“Suppose you get a Covid test and you actually have the infection and it comes back negative,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “You may believe you’re OK and that may leave you in your home, exposing family and friends to the virus when you should quarantine.”
Earlier this year, the F.D.A. noted just that problem. In response to an inquiry, agency spokeswoman Emma Spaulding said in a statement in May that there were problems with some of the laboratory coronavirus tests whose developers had applied for emergency authorization.
The Coronavirus Outbreak ›
Frequently Asked Questions
Updated August 24, 2020
What are the symptoms of coronavirus?
- In the beginning, the coronavirus seemed like it was primarily a respiratory illness — many patients had fever and chills, were weak and tired, and coughed a lot. Those who seemed sickest had pneumonia or acute respiratory distress syndrome — which caused their blood oxygen levels to plummet — and received supplemental oxygen. In severe cases, they were placed on ventilators to help them breathe. By now, doctors have identified many more symptoms and syndromes. (And some people don’t show many symptoms at all.) In April, the C.D.C. added to the list of early signs sore throat, fever, chills and muscle aches. Gastrointestinal upset, such as diarrhea and nausea, has also been observed. Another telltale sign of infection may be a sudden, profound diminution of one’s sense of smell and taste. Teenagers and young adults in some cases have developed painful red and purple lesions on their fingers and toes — nicknamed “Covid toe” — but few other serious symptoms. More serious cases can lead to inflammation and organ damage, even without difficulty breathing. There have been cases of dangerous blood clots, strokes and brain impairments.
Why does standing six feet away from others help?
- The coronavirus spreads primarily through droplets from your mouth and nose, especially when you cough or sneeze. The C.D.C., one of the organizations using that measure, bases its recommendation of six feet on the idea that most large droplets that people expel when they cough or sneeze will fall to the ground within six feet. But six feet has never been a magic number that guarantees complete protection. Sneezes, for instance, can launch droplets a lot farther than six feet, according to a recent study. It’s a rule of thumb: You should be safest standing six feet apart outside, especially when it’s windy. But keep a mask on at all times, even when you think you’re far enough apart.
I have antibodies. Am I now immune?
- As of right now, that seems likely, for at least several months. There have been frightening accounts of people suffering what seems to be a second bout of Covid-19. But experts say these patients may have a drawn-out course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may last in the body only two to three months, which may seem worrisome, but that’s perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it’s highly unlikely that it would be possible in a short window of time from initial infection or make people sicker the second time.
I’m a small-business owner. Can I get relief?
- The stimulus bills enacted in March offer help for the millions of American small businesses. Those eligible for aid are businesses and nonprofit organizations with fewer than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some industries are also eligible. The help being offered, which is being managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Disaster Loan program. But lots of folks have not yet seen payouts. Even those who have received help are confused: The rules are draconian, and some are stuck sitting on money they don’t know how to use. Many small-business owners are getting less than they expected or not hearing anything at all.
What are my rights if I am worried about going back to work?
“Some of the laboratories didn’t do their validation properly, making it impossible to tell if they had a good test or not,” Ms. Spaulding said. “Others included data that suggested the test did not perform well, likely missing far more positive cases than authorized tests.”
Other laboratories, she added, had manufacturing problems such as contamination. And several made unsupported claims in their labels for home testing.
With the new change, the agency would not find out about these problems. Under the policy, the F.D.A. retains the power to give emergency authorizations to companies that voluntary apply for them. The agency may also attempt to institute new rules for these tests, but would have to go through a cumbersome formal review process first. Such rules are subject to White House approval.
The new policy covers tests developed by laboratories certified under the Clinical Laboratory Improvement Amendments program, which is part of the Centers for Medicare and Medicaid Services. It does not change the requirements for tests that are made and marketed by companies to be sold off site, such as the rapid point-of-care tests for the coronavirus.
Susan Van Meter, executive director of AdvaMedDx, the diagnostic division of AdvaMed, the medical device trade group, said her organization was still trying to assess the implications of the policy. Ms. Van Meter also said her organization would like to see the F.D.A.’s entire policy on lab-developed tests updated.
“We really think a new, overarching, modernized regulatory framework for all diagnostic tests” is important, she said.