Many U.S. At-Home COVID-19 Test Results Could Be Going Unreported

Popular at-home COVID-19 tests from Abbott Laboratories and Quidel Corp., available without a prescription, were launched without a mechanism for reporting results to health officials, potentially leaving many cases uncounted by authorities as the delta variant spreads around the U.S.

How many of the products have been sold in pharmacies and online and used isn’t clear. When Abbott’s BinaxNOW Self Test became available through retail stores in late April, the company said it planned to make at least tens of millions each month. The company last month said a group of COVID tests including BinaxNOW brought in $1 billion in global sales.

While COVID testing sites and labs are required to report their findings, the Food and Drug Administration relaxed requirements for some at-home tests to speed their path to market. Abbott said customers are encouraged to report results of its tests, while Quidel didn’t respond to a request for comment.

COVID cases are still one of the best indicators of the direction of the pandemic, and health officials are watching them as closely as ever for signs that the latest surge may be near a peak, at least in some parts of the U.S. Although new, accessible testing technologies have been helpful, data gaps can be dangerous, said Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health who studies diagnostics.

“We should be doing a better job of keeping track,” he said in an interview. “We should be planning and creating ways that really allow us to capture that information, for no other reason than for monitoring and planning at the public health level.”

Instead, once a person finds out they’re positive, “then their families are going out and buying the same kind of test. And nobody knows that there’s a little cluster of people that are infected right here,” he said. “The public health authorities don’t have any view into that.”

Abbott and Quidel shares were little changed as of 3:45 p.m. Monday in New York.

Testing has long been a key way to measure the spread of the coronavirus and risk posed in different parts of the country, although it has taken a back seat since vaccines became available late last year. With nearly 30% of adults still lacking even a single shot, the U.S. is again navigating a wave of COVID-19 cases that’s stretching hospital capacity and threatening plans to return to workplaces and schools.

About 9% of U.S. virus tests over the last seven days returned positive results, according to Centers for Disease Control and Prevention data, well above a World Health Organization threshold of 5% or lower for reopening. About 1.2 million tests a day, on average, were performed and reported last week through Friday, according to data compiled by Bloomberg.

Authorized by the FDA at the end of March, the Abbott BinaxNOW Self Test and Quidel QuickVue At-Home OTC COVID-19 test are user-friendly and don’t require prescriptions. They use a self-collected swab to seek out a specific viral marker, providing results in 10 to 15 minutes. The cost for a pack of two is $20 to $25.

As demand for the rapid tests waned earlier this year, Abbott told workers to get rid of the products, laid off employees and shut down one of its factories, according to a New York Times report.

In a response to the same article provided to Bloomberg, Abbott said that test cards were destroyed, not completed products, and that they were near the end of their shelf life and couldn’t have received approvals quickly enough to be provided to governments overseas. Abbott chose to store parts of those tests, such as reagent bottles, swabs and nitrocellulose strips “in the event that we needed to scale back up, which is exactly what’s happening now,” according to a statement.

Demand Rebuilds

Interest has surged, with over-the-counter COVID tests becoming top sellers since mid-July at CVS Health Corp. stores that sell BinaxNOW and other products, according to a CVS spokesperson.

On Friday, the BinaxNOW product was listed as the No. 1 seller on the Amazon.com Inc. website’s industrial & scientific category, ahead of face masks and toilet paper; the Quidel QuickVue at-Home OTC test ranked 10th. The BinaxNOW test was listed as usually shipping within one to three weeks, and the Quidel test was sold out. BinaxNOW has since become unavailable, too.

While lack of a prescription requirement takes some of the red tape out of getting tested, health-care providers and laboratories aren’t involved, making results harder to track. Some other at-home testing companies require the use of an app to read a positive or negative result. The app automatically reports the result.

Abbott said in a separate statement that it prioritized developing the test and making it available to people, and that users were encouraged to report results through their health-care providers. Under a recent update to the test’s emergency use authorization, test-takers will be able to report results using Abbott’s Navica website or phone application — but it’s optional.

Self-Reporting Encouraged

“We encourage all people to report their test results and Navica will now allow them to do this in an easier way, but it is reliant on the individual to report,” a spokeswoman said. “This development will help give better visibility to public health officials about the status of COVID in their communities.”

When the FDA gave the Abbott and Quidel tests emergency authorizations, the regulator required them to develop reporting mechanisms “so as not to delay consumer access to at-home tests,” an agency spokesman said.

“FDA’s approach to reporting mechanism requirements at the time of authorization provided maximum flexibility in working with test developers to help meet the needs of both individual consumers and populations in the context of a rapidly changing pandemic,” the spokesman said.

Other virus tests, including another Quidel at-home product, the QuickVue At-Home COVID-19 Test, which requires a prescription, have also been cleared without a way to report results to public health officials, the FDA spokesman said. In those cases, the agency has asked companies to later develop a way to help with results reporting.