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F.D.A. Approves First Antigen Test for Detecting the Coronavirus F.D.A. Approves First Antigen Test for Detecting the Coronavirus
(about 16 hours later)
The Food and Drug Administration has approved the first antigen test that can rapidly detect whether a person has been infected by the coronavirus, a significant advancement that promises to greatly expand the nation’s testing capacity.The Food and Drug Administration has approved the first antigen test that can rapidly detect whether a person has been infected by the coronavirus, a significant advancement that promises to greatly expand the nation’s testing capacity.
The test, by the Quidel Corporation of San Diego, was given emergency use authorization late Friday by the F.D.A., according to a notice on the agency’s website.The test, by the Quidel Corporation of San Diego, was given emergency use authorization late Friday by the F.D.A., according to a notice on the agency’s website.
Unlike commonly available coronavirus tests that use polymerase chain reaction, or PCR, antigen diagnostics work by quickly detecting fragments of virus in a sample. The newly approved Quidel test will rely on specimens collected from nasal swabs, according to the F.D.A., and they can only be processed by the company’s lab instruments.Unlike commonly available coronavirus tests that use polymerase chain reaction, or PCR, antigen diagnostics work by quickly detecting fragments of virus in a sample. The newly approved Quidel test will rely on specimens collected from nasal swabs, according to the F.D.A., and they can only be processed by the company’s lab instruments.
“Diagnostic testing is one of the pillars of our nation’s response to Covid-19, and the F.D.A. continues to take actions to help make these critical products available,” the agency said in a statement on Saturday. “One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes.” The F.D.A. said it expects to grant emergency clearance for other antigen tests in the near future.“Diagnostic testing is one of the pillars of our nation’s response to Covid-19, and the F.D.A. continues to take actions to help make these critical products available,” the agency said in a statement on Saturday. “One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes.” The F.D.A. said it expects to grant emergency clearance for other antigen tests in the near future.
A shortage of coronavirus tests in the United States has hampered efforts to contain the pandemic, and has limited the capabilities of states seeking to ease the lockdowns and social distancing measures that have throttled the nation’s economy.A shortage of coronavirus tests in the United States has hampered efforts to contain the pandemic, and has limited the capabilities of states seeking to ease the lockdowns and social distancing measures that have throttled the nation’s economy.
Although antigen tests are extremely accurate in detecting positive infections, they cannot detect all active infections and they have a higher chance of false negatives than PCR tests. Positive test results may also need to be confirmed with the slower but more accurate PCR test, which relies on detecting the presence of genetic material.Although antigen tests are extremely accurate in detecting positive infections, they cannot detect all active infections and they have a higher chance of false negatives than PCR tests. Positive test results may also need to be confirmed with the slower but more accurate PCR test, which relies on detecting the presence of genetic material.
Experts said the approval of an antigen test for Covid-19 would boost testing efforts by giving medical workers and health authorities an inexpensive tool for mass rapid testing. Further developed, antigen tests also hold potential for use at home, in the manner of a home pregnancy kit.Experts said the approval of an antigen test for Covid-19 would boost testing efforts by giving medical workers and health authorities an inexpensive tool for mass rapid testing. Further developed, antigen tests also hold potential for use at home, in the manner of a home pregnancy kit.
Updated June 16, 2020Updated June 16, 2020
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.
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
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.)
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
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.
“I am very enthusiastic about antigen testing because of its ability to be scaled up to millions of tests a day, and because it has a much more rapid turnaround,” said Dr. Ashish Jha, director of the Harvard Global Health Institute. “A lot of us have been looking forward to this moment.”“I am very enthusiastic about antigen testing because of its ability to be scaled up to millions of tests a day, and because it has a much more rapid turnaround,” said Dr. Ashish Jha, director of the Harvard Global Health Institute. “A lot of us have been looking forward to this moment.”
Dr. Jha said he still had questions about the sensitivity and specificity of the test. He noted that even an antigen test that produces false positives is preferable to one that results in false negatives, because infected people given a negative result could unknowingly spread the virus to others.Dr. Jha said he still had questions about the sensitivity and specificity of the test. He noted that even an antigen test that produces false positives is preferable to one that results in false negatives, because infected people given a negative result could unknowingly spread the virus to others.
“It’s ideal to have low false positives and false negatives, but usually you’re trading off between the two,” Dr. Jha said. “The reason you’re wiling to live with more false positives is you want to be able to screen people, and if they are negative you want to feel confident that they are truly negative.”“It’s ideal to have low false positives and false negatives, but usually you’re trading off between the two,” Dr. Jha said. “The reason you’re wiling to live with more false positives is you want to be able to screen people, and if they are negative you want to feel confident that they are truly negative.”