Fears of ‘Wild West’ emerge as virus blood tests hit market
WASHINGTON — Blood tests for the coronavirus could play a key role in deciding whether millions of Americans can safely return to work and school. But public health officials warn the current “Wild West” of unregulated tests is creating confusion that could ultimately slow the path to recovery.
More than 70 companies have signed up to sell antibody tests in recent weeks, according to U.S. regulators. Governments around the world hope that the rapid tests, which typically use a finger-prick of blood on a test strip, could soon ease public restrictions by identifying people who have previously had the virus and have developed some immunity to it.
But key questions remain: How accurate are the tests, how much protection is needed and how long will that protection last?
The blood tests are different from the nasal swab-based tests currently used to diagnose active COVID19 infections. Instead, the tests look for blood proteins called antibodies, which the body produces days or weeks after fighting an infection. The same approach is used for HIV, hepatitis, Lyme disease, lupus and other diseases.
Because of the relative simplicity of the technology, the Food and Drug Administration decided to waive initial review of the tests as part of its emergency response to the coronavirus outbreak.
Right now, the tests are most useful for researchers studying how the virus has spread through the U.S. population. The government said Friday it has started testing 10,000 volunteers. The White House has not outlined a broader plan for testing and how the results might be used.
With almost no FDA oversight of the tests, “Right now it’s a wild West show out there,’’ said Eric Blank of the Association for Public Health Laboratories. “It really has created a mess that’s going to take a while to clean up.
“In the meantime, you’ve got a lot of companies marketing a lot of stuff and nobody has any idea of how good it is.”
Members of Blank’s group, which represents state and local lab officials, have urged the FDA to revisit its lax approach toward the tests. That approach essentially allows companies to launch as long as they notify the agency and include disclaimers. Companies are supposed to state that their tests have not been FDAapproved and cannot rule out whether someone is currently infected.
Last week, FDA Commissioner Stephen Hahn said in a statement that the agency will “take appropriate action” against companies making false claims or selling inaccurate tests.
During an interview Sunday on NBC’s “Meet the Press,” Hahn expressed
“concern” that tests being sold “may not be as accurate as we’d like them to be.”
“What we don’t want are wildly inaccurate tests. That’s going to be much worse, having wildly inaccurate tests than having no test.”
Dr. Allison Rakeman of New York City’s Public Health Laboratory said some local hospitals are assuming the tests, which are listed on FDA’s website, “have been vetted, when they have not.”
The danger of faulty testing, Rakeman says, is that people will mistakenly conclude that they are immune or are no longer spreading the virus.
“Then somebody goes home and kisses their 90-year-old grandmother,” Rakeman said. “You don’t want to give someone a false sense of security.”
For many infections, antibody levels above a certain threshold indicate that the person’s immune system has successfully fought off the virus and is likely protected from reinfection. For COVID-19, it’s not yet clear what level of antibodies render patients immune or how long immunity might last.
Adding to the confusion is the fact that both legitimate companies and fraudulent operators appear to be selling the kits. Distinguishing between the two can be a challenge.
The firm 20/20 BioResponse is one of dozens of U.S. companies selling the tests to hospitals, clinics and doctor’s offices. The Rockville, Maryland-based company imports the tests from a Chinese manufacturer but CEO Jonathan Cohen says his company independently confirmed its performance in 60 U.S. patients. He estimates the company has shipped 10,000 tests and has had to limit orders due to demand.
Cohen said antibody tests are not a “panacea but they’re not garbage either.”