There have been reports of fraudulent tests on the market. The Food and Drug Administration (FDA) recently recalled about 200,000 test kits that were not authorized.
Luckily, the federal government will soon be mailing out free authorized at-home rapid antigen tests to anyone who wants them. However, the help is coming a little late in the game. People have been scrambling to in-person and online storefronts to stock up on tests throughout the pandemic.
Recalled Test Kits
Recently, the FDA recalled 200,000 boxes of the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which is made by ACON Laboratories. The test does not have an emergency use authorization (EUA) from the FDA. The recalled test is in a blue box while the approved version is in a white box.
However, ACON has another test—the Flowflex COVID-19 Antigen Home Test—that does have FDA authorization.
Recalls have also affected Ellume at-home tests, which were authorized, but showed too many false positives.
In addition to the recalled tests, fake test kits have also started to circulate. The Federal Trade Commission (FTC) is warning consumers that not only are the bogus tests a waste of money, but they’re also dangerous. Unreliable test results could mislead people who are sick with COVID-19 and contribute to the continued spread of the virus.
Fake Tests and Sites
Local and state public health departments have been distributing at-home test kits, too. While they might seem like a safe bet, some of these locations have also fallen prey to unauthorized testing. At least one county in New York found that it was giving out kits that had been recalled by the FDA and specifically two test sites in Orange County gave out these unapproved tests.
Gigi Gronvall, PhD, a senior scholar at the Johns Hopkins Center for Security at the Bloomberg School of Public Health who is working with the school’s COVID-19 Testing Toolkit, told Verywell that sellers of fake tests are “looking to make a quick buck.”
Gronvall is “thoroughly unsurprised” that fraudulent tests and sites have popped up and said that one reason why we’re in this situation is that we’ve taken “a market-based approach to testing” throughout the pandemic.
Before the Delta variant showed up, there were plenty of rapid tests available, but the need for them tailed off as COVID vaccines arrived. Since manufacturers reduced production, the country was caught short when new variants like Omicron appeared. Now, test manufacturers have ramped up production again, but it’s lagging behind the demand.
As the demand for testing increased, sites that offered rapid testing started to pop up on streets in cities around the country. While most are valid and run by health organizations, fraudulent sites have appeared, too.
For example, fake sites in Chicago were asking for people’s credit card information or Social Security numbers. Giving out this sensitive information, which should not be required for a real COVID test, opens people up to identity theft. In Philadelphia, a fake testing site claimed that it was working for the Federal Emergency Management Agency, which was not true.
Signs a Test Is Real
Robert Amler, MD, MBA, the dean of the School of Health Sciences and Practice at New York Medical College, told Verywell that the best indication that a test is reliable is that it’s FDA-authorized.
According to Amler, who is also the former Chief Medical Officer at the Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry, “many test descriptions indicate FDA emergency use authorization (EUA), but some may not show it.”
Your first step should be carefully checking the packaging for the product. It should describe the type of test and whether it has any approvals or endorsements. The package should also include instructions for using the test.
Being mindful about where you purchase a test matters, too. To avoid getting a test that’s not the real deal, Gronvall suggested “going to a reliable retailer if you’re going to buy them.”
Conserving Our Test Supply
Testing is still a crucial part of controlling the pandemic. While the most accurate COVID tests are those that detect very small amounts of the COVID-19 virus (polymerase chain reaction [PCR] or nucleic acid amplification tests [NAAT]) they’re not always the easiest and fastest option.
There are situations where it makes sense to use at-home tests, which are rapid antigen tests. They detect viral proteins called antigens that show if you have a current COVID-19 infection. You’ll usually get the results in a half hour—and without having to leave your home.
“Remember that any positive test is a positive result, with extremely rare exceptions,” said Amler, though as a reminder, they added that the accuracy of any COVID-19 test depends on factors “such as the timing of specimen collection and whether the specimen was collected and handled properly.”
For the most part, Amler said that “once you test positive, there is no further value or need for testing. Indeed, health departments ask that you not test anymore to avoid depleting the short supply of test kits.”
The bottom line? Once you’ve got enough legitimate at-home COVID-19 tests for your household, think carefully about using them—and try not to stockpile more than you really need.
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.
Here are some resources to make sure that tests you get are legit:
The FTC has information on how to avoid buying fake COVID tests here. The FDA has a list of authorized antigen and PCR tests here. You can now order 4 COVID-19 antigen test kits to be mailed to your home by the United States Post Office. Orders will ship starting in late January.
