WASHINGTON—The United States will begin to see a “spike” in the number of confirmed cases of COVID-19 as the nation ramps up its testing capacity this week, the White House coronavirus response coordinator warned on March 15.
“So you will notice, as these tests roll out over this next week, we will have a spike in our curve,” Dr. Deborah Birx said at a press briefing by the White House Coronavirus Task Force.
“For those of you who watched China and China reporting, remember when they changed their definition and, all of a sudden, there was a blip in their curve? We are going to see that. We are going to see a spike as more and more people have access.”
Birx who joined Trump’s task force in late February said that in the past two weeks, the team has been working closely with commercial labs to ensure that these facilities could step in and provide a much higher volume of testing.
2,000 Labs Come Online
Speaking at the press briefing, Vice President Mike Pence, who leads the coronavirus task force, said state labs and the U.S. Centers for Disease Control and Prevention (CDC) have been using manual tests that allow for 40 to 60 tests a day.However, he said, with the inclusion of commercial labs, the public-private partnership would bring “the high-throughput testing for coronavirus available in real-time.”
Pence said that the FDA already approved high-throughput coronavirus testing for Roche and Thermo Fisher, which would allow more than 2,000 labs across the country to have the testing equipment and begin conducting tests rapidly.
In addition, more than 10 states, including New York, Colorado, Delaware, Washington, and Texas have implemented their own drive-through testing sites where people can get tested.
Most of these sites are using the current manual CDC testing, Pence said, but the new testing regimen will be available soon for these places.
The president declared a national emergency on March 13 to curb the spread of the coronavirus pandemic in the country. The action provides up to $50 billion in disaster relief funds to state and local governments to respond to the outbreak.
Following the declaration of emergency, community-based testing sites outside of usual healthcare facilities will be formed in all 50 states, Pence said.
Speaking at the press briefing, Adm. Brett Giroir, the assistant secretary for health at the Department of Health and Human Services and head of the Public Health Service, said some states are rolling out their own community-based testing.
“They need to be augmented. We believe we’ve created a model, based on the Public Health and the FEMA system, that is optimized, that can be used for drive-through or potentially walk-through,” he said.
Red Tape
Overregulation of diagnostic testing has played a major role in delaying the U.S. response to the coronavirus outbreak, according to experts.The Food and Drug Administration (FDA) has an Emergency Use Authorization (EUA) testing protocol through which it clears tests from labs around the country for use in emergency cases such as outbreaks.
Health experts claimed that in the past outbreaks, EUAs were granted very rapidly. However, this time, the red tape made it so complicated that it took weeks to receive the authorization from the FDA, they said.
Roger Klein, a physician, attorney, and health policy expert, echoed the same concern about red tape.
The Trump administration has taken the right step in providing regulatory relief. However, there is an ongoing legal debate over whether the FDA should regulate lab-developed tests.
“In my view, the hospital laboratories shouldn’t need to apply for EUAs,” Klein said.
“The FDA needs to step aside and let the hospital laboratories go ahead. These are very skilled professionals who know how to set up lab tests, and they need to leave them alone.”
