USFDA Approves Rapid Diagnostic Test to Detect COVID-19 in 45 Minutes


New Delhi: The US Food and Drug Administration (USFDA) has approved the first diagnostic test that can detect Coronavirus (COVID-19) in just 45 minutes.

The test, made by California-based Cepheid, got emergency clearance from the USFDA on Saturday, eight days after the agency gave fast-track approval for a test by Roche, which can diagnose the novel coronavirus within three hours.

“The US Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test”, a statement issued by the FDA said.

Cepheid, which makes the test, says they can start shipping it next week.

“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. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” said Dr. David Persing, the chief medical and technology officer at Cepheid.

The test is a significant advancement because some patients have complained it took them days to get results.

The experts say faster testing will help alleviate some of the pressure on hospital resources.

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