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The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish at home, paving a potential path for more widespread testing outside of health care settings.
The test, developed by the California-based company Lucira Health, requires a prescription from a health care provider. People under the age of 14 also cannot perform the test on themselves. But with a relatively simple nasal swab, the test can return results in about half an hour, and is projected by the company to cost $50 or less, according to the product’s website. Clinicians can also run the test on patients, including children under the age of 14, potentially delivering answers during a single visit to a care center or pharmacy, instead of routing a tough-to-collect sample through a lab.
A handful of other tests have been cleared by the F.D.A. for at-home collection of samples, which are then shipped to a lab for processing. But Lucira’s test is the first to remove the need for an intermediary.
“Today’s authorization for a complete at-home test is a significant step toward F.D.A.’s nationwide response to Covid-19,” Jeff Shuren, director of F.D.A.’s Center for Devices and Radiological Health, said in a statement. “Now, more Americans who may have Covid-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”
People who test positive for the coronavirus are expected to isolate themselves from others for 10 days from the day their symptoms started, or the day they tested positive, per guidelines from the Centers for Disease Control and Prevention.
Laboratory tests that look for the coronavirus’s genetic material using a technique called polymerase chain reaction, or P.C.R., are still considered the gold standard for detecting the virus. But the new at-home test relies on similar principles by using a method called a loop mediated amplification reaction, or LAMP. Like P.C.R., LAMP repeatedly copies genetic material until it reaches detectable levels, making it possible to identify the virus even when it is present at only very low levels in the respiratory tract. While faster and less cumbersome than P.C.R., LAMP is generally thought to be less accurate.
People taking the battery-powered test must swirl a swab in both of their nostrils, then dip and stir the swab into a vial of chemicals. That vial is then plugged into a test cartridge that processes the sample. Within half an hour, the test cartridge will light up as “positive” or “negative.” Federal guidelines note that people taking the test should report the results to their health care providers, who must then inform public health authorities to help track the virus’s spread.
An at-home test for the virus “was going to happen,” said Omai Garner, a clinical microbiologist and diagnostics expert at the University of California, Los Angeles Health System. “I am hopeful that it works well.”
Dr. Garner said the news should be taken with a note of caution, however. In recent months, several experts have called for more widespread at-home testing as a way to help curb the virus’s spread. But others have raised concerns about the practicality of a strategy that would likely rely on tests that sacrifice a degree of accuracy for convenience and a more affordable price tag.
According to the product’s instructions, Lucira’s LAMP test was able to accurately detect 94 percent of the infections found by a well-established P.C.R.-based test. It also correctly identified 98 percent of the healthy, uninfected people.
Representatives at Lucira Health did not respond immediately to requests for comment.
Saskia Popescu, an infection prevention expert and epidemiologist at George Mason University, also cautioned that home testing, while a notable advance, should not be seen as a panacea. To help fill more of the gaps in coronavirus diagnostics, Dr. Popescu said, “We need more accessible and fast lab-based testing.”
In the spring, as European governments imposed draconian lockdown orders that turned capitals into ghost towns and forced people to largely confine themselves to their homes, Sweden opted for a lighter touch.
The “Sweden model,” as it came to be known, has been the subject of fascination and study even as the effectiveness of the approach is still hotly debated.
But on Tuesday, in a few short words posted on social media, King Carl XVI Gustaf captured the dramatically different mood as a resurgent virus sweeps across Europe.
“Hold on tight,” he said in a statement posted on Instagram. “Hold on!”
This week, the government announced the strictest limitations on the country since the coronavirus first appeared and warned that there will be darker days ahead.
“It is a clear and sharp signal to every person in our country as to what applies in the future,” Prime Minister Stefan Lofven said during a news conference on Monday. “Don’t go to the gym, don’t go the library, don’t have dinner out, don’t have parties — cancel!”
With governments around Europe struggling to avoid sweeping national lockdown orders this time around — but moving step by step in that direction as new restrictions are put in place — Sweden is no longer the outlier.
