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| Start-Ups Jump the Gun on Home Kits for Coronavirus Testing | Start-Ups Jump the Gun on Home Kits for Coronavirus Testing |
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| Last week, two high-profile San Francisco health start-ups began marketing at-home coronavirus kits that let people collect their own saliva samples or oral throat swabs and then send the specimens to commercial labs to be tested for the virus. | Last week, two high-profile San Francisco health start-ups began marketing at-home coronavirus kits that let people collect their own saliva samples or oral throat swabs and then send the specimens to commercial labs to be tested for the virus. |
| The start-ups, Carbon Health and Nurx, each said they were preparing to offer thousands of the kits in the coming weeks. By Friday afternoon, the Nurx site said its kits had “reached capacity for today” and promised more would be available for sale this week. | The start-ups, Carbon Health and Nurx, each said they were preparing to offer thousands of the kits in the coming weeks. By Friday afternoon, the Nurx site said its kits had “reached capacity for today” and promised more would be available for sale this week. |
| But on Friday evening, the Food and Drug Administration issued an alert warning consumers that it had “not authorized any test” for the coronavirus that people could buy and administer at home. Carbon Health and Nurx subsequently suspended sales of their kits. | But on Friday evening, the Food and Drug Administration issued an alert warning consumers that it had “not authorized any test” for the coronavirus that people could buy and administer at home. Carbon Health and Nurx subsequently suspended sales of their kits. |
| As the coronavirus pandemic intensified across the country, the two companies and other start-ups rushed to market collect-your-own specimen kits without rigorous published studies proving the effectiveness of at-home swabbing for coronavirus testing. | As the coronavirus pandemic intensified across the country, the two companies and other start-ups rushed to market collect-your-own specimen kits without rigorous published studies proving the effectiveness of at-home swabbing for coronavirus testing. |
| The dash to sell at-home kits coincided with a push by the White House to promote rapid innovation in coronavirus testing by relaxing federal health regulations. Last Wednesday, President Trump announced that his administration was studying the possibility of introducing self-swabbing on a mass scale — an effort that could free up health providers to focus more on treating seriously ill patients and less on collecting specimens. Then on Monday, the White House appeared to overrule the F.D.A., saying that “self-swabbing options” should be available to Americans this week. | The dash to sell at-home kits coincided with a push by the White House to promote rapid innovation in coronavirus testing by relaxing federal health regulations. Last Wednesday, President Trump announced that his administration was studying the possibility of introducing self-swabbing on a mass scale — an effort that could free up health providers to focus more on treating seriously ill patients and less on collecting specimens. Then on Monday, the White House appeared to overrule the F.D.A., saying that “self-swabbing options” should be available to Americans this week. |
| Tech giants and some of their top executives are also racing to help track the spread of the virus and rapidly increase testing. The Bill & Melinda Gates Foundation is sponsoring research at major medical centers on at-home kits. | Tech giants and some of their top executives are also racing to help track the spread of the virus and rapidly increase testing. The Bill & Melinda Gates Foundation is sponsoring research at major medical centers on at-home kits. |
| The studies are examining whether swabbing inside your nostrils with a short Q-tip-like wand at home could work as well for coronavirus testing as the medical-grade specimens that health professionals collect — an often uncomfortable process that involves pushing a long swab up through the nose to collect samples from the back of a patient’s throat. | The studies are examining whether swabbing inside your nostrils with a short Q-tip-like wand at home could work as well for coronavirus testing as the medical-grade specimens that health professionals collect — an often uncomfortable process that involves pushing a long swab up through the nose to collect samples from the back of a patient’s throat. |
| “There are significant differences between these collection methods,” Dr. Dan Wattendorf, director of innovative technology solutions at the Gates Foundation, said in recent comments on the foundation’s site. “So it’s essential for the F.D.A. to evaluate their relative performance through rigorous, well-designed studies.” | “There are significant differences between these collection methods,” Dr. Dan Wattendorf, director of innovative technology solutions at the Gates Foundation, said in recent comments on the foundation’s site. “So it’s essential for the F.D.A. to evaluate their relative performance through rigorous, well-designed studies.” |
