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Wondfo COVID-19 Antigen Test, BfArM Approval for Self Use
April 09,2021 (Edit) Wondfo

Wondfo 2019-nCov antigen test has received special approval from the German Federal Institute for Drugs and Medical Devices (BfArM) according to §11 paragraph 1 of the German Medical Devices Act (MPG) of antigen tests for self-administration by laypersons for the detection of coronavirus.




(Source: https://www.bfarm.de/DE/Medizinprodukte/Antigentests/_node.html;jsessionid=82E1F52304C19AE9BB214FA34B455616.1_cid329)

Adhering to the philosophy of “Racing for Life”, Wondfo has been continuously working to satisfy the global demand for rapid tests in the prevention and control of pandemics worldwide. Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) which is performed with a swab sample from the nasal cavity delivers results in 15 minutes, significantly shortening the detection time, comparing to the PCR method. The test can be used by laypeople with the help of the instructions for use and gives users high flexibility with very good quality results.

German Health Minister Jens Spahn said the approval of COVID-19 antigen tests for self-administration allows larger population to get tested. The early identification of asymptomatic individuals can efficiently break the chain of infection, stopping the spread of infection. Under this strategy, a positive at-home test result should be then subjected to a laboratory nucleic acid test. At present in Germany, individuals are required to get tested at home twice a week, increased from once a week earlier. In the key populations, as often as five times a week is required.

As the only company that holds both certificates of the 2019-nCoV antigen test and the 2019-nCoV antibody test, Wondfo is committed to making contributions to the global battle against the pandemics. Wondfo’s multiple COVID-19 tests have achieved CE mark approval and been validated by the importer's country according to the local standards and regulations. Wondfo is now providing a “PCR+ Antigen+ Antibody” integrated solution that meets various application scenarios of on-spot diagnosis of COVID-19 infection.

About Wondfo

Wondfo, a POCT leader in China, now owns multiple advanced technology platforms including immune colloidal gold, immunofluorescence, electrochemistry, dry biochemistry, chemiluminescence, molecular diagnostics, pathology, etc.

Based on the above technology platforms, Wondfo has extended the product lines to the rapid identification of cardiovascular diseases, inflammation, tumor, infectious diseases, drug abuse, pregnancy, etc. 

The products are widely used in clinical laboratory diagnosis, primary care, the effective management of critical and severe diseases, pandemics prevention and control, forensic expertise, personal healthcare, and other fields, widely sold to 140+ countries and regions.