Press "Enter" to skip to content

FDA Head: ‘Millions’ of COVID-19 Tests on the Way

WASHINGTON — The CDC has shipped enough COVID-19 test kits to U.S. public health labs to test about 75,000 people, according to the FDA commissioner.

Another 2.1 million tests for COVID-19 will be sent to commercial labs by Monday, which is enough to test 850,000 people, said Stephen Hahn, MD, during an off-camera White House press briefing Saturday, adding that manufacturers have told him that they can ramp up production and ship 4 million more tests by the end of next week.

“The actual number of tests that have shipped is larger than the number of patients that can be tested,” he clarified in prepared remarks.

“As the President, Vice President, and Secretary have promised, we are committed to being transparent about this situation,” the commissioner stated. “What’s important here is that we have a test that the American people can trust.”

‘Anybody That Wants a Test Can Get a Test’

The weekend press briefing came after widespread criticism of how the Trump administration is handling the outbreak, including communication snafus and mounting concerns over access to tests, as MedPage Today, the Associated Press, and other media have reported.

During a visit to the CDC Friday, President Trump told reporters that “Anybody that wants a test can get a test,” according to USA Today.

But many states have implemented strict testing criteria in order to avoid flooding their labs, according to the Washington Post.

In his prepared remarks, Hahn argued that the outbreak is “dynamic and constantly evolving,” which has created “some confusion about the quantity of diagnostic tests available and how many patients can be tested.”

Hahn acknowledged that there were were initially manufacturing problems with the CDC’s test that have been resolved. However, those issues created downstream complications for developers, some of whom were relying on the CDC test to serve as the basis for their own, he said.

In late February, the FDA issued a new policy to ease regulatory burdens for labs that want to develop their own tests as a means of scaling testing capacity.

Also at a late February House committee hearing, CDC Director Robert Redfield, MD, said the agency broadened COVID-19 testing criteria.

As of March 7, the CDC has tested 1,583 people since the first cases were discovered, Hahn stated. Additionally, between the CDC and public health labs, 5,861 tests have been completed as of March 6, but officials at the briefing could not provide the total number of patients tested by both the agency and outside labs, according to The Hill.

By comparison, South Korea, which has implemented drive-thru testing, has the capacity to test 15,o00 people daily, according to VOA News. In the U.K, approximately 21,460 people have been tested, and 206 have been confirmed positive, British health officials told CNN.

Hahn said the number of tests any individual lab can process daily will “vary widely,” depending on the size of the lab. Some states have raised concerns over a shortage of lab technicians, according to Wisconsin’s WKOW.

There are currently 335,700 medical and clinical laboratory technologists and technicians in the country, according to 2016 data from the American Society for Clinical Laboratory Science, with the highest “vacancy rates” in the Northeast.

More Cases and Counting

According to early Sunday morning figures from the New York Times, 19 people in the U.S. have died from novel coronavirus — 16 in Washington state, one in California, and two in Florida. The total number of individuals confirmed to have the virus has risen to over 400.

Off the California coast, 21 people tested positive for COVID-19 aboard the Grand Princess cruise ship, including 19 crew members and two passengers. But only a small fraction of the over 3,500 on the ship have been tested. The ship is expected to dock on Monday in Oakland, California, according to Huffington Post.

The Department of Health and Human Services announced Sunday that these passengers “will be transferred to federal military installations for medical screening, COVID-19 testing, and a 14-day quarantine. Nearly 1,000 passengers who are California residents will complete the mandatory quarantine at Travis Air Force Base and Miramar Naval Air Station, and residents of other states will complete the mandatory quarantine at Joint Base San Antonio Lackland in Texas or Dobbins Air Force Base in Georgia.”

At a Friday press briefing, Vice President Mike Pence said all passengers and crew would be tested for coronavirus. “Those that need to be quarantined will be quarantined. Those that require additional medical attention will receive it,” he said.

In New York, Gov. Andrew Cuomo declared a state of emergency on Saturday after 76 people in his state tested positive.

Washington, D.C. Mayor Muriel Bowser announced the first “presumptive” positive case of coronavirus in the nation’s capital on Saturday evening — a man in his 50s who has been hospitalized due to the condition — and that the man was not believed to have traveled outside the U.S., nor was he in close contact with anyone else infected, the Washington Post reported.

The American Conservative Union (ACU) announced Saturday that an attendee of the Conservative Political Action Conference (CPAC), in National Harbor, Maryland, in late February tested positive for novel coronavirus, according to Axios. Trump and Pence attended the meeting but the ACU said that the attendee had “no interaction” with either.

Asked Saturday if he was worried that the virus was inching closer to the White House, Trump said “I’m not concerned at all.” But on Friday, the White House tightened its visitor rules because of coronavirus concerns, according to CBS News.

International Update

Italy has placed Lombardy, and 14 other central and northern provinces, under quarantine because of new cases, and a total of 16 million people are considered under quarantine, according to the BBC. Milan and Venice are both affected by the quarantine.

The number of cases in Italy spiked by 1,200 in 24 hours, to 5,883 on Saturday and more than 230 people have died, with 36 of those deaths occurring in 24 hours, the BBC said.

In southeastern China, a hotel housing people under quarantine collapsed, trapping 71 people, 10 of whom have died. Another 48 have been removed from the collapsed building and 23 have not been accounted for, CNN reported.

Egypt has confirmed 33 new cases of COVID-19 on a Nile River Cruise Ship; 12 cases were reported a day earlier, raising the total number to 45, according to The Guardian.

In Iran, 49 new deaths were reported in 24 hours, raising the total number of deaths in the country to 194. The number of infections also jumped from 743 to 6,566 cases, according to Al Jazeera.

Molly Walker, Associate Editor at MedPage Today, contributed to this article.

Last Updated March 08, 2020