The tests, many made in China without F.D.A. approval, are often inaccurate. Some doctors are misusing them. The rollout is nowhere close to the demand.
By Steve Eder, Megan Twohey and Apoorva Mandavilli
April 19, 2020 The New York Times
A law firm in Scottsdale, Ariz., tested employees who hoped, with the prick of a finger, to learn if they might be immune. In Laredo, Texas, community leaders secured 20,000 of the new tests to gauge how many residents had been infected. In Chicago, a hospital screened firefighters to help determine whether they could safely stay on the job.
In recent weeks, the United States has seen the first rollout of blood tests for coronavirus antibodies, widely heralded as crucial tools to assess the reach of the pandemic in the United States, restart the economy and reintegrate society.
But for all their promise, the tests — intended to signal whether people may have built immunity to the virus — are already raising alarms.
Officials fear the effort may prove as problematic as the earlier launch of diagnostic tests that failed to monitor which Americans, and how many, had been infected or developed the disease the virus causes. Criticized for a tragically slow and rigid oversight of those tests months ago, the federal government is now faulted by public health officials and scientists for greenlighting the antibody tests too quickly and without adequate scrutiny.
The Food and Drug Administration has allowed about 90 companies, many based in China, to sell tests that have not gotten government vetting, saying the pandemic warrants an urgent response. But the agency has since warned that some of those businesses are making false claims about their products; health officials, like their counterparts overseas, have found others deeply flawed.
Tests of “frankly dubious quality” have flooded the American market, said Scott Becker, executive director of the Association of Public Health Laboratories. Many of them, akin to home pregnancy tests, are easy to take and promise rapid results.
And the federal guidance that does exist is so confusing that health care providers are administering certain tests unaware that they may not be authorized to do so. Some are misusing antibody test results to diagnose the disease, not realizing that they can miss the early stages of infection.
“People don’t understand how dangerous this test is,” said Michael T. Osterholm, an infectious disease expert at the University of Minnesota. “We sacrificed quality for speed, and in the end, when it’s people’s lives that are hanging in the balance, safety has to take precedence over speed.”
Even as government agencies, companies and academic researchers scramble to validate existing tests and create better ones, there are doubts they can deliver as promised. Most tests now available mistakenly flag at least some people as having antibodies when they do not, which could foster a dangerously false belief that those people have immunity.
And even if the tests do improve, their availability could be hampered by the same manufacturing shortages that have prevented the Covid-19 diagnostic tests from scaling up adequately.
As President Trump presses to reopen the country and several states are considering lifting lockdowns in the next few weeks, widespread screening is considered critical. On Friday, Mr. Trump cheered the F.D.A.’s emergency approval of some antibody tests, saying they would support efforts to get Americans back to work “by showing us who might have developed the wonderful, beautiful, immunity.”
Epidemiologists are testing for antibodies in hot spots to better measure the extent of the outbreaks, and government officials intend to use those results to help decide when and how to return residents to daily life. But many scientists and political leaders say the country is nowhere close to deploying enough diagnostic and antibody tests at the speed and volume required.
“The more testing, the more open the economy,” Gov. Andrew M. Cuomo of New York said on Wednesday. He has pushed for the production of antibody tests as a central cog in plans to ease stay-at-home restrictions, saying that New York would eventually screen 100,000 people a day.