President Joe Biden took to social media recently to announce that Americans can once again order free covid-19 tests.
“Covid cases are rising across America as folks gather for the holidays,” Biden tweeted on Dec. 15. “That's why, starting today, every household can order 4 free Covid tests to be shipped straight to your door.”
The program was paused in September after more than 600 million tests were distributed.
Covid-19 cases have resurged in the U.S. in recent weeks, with nearly 459,000 cases reported the week of Dec. 7, including nearly 3,000 deaths,.
Health officials are concerned about the coming winter and the so-called tripledemic of the coronavirus, influenza and respiratory syncytial virus, or RSV.
The situation prompted various cities and counties to encourage people once again to wear masks in indoor public spaces.
Detect Inc. Recalls 11,000 Home Covid Test Kits
Meanwhile, health officials said that Detect Inc. was voluntarily recalling about 11,000 of its at-home covid-19 tests because they may produce false negative results.
The recall affects a total of 11,102 tests shipped to customers from July 26 through Aug. 26, the U.S. Food and Drug Administration said on its website.
The FDA granted this test emergency use authorization on Oct. 28, 2021. Affected lots from Detect include HB264, HY263 and HY264.
"Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots," the FDA said.
"To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution."
The reliability of positive test results is not affected, the FDA said.
Detect is notifying all customers and distributors affected by the recall. Anyone who has any unused tests from the affected lots should dispose of them.
The outer packaging is recyclable while all the test components can be discarded as regular trash, the FDA said. Detect Hubs are not affected by the recall and do not need to be discarded.
The company has also agreed to issue refunds for recalled tests.
Detect, which is based in Guilford, Conn., was founded by a scientist and entrepreneur, Jonathan Rothberg, and a consumer-electronics executive, Hugo Berra, at the outset of the covid-19 pandemic. They aimed to bring rapid and affordable lab-quality pathogen testing into the home.
Rothberg, according to the company’s website, “is best known for inventing and commercializing massively parallel DNA sequencing,” which earned him a National Medal of Technology and Innovation from President Barack Obama,
Rothberg, who was named Connecticut's Innovator of the Year by the Hartford Business Journal this year, is the founder of several health technology companies, including CuraGen, 454 Life Sciences, Ion Torrent, Butterfly Network. Quantum-Si, and Hyperfine.
In an interview with the Hartford Journal, Rothberg said that Detect was born out of his intuition in the earliest days of the pandemic that covid-19 "was about to upend science." He added that it proved comparable "to a world war in terms of spurring technological change."
First Home Covid Test Approved in 2020
More than 20 versions of at-home covid test kits have been approved by the FDA.
The FDA authorized the first home covid-19 test on Nov. 17, 2020, when the agency issued an emergency-use authorization for the Lucira Covid-19 All-In-One Test Kit, a molecular single-use test intended to detect the novel coronavirus SARS-CoV-2 that causes covid-19.
Stephen Hahn, who was FDA commissioner at the time. said in a statement that "this new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
The Centers for Disease Control and Prevention said in a March 25 study that "providing reliable and low-cost or free at-home test kits to underserved populations with otherwise limited access to covid-19 testing could assist with continued prevention efforts."
The report said that a rapid increase in U.S. at-home-test use occurred between the SARS-CoV-2 delta- and omicron-predominant periods.
At-home-test use was lower among persons who self-identified as African-American, 75 years or older, had lower incomes, and had a high school level education or less, the report said.
Covid-19 testing, including at-home tests, along with prevention measures such as quarantine and isolation when warranted, wearing a well-fitted mask when recommended after a positive test or known exposure, and staying up to date with vaccination can help reduce the spread of covid-19, the CDC said.
