The difference in the development of COVID-19 tests is a tale of many contrasts in the two nations’ public health systems.
March 18, SEOUL - In late January, South Korean health officials summoned representatives from more than 20 medical companies from their lunar New Year celebrations to a conference room tucked inside Seoul’s busy train station.
The United States, whose first case was detected the same day as South Korea’s, is not even close to meeting demand for testing. About 60,000 tests have been run by public and private labs in a country of 330 million, federal officials said Tuesday. The delayed and chaotic testing in the United States will cost lives, potentially including those of doctors and nurses, many medical experts predict. Already more than 100 people have died overall, and fears of rampant spread have led to extraordinary restrictions on social interaction, upending the U.S. economy, schools, hospitals and everyday life.
South Korea took a risk, releasing briskly vetted tests, then circling back later to spot check their effectiveness. By contrast, the United States’ FDA said it wanted to ensure, upfront, that the tests were accurate before they went out to millions of Americans. It’s a problem many Americans, accustomed to hearing they have the most advanced medical care in the world, find hard to fathom.
“The government acted quickly,” said Myoah Baek, an executive director at Kogene. The Korean CDC “disclosed information on test methods so test kit makers were able to speed up development.”“Of course, a kit that’s approved in one week isn’t as good as one that goes through a year of clinical trials,” he said. So in the early days, Lee said, the government cross-checked cases to ensure the tests were working properly.
Though coronavirus was now the hottest topic in global medicine, a broadcast of the meeting conveyed little sense of urgency about the epidemic sweeping the globe. It was mentioned in passing but regulators mostly stuck to their Powerpoint presentations. As of mid-February, the federal government remained stuck in first gear. The CDC was the primary supplier of tests across much of the country, and other labs couldn’t immediately deploy their own without the FDA’s blessing.
The declaration eased the way for drugmakers to pursue vaccines and antiviral treatments for COVID-19. But public health experts said that the same declaration made it harder to expand diagnostic testing outside the CDC. “Traditional public health thinking is,‘Don’t create widespread panic and don’t go over the top. Keep the testing narrow in a precision rifle approach rather than a mass, shotgun approach,’” Schaffner said. “That failed in this instance. This virus acted differently and it overwhelmed the U.S. system. South Korea had a much better sense of what was happening.”
In mid-February, cases spiked at a secretive church in the southeastern city of Daegu. On Feb. 26, Daegu city officials said they would test every single member of the church, including those without symptoms. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories,” Scott Becker, chief executive of the Association of Public Health Laboratories, and Grace Kubin, lab services director at the Texas Department of State Health Services, wrote to Hahn on Feb. 24 in a letter reviewed by Reuters.
Two days after receiving Becker’s letter, the FDA commissioner said his agency was ready to approve new outside tests quickly - if its requirements for accuracy were satisfied. On March 2, Stenzel at the FDA’s diagnostic testing office hosted a webinar for lab test developers, highlighting additional challenges, including a shortage of viral samples needed for validation of test results. Some labs also have reported shortages of other key supplies and ingredients, as well as the need for more trained personnel.
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