Federal officials allowed distribution of COVID-19 antibody tests after they knew many were flawed
Federal officials failed to immediately stop the distribution of many COVID-19 antibody tests they knew were flawed, leading to inaccurate data about the spread of the virus. Congress is now investigating why the FDA did not review the tests it allowed to be distributed widely throughout the U.S. Sharyn Alfonsi's three-month investigation into the faulty tests will be broadcast on 60 Minutes, Sunday, June 28 at 7 p.m. ET/PT on CBS.
COVID-19 diagnostic kits were in short supply when the pandemic broke out. An alternative test to detect the presence of antibodies in blood was sold as a way to indicate who was exposed to the virus at some point and could now be immune. Such tests would help officials track the disease and determine when it might be safe to begin opening up the economy. The FDA said it would allow the antibody tests to enter the US market and would do so without a formal review. Over 200 companies hit the market with the tests.
Laredo, Texas, wound up getting thousands of antibody test kits from a Chinese company. The untested kits were then tested by the city's health director, Dr. Hector Gonzalez, who found the tests accuracy to differ wildly depending on when it was given and how long after a person was exposed to the virus. The small sample he tested was only about 20% accurate. "We had such high hopes to test… we were ready to do public drive-through testing… Now we couldn't. We were on hold," recalls Gonzalez.
Laredo officials reported the faulty tests to federal agents at Homeland Security and officials came to town to seize the tests and start an investigation, but the federal government did little to halt the spread of other un-proven antibody testing kits.
https://www.cbsnews.com/news/federal-officials-allowed-flawed-covid-19-antibody-tests-2020-06-25/?ftag=CNM-00-10aab7d&linkId=92064279
