At-Home Covid-19 Tests Are On the Horizon, But Can You Trust Them?

The FDA has not yet approved any at-home tests for Covid-19. Here's why, and some of the reasons you should watch out for fakes.

By now, most people know that the United States has had a severe shortage of tests for Covid-19. These tests are important not only to determine if a particular individual is sick, but also to gauge how far the virus has spread and to aid in efforts to contain it.

The Centers for Disease Control and Prevention (CDC) has sent tests to state and local health departments. However, commercial medical manufacturers are also making tests, including some companies, such as Everlywell and Nurx, that are manufacturing at-home collection kits.

On March 20th, the Food and Drug Administration (FDA) issued a general alert on Covid-19 tests, warning that some may be “fraudulent” and “unauthorized”.

“At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for Covid-19,” the federal agency said. “The FDA sees the public health value in expanding the availability of Covid-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”

So that means that at-home coronavirus tests are not available to the average person. But at some point in the future they could come to the market. How reliable will they be and can they help fight the current pandemic?

There are different kinds of at-home tests

Home tests allow you to test for—or monitor—diseases or conditions at home. They offer convenience and privacy and are usually cost-effective, says the FDA.

These tests fall into one of two categories, says Jacqueline Linnes, PhD, Marta E. Gross assistant professor of biomedical engineering at Purdue University in West Lafayette, Indiana. The first type includes at-home collection tests that involve taking a sample at home (for example, a nasal swab or saliva sample) then sending it to a lab for actual testing and results. The second type of at-home test allows you to both take the sample and get the result at home.

There are dozens of both types on the market, from home pregnancy kits to tests for HIV and other sexually transmitted diseases, hepatitis, urinary tract infections, blood glucose levels and even ketosis tests for people following the keto diet, says Dr. Linnes, whose lab is working on a handheld portable device that could test for Covid-19 and other viruses.

Many types of at-home tests are accurate

The reliability of a test really depends on which test you’re talking about: Home tests that have been approved by the FDA and have been around a while are generally quite reliable. (Look for their accuracy rating on the packaging or the manufacturer’s website.) One home HIV test, says Dr. Linnes, is 99.9 percent accurate.

“One of the keys to a reliable home test will be adequate sample collection,” says S. Wesley Long, MD, assistant professor of pathology and genomic medicine at Houston Methodist Hospital. “Home testing or monitoring for conditions like hypertension or diabetes is well established and useful, and typically uses FDA-approved medical devices.” Dr. Long points out, however, that this type of test is for monitoring already diagnosed conditions. They do not actually diagnose the condition. Home testing for diagnosis is relatively new.

Another issue is the quality of the instructions. “I think that people can do these things if you give them really good instructions,” says Dr. Linnes.

nurse or doctor holding test swab and test tube for coronavirus testingsonreir es gratis/Getty Images

At-home Covid-19 tests have pluses and minuses

Both the Everlywell and Nurx tests are actually at-home collection tests. This means you get a kit that contains everything you need to get a nasopharyngeal (back of the throat and nose) swab. You are responsible for doing the actual swab and sending it off to the lab. The lab will do the testing and get the results, often within 48 hours.

The collection method is a concern for some experts. On the podcast, Sawbones: A Marital Tour of Misguided Medicine, Sydnee McElroy, MD, said the main problem was the consumer’s ability—or inability—to collect an adequate sample on their own. “It’s not something you as a lay consumer at home would necessarily be skilled at doing,” she said in the podcast. “It’s difficult for me to swab myself and I know how to do this. I’ve been trained.” That would throw into doubt the validity of any results. “If you don’t get a decent sample because it is so uncomfortable then you’re going to get a false negative result and then you might think you don’t have it when you do, which is bad.” 

A false negative result, says Dr. Long, “could lead to individuals who have Covid-19 disease thinking they are ‘safe’ and then moving into the community and potentially infecting others, continuing the spread of this disease.” Dr. Long adds that it may be difficult to gauge reliability of at-home Covid-19 tests if a lot of products are coming onto the market at the same time.

According to Everlywell, their test was supposed to go to market for sale directly to consumers on March 23; after the FDA notice, they instead decided to ship their tests for use in hospitals and healthcare settings.

“We launched on Monday [March 23] and shipped our first orders on Tuesday,” a spokesperson told us in an email on March 26. “We’re on track to ship thousands of kits to hospitals, community clinics, and nursing homes.”

