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F.D.A. Authorizes First In-Home Test for Coronavirus F.D.A. Authorizes First In-Home Test for Coronavirus
(32 minutes later)
The Food and Drug Administration on Tuesday said it had granted emergency clearance to the first in-home test for the coronavirus, a nasal swab kit that will be sold by LabCorp.The Food and Drug Administration on Tuesday said it had granted emergency clearance to the first in-home test for the coronavirus, a nasal swab kit that will be sold by LabCorp.
The agency said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor’s office, hospital or other testing site.The agency said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor’s office, hospital or other testing site.
“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” Dr. Stephen M. Hahn, the F.D.A. commissioner, said in a statement.“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” Dr. Stephen M. Hahn, the F.D.A. commissioner, said in a statement.
Patients will swab their own nose using a testing kit sent by the company, and will mail it in an insulated package back to the company. The Pixel by LabCorp COVID-19 test will be available to consumers in most states, with a doctor’s order, the agency said.Patients will swab their own nose using a testing kit sent by the company, and will mail it in an insulated package back to the company. The Pixel by LabCorp COVID-19 test will be available to consumers in most states, with a doctor’s order, the agency said.
LabCorp said that it would first make the tests available to health care workers and emergency workers who may have been exposed to the virus or have symptoms, and that it would be making the self-collection kits available to consumers “in the coming weeks.” The company also noted that because the tests are done by consumers in their own home, it would cut down on the demand for masks and other protective equipment that is usually needed to collect testing specimens.LabCorp said that it would first make the tests available to health care workers and emergency workers who may have been exposed to the virus or have symptoms, and that it would be making the self-collection kits available to consumers “in the coming weeks.” The company also noted that because the tests are done by consumers in their own home, it would cut down on the demand for masks and other protective equipment that is usually needed to collect testing specimens.
The company said the test will cost $119. Consumers will have to pay out of pocket for the test, a company spokesman said, and ask their insurer for reimbursement. The Trump administration has repeatedly said that diagnostic tests for the coronavirus will be covered so that consumers don’t have to foot the bill.The company said the test will cost $119. Consumers will have to pay out of pocket for the test, a company spokesman said, and ask their insurer for reimbursement. The Trump administration has repeatedly said that diagnostic tests for the coronavirus will be covered so that consumers don’t have to foot the bill.
At a moment when governors across the country say their states are facing a shortage of tests, and companies like CVS and Walmart are setting up drive-through testing centers in parking lots, the arrival of kits that let people collect their own nasal specimens at home has the potential to open up testing to a wider audience.At a moment when governors across the country say their states are facing a shortage of tests, and companies like CVS and Walmart are setting up drive-through testing centers in parking lots, the arrival of kits that let people collect their own nasal specimens at home has the potential to open up testing to a wider audience.
Medical experts said the home-swabbing tests could increase convenience for consumers — and reduce the need for people to go to medical offices where they might inadvertently expose health providers and other patients to the infection.Medical experts said the home-swabbing tests could increase convenience for consumers — and reduce the need for people to go to medical offices where they might inadvertently expose health providers and other patients to the infection.
“This is not a game-changer, but it’s potentially another piece of the large and rather messy puzzle we’re assembling to test enough people to stop Covid-19,” Dr. Sheldon Campbell, associate director of the Yale School of Medicine’s Clinical Microbiology Laboratory, said of the at-home nasal self-swabbing kits. “A home-collection testing procedure will support telemedicine and help patients with transportation difficulties and in hard-to-reach places to access testing.”“This is not a game-changer, but it’s potentially another piece of the large and rather messy puzzle we’re assembling to test enough people to stop Covid-19,” Dr. Sheldon Campbell, associate director of the Yale School of Medicine’s Clinical Microbiology Laboratory, said of the at-home nasal self-swabbing kits. “A home-collection testing procedure will support telemedicine and help patients with transportation difficulties and in hard-to-reach places to access testing.”
Experts also cautioned, however, that the nasal swabs can be less accurate for testing than the gold standard specimen collection for the coronavirus that health providers perform — which involves inserting a long-nasal swab up through the nose into the back of the throat. One small peer-reviewed study from France, for instance, reported last week that coronavirus tests using nasal swabs had a higher false negative rate than the longer swabs.
Updated June 22, 2020Updated June 22, 2020
A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.
The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
Experts also cautioned, however, that the nasal swabs can be less accurate for testing than the gold standard specimen collection for the coronavirus that health providers perform — which involves inserting a long-nasal swab up through the nose into the back of the throat. One small peer-reviewed study from France, for instance, reported last week that coronavirus tests using nasal swabs had a higher false negative rate than the longer swabs.
Home-sampling may also increase the time it takes people to obtain test results.Home-sampling may also increase the time it takes people to obtain test results.
As the virus spread in the United States, several companies rushed unauthorized home kits to the market, even though the F.D.A. had said it had not evaluated whether they worked properly.As the virus spread in the United States, several companies rushed unauthorized home kits to the market, even though the F.D.A. had said it had not evaluated whether they worked properly.
Many of those companies then suspended their marketing of the kits. But one company, Vault, which normally sells testosterone to men, began advertising a Covid-19 kit using saliva on April 14. The F.D.A. has not auhorized that company to sell a testing kit, and a notice on Vault’s website said the tests are currently unavailable until at least Wednesday.Many of those companies then suspended their marketing of the kits. But one company, Vault, which normally sells testosterone to men, began advertising a Covid-19 kit using saliva on April 14. The F.D.A. has not auhorized that company to sell a testing kit, and a notice on Vault’s website said the tests are currently unavailable until at least Wednesday.