The regulator reportedly extended the expiration date of some COVID-19 test kits. It appeared to be a move to assuage concerns among the general public that the free COVID-19 tests would be useless. The Biden administration first procured the free test kits – actually charged to the taxpayer dime – in January 2022.
"To help ensure Americans have tests on hand if a need arises, the Biden administration is purchasing one billion at-home, rapid COVID-19 tests to give to Americans for free. A half-billion tests will be available for order on Jan. 19 and will be mailed directly to American households … within seven to 12 days of ordering," the White House said in a Jan. 14, 2022 statement. (Related: Biden's free COVID tests found to be not helpful as false positives skewed pandemic picture.)
The FDA's move followed remarks by the Centers for Disease Control and Prevention (CDC) that related hospitalizations have increased by over seven percent in the past month. According to the CDC, the COVID-19 tests currently in circulation will work with the BA286 Pirola and EG5 Eris strains of SARS-CoV-2.
The move also coincided with a $600 million investment by the Biden administration to bolster domestic manufacturing of COVID-19 tests. This amount would be distributed among 12 domestic test makers, according to a Sept. 20 statement by the Department of Health and Human Services (HHS). It also announced the reopening of the COVIDTests.gov website for those wanting to obtain the free test kits.
"These critical investments in U.S. manufacturing will improve preparedness for COVID-19 and other pandemic threats of the future; strengthen the nation’s capacity to manufacture tests; and secure approximately 200 million new over-the-counter COVID-19 tests for future federal government use," the HHS statement said.
Despite the FDA guidance assuring that the expired tests are still safe to use, many medical professionals advise against doing so. Professor Nam Tran, a senior director of clinical pathology at UC Davis Health, warned that continuing to use test kits beyond the indicated expiration date would give false results.
According to him, the public is better off using brand-new tests, adding: "Would you drink milk that expired months ago?"
Tran explained that most home COVID-19 test kits are antigen-based lateral flow assays. These tests use antibodies from the manufacturer to capture proteins of interest – in this case, SARS-CoV-2 proteins. The kits also come with a liquid solution that can break the virus apart.
"For some tests, this [liquid] helps kill the virus and releases viral proteins that are essential for detection," the professor explained. "This solution also helps move the protein along the test strip to enable the tests to detect the unique antibodies."
If even one of these components is compromised as the kit ages, the test could produce unreliable results.
"Chemicals can go bad. The antibodies used to detect the virus can degrade due to time, heat and air exposure. Even humidity getting into the test kit can impact the paper strip, among other issues," said Tran.
"The risk is that you get a false negative and then spread the disease. Alternatively, a false positive may prevent you from going to work or other functions. Essentially, if you get a false answer – you may be worse off than if you didn't test at all."
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Watch this NewsNation report about the dangerous chemical sodium azide present in rapid COVID-19 test kits, which the Biden administration is issuing for free.
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