A critical scientific piece in moving toward a state of normalcy in our current pandemic-worried world is to have an inexpensive — and preferably quick — test that would let people who are not sick know whether they have already been infected by the new coronavirus without realizing it.
What has driven the partial lockdowns, the social distancing and the paranoia is mostly this fear of asymptomatic carriers — that is, people who are infected with the new coronavirus, are contagious but are not showing any of the symptoms of the disease.
As long as there is no readily available and reliable way of telling who is a potential death threat and who is not, everyone gets treated as a pariah.
The result has been that people who may have already unwittingly acquired some immunity from COVID-19 are being ordered to shelter in place to protect themselves and others, when in fact they probably should be back at work, helping to restart the economy and assisting those who are truly at risk.
There is no shortage of companies that recognize a huge business opportunity in this demand for blood tests to determine who has had COVID-19 among the seemingly healthy.
More than 90 companies are reportedly selling these tests already. The problem is, no one knows if most of them do what they claim: detect the antibodies specific to COVID-19 that would show whether the person has recently had and beat the infection.
That’s because the U.S. Food and Drug Administration, which should have been regulating the development of the antibody tests, took a hands-off approach and basically told companies that if they thought they had a test that works, go for it.
Just don’t advertise that the FDA has approved what they are selling.
The Cepheid Infinity System being used by Forrest General has not been approved by the FDA and it’s unclear if the tests have a high rate of reliability.
Officials from Merit Health Wesley declined to say which test is being used there.
Belatedly the FDA is recognizing its mistake. This week, it announced that government scientists would start reviewing the data on these different companies’ lab tests and presumably let the public know the results, so it can steer clear of tests with a low rate of reliability.
The FDA should do more than that. It should not allow companies to sell COVID-19 tests before they have been independently vetted for accuracy.
That might slow down their development some, but the tests have got to be right, or at least as close to it as scientifically reasonable.
People who take these antibody tests are going to make decisions about their behavior based on the results. If they are led to believe incorrectly that they are immune, the consequences to them or others could be fatal.
