Test results can be obtained as early as 45 minutes after the test. The U.S. Food and Drug Administration (FDA) has approved the first coronavirus rapid diagnostic test, which can be obtained after 45 minutes. This was announced on Saturday by the developer of the test – the California-based company Cepheid, engaged in the development of molecular diagnostics.
A Cepheid statement said the company received permission from the FDA to conduct emergency tests, which will be used primarily in hospitals and emergency rooms. The company plans to begin shipping tests to hospitals next week.
Previously developed testing technologies did not allow reaching such a fast time for virus detection. At the moment, all samples of the taken tests are sent to a centralized laboratory, and waiting for the results may take several days.
According to a company spokesperson, a diagnostic test for the virus that causes COVID-19 has been developed to work on any of the more than 23,000 GeneXpert Cepheid automated systems installed in medical laboratories around the world.
According to Cepheid President Warren Cokmond, systems are capable of working around the clock. Laboratory assistants do not need to undergo special training for testing, since the technology is quite simple.
The cost of the test kit is still unknown.
The FDA is an agency within the US Department of Health and Human Services. The department is involved in quality control of food products, pharmaceuticals, cosmetics, tobacco products and some other categories of goods, and also monitors compliance with legislation and standards in this area.