| The Gates Foundation and others are optimistic that self-collected swabs might prove effective for the coronavirus. The hope is that the kits could help stem the pandemic by enabling millions of people who are carrying the virus to safely collect their own testing samples without going to doctors’ offices, where they might infect health providers and other patients. | The Gates Foundation and others are optimistic that self-collected swabs might prove effective for the coronavirus. The hope is that the kits could help stem the pandemic by enabling millions of people who are carrying the virus to safely collect their own testing samples without going to doctors’ offices, where they might infect health providers and other patients. |
| The start-ups were not marketing a novel method of testing for infectious diseases. At-home kits have proved effective for other infections, such as gonorrhea. | The start-ups were not marketing a novel method of testing for infectious diseases. At-home kits have proved effective for other infections, such as gonorrhea. |
| Founded in 2015, Nurx markets self-swabbing kits and online consultations for sexually transmitted diseases. The start-up, whose investors include the venture capital firms Kleiner Perkins and Union Square Ventures, said it had worked with Molecular Testing Labs, its longstanding diagnostic testing provider, to develop its coronavirus kits and was confident the tests were accurate. | Founded in 2015, Nurx markets self-swabbing kits and online consultations for sexually transmitted diseases. The start-up, whose investors include the venture capital firms Kleiner Perkins and Union Square Ventures, said it had worked with Molecular Testing Labs, its longstanding diagnostic testing provider, to develop its coronavirus kits and was confident the tests were accurate. |
| Executives at Carbon Health, which offers telemedicine consultations as well as in-person medical care at its own clinics, said it had decided to offer self-administered sampling kits after doctors there treated some of the first coronavirus patients in California and ran into obstacles getting them tested. It worked with Curative, a three-month-old start-up, to develop a saliva test for the virus. | Executives at Carbon Health, which offers telemedicine consultations as well as in-person medical care at its own clinics, said it had decided to offer self-administered sampling kits after doctors there treated some of the first coronavirus patients in California and ran into obstacles getting them tested. It worked with Curative, a three-month-old start-up, to develop a saliva test for the virus. |
| “Having a saliva sample that can be mailed back and that is just as accurate, or nearly as accurate, as the nasal or the throat swab was very attractive to us,” said Dr. Caesar Djavaherian, the medical director of Carbon Health. | “Having a saliva sample that can be mailed back and that is just as accurate, or nearly as accurate, as the nasal or the throat swab was very attractive to us,” said Dr. Caesar Djavaherian, the medical director of Carbon Health. |
| Another San Francisco start-up, Forward, which runs health care clinics using a health-club-like membership model, announced last week that it was offering self-swabbing kits on a limited basis to members it determined to be at high risk for the virus. Forward’s investors include Joshua Kushner, the brother of Jared Kushner, Mr. Trump’s adviser and son-in-law. | Another San Francisco start-up, Forward, which runs health care clinics using a health-club-like membership model, announced last week that it was offering self-swabbing kits on a limited basis to members it determined to be at high risk for the virus. Forward’s investors include Joshua Kushner, the brother of Jared Kushner, Mr. Trump’s adviser and son-in-law. |
| But public health and laboratory medicine experts cautioned that tests based on self-swabbing might not be accurate, noting that many of the at-home kits did not adhere to current medical standards of care. | But public health and laboratory medicine experts cautioned that tests based on self-swabbing might not be accurate, noting that many of the at-home kits did not adhere to current medical standards of care. |
| For coronavirus testing, the Centers for Disease Control and Prevention recommends that health care professionals first and foremost collect nasopharyngeal samples — the ones involving the long swabs through the nose. Experts said that was because there was not yet enough effectiveness data available on testing other kinds of specimens for coronavirus. | For coronavirus testing, the Centers for Disease Control and Prevention recommends that health care professionals first and foremost collect nasopharyngeal samples — the ones involving the long swabs through the nose. Experts said that was because there was not yet enough effectiveness data available on testing other kinds of specimens for coronavirus. |
| The Nurx kit uses oral swabs of the throat, the Forward kit uses inner-cheek swabs, and the Carbon Health kit uses saliva. | The Nurx kit uses oral swabs of the throat, the Forward kit uses inner-cheek swabs, and the Carbon Health kit uses saliva. |
