Beckman Coulter’s SARS-CoV-2 IgG Antibody Test Receives CE Mark

Beckman Coulter (Brea, CA, USA) has announced that its Access SARS-CoV-2 IgG assay is now available in markets accepting the CE Mark.

The Beckman Coulter Access SARS-CoV-2 IgG assay detects immunoglobulin G (IgG), and targets antibodies that recognize 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 neutralizing 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.

The company has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the US and has begun shipping to customers globally. Beckman Coulter has more than 16,000 immunoassay analyzers worldwide and has ramped its manufacturing to deliver more than 30 million tests a month. Many of Beckman Coulter’s analyzers can deliver up to 400 routine tests an hour. A large number of analyzers 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 analyzer, a compact table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. The test seamlessly integrates into laboratory workflows making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing, so health systems can begin to comprehensively determine the immune status of their communities.

“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 combatting the disease in seriously ill patients,” said Julie Sawyer Montgomery, president of Beckman Coulter. “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.”

“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,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer Beckman Coulter. “The very high sensitivity and specificity of this assay provides a high positive predictive value, even when overall incidence of disease is low. Additionally, since our assay can be run on multiple different types of analyzers, it can be adapted to a variety of healthcare settings to best meet the needs of each community.”