En español | Soon it will be possible to take a COVID-19 test and get results in minutes — all without leaving your house.
The Food and Drug Administration (FDA) has given the green light to five COVID-19 rapid tests that deliver results in real time at home, including four that will be sold over the counter without a doctor's prescription.
For months, consumers have been able to purchase test kits that allow them to collect a sample at home and mail it to a lab. But those kits typically cost more than $100, and patients have to wait a few days for the results.
The new at-home coronavirus tests are different because they're less expensive, more convenient and deliver results on the spot. Even though vaccination has started, public health experts say at-home tests are an important tool for helping slow the virus over the next few months until most Americans have the opportunity to get the vaccine.
The FDA has said the tests are a key tool for schools, workplaces and communities to use to quickly screen people for COVID-19 during the pandemic.
"COVID has turned out to be so difficult to control because so much of its transmission happens from people who don't know they're infected,” said Mark McClellan, M.D., director of the Center for Health Policy at Duke University and former FDA commissioner. “The faster, easier and cheaper we can make it to find out if you're infectious, the better."
Here are the answers to some common questions about the new at-home tests.
What are the different types of at-home tests?
So far, the FDA has given what's called emergency use authorization (EUA) to five at-home tests. That means the tests haven't gone through the full rigorous FDA approval process, but the agency wanted to get them on the market quickly due to the severity of the pandemic. The tests are:
- Ellume's COVID-19 Home Test: This was the first at-home test to be authorized that can be done without a prescription. It uses so-called antigen technology, meaning it looks for fragments of viral proteins. On Feb. 1, the federal government announced a $231.8 million deal to boost manufacturing of the test. The company is working with retailers to get the test on store shelves, a spokeswoman said, and it will also be sold online. It will cost about $30. The test delivers your results wirelessly to a smartphone app in 15 to 20 minutes.
- Abbott's BinaxNOW COVID-19 Antigen Self Test: This rapid antigen test has been used for months by health care providers, but on March 31, the FDA authorized it to be sold over the counter and used at home, even by those who have no symptoms. The test will be sold in packs of two, and the instructions call for it to be administered twice over three days. Repeat testing helps reduce the chance of inaccurate results. In a March 31 press release, Abbott said the test will be available “in coming weeks” on drugstore and grocery store shelves. Results are delivered in about 15 minutes on a device the size of a credit card.
- Quidel’s QuickVue At-Home OTC COVID-19 Test: This is another antigen test that will be sold over the counter. Like the one from Abbott, it will be sold in packs of two, and the instructions call for users to test themselves twice over two or three days, with at least 24 hours between tests. Results are delivered on a paper test strip that changes color in 10 minutes, similar to a home pregnancy test.
- Cue’s COVID-19 Test for Home and Over the Counter Use: This test is also authorized to be sold over the counter without a prescription, but it uses molecular technology, which can pick up very small amounts of genetic material. Molecular tests are generally more accurate than those that use antigen technology, especially in patients who are asymptomatic. Results are available in about 20 minutes. Cue Health cofounder and chief product officer Clint Sever said the company is working to make the test available at retailers nationwide, but he did not have a time frame. The company has yet to set a price for the test.
- Lucira's COVID-19 All-In-One Test Kit: Like the Cue test, the Lucira one uses molecular technology. It is priced at $50, and you need a prescription to use it. Lucira is selling the test directly to health care providers; a spokesman says your doctor can order it for you. It takes about 30 minutes to deliver results.
How accurate are the tests?
Data submitted to the FDA for all of the four tests shows high accuracy rates – above 80 percent — but testing experts noted that their effectiveness in the real world will likely be lower due to user error and other factors.
"When manufacturers are preparing data to submit to FDA, they are conducting studies under very specific, highly controlled conditions that optimize the performance of the test,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories.
The Ellume, Abbott BinaxNOW and Quidel QuickVue tests use the same antigen technology as many of the rapid tests given by health care providers. Antigen tests are less accurate than the gold standard method used by labs called polymerase chain reaction, or PCR.
