Several obstacles contributed to ongoing testing shortfalls

From the early days of the coronavirus outbreak in the U.S., several obstacles contributed to ongoing testing shortfalls, including critical supply shortages and vague guidelines on whom to test. Adding insult to injury, a weeks-long testing delay deterred public health officials from aggressive and widespread testing. Had federal agencies fully executed their plan to ramp up testing during a national health crisis, it may have significantly reduced the speed and scale of the pandemic’s scope.

While many public health labs were waiting for the revised CDC tests, commercial and clinical labs were banned from conducting their own tests without undergoing an elaborate, slow process approved by the U.S. Food and Drug Administration (FDA).

Government delays and testing inaccuracies

Testing is critical for identifying people who have been infected and understanding the exact scope of the outbreak. However, when the initial test from the Centers for Disease Control and Prevention (CDC) was presented to state public health laboratories in early February, one of its components was flawed. It took weeks to correct, and labs across the country were largely sidelined. While many public health labs were waiting for the revised CDC tests, commercial and clinical labs were banned from conducting their own tests without undergoing an elaborate, slow process approved by the U.S. Food and Drug Administration (FDA).

Excessive government bureaucracy?

Three “alphabet soup” agencies within the U.S. Department of Health and Human Services (HHS)—the CDC, the FDA, and CMS (Centers for Medicare & Medicaid Services)—have overlapping authority over laboratories and testing. For example, before the CDC could distribute its test kits to public health labs, it needed FDA approval for an “emergency use authorization” (EUA), which the FDA issued to the CDC on February 4.

On February 6, CMS asked state health officials who survey labs to notify the agency if they discovered any labs working to conduct a coronavirus test without an emergency use authorization. CMS explained the memo was to confirm that “laboratories are following protocols to ensure accurate testing and patient safety.”

CMS asked state health officials who survey labs to notify the agency of labs working to conduct a coronavirus test without an emergency use authorization. CMS explained the memo was to confirm that “laboratories are following protocols to ensure accurate testing and patient safety.”

Developing valid tests far easier than getting approval?

Developing the coronavirus test was easy for most labs; however, getting approval from the FDA and CDC was not as easy. Initially, the FDA required private labs to duplicate the CDC’s test design and have the agency review their tests before they could begin administering them. It took more than three weeks and growing public criticism for the FDA to update its guidelines to allow certain labs to start testing once they had validated their tests internally.

The FDA loosened its regulations on February 29, allowing clinical labs to test for coronavirus using tests they developed and validated. However, they were required to notify the FDA and submit EUA requests within 15 days. The FDA made additional changes on March 16 to enable broader testing, after weeks of pressure from labs across the country.

A spokesman for the CDC, Benjamin Haynes, acknowledged that “the agency’s quality control measures were insufficient during the coronavirus test development.” At the same time, the FDA also took a hit for not initially allowing private labs to begin ramping up production of their own tests.

Spokesman for the CDC, Benjamin Haynes, acknowledged that “the agency’s quality control measures were insufficient during the coronavirus test development.” At the same time, the FDA also took a hit for not initially allowing private labs to begin ramping up production of their own tests.

South Korea’s moment

The U.S. and South Korea both reported their first coronavirus case within a day of each other. Just a week later, South Korean officials allowed their commercial labs to develop coronavirus tests. Within two weeks, they were shipping thousands of test kits daily. By mid-March, South Korea’s per-capita testing rate was 40 times higher than the U.S., and they were able to “flatten the curve” of coronavirus cases by late March, without mandating a nationwide shutdown. It would appear that South Korean public-health officials recognized the necessity of early and expansive testing and the importance of isolating new patients.

“It’s the failure of a federal strategy that led us to his point,” said Dr. Joshua Sharfstein, a professor and vice dean at Johns Hopkins Bloomberg School of Public Health.

An opinion only time will completely answer

“It’s the failure of a federal strategy that led us to his point,” said Dr. Joshua Sharfstein, a professor and vice dean at Johns Hopkins Bloomberg School of Public Health. Containing a pandemic requires close collaboration between the CDC, the FDA, and other parts of the Department of Health and Human Services. An HHS investigation into the COVID-19 testing debacle is under way, however they are not expected to release their report until 2021.