Beckman Coulter announced today that it received FDA emergency use authorization (EUA) for its Access SARS-CoV-2 IgG assay.
Brea, Calif.-based Beckman Coulter has already shipped its COVID-19 antibody assay to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and began distribution globally to countries that accept EUA and its recently garnered CE Mark, according to a news release.
Beckman Coulter said it is capable f delivering more than 30 million tests a month, having already received independent validation for its test from the Henry Ford Health System, along with regulatory authorization.
“We selected the Beckman Coulter Access SARS-CoV-2 IgG antibody assay to be the backbone of Henry Ford’s COVID-19 serology testing program because of its outstanding performance in our rigorous independent evaluation,” Henry Ford Health division head of chemistry-pathology Dr. Bernard Cook said in the release. “Henry Ford found when running the Beckman Coulter SARS-CoV-2 assay on 204 PCR-confirmed COVID-19 patient samples, a test sensitivity of 100% at 14 days post-PCR and testing of 80 patient samples from the pre-COVID era yielded a specificity of 100%.”
Beckman Coulter touts its test as, among the only one developed by the top-four in vitro diagnostic manufacturers capable of delivering high-volume testing to the U.S., the only assay that targets antibodies that recognize the receptor-binding domain (RBD) of the spike protein that SARS-CoV-2 uses to bind to a human cell receptor.
Antibodies that target the RBD have the potential to be neutralizing and could prevent future infection by blocking the virus from entering the cell, the company said.
The company said it has more than 16,00 immunoassay analyzers worldwide, with 3,500 in the U.S. Many of them can deliver up to 400 routine tests per hour and can be run on Beckman Coulter’s Access 2 analyzer in small hospitals and clinics.
“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,” Beckman Coulter chief medical officer Dr. Shamiram Feinglass said. “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.”