The United States Food and Drug Administration (FDA) on Friday announced that the agency approved the first of its kind rapid response test to detect the Wuhan coronavirus. The agency used an emergency use authorization to fast-track the test's approval. According to the FDA, the test's results are produced roughly 45 minutes after the test is administered.
The company producing the tests, Cepheid, said the test was designed so that the tests could be used in the 5,000 GeneXpert testing systems throughout the country. This means hospitals could receive results at the point-of-care. These systems are automated, do not require specific training and are capable of running 24/7, something hospitals across the nation already do.
"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," Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid said in a statement. "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."
Cepid said the tests will begin shipping next week.
Although these test will be readily available, Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, said asymptomatic people should not be tested for the Wuhan coronavirus. Doing so puts health care workers at greater risk because of the lack of personal protective equipment [PPE].
"Let me tell you about one of the unintended consequences of individuals who don't need to get tested flood the desire to get tested. Currently, and I hope we will be able to change it, and make it much less reliable, PPEs," he explained during Saturday's press conference. "When you go in and get tested, you are consuming personal protective equipment: masks and gowns. Those are high priority for the health care workers who are taking care of people who have coronavirus disease."