The FDA authorizes a fully at-home test as more Covid-19 patients are hospitalized than ever before

By Holly Yan, Steve Almasy and Christina Maxouris, CNN

The US Food and Drug Administration gave emergency authorisation Tuesday for the first Covid-19 test that can be fully taken at home.

Other at-home tests require a prescription or require people to send test samples to a lab to get results. But the Covid-19 home test developed by Australian company Ellume is sold over-the-counter and produces results that can be read at home.

“Today’s authorisation is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Dr Stephen Hahn said in a written statement. “By authorising a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”

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The test uses an analyser that connects with a software application on a smartphone to help users perform the test and interpret results, the FDA said.

The Ellume test is an antigen test that “correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms,” the FDA said.

In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples, the FDA said.

Testing Americans is an important issue, Dr. Sanjay Gupta, CNN chief medical correspondent, said.

“This is one of the untold or under-told sort of issues of this entire (pandemic),” he said. “I think it would be a big deal if they could produce enough of these tests to get them in most, if not all, households in America.”

Being tested on a regular basis with rapid results could help inform people when to stay home or go out, he said.

“That type of testing is critically important, has been critically important and will remain critically important,” he added.

Because the test is not perfect, people who get a negative result should still presume they may be infected and act accordingly — wearing a mask and keeping away from others.

Ellume expects to produce more than 3 million tests in January. When it applied for emergency use authorization, the company said it would charge $30 for the test.

Shutdown decisions on the minds of officials

As doctors and nurses across the nation roll up their sleeves to get vaccinated, governors and mayors are having to consider implementing stricter health measures to blunt the impact of the virus before inoculations become widespread.

New York Mayor Bill de Blasio told CNN on Tuesday that while it’s up to the state’s governor, he would recommend tight stay-at-home orders for the holidays.

“We’ve seen the numbers go up. We are concerned about our hospitals, protecting the ability of hospitals to serve people. Clearly we are going to need a pause, we’re going to need a shutdown,” he said. “And I think the sooner the better.”

The Mayor has said after Christmas might be a good time for a shutdown but on Tuesday, de Blasio said if Gov. Andrew Cuomo wants to shutdown sooner, he would agree with that.

De Blasio said a shutdown should last between two and four weeks, because that’s the amount of time it takes before the effects of a shutdown can be measured.

Many people are worried about the financial impacts of mandates. This week, the city shut down indoor dining for two weeks, something that is going to affect the bottom line of restaurants.

“We have pivoted, we’ve changed, we’ve opened, we’ve done everything that has been asked,” said Melba Wilson, owner of Melba’s Restaurant in Harlem and the president of the New York City Hospitality Alliance. “I don’t know that we can come back from this,” she added.

California is in the middle of stay-at-home orders in the most populated regions of the state based on ICU capacity. Cases, deaths and hospitalizations continue to rise and the number of ICU beds available continues to fall.

Boston just moved to more restrictive measures on public activities, limiting gathering size. Indoor dining is limited to 90 minutes, according to Mayor Marty Walsh.

“I want to be clear, this is not about targeting specific sectors, this is an effort to reduce overall activity outside the home, he said. If the upward trend doesn’t slow or reverse, it will be a very difficult winter, he told reporters.

– HERALD