Are At-Home COVID Tests Accurate?

Businesses and workplaces now require customers and employees to be tested negative for COVID before entering the premises. This has resulted in the rise in demand for at-home test kits in recent months. There are a number of at-home test kits which has received authorization from the FDA, but there are some concerns regarding some test kits giving false-positive results. So how accurate are the at-home test kits? Let’s explore this in detail.

As of now, the most accurate COVID test is a PCR test, but this method does not give immediate results as the test has to be sent to a laboratory. The most common at-home tests instead rely on antigen testing. With these at-home antigen tests, there's a ratio of getting false positives or false negatives. Because of the small chance of getting false positives or false negatives, it is recommended that those with lingering symptoms and known exposure who test negative continue to isolate and monitor, and take another test in a few days to get more accurate results.

In the first place, if someone has severe symptoms, it is not recommended that they do a home test. Instead, they should consult with a doctor or their healthcare provider. But if the symptoms are mild and lingering, and test results are negative, then it is recommended to take precautions by isolating and then retake the test in three to five days. This is the reason why most of at-home kits come with two tests.

The advantages of at-home tests

The test that has been available the longest is BinaxNow, which are available at major stores in the country. As of today, there are nearly a dozen over-the-counter tests authorized by the FDA for at-home results. Most recently, the agency gave emergency use authorization to the Celltrion DiaTrust COVID Test, joining other such as BinaxNow and Flowflex. According to the FDA, these tests can be used by people with COVID symptoms, and these tests don’t require prescriptions. It can also be used by people without symptoms for serial testing, which means the test is performed twice over three days. 

Medical experts agree that antigen at-home COVID tests are both accurate and convenient. These at-home tests allow people to buy an accurate and affordable test on their own terms, when and where they need it. They can self-administer the test using a short nasal swab and check test results in 15 minutes. According to the instructions for use for the current at-home tests, people should test themselves twice with at least 36 hours between tests. However, if someone has severe symptoms, it is recommended they consult a doctor, or stay home and get a PCR test. For people with mild or no symptoms, it is strongly recommended to take at-home tests. Those who test negative should continue to stay cautious and isolate as much as possible.

Do positive test results get reported to health officials?

Those who test positive are asked to follow the latest CDC guidelines and communicate the results to the healthcare provider. The healthcare provider is responsible for reporting your test results to the state health department. However, this process is not enforced for every test. Though many home tests are not being reported, most positive results are still provided to healthcare providers, then to the health departments.

What about false positive results?

The FDA has previously issued an alert about the potential for false-positive results with some home COVID tests produced by Ellume, which were sold at various retailers across the country. It was noted that there was an increased chance that Ellume COVID Home Tests may provide an incorrect positive result. However, the company clarified that the reliability of negative results is unaffected by this issue and are not included in the recall. A manufacturing issue is said to be the cause of the false positive results, and the affected test kits are being pulled off store shelves.

The FDA recommends contacting your healthcare provider, urgent care facility, or other COVID testing sites and request a COVID molecular diagnostic test if you received a positive test result with one of the affected lots of the Ellume COVID Home Test in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result. But according to the FDA, all tests can experience some degree of false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their healthcare provider. Individuals who test negative and experience COVID symptoms should also follow up with their health care provider as negative results do not completely rule out a COVID infection.