Among the lost opportunities in the federal response to COVID-19 was the failure to make a rapid, easy-to-use, at-home test for the coronavirus available to Americans.
Over-the-counter antigen tests enable people to find out in a few minutes whether they are carrying enough of the coronavirus to infect those around them. At-home tests have been widely available since last year in Europe, notably in the United Kingdom, Germany, and France, where they are generously subsidized by the government.
“Rapid home tests are being sent for free to Swiss households and are being used daily to test children attending German schools,” said John Goodman, president of the Goodman Institute for Public Policy Research and co-publisher of Health Care News. “They are being used to test outbreak neighborhoods in the U.K.
“When it comes to rapid testing, the United States is way behind the rest of the world,” said Goodman.
Shortcomings of Lab Tests
Rapid antigen tests are available in many clinics and pharmacies throughout the United States but processing them requires special equipment and results can take a few hours. When rapid antigen tests were first approved by the Food and Drug Administration (FDA), they required a referral from a medical doctor.
The most widely used COVID-19 test in the United States has been the polymerase chain reaction (PCR) test. But the PCR test has two distinct disadvantages.
First, it takes 24 hours or longer to produce results because most tests must be processed in a laboratory. Such a delay can result in infected people unwittingly spreading the disease while waiting for the test results.
Second, because the PCR test can detect trace elements of dead or near-dead viruses, it can produce “positive” readings even if the patient is not contagious and therefore not a risk to anyone else. By contrast, the less-sensitive antigen test only produces “positive” results when the patient is contagious and poses a risk to others.
Despite these drawbacks, the FDA has stuck with PCR tests, even though an antigen test widely used in Europe is produced by San Diego-based ACON Laboratories. Limited supplies of antigen tests have been available in some U.S. pharmacy chains, but the shortages were not seen as a major problem by federal health officials, because the United States appeared to have turned the corner on COVID-19 in the spring and the Biden administration has been pushing for most of the country to receive the vaccines.
The rapid spread of the Delta variant over the summer renewed calls to make antigen tests widely available.
FDA, White House Reverse Course
Responding to mounting criticism, the FDA on October 4 authorized the sale of ACON Laboratories’ at-home antigen tests. Two days later the Biden White House announced that the administration will make $1 billion available for the purchase of rapid, at-home tests.
At a White House briefing, Biden’s coronavirus coordinator Jeff Zients said 200 million tests per month would be available by December. Zients added that the administration will double to 20,000 the number of pharmacies offering free testing through a partnership with the federal government.
Both antigen and new PCR tests are coming on the market. The problems with PCR tests are well known, but some antigen tests have similar shortcomings. The Australian company Ellume recalled roughly 195,000 of its at-home antigen tests in early October after discovering an increased chance that some kits could deliver a false-positive result, ABC News reported on October 6. According to the Wall Street Journal (October 7), seven companies currently offer over-the-counter antigen tests in the United States, some of which people will soon be able to purchase online.
Home Testing Welcome
The new antigen and PCR tests belated coming on the U.S. market are welcome developments, says Doug Badger, senior fellow in domestic policy studies at the Heritage Foundation and senior fellow at the Galen Institute.
“Widespread availability of rapid COVID-19 tests will enable us to determine if we are infected and take necessary precautions to protect our friends, loved ones, and co-workers,” said Badger.
“The government has been slow to approve these tests and should provide more funding to manufacturers to boost supply, as it did with vaccines,” said Badger. “The Biden administration has finally taken some small steps in this direction, but it needs to do more.”
Bonner R. Cohen, Ph.D., (bcohen@nationalcenter.org) is a senior fellow at the National Center for Public Policy Research.