Beckman Coulter received an FDA emergency authorization for its mass-produced coronavirus antibody test, with plans to deliver more than 30 million tests per month worldwide. The company said it has already begun shipping kits to more than 400 U.S. hospitals, clinics and laboratories, as well as locations in Europe.
The test is designed to run on a variety of the manufacturer’s machines—including high-throughput models capable of processing 400 results an hour—in addition to the company’s Access 2 tabletop device, made for small labs and clinics. Beckman Coulter counts more than 16,000 immunoassay analyzers globally, including about 3,500 in the U.S.
“We anticipate that understanding the immune status of communities and convalescent plasma donation will play important roles in the fight against COVID-19 before a vaccine is widely available,” said Shamiram Feinglass, Beckman Coulter’s chief medical officer.
“While there is more to learn regarding how long an individual’s immune response to the SARS-CoV-2 virus lasts, this test may be crucial to determining the portion of the population that may already be immune,” Feinglass added.
Detroit’s Henry Ford Health System was one of the first to receive the antibody test and make it the backbone of its serology testing program after working to independently validate its accuracy. The nonprofit hospital system’s clinicians saw no false-positive or false-negative results after screening patients’ blood samples two weeks after a positive molecular test.
“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,” said Beckman Coulter President Julie Sawyer Montgomery. “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%.”
In addition, the test is designed to capture IgG antibodies produced by the body that actively work against the novel coronavirus by neutralizing the spike protein it uses to enter human cells. These antibodies may help prevent future infections and are a main focus of vaccine development.
Beckman Coulter is also developing an IgM diagnostic for antibodies that play a larger role in the body’s initial immune response as well as a test for interleukin 6, a blood-based biomarker used to predict potentially severe infections of COVID-19.