After earlier adopting a ban on serving alcohol after 10 p.m. and advising against the use of public transportation, Mr. Lofven announced a ban on public gatherings of more than eight people starting next week.
While Sweden’s number of Covid-19 deaths still pales in comparison to those of some European countries like Italy or Spain, it is more than 10 times higher than in Finland or Norway. Over the past five days, Sweden has recorded more than 15,000 new infections and Mr. Lofven warned that “it will get worse.”
Still, despite introducing tighter virus control measures, the Swedish leader said that a national lockdown was still not on the table.
“We don’t believe in a total lockdown,” he said.
Senator Charles E. Grassley, Republican of Iowa, 87, on Tuesday became the latest lawmaker to be affected, announcing that he had tested positive. His absence helped to temporarily derail the confirmation of President Trump’s nominee for the Federal Reserve Board and shattered Mr. Grassley’s pride and joy, the longest consecutive voting streak in Senate history.
His diagnosis came the day after Representative Don Young of Alaska, also 87, disclosed that he had been hospitalized over the weekend after what he described as a particularly brutal bout with Covid-19. The twin announcements from two men whose gender and age put them at peak vulnerability to being killed by the virus underscored the risks that lawmakers are operating under as Congress continues to meet.
The marble-and-stone petri dish that is Capitol Hill is a vivid microcosm of the national struggle to confront and contain the spread of the pandemic, with partisan bickering often thwarting already unevenly enforced health precautions. Having effectively declared themselves essential workers, the nation’s lawmakers — a group of older Americans whose jobs involve weekly flights, ample indoor contact and near-constant congregating in close quarters — are yet again struggling to adapt their legislative and ceremonial routines to stem the spread of the virus, even as it rages within their ranks.
As of Tuesday afternoon, both Senator Rick Scott, Republican of Florida, and Mr. Grassley were in quarantine as a result of possible exposure, marking the first time Mr. Grassley had missed a vote since 1993. In the House, Mr. Young — who noted on Monday that he was “alive, feeling better and on the road to recovery” after being discharged — is among four lawmakers who have revealed they contracted the virus in the past month.
More than 80 members of Congress have either tested positive, quarantined or come into contact with someone who had the virus, according to GovTrack.
On Tuesday, the absence of Mr. Grassley and Mr. Scott temporarily stalled the confirmation of Judy Shelton, Mr. Trump’s Fed nominee, after Republicans fell short of the support necessary to advance to a final vote.
“There’s this kind of macho, ‘Well, I’m not afraid of Covid’ thing going on,” said Senator Brian Schatz, Democrat of Hawaii, who has one of the longest congressional commutes and has instructed his entire staff to work remotely. “We have to run the government — that’s our obligation. Our obligation is not to show that we’re personally unafraid, because we have to pass legislation to address this crisis, and we’re no good to anybody if we’re sick or quarantining.”
The state of South Australia will go into lockdown for six days in an effort to contain a growing coronavirus outbreak. The cluster, which has been traced to a traveler quarantining in a hotel, has included 22 cases since Saturday.
It is the first major outbreak in Australia since one in Victoria state in June that was also traced to a hotel quarantine. Tight restrictions were in place across Victoria for nearly four months.
Starting at midnight on Wednesday, only one person from each household in South Australia will be able to go out per day to access essential services: to buy groceries, access medical services or for caregiving purposes. Restaurants, cafes, pubs and retail stores will close, as will schools and universities. Outdoor sports and physical activities are banned, and masks will be mandatory.
“This is about South Australia pausing so that we stay ahead of the virus,” South Australia’s premier, Steven Marshall, said at a news conference. “Our concern is that if we don’t have this circuit breaker, that we will not stay ahead of this.”
After the six-day lockdown, South Australia will face another eight days of lesser restrictions, details of which have not yet been announced.
In other developments around the world:
Switzerland has reached capacity in its intensive care wards, a national medical association said Tuesday, urging people who are especially vulnerable to the virus to consider writing a living will, specifying whether they would want to be put on life support. All of the country’s 876 adult intensive care beds, which are certified by the Swiss Society of Intensive Care Medicine, “are currently completely full,” the society said in a statement.
