A Blog by Jonathan Low

 

Sep 19, 2021

The US Lags Other Countries In Promoting Rapid Covid Tests

Manufacturers began to lose interest when it appeared the pandemic was under control in the spring. 

The Delta variant has created demand but a significant supply problem remains - and prices are high compared to other countries - or to vaccination. JL 

Brianna Abbott reports in the Wall Street Journal:

Manufacturers are falling short of demand, and prices remain too high to encourage people to use the tests regularly. Rapid tests now cost $14 for a two-pack at U.S. retailers, compared with $5 or less in countries, including Germany. The U.K. distributes them for free. More than 30 tests in Europe carry the European Union’s mark of compliance. Many tests used in other countries haven’t been submitted for review in the U.S. The FDA has received fewer submissions than the number of tests on the market in some countries.

The U.S. is behind the curve on rapid tests.

The Biden administration last week committed $2 billion to boost test manufacturing and distribute free rapid tests to some community sites. Retailers are discounting their prices for consumers. But manufacturers are falling short of demand, and prices remain too high to encourage people to use the tests regularly, public-health experts and economists say.

Rapid tests now cost at least $14 for a two-pack at U.S. retailers, compared with $5 or less in some countries, including Germany. The U.K. government distributes them for free. In those and some other countries, such tests are nearly ubiquitous, while this summer they became hard to find at some U.S. retailers and e-commerce sites as the Delta variant pushed up infections.


“The U.S. government wouldn’t have let the supply of vaccines run out if it could be avoided, and they shouldn’t have let the supply of rapid tests run out either,” said Zoë McLaren, a health economist at the University of Maryland, Baltimore County. “It’s emblematic of the U.S.’s approach to testing the entire pandemic—laissez faire.”

The White House referred questions to the Department of Health and Human Services, which didn’t respond to requests for comment.

The Food and Drug Administration has authorized over-the-counter rapid-antigen tests from six companies, including two in recent weeks, as well as two at-home molecular tests that use technology similar to a polymerase-chain reaction, or PCR.

Some other countries have made more rapid tests available. Dozens of self-antigen tests are on the market in Germany. More than 30 tests in Europe carry the European Union’s mark of compliance, researchers said. The World Health Organization has approved antigen tests from at least three companies.

An FDA official said that many tests used in other countries haven’t been submitted for review in the U.S. The official wouldn’t say how many at-home tests are under review but said the agency has received fewer submissions than the number of tests on the market in some countries.

“Our role is to ensure the American public has access to accurate and reliable Covid-19 tests,” said FDA spokeswoman Stephanie Caccomo. “Using inaccurate or poor-performing tests endangers lives and thwarts our ability to stop the spread of the disease.”

The most common type of rapid Covid-19 tests are rapid-antigen tests, which can provide results in about 15 minutes wherever the sample was taken. They aren’t as precise as PCR tests, which are most often performed in laboratories and hunt for and amplify the virus’s genetic material.

Some public-health experts and economists started advocating for the use of rapid tests early in the pandemic, when some people were waiting more than a week for test results from overburdened laboratories. Federal health officials launched a competition to fund and support test makers.

The Trump administration bought more than 150 million rapid tests last summer, primarily from Abbott Laboratories, and distributed them to institutions including nursing homes and universities. Some states and organizations procured tests on their own. The tests were authorized for use by healthcare workers in places like nursing homes or schools at the time.

Some sat unused in health-department repositories or nursing-home closets, in part because of logistical burdens including training staff to administer them or report the results. Some public-health experts said they were worried about losing sight of where the virus was spreading if results of the tests weren’t conveyed to officials.

Many doctors and public-health officials were also split over whether they should be used on people without symptoms. Advocates dubbed them “contagiousness tests,” saying they could identify people shedding a lot of virus, whether they had symptoms or not. Others worried the tests weren’t accurate enough.

“We were concerned about quality issues,” said Scott Becker, the chief executive officer of the Association of Public Health Laboratories. “They have largely proven to live up to their claims.”

The FDA in December authorized the first over-the-counter rapid antigen test from Ellume USA LLC, which had been funded in part through the federal initiative to encourage test development. It took months for the $38, Bluetooth-connected tests to arrive at many retailers.

The FDA in March authorized Abbott’s simpler, paper-strip-like rapid test and a similar test from Quidel Corp. for nonprescription purchase as long as they were administered repeatedly over a few days to boost accuracy. The tests appeared on pharmacy shelves and online in April, priced at about $25 for a two-pack.

Countries including the U.K. and Germany distributed rapid tests more widely and encouraged people to use them. The U.K. said in April that everyone in England would have access to free rapid Covid-19 tests twice a week. Germany offered free testing and made a negative result a way to return to bars and restaurants, and self-tests also appeared for sale at retailers. Germany is ending its free testing program in October.

In the U.S., the Centers for Disease Control and Prevention said in May that vaccinated people didn’t need to get tested in most situations, and cases and hospitalizations were dropping. Abbott scaled back production of its rapid test.

Within a few months, the Delta variant prompted a new surge in Covid-19 cases and hospitalizations, and supplies were suddenly stressed.

“There wasn’t a push by the federal government like there was for vaccines,” said Cherie Lynn Ramirez, a biochemist and public health-expert at Simmons University in Boston. “Now we’re realizing we need to do both.”

Public-health experts welcomed the Biden administration’s moves to boost testing last week. But some said more tests and efforts to train people on their use are needed heading into colder months when respiratory illnesses traditionally spread.

“We can’t be caught flat-footed again,” said Mr. Becker, of the public-health laboratories organization.

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