New COVID-19 antibody test available where CE mark accepted

Beckman Coulter has announced that its Access SARS-CoV-2 IgG assay is now available in markets accepting the CE mark.

The company has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and has begun shipping to customers globally. Beckman Coulter has more than 16,000 immunoassay analysers worldwide and has increased its manufacturing to deliver more than 30 million tests a month.

Henry Ford Health System was one of the first health systems to receive Beckman Coulter’s test and independently validate its performance.

Dr. Bernard C Cook, division head of Chemistry-Pathology, Henry Ford Health System, said: “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 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%.”

The Beckman Coulter Access SARS-CoV-2 IgG assay detects immunoglobulin G (IgG), and targets antibodies that recognise the receptor-binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor. This is significant as antibodies that target the RBD have the potential to be neutralising and thus prevent future infection by blocking the virus from entering the cell. It is for this reason many vaccine developers are also targeting the RBD of the spike protein in their vaccine development.

Julie Sawyer Montgomery, president of Beckman Coulter, said: “Our assay has the potential to identify individuals who have already mounted an immune response to the novel Coronavirus and could donate convalescent plasma for use in combating the disease in seriously ill patients. Convalescent plasma therapy will be a critical tool in our treatment arsenal in the absence of an effective vaccine as we look toward the fall and winter when many epidemiologists anticipate a second large wave of infections.”

Many of Beckman Coulter’s analysers can deliver up to 400 routine tests an hour. A large number of analysers are connected to hospital information systems, enabling laboratories to automate the reporting of serology test results. The Access SARS-CoV-2 IgG test can also be run on Beckman Coulter’s Access 2 analyser, a compact table-top analyser enabling high-quality serology testing to be carried out in small hospitals and clinics. 

Shamiram R. Feinglass, chief medical officer at Beckman Coulter, said: “An IgG antibody assay such as the test Beckman Coulter has developed can provide valuable information regarding community levels of immunity that will inform public health decision making and rollout of a vaccine when one does become available. The very high sensitivity and specificity of this assay provides a high positive predictive value, even when the overall incidence of disease is low. Additionally, since our assay can be run on multiple different types of analysers, it can be adapted to a variety of healthcare settings to best meet the needs of each community.”

Beckman Coulter will continue to focus on bringing innovative tests to market, and will be seeking CE mark for its Access SARS-CoV-2 IgM assay in the near future.