The promising news that not just one but two coronavirus vaccines were more than 90 percent effective in early results has buoyed hopes that an end to the pandemic is in sight.
But even if the vaccines are authorized soon by federal regulators — the companies developing them have said they expect to apply soon — only a sliver of the American public will be able to get one by the end of the year. The two companies, Pfizer and Moderna, have estimated they will have 45 million doses, or enough to vaccinate 22.5 million Americans, by January.
Industry analysts and company executives are optimistic that hundreds of millions of doses will be made by next spring. But the companies — backed with billions of dollars in federal money — will have to overcome hurdles they’ve encountered in the early days of making vaccines. Moderna’s and Pfizer’s vaccines use new technology that has never been approved for widespread use. They are ramping up into the millions for the first time. Other challenges include promptly securing raw vaccine ingredients and mastering the art of creating consistent, high-quality batches.
Operation Warp Speed — the federal effort to accelerate vaccine development — set as a goal producing 300 million doses this year, but fell far short of that, reflecting just how difficult and unpredictable the manufacturing process has been.
Pfizer said this summer that it expected to make 100 million doses by year’s end, but has now said it can produce only half that goal.
“Manufacturing a biological product is a science and an art in some ways,” said Prashant Yadav, who studies health care supply chains at the Center for Global Development in Washington.
Children in the United States are on pace this year to miss nine million vaccine doses for measles, polio and other highly contagious diseases, according to medical claims data — a disruption that health care authorities called alarming and attributed to the coronavirus pandemic.
The data was made public on Wednesday by the Blue Cross Blue Shield Association, one of the nation’s largest federations of insurance companies, which said that routine childhood vaccinations had declined by as much as 26 percent, compared with 2019.
The findings emerged less than two weeks after the World Health Organization and UNICEF warned that progress vaccinating children from polio and measles was being threatened by the pandemic. In an emergency call to action, the two organizations said that the risk of measles and polio outbreaks was on the rise.
Last week, the Centers for Disease Control and Prevention and the W.H.O. reported that measles deaths worldwide had soared to their highest level in 23 years in 2019 and were 50 percent higher than just three years earlier.
Dr. Megan Ranney, an emergency physician at Brown University in Rhode Island who specializes in public health research, said that failure to maintain childhood vaccine rates could compromise what is known as herd immunity. The term refers to the point at which a disease stops spreading because nearly everyone in a population has become immune to it.
“We know that once you fall below herd immunity, it offers a foothold for these deadly childhood diseases to once again rear their head in our communities,” Dr. Ranney said in an interview.
Blue Cross Blue Shield said that 40 percent of parents and legal guardians whom it had surveyed said that their children missed their vaccinations because of the pandemic. The majority of missed appointments occurred from March through May, at the beginning of the pandemic, and in August, which is when many children typically get vaccinated before school resumes, the association said.
British police say the coronavirus pandemic and the subsequent social isolation have contributed to a “perfect storm” that is making more young people vulnerable to radicalization.
Neil Basu, the assistant commissioner of the Metropolitan Police, said that police had already seen a sharp increase in extremist material online and, with young people spending more time online in isolation without the protective influence of schools and support networks, they were increasingly at risk.
“In my opinion that is a perfect storm, one which we cannot predict and that we might be feeling the effects of for many years to come,” Mr. Basu said in a statement released by the police on Wednesday.
The comments come after a series of attacks in France and a shooting this month in Vienna, all linked to Islamist extremists. Britain’s terror threat level was raised to its highest — severe — in the wake of the violence, meaning authorities suspect an attack is likely, though without a specified threat.
Mr. Basu also noted that the police are seeing more young people being drawn to terrorist activity. In 2019, 12 children under the age of 18 — including some as young as 14 — were arrested in relation to terrorism offenses, he said.
“That is a relatively new and worrying trend in the U.K., because just a few years ago we were not seeing anyone that young amongst our casework,” Mr. Basu said.
The information was released as the authorities introduced a new website, called ACT, that encourages the family and friends to reach out if they fear someone they know is in danger of being radicalized.