| “That sounds to me like a really terrible idea,” Dr. Sheldon Campbell, associate director of the Yale School of Medicine’s Clinical Microbiology Laboratory, said of collecting saliva samples at home. “There is concern, in this outbreak emergency setting, that good labs will cut corners and that bad labs will spring up to exploit the opportunity to make a quick buck.” | “That sounds to me like a really terrible idea,” Dr. Sheldon Campbell, associate director of the Yale School of Medicine’s Clinical Microbiology Laboratory, said of collecting saliva samples at home. “There is concern, in this outbreak emergency setting, that good labs will cut corners and that bad labs will spring up to exploit the opportunity to make a quick buck.” |
| Last month, the F.D.A. issued guidance for the pandemic allowing accredited commercial labs to develop and perform tests for the coronavirus — as long as they applied for an emergency use authorization from the agency within 15 days of initiating testing. | Last month, the F.D.A. issued guidance for the pandemic allowing accredited commercial labs to develop and perform tests for the coronavirus — as long as they applied for an emergency use authorization from the agency within 15 days of initiating testing. |
| Updated June 5, 2020 | |
| 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. |
| Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home. | Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home. |
| 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. |
| 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. |
| 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. |
| Carbon Health, Forward, Nurx and Everlywell, another start-up that promoted at-home kits, each said last week that they were working with accredited labs that had received the F.D.A. emergency authorization. They also said the labs met federal standards for demonstrating the accuracy of their coronavirus tests. | Carbon Health, Forward, Nurx and Everlywell, another start-up that promoted at-home kits, each said last week that they were working with accredited labs that had received the F.D.A. emergency authorization. They also said the labs met federal standards for demonstrating the accuracy of their coronavirus tests. |
| But on Friday, the F.D.A. clarified that the coronavirus testing guidelines for accredited labs did not apply “to at-home testing, including self-collection of samples to be sent to a clinical laboratory.” | But on Friday, the F.D.A. clarified that the coronavirus testing guidelines for accredited labs did not apply “to at-home testing, including self-collection of samples to be sent to a clinical laboratory.” |
| The agency also noted that it saw the “public health value in expanding the availability” of safe and accurate coronavirus tests that may include home collection. “We are actively working with test developers in this space,” the agency said. | The agency also noted that it saw the “public health value in expanding the availability” of safe and accurate coronavirus tests that may include home collection. “We are actively working with test developers in this space,” the agency said. |
| Nurx and Forward said on Monday that they had suspended sales of their kits. | Nurx and Forward said on Monday that they had suspended sales of their kits. |
| In a statement, Carbon Health said it was discontinuing the at-home kits and contacting the 50 people who had used them to schedule testing in its clinics. | In a statement, Carbon Health said it was discontinuing the at-home kits and contacting the 50 people who had used them to schedule testing in its clinics. |
| Everlywell said it was moving to provide its kits, which use the long swabs for nasopharyngeal testing, to health care providers and hospitals. | Everlywell said it was moving to provide its kits, which use the long swabs for nasopharyngeal testing, to health care providers and hospitals. |
| Researchers working on the Gates-sponsored nasal self-swabbing study said they hoped to have results soon showing the efficacy of at-home coronavirus kits. Among other things, the researchers are studying whether self-administered nostril swabs pick up sufficient cells to produce accurate results. | Researchers working on the Gates-sponsored nasal self-swabbing study said they hoped to have results soon showing the efficacy of at-home coronavirus kits. Among other things, the researchers are studying whether self-administered nostril swabs pick up sufficient cells to produce accurate results. |
| “One of the things we are trying to figure out is, how accurate is this nasal test going to be?” said Dr. Yvonne Maldonado, a professor of pediatrics, health research and policy at Stanford University School of Medicine who specializes in infectious diseases. “If you are negative, how likely are you to be still infected?” | “One of the things we are trying to figure out is, how accurate is this nasal test going to be?” said Dr. Yvonne Maldonado, a professor of pediatrics, health research and policy at Stanford University School of Medicine who specializes in infectious diseases. “If you are negative, how likely are you to be still infected?” |
| On Monday, the F.D.A. said it believed that, for those people who are exhibiting coronavirus symptoms, nostrils swabs “that access just the front of the nose rather than the depth of the nasal cavity” could be used for testing. That would allow people to collect their own samples for testing. | On Monday, the F.D.A. said it believed that, for those people who are exhibiting coronavirus symptoms, nostrils swabs “that access just the front of the nose rather than the depth of the nasal cavity” could be used for testing. That would allow people to collect their own samples for testing. |