As of March 30, 20 coronavirus diagnostic tests had been “fast track” approved by the FDA.
By Aaron Sull, World Israel News
Just because you may test negative for coronavirus doesn’t mean you aren’t infected.
New research suggests that roughly 30 percent of coronavirus diagnostic tests administered come back as a “false negative,” reported The Wall Street Journal last week.
Bill Miller, a physician, and epidemiologist at Ohio State University, said Americans should be especially worried because the U.S. Food and Drug Administration (FDA) has been approving a myriad of coronavirus tests without going through its normal lengthy approval procedures.
“The whole testing field is in flux,” Bill Miller told the Journal.
“The thing that is different this time is most of these tests are going through a really rapid validation process. As a result, we can’t be completely confident in how they will perform.”
This isn’t a conspiracy theory either.
FDA Commissioner Stephen Hahn released a statement on March 30 that said he is giving “unprecedented flexibility” in approving coronavirus diagnostic tests.
“The FDA has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S.,” Hahn said.
“Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.”
As of March 30, twenty coronavirus diagnostic tests had been approved by the FDA.
Dr. Mark Abdelmalek, an ABC News medical contributor, said the high rate of coronavirus “false negatives” may be attributed to tests not being administered correctly or the samples are being mishandled on the way to the lab.
Regardless of the reasons, doctors are very worried that “false negatives” will put more people at risk because it gives a false sense of security, which may lead to carelessness about hygiene and social distancing.