ANOTHER VIEW: Tests should be reliable
Antibody tests are among the more favored tools for state and local leaders as they forge ahead with plans to reopen Florida’s coronavirus-ravaged economy.
The quick, easy-to-use tests have been aggressively hawked by none other than President Donald Trump and Gov. Ron DeSantis. The promise: That with blood drawn from a simple finger stick, folks can find out in as little as 10 minutes whether they have been exposed to the new coronavirus and have antibodies that may offer some immunity — and help contain the virus spread.
But a good strategy is only as good as the tools used. And therein lies a problem. A troubling number of tests are yielding unreliable results. Too many consumers are being told they have antibodies when they don’t — or that they don’t have the antibodies when they do. And they’re paying up to $200 a finger-stick at private labs.
Earlier this month, the U.S. Food and Drug Administration, after studies raised questions about the efficacy of some antibody tests on the market, was forced to backpedal on its previous relaxing of rules. Why? Because the FDA still does not know if people are “fully protected from reinfection” if they’ve developed antibodies. And even if they are, it’s still unclear how long that immunity lasts.
That’s not much of a confidence booster for returning to your favorite restaurant, theme park or Memorial Day spot on the beach.
Natalie Dean, a biostatistician and professor at the University of Florida’s College of Public Health and Health Professions, told the Miami Herald that antibody tests that are more likely to produce false negatives are less of a concern than those that give consumers a false sense of security that they’re immune to COVID-19.
We’re beyond raising caution flags here. A majority of citizens are still nervous about reopening the state too soon after sacrificing so much through social distancing to get us to this point.
And rightly so. The state’s number of reported cases and deaths continues to grow, despite our governor’s attempts to paint a rosier picture.
The FDA must do a better job of warning consumers about tests that haven’t been approved, if they’re not going to remove them from the market.
The idea of using antibody tests is a good one, to be sure. But this testing strategy, a key step to implementing “contact tracing,” is useless if the results are unreliable.
Dozens of antibody tests became available to U.S. consumers in March when FDA officials offered “regulatory flexibility” for developers to increase testing capacity. But after health experts began raising concerns, the agency changed course May 4 and now requires all manufacturers to submit the results of a clinical study and to apply for emergency use authorization, or EUA.
The FDA has reviewed and authorized 13 serology tests for emergency use to date, while over 120 others are currently on the market. The bottom line, says the AMA: Antibody tests should not be used as justification for returning for work or discontinuing social distancing practices.
This guest editorial was originally published by USA TODAY, a sister newspaper within Gannett.