CBS News: Flawed COVID-19 Antibody Tests Shipped Without FDA Review
This weekend, a 60 Minutes investigation found that the Trump administration took the unprecedented step of allowing COVID-19 antibody tests to enter the U.S. market without FDA review. These tests were soon found to be unreliable by independent researchers and countries across the world. Even after questions about the accuracy of these antibody tests became public, the FDA allowed such tests to remain on the market for nearly three months, allowing hundreds of thousands of Americans to take faulty tests.
As the U.S. starts to reopen, the decision to allow potentially flawed antibody tests to enter and remain on the market for so long could prove to be deadly — people who have received a false positive may operate as though they have COVID-19 antibodies when they truly do not, increasing risk of exposure. Here’s a look at what CBS uncovered:
In March, The FDA Began Allowing Antibody Tests To Enter U.S. Markets Without FDA Review
- On March 16, The FDA Announced it Announced It Would Allow Antibody Tests Into The U.S. Market Without FDA Review Or Formal Clearance. “On March 16, in an attempt to get those tests to the public, the FDA took an unusual step. It announced it would allow antibody tests into the U.S. market without FDA review or formal clearance. Almost immediately, more than 100 companies offering antibody tests flooded the market. They came from every corner of the world, and none of them were FDA tested.” [CBS News, 6/28/20]
Antibody Tests The FDA Let Enter Without Review Were Soon Found To Be Flawed — Some Had Only A 20 Percent Accuracy Rate
- CBS News: “Federal Officials Knew Many Of The Antibody Tests Were Seriously Flawed But Continued To Allow Them To Be Sold Anyway.” “Back in March, the Food and Drug Administration took the unprecedented step of allowing COVID antibody tests to flood the market without review. The tests were billed as a critical tool to assess where the virus had spread and who might have immunity. But in the government’s rush to get more people tested quickly, it may have missed the mark. Over the course of a three-month investigation, 60 Minutes has learned that federal officials knew many of the antibody tests were seriously flawed but continued to allow them to be sold anyway.” [CBS News, 6/28/20]
- When Laredo Director Of Health Dr. Hector Gonzalez Tested A Small Sample Of Antibody Tests The City Received, He Found That Only 20 Percent Were Accurate. “Dr. Hector Gonzalez: ‘It was supposed to be 95%. All the tests, especially serologies, have to be 95% or better.’ But Dr. Gonzalez found the tests results varied wildly. The tests didn’t work well if the person had been recently exposed to the virus. The small sample he tested was only 20% accurate.” [CBS News, 6/28/20]
- After Dr. Hector Gonzalez’s Initial Tests Finding Low Accuracy Rates, Hundreds Of Thousands Of Unreviewed Tests Continued To Be Mailed To Businesses, Clinics, And Hospitals. “Meanwhile, hundreds of thousands of other antibody tests that the FDA also never reviewed continued to be mailed to businesses, clinics and hospitals where they were used to test patients, first line responders, and healthcare workers.” [CBS News, 6/28/20]
- Dr. Alex Marson Explained Of Antibody Tests He And A Group Of Fifty Scientists Found That All But One Test They Evaluated Delivered A False Positive For Antibodies. Dr. Alex Marson: “Some were way off. The tests are much less accurate when used on a person who was recently exposed to the virus. 20 days after exposure, the tests get better but none are perfect. All but one test delivered so-called false-positives, meaning they mistakenly signaled antibodies in people who did not have them.” [CBS News, 6/28/20]
Even After It Became Clear Tests May Have Been Flawed, They Continued To Let Such Tests Enter And Remain On The Market For Weeks
- As Countries Including Spain And Britain Raised Flags About Faulty Antibody Tests In March, The FDA Decided Not To Change Its Open-Door Policy Regarding Antibody Tests. “Others were also raising red flags about antibody tests. On March 26, problems with the tests in Spain were made public. A week later, Britain tossed out $20 million worth of antibody tests because of false results. And days later, the World Health Organization issued more warnings about the test. But the White House continued to sell the idea of antibody tests… And the FDA? It still did not change its open-door policy. We asked the FDA why, and they said the decisions were made with a ‘careful balancing of risks and benefits.’” [CBS News, 6/28/20]
- It Took The FDA 50 Days To Reverse Its Course On Antibody Tests And Begin Requiring Developers To Submit Data Showing Their Tests Worked. “It took 50 days for the FDA to reverse its course on antibody tests. In May, the agency required developers to apply for emergency authorization and submit data to show their tests worked. But by then it was too late.” [CBS News, 6/28/20]
- The FDA Did Not Start Pulling Unreviewed Antibody Tests Of The Market Until Late May, Nearly Three Months After Unregulated Tests First Flooded U.S. Markets. “Then in late May, nearly three months after the wave of unregulated antibody tests came to the U.S., the FDA started pulling tests off the market. 50 so far. Including the Anhui DeepBlue test that was sold to Laredo. Customs agents and Homeland Security investigators now have the difficult task of trying to stop all the banned tests from entering the country. But the flawed antibody tests are still being used and the bad data collected from them is guiding critical decisions about when to reopen communities.” [CBS News, 6/28/20]