A recent survey indicates that fewer than half of Americans intend to receive COVID-19 or flu vaccines this year. In parallel, some of the leading manufacturers of highly accurate home COVID-19 tests have voiced their exclusion from the latest round of free tests being offered by the Biden administration through COVIDTests.gov. This initiative, now in its seventh iteration, will again emphasize less sensitive “antigen” tests, which tend to be the less expensive options found at pharmacies.
Federal health officials have defended their investment in various test manufacturers, asserting that it is essential to support U.S. factories that can produce tests in preparation for potential future pandemics, especially as current demand for testing has significantly decreased.
The funds have primarily gone to companies producing affordable rapid antigen tests, such as Access Bio and iHealth, rather than to more precise “molecular” tests that the Food and Drug Administration has also approved.
A spokesperson from the Administration for Strategic Preparedness and Response stated that all tests distributed meet the FDA’s sensitivity and specificity requirements. The spokesperson emphasized that the administration has focused on acquiring tests that are not only affordable but also accurate and made domestically.
The FDA has currently authorized only four over-the-counter molecular COVID-19 test brands, which are considered the most accurate yet also the most costly options. These include:
– Lucira by Pfizer, priced at $39.99 for a single-use test detecting both COVID-19 and influenza, with results in about 30 minutes and an 18-month shelf life.
– Aptitude Medical Systems offers a “starter bundle” for $99.97, which includes a reusable reader and two test kits, with additional kits for $24.99. Results also take around 30 minutes and have an 18-month shelf life.
– 3EO Health sells a “starter kit” for $195, which includes a reusable testing device and two swabs, taking around 30 minutes for results, with a four-month shelf life for the tests.
– Cue Health’s reusable reader costs $199, although test kits are currently out of stock. Results can be obtained in about 20 minutes, with a shelf life of four months.
These prices surpass those of antigen testing options, but manufacturers point out that COVID-19 tests can typically be purchased using flexible spending or health savings accounts, and may be reimbursable through certain health insurance plans.
Molecular test results can take longer to obtain because they rely on chemical reactions to amplify the virus traces that might be missed by less accurate tests. This method allows for a sensitivity rate of over 90%, even in asymptomatic individuals.
In contrast, the FDA cautions that those relying on antigen tests should be prepared to utilize multiple kits if they suspect infection. Antigen tests carry a higher chance of false negative results, particularly in the early stages of infection, prompting the FDA to recommend repeated testing over several days following an initial negative test.
This distinction is vital at the onset of a COVID-19 infection, as the CDC notes that individuals are typically most contagious just before and after symptoms emerge. The CDC’s latest guidance indicates that receiving a negative result on antigen tests can still serve as a helpful “option” in determining when it may be safe to end isolation and provides a rough estimate of ongoing infectiousness.
Regarding the brands of antigen tests being distributed by COVIDTests.gov, manufacturers have confirmed they continue to supply kits to the federal government via previous contracts. These tests are being allocated to health centers, long-term care facilities, food banks, and other community outlets.
Some of the brands that have secured the FDA’s traditional marketing authorization to continue selling tests as emergency measures conclude include:
– CorDx, offering two-packs at $14.99 with results in 10 minutes
– iHealth Labs, presenting two-packs for $17.98 with results in 15 minutes
– InBios International, selling two-packs for $8.50 with 20-minute results
– Quidel Corporation, pricing two-packs at $16.99 with 10-minute results
Certain tests remain under emergency use authorization, such as OraSure’s InteliSwab kit, which is being provided for free to Americans who are blind or have low vision through the Administration for Community Living. Although antigen tests are less accurate than molecular tests, the ASPR maintains that they will still be capable of detecting currently circulating COVID-19 variants this year.