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F.D.A. Clears First Home Saliva Test for Coronavirus F.D.A. Clears First Home Saliva Test for Coronavirus
(1 day later)
The Food and Drug Administration said on Friday that it had granted emergency authorization for the first at-home saliva collection kit to test for the coronavirus.The Food and Drug Administration said on Friday that it had granted emergency authorization for the first at-home saliva collection kit to test for the coronavirus.
The test kit was developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs. ​The test kit was developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs. ​
Rutgers received F.D.A. permission last month to collect saliva samples from patients at test sites but can now sell the collection kits for individuals to use at home. They must be ordered by a physician.Rutgers received F.D.A. permission last month to collect saliva samples from patients at test sites but can now sell the collection kits for individuals to use at home. They must be ordered by a physician.
The agency has come under fire in recent weeks for allowing myriad companies to offer diagnostic and antibody tests without submitting timely data for review, under its emergency use authorization policy because of the pandemic. Tests have varied widely in terms of their accuracy, and access to diagnostic testing has been scattered, with shortages of tests and the materials required to process them straining capacity from one state to another.The agency has come under fire in recent weeks for allowing myriad companies to offer diagnostic and antibody tests without submitting timely data for review, under its emergency use authorization policy because of the pandemic. Tests have varied widely in terms of their accuracy, and access to diagnostic testing has been scattered, with shortages of tests and the materials required to process them straining capacity from one state to another.
To date, 8.1 million people in the United States have been tested for the coronavirus. But public health experts like Dr. Anthony Fauci, the nation’s leading infectious disease expert, said testing needed to double by the end of May.To date, 8.1 million people in the United States have been tested for the coronavirus. But public health experts like Dr. Anthony Fauci, the nation’s leading infectious disease expert, said testing needed to double by the end of May.
Just last week, the F.D.A. ordered dozens of companies it had allowed to market antibody tests, which some states and public health experts hope will help indicate the depth of infection in communities and quantify who has recovered and perhaps developed some immunity, to submit data proving accuracy within 10 days, or it warned the products could be removed from the market.Just last week, the F.D.A. ordered dozens of companies it had allowed to market antibody tests, which some states and public health experts hope will help indicate the depth of infection in communities and quantify who has recovered and perhaps developed some immunity, to submit data proving accuracy within 10 days, or it warned the products could be removed from the market.
The F.D.A. said that Rutgers had submitted data showing that testing saliva samples collected by patients themselves, under the observation of a health care provider, was as accurate as testing deep nasal swabs that the health professional had collected from them. The agency also said the spit collection kits should be limited to people who are exhibiting Covid-19 symptoms.The F.D.A. said that Rutgers had submitted data showing that testing saliva samples collected by patients themselves, under the observation of a health care provider, was as accurate as testing deep nasal swabs that the health professional had collected from them. The agency also said the spit collection kits should be limited to people who are exhibiting Covid-19 symptoms.
“A patient can open the kit, spit into the tube, put the cap back on and ship it back to our lab,” said Dr. Andrew Brooks, chief operating officer and director of technology development at RUCDR. “We bring the test to the patient, instead of the patient to the test.”“A patient can open the kit, spit into the tube, put the cap back on and ship it back to our lab,” said Dr. Andrew Brooks, chief operating officer and director of technology development at RUCDR. “We bring the test to the patient, instead of the patient to the test.”
The F.D.A. said it still preferred tests based on deep nasal samples, which involve a health professional inserting a long swab up through the nose and into the back of the throat. But even those have had problems. In mid-April, for example, an unnamed team of health providers reported to the F.D.A. that the new Abbott ID Now test failed to detect coronavirus on six patients who were known to have Covid-19.The F.D.A. said it still preferred tests based on deep nasal samples, which involve a health professional inserting a long swab up through the nose and into the back of the throat. But even those have had problems. In mid-April, for example, an unnamed team of health providers reported to the F.D.A. that the new Abbott ID Now test failed to detect coronavirus on six patients who were known to have Covid-19.
Rutgers has 75,000 of the saliva test kits ready to ship and can process 20,000 tests each day, with a 48-hour turnaround. Dr. Brooks said he expected other labs around the country to adopt it for their own use.Rutgers has 75,000 of the saliva test kits ready to ship and can process 20,000 tests each day, with a 48-hour turnaround. Dr. Brooks said he expected other labs around the country to adopt it for their own use.
He said that the Centers for Medicare and Medicaid had approved a $100 fee per test, but prices will vary. One company, Vault Health, is now offering telehealth appointments in which a health practitioner supervises the spit test via video. Vault charges $150 per test.He said that the Centers for Medicare and Medicaid had approved a $100 fee per test, but prices will vary. One company, Vault Health, is now offering telehealth appointments in which a health practitioner supervises the spit test via video. Vault charges $150 per test.
The spit tests are part of an emergency pandemic response effort by the F.D.A. to help developers of novel tests for the coronavirus quickly get to market. Last month, the agency authorized the first type of at-home kit for the virus in the United States, a kit sold by LabCorp that enables people to swab their own noses and send the samples to be tested at the company’s labs around the country.The spit tests are part of an emergency pandemic response effort by the F.D.A. to help developers of novel tests for the coronavirus quickly get to market. Last month, the agency authorized the first type of at-home kit for the virus in the United States, a kit sold by LabCorp that enables people to swab their own noses and send the samples to be tested at the company’s labs around the country.
