It’ll soon get easier to find out whether a person has COVID-19 without leaving home or sending a swab specimen to a lab.
Three rapid at-home tests that provide results in minutes have been cleared by the U.S. Food and Drug Administration for emergency use and should start becoming more readily available.
The new options will be much quicker than driving to a test site or taking a home test that requires consumers to ship a nasal swab or a saliva sample to a laboratory, allowing people to self-isolate right away if they get a positive result.
That can be “a tremendous game changer,” particularly if the tests can reliably detect the disease when someone is still infectious, said Dr. Howard Forman, who directs the health care management program in the Yale School of Public Health in New Haven, Connecticut.
“One of the limitations to our testing schemes right now — and the public misunderstands this, I think — is it's not enough to diagnose somebody as having (COVID-19). The real intention is to get them off the street before they spread it,” Forman told TODAY.
“For the average person who is not willing to isolate until they know that they have the illness, that could make a huge difference in terms of mitigating spread in our communities.”
The at-home tests reduce the burden on labs and give Americans more testing options “from the comfort and safety of their own homes,” said Dr. Stephen Hahn, the FDA commissioner, in a statement.
How do they work?
The kits include a swab for people to insert into their nose — but usually not as deeply as the traditional tests — and a test card or portable device where the sample is inserted and automatically analyzed. Some of these devices connect to the internet via Bluetooth.
Like other testing options, some of the new products rely on antigen testing, while others on molecular testing.
An antigen test — which detects specific proteins from the virus — can offer faster results with less lab work, but it’s less sensitive than a molecular test. Positive results are “usually highly accurate,” while negative results may need to be confirmed with a molecular test, the FDA noted.
A molecular test detects the virus’s genetic material and is “typically highly accurate,” according to the agency. Both types of tests diagnose an active coronavirus infection.
Forman, who has been testing an at-home option that hasn’t received FDA authorization yet, said there can be issues with people swabbing themselves incorrectly — a user error he's committed a couple of times.
“You have to be able to do it right in order for it to be a useful result,” he said. “In perfect hands, they may work really well. But if they're not in perfect hands, how reliable will they be?”
People should still wear masks and social distance even if they get a negative result. The tests can reduce the risk, not eliminate the risk, Forman said.
Will the tests be covered by insurance?
Health insurance providers continue to cover the full cost of any test that's recommended by a health care clinician, including at-home tests, said David Allen, a spokesman for America's Health Insurance Plans, an industry trade association.
The question remains whether someone who has no symptoms and no prescription would get reimbursed for a rapid test. Forman doubted that would happen, but anticipated the price of the tests would eventually drop to $5.
“We need a whole industry around this — this should be so common that there are 20 companies competing in this space, maybe even more,” he said.
Here are the at-home tests coming to the market:
This antigen test will be available by prescription for people who are suspected of having COVID-19 by their doctor and are within the first seven days of the start of symptoms.
If those criteria are met, the test kit will be shipped directly to the patient’s home or a pick-up location. People swab themselves and the sample is analyzed through a test card and smartphone app under the supervision of an eMed telehealth provider. For patients younger than 15, the FDA recommends that an adult perform the nasal swab. Test results are ready in about 20 minutes, according to eMed.
The test correctly identified 91.7% of positive samples and 100% of negative samples in people with symptoms, but Abbott said results from four investigational sites are still being analyzed.
Availability: 30 million kits are expected to be available in the first quarter of 2021, with an additional 90 million tests available in the second quarter, according to Abbott.
Also an antigen test, this option received emergency use authorization from the FDA in mid-December. It doesn’t require a prescription, with the FDA calling an over-the-counter at-home option “a major milestone” in COVID-19 testing.
It requires a user to perform a nasal swab and place the sample into a Bluetooth-connected analyzer that syncs with a smartphone app.
The test correctly identified 96% of positive samples and 100% of negative samples in people with symptoms, the FDA said. In people who are not symptomatic, the test correctly identified 91% of positive samples and 96% of negative samples.
Cost: Currently estimated at $30 or less
Availability: Ellume expects to produce more than 3 million of the tests in January. They will be available in pharmacies, drug stores and online, the company told NBC News.
This molecular at-home test, which received emergency use authorization from the FDA in November, requires a prescription.
It’s meant for people 14 and older who are suspected of having COVID-19 by their doctor. (The test can be used in children under 14 if the nasal swab is performed by a health care provider in places such as a doctor’s office or a hospital.)
The test works by swirling the self-collected sample swab in a vial that’s then placed in the test unit. Results appear in about 30 minutes and can be read directly from the test unit’s light-up display, according to the FDA.
The test correctly identified 94% of positive samples and 98% of negative samples when compared to the results of a high-sensitivity test, the company said.
Availability: The kits are initially being rolled out in California and Florida and will be widely available across the country in the spring of 2021.
This story was updated on Jan. 27, 2020.