The US Food and Drug Administration (USFDA) has approved the first rapid diagnostic test that would reduce detection time of the novel coronavirus to 45 minutes.
FDA has granted Emergency Use Authorization (EUA) for molecular diagnostics company Cepheid's point-of-care COVID-19 diagnostic, Xpert Xpress SARS-CoV-2.
Under existing testing regime in the US, samples of swab from the back of a person's nose will be tested at a centralised lab, which might take several days. The newly approved test kit can be used to test the swab locally.
The decision has come as a great relief after medical experts cautioned about delays and chaotic testing that would endanger lives, including that of medicos fighting Covid-19.
Confirming this Cepheid, a Silicon Valley company, said it will be used primarily in hospitals and emergency rooms. The company plans to begin shipping next week so that it can roll out the availability of its testing by March 30. The FDA has been pushing to expand screening capacity for the virus.
The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said.
“During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said Dr David Persing, chief medical and technology officer at the California-based Cepheid.
The systems do not require users to have special training to perform testing, and are capable of running around the clock, Cepheid President Warren Kocmond said in the statement. However, the company has not revealed details like cost of the test.
