Beckman Coulter has launched its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 100% sensitivity at >18 days post symptom onset and post positive PCR. Beckman Coulter’s IgM assay is part of a full suite of testing solutions the company is developing to inform clinical and public health decision making during the COVID-19 pandemic. Beckman Coulter is also developing a SARS-CoV-2 antigen test and quantitative IgG assay. Beckman Coulter’s antibody assays and its other planned SARS-CoV-2 offerings run on the organisation’s award-winning immunoassay analysers, including the DxI 800 high-throughput analyser, which is capable of processing 200 samples per hour.

The full suite of testing solutions, including the IgM and IgG assays currently available and the antigen and quantitative IgG assay under development, provide valuable information in clinical decision making for patients suffering from COVID-19. The company developed separate SARS-CoV-2 IgM and SARS-CoV-2 IgG antibody assays to help clinicians determine a patient’s immune status in response to a recent or past infection. The Beckman Coulter IgM assay detects antibodies that may emerge earlier in the course of infection and then dissipate, while the IgG test detects antibodies associated with the longer-term immune response. Both IgM and IgG assays can identify antibodies in asymptomatic individuals. Since each person’s seroconversion process is different, the two tests can be used together to provide the most accurate view of their immune response.

Able to deliver more than 15 million tests each month, the company can meet its customers’ global demands, including more than 16,000 immunoassay analysers worldwide.

For more information, visit: https://www.BeckmanCoulter.com/Coronavirus