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Millions of rapid COVID-19 test results risk going uncounted

Asimina, a second-grade high school student performs self-testing for COVID at her home in Athens, on the eve of high school opening on April 11, 2021.LOUISA GOULIAMAKI/AFP via Getty Images

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.”


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.