The same week that the Food and Drug Administration tightened its restrictions on COVID-19 antibody tests, researchers at the University of Washington School of Medicine in Seattle found Abbott Laboratory’s COVID-19 antibody blood test to “demonstrate excellent performance.”
Antibody tests can tell if someone has been previously infected with the virus, whether they exhibited symptoms or not. Large-scale antibody testing is seen as an important next step in moving society forward until there is a COVID-19 vaccine. These tests, in theory, could determine who is safe to return to the work force without fear of contracting the virus.
Abbott, which is headquartered in Lake County, is the same laboratory that created a rapid test that can detect the virus in as little as five minutes.
According to new research published in the Journal of Clinical Microbiology. University of Washington researchers tested 1,020 patients with Abbott’s antibody test and found a specificity (ability to exclude false positives) of 99.9%. Testing on 125 confirmed COVID-19 cases found 100% sensitivity (ability to exclude false negatives), 17 days or more after symptoms began.
Abbott, in a news release, said it has already scaled up manufacturing and shipped more than 10 million antibody tests to hospitals and reference labs in all 50 states.
This news comes as the FDA announced tighter restrictions on antibody tests trying to reach the market. In mid-March, the FDA allowed internal validation of new antibody tests, meaning the FDA didn’t review the performance of new tests.
The FDA is now changing course, telling manufacturers that they must submit a request for emergency use authorization, and that tests must meet a specific performance threshold.
In a letter published to the FDA’s website, Dr. Anand Shah and Dr. Jeff Shuren wrote that when the initial guidance was issued on March 16, the country needed the flexibility to rapidly develop antibody tests.
“However, flexibility never meant we would allow fraud,” the doctors wrote. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety. Some test developers have falsely claimed their serological tests are FDA approved or authorized.”
Dr. Matt McCarthy, an assistant professor at Weill Cornell Medicine in New York, and author of a 2019 book titled “Superbugs: The Race to Stop an Epidemic,” wrote in a post to Twitter that there are now more antibody tests for COVID-19 than any other infectious disease.
“Many of the 200 new tests on the market (or in development) are worthless,” McCarthy wrote to his more than 24,000 Twitter followers.
The Abbott antibody test, according to Abbott’s website, has not been FDA approved yet, but is approved for use by authorized labs.
“Health systems will play a critical role in large scale testing, and collaboration with leaders such as the University of Washington helps to ensure that our tests are performing at the highest standards when they are used in real-world settings,” said Robert B. Ford, president and chief executive officer at Abbott. “We want to do our part in providing hospitals and reference labs around the world with access to reliable antibody testing.”
Source: The Daily Chronicle