First antigen based COVID-19 test approved by US FDA
The test results can be obtained within 45 minutes after the test
The US Food and Drug Administration (FDA) has approved the first rapid diagnostic test for coronavirus, the results of which can be obtained in 45 minutes. This was announced on Saturday by the developer of the test – the Californian company Cepheid, which is developing in the field of molecular diagnostics..
In a statement, Cepheid said the company received FDA approval for emergency tests, which will be used primarily in hospitals and emergency departments. The company plans to start shipping tests to hospitals next week.
Previously developed testing technologies did not allow achieving such a fast virus detection time. At the moment, all samples of taken tests are sent to a centralized laboratory, and it may take several days to wait for the results..
The diagnostic test for the virus that causes COVID-19 has been designed to work on any of the more than 23,000 GeneXpert Cepheid automated systems installed in medical laboratories around the world, according to a company spokesman..
Cepheid President Warren Cockmond says the systems are capable of running around the clock.. Laboratory technicians do not need to undergo special training to conduct testing, since the technology is quite simple.
The cost of the test kit is still unknown.
The FDA is an agency within the United States Department of Health and Human Services. The department is engaged in quality control of food products, medicines, cosmetics, tobacco products and some other categories of goods, and also monitors compliance with legislation and standards in this area..
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