The Food and Drug Administration (FDA) has approved a coronavirus test that can provide a diagnosis of COVID-19 in as little as 45 minutes. The test, conducted by Cepheid, a California-based molecular diagnostics company, obtained emergency clearance on Saturday, eight days after the agency quickly cleared a Roche test, which can diagnose the new coronavirus in three hours.
The turnaround time on test results so far ranges from 24 hours to four days, which is clearly unacceptable. If cases of the disease are not quickly identified and community spread continues uncontrolled, we would find a medical system overwhelmed by outbreaks , just as it happened in Wuhan, China.
The tests will begin shipping this week , according to a statement from Cepheid, which makes the new tests.
“During this time of increased demand for hospital services, physicians urgently need a real-time diagnostic test to treat patients who are being evaluated for admission to health centers,” said David Persing, chief medical and technology officer for Cepheid.
The company has not disclosed how much the tests will cost.
“An accurate test close to the patient can make a difference and help ease the pressure that the emergence of the COVID-19 outbreak has placed on healthcare facilities that need to properly allocate their respiratory isolation resources,” Persing added.
The diagnostic test has been designed to work on any of Cepheid’s 23,000 GeneXpert Systems automated systems worldwide.
This announcement of a much more efficient coronavirus test occurs when the medical community was seeking precisely to obtain faster results to stop the wave of infections in recent days in many countries on the planet such as the United States, Italy or Spain.
However, it is likely that at this time the tests are only used in a hospital setting , where the patient is already in an emergency room or a hospital triage ward and needs a rapid diagnosis, not for people concerned about their condition that they go to the doctor’s office.
In part, this is because Cepheid’s production capacity is limited ; It can produce millions of tests in the next few weeks, but not every week.
The United States and Spain are two of the examples that have been affected by a serious shortage of tests , which allowed the new coronavirus SARS-CoV-2 to spread undetected for weeks. Furthermore, in the US, the test kits initially shipped by the Centers for Disease Control and Prevention were defective, and for weeks the government prohibited local labs from developing their own kits, prompting the country have seen an unstoppable rise in contagion cases in recent weeks (the global shortage of essential chemicals needed for testing didn’t help either).
Meanwhile, the World Health Organization has called for “order and discipline” in the market for the health equipment necessary to combat the outbreak.
As we’ve discussed, the new Cepheid test will ship to hospitals this week, but the FDA’s emergency clearance means it will be usable in all hospital care settings.