Now, at a time when some states say they are still facing a shortage of tests, the at-home spit-collection kits have the potential to widen the audience for virus screening. By keeping people with symptoms at home, instead of asking them to go to medical centers to be tested, the spit kits could reduce the risk of spreading the infection to health care workers.Now, at a time when some states say they are still facing a shortage of tests, the at-home spit-collection kits have the potential to widen the audience for virus screening. By keeping people with symptoms at home, instead of asking them to go to medical centers to be tested, the spit kits could reduce the risk of spreading the infection to health care workers.
They may also appeal to people who would feel more comfortable spitting into a container than inserting swabs into their noses to collect virus specimens.They may also appeal to people who would feel more comfortable spitting into a container than inserting swabs into their noses to collect virus specimens.
“This combines the ease of saliva collection with at-home collection,” Dr. Stephen Hahn, the F.D.A. commissioner, said in an interview on Friday.“This combines the ease of saliva collection with at-home collection,” Dr. Stephen Hahn, the F.D.A. commissioner, said in an interview on Friday.
Updated June 30, 2020
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.
Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles.
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 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.
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.
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.
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.
Some public health experts, however, have cautioned that at-home sampling kits can also come with downsides. One is that it can take longer for people to get test results when they use at-home kits that need to be sent to labs. Because the infection can take several days to develop, they said, the time lag could result in some people receiving false negative test results for coronavirus. Physicians, they said, should make patients aware of the limitations.Some public health experts, however, have cautioned that at-home sampling kits can also come with downsides. One is that it can take longer for people to get test results when they use at-home kits that need to be sent to labs. Because the infection can take several days to develop, they said, the time lag could result in some people receiving false negative test results for coronavirus. Physicians, they said, should make patients aware of the limitations.
In its emergency authorization for the Rutgers test, the F.D.A. noted that negative test results would not preclude a coronavirus infection and “should not be used as the sole basis for patient management decisions.”In its emergency authorization for the Rutgers test, the F.D.A. noted that negative test results would not preclude a coronavirus infection and “should not be used as the sole basis for patient management decisions.”
The agency also noted that the Rutgers lab was the only entity it had authorized to market at-home coronavirus self-sampling kits for saliva. In March, the F.D.A. cracked down on several health start-ups that had rushed to market unauthorized at-home kits that involved consumers collecting their own spit or throat swabs for testing.The agency also noted that the Rutgers lab was the only entity it had authorized to market at-home coronavirus self-sampling kits for saliva. In March, the F.D.A. cracked down on several health start-ups that had rushed to market unauthorized at-home kits that involved consumers collecting their own spit or throat swabs for testing.
“This is not a general authorization,” the F.D.A. said of the Rutgers spit kits, “for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.”“This is not a general authorization,” the F.D.A. said of the Rutgers spit kits, “for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.”
The F.D.A.’s decisions to issue more than 100 emergency use authorizations has drawn intense criticism from Democratic lawmakers. Earlier this week, Senator Elizabeth Warren, of Massachusetts, and Senator Patty Murray, of Washington, both Democrats, sent a letter to Dr. Hahn requesting information on how the agency was tracking the use, safety and effectiveness of Covid-19 treatments. and diagnostic tests given emergency use authorization because of the pandemic.The F.D.A.’s decisions to issue more than 100 emergency use authorizations has drawn intense criticism from Democratic lawmakers. Earlier this week, Senator Elizabeth Warren, of Massachusetts, and Senator Patty Murray, of Washington, both Democrats, sent a letter to Dr. Hahn requesting information on how the agency was tracking the use, safety and effectiveness of Covid-19 treatments. and diagnostic tests given emergency use authorization because of the pandemic.
The lawmakers said they were particularly concerned about the F.D.A.’s tracking of adverse events caused by hydroxychloroquine, a treatment repeatedly promoted by President Trump.The lawmakers said they were particularly concerned about the F.D.A.’s tracking of adverse events caused by hydroxychloroquine, a treatment repeatedly promoted by President Trump.
The senators noted evidence of the drug’s lethal cardiac side effects and its lack of evidence as a treatment for Covid-19. “There are also reports that the F.D.A. lowered its quality-control standards so that the administration could accept Bayer Pharmaceutical’s donation of millions of hydroxychloroquine tablets for distribution,” they said.The senators noted evidence of the drug’s lethal cardiac side effects and its lack of evidence as a treatment for Covid-19. “There are also reports that the F.D.A. lowered its quality-control standards so that the administration could accept Bayer Pharmaceutical’s donation of millions of hydroxychloroquine tablets for distribution,” they said.
The senators also told the F.D.A. to make sure that it tracked all reports of adverse events from remdesivir, which received emergency use authorization to treat patients hospitalized with Covid-19.The senators also told the F.D.A. to make sure that it tracked all reports of adverse events from remdesivir, which received emergency use authorization to treat patients hospitalized with Covid-19.