Thousands in Miami-Dade County sought to be tested to find out if they have developed antibodies for the disease. But the results are in question.
In the midst of the relentless COVID-19 pandemic, many who were or believe to have been exposed to the novel coronavirus are trying to determine if they have some level of immunity to the illness.
So even though health experts have strongly warned that at this time it is not clear whether past exposure means you can’t get coronavirus again, even for a period of months — in the last weeks — thousands in Miami-Dade County sought to be tested to find out if they have developed antibodies for the disease that so far has claimed nearly 90,000 lives in the U.S. alone.
However, the drive-thru tests administered at Aventura Mall as of April 13 and at Bal Harbour Shops as of May 4, have raised some very serious questions regarding their accuracy. The tests, which are not meant to diagnose active COVID-19 infections, just seek to determine past exposure, according to the Miami Herald.
Results Are “Troubling”
As reported by the Herald, the test Banyan Medical Systems from Omaha uses to determine whether a person has had coronavirus, has not been validated by federal regulators. In fact, it has come under question by scientists at a University of California San Francisco (UCSF) study.
The test has also raised some alarm from a congressional subcommittee, which called the results of the study deeply “troubling” after it found that the test accurately detects antibodies much less often than reported by the manufacturer.
The Banyan test is manufactured in China and sold in the United States under five different brand names and, like many others similar to it, became available in the U.S. after FDA officials relaxed regulations for developers. This was done in order to augment testing capacity. Due to this need, at this time the FDA has authorized 13 serology tests for emergency use. However, Banyan’s test is not one of them. The company has since posted on its Aventura and Bal Harbour operations website that the tests are Emergency Use Allowed (EUA) by the FDA, but that the test “has not been reviewed by the FDA.”
A Dangerous Assumption
Assuming that past contamination makes one immune to the virus can have troubling consequences because it has not been determined that prior exposure renders a person immune to COVID-19. Many health officials believe more testing is needed. Alexander Marson, an immunologist with UCSF and co-author of the study, is one of them.
“I worry [these tests] might be sending an implicit signal that’s not responsible to the people; that they’re somehow protected if they have the antibody,” Marson told the Herald. “We really need more studies before giving that sense to people.”
Similarly, Michael Carome, director of health research for Public Citizen, a non-profit, liberal/progressive consumer rights advocacy group and think tank based in Washington, D.C., agrees with Marson’s statement.
“You have a lot of people who’ve been tested and given results. Some people are already acting on perhaps incorrect information and we don’t know who those people are.”