Studies show antigen tests miss many asymptomatic infections. They work best when you're having COVID-19 symptoms, Wroblewski said. Common signs of COVID include cough, fever, fatigue, muscle aches, congestion, runny nose, loss of taste or smell, nausea, vomiting and diarrhea, according to the U.S. Centers for Disease Control and Prevention (CDC).
The Cue and Lucira tests use a newer molecular technology called isothermal amplification that is similar to PCR. Like PCR, it works by copying the virus's genetic material until there are detectable levels.
David Pride, M.D., director of the clinical molecular microbiology laboratory at the University of California, San Diego, says that while molecular tests are generally more accurate than antigen tests because they can detect the virus at lower levels, they are still less sensitive and less specific than a PCR test done in a lab.
For any at-home test, if you have symptoms and you test positive, “it's very, very likely you have the virus,” Pride said, and you should go into isolation and get in touch with your health care provider.
How confident can you be of a negative result?
A negative test can give you more confidence about going into work or visiting a family member, but experts emphasized that it's not a free pass to stop wearing a mask, practicing social distancing or taking other precautions.
"The danger is that you'll have people use these tests to say I can safely go see grandma, when they may be brewing an infection that is below the limit of detection,” said Gary Procop, M.D., medical director in clinical virology at the Cleveland Clinic. “People really need to understand these subtleties, and they're not all on the package insert,” he added.
Antigen tests, in particular, are likely to miss the virus if you're early in the infection or if you don’t have symptoms.
A study published by the CDC on Jan. 22 found that Abbott's antigen test identified only 34 percent of COVID-19 infections in people without symptoms.
A large-scale review of 68 studies published March 24 found that rapid antigen tests identify about 72 percent of people with symptoms and only 58 percent of those without symptoms. Antigen tests are most accurate when used within the first week after symptoms develop, the review found.
The FDA-authorized instructions for use for antigen tests stress that “negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.”
If you test negative but have symptoms, reach out to your health care provider, because there's a high risk it's a false negative, Procop said. Your doctor may order a PCR test to confirm your result.
How difficult is it to give yourself a test?
The authorized at-home tests all require you to collect a sample by swabbing your nostrils, either just inside or a little deeper, depending on the test. The good news: You don't have to insert a swab into the deepest part of your nose like some of the tests performed by health care providers.
As a general rule of thumb, “make sure you're really swirling it around and hitting skin,” Wroblewski advised. Also, avoid blowing your nose right before you take the test.
All of the tests include detailed instructions with pictures.
When is it better to get the test from a health care provider?
If your symptoms are severe or if you are in a group at high risk of complications from COVID-19, some experts recommend getting tested by a health care provider rather than doing an at-home test.
"With COVID, your oxygen saturation counts can decrease pretty quickly, particularly if you are in a high-risk group, so you want to make sure someone is monitoring your condition,” Wroblewski said.
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High-risk groups include those with cancer, chronic kidney disease, chronic lung diseases, dementia, diabetes, Down syndrome, heart conditions, HIV infection, liver disease, overweight/obesity (BMI of 25 or higher), sickle cell disease, a weakened immune system, stroke or cerebrovascular disease, solid organ or blood stem cell transplant, or substance use disorders, or those who smoke, according to the CDC.
Whether you conduct your COVID-19 test at home or at a clinic, if it's ordered by a licensed health care professional who believes it's medically appropriate, then federal legislation requires your private health plan to cover the cost, said Sabrina Corlette, a research professor who studies health insurance policy at the Center on Health Insurance Reforms at Georgetown University.
Medicare Part B also covers medically appropriate COVID-19 tests when a doctor or other practitioner orders them.
However, it may be difficult to get a health care provider to order the test if you don't have symptoms or a known exposure, Corlette said. And you probably won't be able to get your insurance to pay if you pick up an over-the-counter test at your local drugstore and there's no doctor involved, she said.
"If you're asymptomatic and you just want some assurance before you travel or visit a family member, your primary care provider may say you don't medically need a test,” she said. “But now you can just go and pick one up.”
This story, originally published on January 4, 2021, has been updated to reflect new information.
Michelle Crouch is a contributing writer who has covered health and personal finance for some of the nation's top consumer publications. Her work has appeared in Reader's Digest, Real Simple, Prevention, The Washington Post and The New York Times.