The US Food and Drug Administration has issued an emergency use authorization to the company Beckman Coulter for its Covid-19 antibody test.
Beckman Coulter announced the authorization on Monday and noted that it has already shipped tests to more than 400 hospitals, clinics and diagnostics labs in the United States, as well as begun distributing the test globally. The company claims it is able to deliver more than 30 million tests a month.
"At a time when significant confusion was created by the initial influx of poor-quality antibody tests, our team worked meticulously to develop a highly sensitive and specific assay," Julie Sawyer Montgomery, president of Beckman Coulter, said in the company's announcement.
"With 100% Positive Percent Agreement and 99.6% Negative Percent Agreement, our test significantly reduces the risk for false positives, delivering the results that health care providers and their patients can trust," Sawyer Montgomery said. "A lot has been written about accuracy issues with the initially launched antibody tests, but a test at this level offers positive predictive values greater than 90% even in very low prevalence communities. And, in areas hardest hit by the virus, the positive predictive values of our assay are greater than 98%."
Some context: As of Monday, the FDA has authorized 24 antibody tests for emergency use in the United States, according to the agency. The tests are an important public health tool to determine who has had Covid-19 in the past. They look for antibodies that are evidence of an immune response to coronavirus infection.