Beckman Coulter’s SARS-CoV-2 IgG antibody test now available in markets accepting CE Mark

Beckman Coulter’s Access SARS-CoV-2 IgG assay is now available in markets accepting the CE Mark, the company said in statement 15 June. It has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the United States and has begun shipping to customers globally. Beckman Coulter has more than 16,000 immunoassay analysers worldwide and has increased manufacturing to deliver more than 30 million tests a month.

Many of Beckman Coulter’s analysers can deliver up to 400 routine tests an hour. 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.

The Access SARS-CoV-2 IgG Assay is a qualitative immunoassay that detects IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus that is driving the ongoing global pandemic. It is believed that these antibodies have the potential to be neutralizing antibodies and may play a role in lasting immunity. The test has a confirmed 99.8% specificity and 100% sensitivity at 18 days post PCR confirmed positive test. The assay uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies.

Commenting on the assay, Shamiram R. Feinglass, M.D., MPH, Chief Medical Officer, 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.”