Beckman Coulter Launches New SARS-CoV-2 Immunoglobulin M (IgM) Antibody Test

Beckman Coulter Diagnostics (Brea, CA, USA) has launched its new Access SARS-CoV-2 Immunoglobulin M (IgM) assay which demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15-30 days post-symptom onset.

Among all the tests developed by the top four in vitro diagnostic manufacturers capable of delivering high-volume testing to the US, Beckman Coulter's test is the only SARS-CoV-2 IgM assay which 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 which target the RBD have the potential to be neutralizing and thus prevent future infection by blocking the virus from entering the cell.

Beckman Coulter's new IgM assay is part of a suite of testing solutions offered by the company to guide clinical and public health decision making during the COVID-19 pandemic. The company has developed separate SARS-CoV-2 IgM and SARS-CoV-2 Immunoglobulin G (IgG) antibody assays to better 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, and since each person's seroconversion process is different, the two tests can be used together to provide the most accurate view into their immune response.

Beckman Coulter is also developing a SARS-CoV-2 quantitative IgG assay, antigen test and currently awaiting FDA Emergency Use Authorization for its interleukin 6 (IL-6) assay. Additionally, Beckman Coulter offers a biomarker that measures monocyte distribution width (MDW), which can be used as an aid in the early detection of sepsis in adult patients presenting to the emergency department. Moreover, the company has received government funding to develop a machine learning algorithm to help accurately predict and detect sepsis in COVID-19 patients leveraging its MDW test. The quantitative IgG, antigen, IL-6 and MDW tests, along with the IgG and IgM assays, could provide valuable information in clinical decision making for patients suffering from COVID-19.

"Our new SARS-CoV-2 IgM assay provides information about an individual's immune status with a positive predicative value of 95.5% in a population with disease incidence as low as 3%," said Julie Sawyer Montgomery, president of Beckman Coulter. "COVID-19 presents as a complex, multi-system disease which requires multiple diagnostic tests to help monitor the disease progression of patients across multiple care settings. Our organization is working tirelessly to provide a multitude of high quality tests that help clinicians not only learn about each patient's disease status, but also the disease pathology of SARS-CoV-2 as a whole."