kits would go on sale in stores such as discounters throughout Germany in the coming days, according to Spahn.
According to the BfArM, the manufacturers of the approved kits are U.S. company Healgen Scientific LLC and the Chinese companies Xiamen Boson Biotech Co., Ltd and Hangzhou Laihe Biotech Ltd., Co.
The BfArM pointed out that with their application for special authorization, the manufacturers had to demonstrate that their products met Germany's relevant safety and performance requirements and the applicable technical standards.
So far, rapid tests for the detection of coronavirus infection had to be conducted by medically trained staff. The German government plans to make the newly approved kits available to all citizens free of charge from early March onwards in doctors' offices and pharmacies.
Germany's COVID-19 cabinet stressed last Monday that rapid tests were an important means to allow an easing of the lockdown in Germany. The country remains in a COVID-19 lockdown, which will last until at least March 7. Strict contact restrictions apply, and non-essential shops, restaurants and leisure facilities are closed.
On Wednesday, the Robert Koch Institute (RKI) reported rising infection numbers again as 8,007 new COVID-19 cases were registered within one day, slightly above the previous week's level. To date, more than 2.4 million COVID-19 infections have been officially registered in Germany since the outbreak of the pandemic.
In 24 hours, 422 coronavirus-related deaths were registered in the country, bringing the cumulative death toll to 68,740.