It would have cost $135 for consumers to buy the test, although the company says that amount would only cover the costs of what it takes to make the test. The company sends the samples that people collect to labs that have been certified by the government.

“We are working with the FDA on a path forward and hope to make an at-home collect test kit for Covid-19 available soon,” the spokesperson said. The sensitivity and specificity ranges to date for the testing exceed 97% and 93% respectively, the company said. (Sensitivity is the ability to pick up cases and avoid false negatives—situations where someone has the condition but tests negative.  Specificity is the ability to diagnose Covid-19 accurately and avoid false positives—situations where a test says someone has the condition when they actually do not.)

The company also plans to provide free Telehealth consults with an independent physician for people who test positive.”They’re not expecting the user to interpret the results,” says Dr. Linnes.

Nurx also put their direct-to-consumer plans on pause given the FDA announcement, says Allison Hoffman, director of brand and communications at Nurx. “Our partner lab is in daily conversations with the FDA and we continue to remain optimistic and confident about the self-collection test they validated,” she said in an email. “I don’t have any specific timing updates to share with you today.”

“Given new guidance from the FDA on March 21, specific to self-collection laboratory testing, Nurx and our longstanding and trusted laboratory partner Molecular Testing Labs have made the responsible decision to pause on providing any additional self-collection Covid-19 tests,” the company said in a statement.

Another test from the University of Washington involves patients collecting their own sample, but only in a healthcare setting. This helps protect workers, saves precious protective equipment, and is fast, the University says. They conducted a study, in partnership with the Bill & Melinda Gates Foundation and Quest Diagnostics, and found that a self-administered sample collection in a healthcare setting picked up 90% of coronavirus-positive patients.

Beware of scams

For the time being, avoid any at-home test you see: None have been authorized by the FDA. “I would only trust a home test that has received EUA (Emergency Use Authorization) clearance from the FDA or is FDA approved, and only if the instructions on sample collection were very detailed and explicit,” says Dr. Long. “People need to understand how critical proper sample collection is to diagnosing Covid-19.”

Dr. Long points to a New England Journal of Medicine video which demonstrates collecting a sample. “It can be fairly easy to collect an NP specimen from yourself, once you have the hang of it,” he says.

If you’re uncertain, the FDA website can tell you if an over-the-counter test is regulated.

You may not even need a test

Given that there’s no specific treatment or therapy yet for Covid-19, a test may not help you. “If you are stable enough to stay home, you don’t necessarily need to know you have Covid-19 because it will not change your management,” says Dr. Long. Even if you’re sick and have symptoms like a mild fever and cough, you should be staying home, he adds.

“If you are ill enough to have been admitted to a hospital, at that point it might be useful to know so that you could enroll in any therapeutic trials which might help you recover,” Dr. Long says.

And if you’re not ill, the advice is still to stay at home.

What about testing after you’ve been sick?

Right now the priority is on testing people who are already in the hospital along with healthcare professionals in healthcare facilities, says the CDC. People without symptoms are at the bottom of the list and, as of now, there’s no real mention of testing people who have already been sick. At-home tests won’t tell you if you’ve been infected in the past—only if you have the infection at the time the sample is collected. A nose or throat swab won’t pick up on the antibodies found in blood that can indicate a past infection.

(On April 1, the FDA approved the first diagnostic test to look for coronavirus antibodies in blood, which is made by the company Cellex Inc. Although the blood test can also be used to diagnose Covid-19, it’s to be used in combination with symptoms and other tests, and it is not an at-home test, according to the federal agency.)

“Most tests right now are focused on diagnosing acute infection,” says Dr. Long. “After infection, [blood] tests can look for antibodies which have developed in your body to fight the infection to tell you if you’ve been infected previously or not.” These antibodies “are being studied both for their long-term protective effects as well as potential therapeutic use,” he adds. (For more information, read about how plasma from Covid-19 survivors may be a lifesaving treatment.)

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Sources

Amanda Gardner
Amanda Gardner is a freelance health reporter whose stories have appeared in cnn.com, health.com, cnn.com, WebMD, HealthDay, Self Magazine, the New York Daily News, Teachers & Writers Magazine, the Foreign Service Journal, AmeriQuests (Vanderbilt University) and others. In 2009, she served as writer-in-residence at the University of Wisconsin School of Medicine and Public Health. She is also a community artist and recipient or partner in five National Endowment for the Arts grants.