FDA cracks down on faulty antibody tests

The Trump administration said Monday it will scrutinize coronavirus antibody tests more closely in response to fears that companies are selling faulty kits as the U.S. response to the COVID-19 pandemic enters the critical phase of figuring out who has been infected, who is most at risk and whether the nation can reopen without major setbacks.

Known as serological tests, the products help determine whether someone has been infected with the coronavirus and has developed natural defenses to it.

Governors see the testing as key to deciding who might be safe to go back to work, though lab associations and others aired concerns about flimsy tests on the market.

The Food and Drug Administration said it will require commercial manufacturers to submit requests for “emergency use authorization” within 10 days of notifying regulators that they had validated their tests.

Previously, companies could validate and sell their tests without emergency use authorization.

A dozen tests have undergone early vetting, but more than 200 have entered the pipeline since the FDA issued its policy on March 16, raising concerns about reliability.

The FDA said it is trying to remain flexible as the nation grapples with COVID-19.

“However, flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” senior FDA officials wrote in a blog post explaining the move. “Some test developers have falsely claimed their serological tests are FDA approved or authorized.”

FDA Commissioner Stephen M. Hahn said he expects companies that are unable to submit requests to withdraw their products from the market.

A faulty antibody test could give false assurance about immunity and exacerbate the transmission of the coronavirus.

Many states have begun to relax societal restrictions and reopen their economies while maintaining some degree of social distancing.

Cases of COVID-19 soared in March, forcing governors to issue stay-at-home orders and the White House to issue guidelines calling on people to work and learn at home and to avoid large gatherings.

The restrictions have helped some places “flatten the curve” of transmission and ensure adequate resources to handle the number of COVID-19 patients, though the nation is still reporting 25,000 to 30,000 new cases and 1,500 to 2,000 deaths per day in various parts of the country, indicating a long slog before the crisis is over.

The epidemic curve “does not decline as quickly as it rises in many cases,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

As social distancing regulations are relaxed, “there will definitely be more cases and we will be dealing with this virus until we have a vaccine,” he said. “The key metric always has to be keeping the cases to a pace the hospitals can handle.”

The New York Times reported Monday that it obtained an internal Trump administration document that projects a steady rise to 200,000 cases and 3,000 deaths in the U.S. each day by June 1.

“This is not a White House document, nor has it been presented to the coronavirus task force or gone through interagency vetting,” White House deputy press secretary Judd Deere said. “This data is not reflective of any of the modeling done by the task force or data that the task force has analyzed. The president’s phased guidelines to open up America again are a scientific-driven approach that the top health and infectious disease experts in the federal government agreed with. The health of the American people remains President Trump’s top priority, and that will continue as we monitor the efforts by states to ease restrictions.”

Records to date show the coronavirus has infected nearly 1.2 million people and COVID-19 has killed nearly 69,000 in the U.S.

New York Gov. Andrew Cuomo said Monday that 226 people died in his hard-hit state during the previous 24 hours, marking a steady, weekslong decrease. Still, the governor said, it’s a long road to normalcy.

“The decline is not as steep as the incline,” he said.

He said New York and the U.S. at large are contending with unknowns. He pointed to a new report from the Centers for Disease Control and Prevention tying strains collected in the New York City area to an origin in Europe as an example of how the situation is constantly changing and officials are learning on the fly.

“The truth is that nobody knows what happens next and when it happens,” he said.

One of the big unknowns is whether people who survive COVID-19 are protected partially or fully from reinfection.

Dr. Hahn said the presence of antibodies should not be viewed as a stamp of full immunity. However, he said the tests will help scientists learn more about COVID-19, such as its prevalence and the share of people who get infected with the coronavirus but never show symptoms.

Scientists say those who have survived COVID-19 should have some defenses, even if the full extent is not clear.

“I do anticipate that people who are antibody-positive will at least have a lower risk of infection than someone who is fully susceptible,” said Michael Mina, an assistant professor of epidemiology at Harvard T.H. Chan School of Public Health.

For instance, a family member who shows signs of antibodies might be designated as the food shopper for the household.

“If somebody has to go to the grocery store, then it might as well be someone who has already been infected and recovered,” he said. “I think it just makes sense from an immunological perspective.”

Serological testing also will give disease trackers a sense of the arc of transmission in places such as an apartment building or nursing home, he said.

If 5% of a complex tests positive for infection but simultaneous serological testing shows 60% of residents survived COVID-19, for example, the location is less likely to be on the cusp of becoming a hot spot.