The Access SARS-CoV-2 Immunoglobulin M (IgM) assay from Beckman Coulter, Brea, Calif, has received FDA emergency use authorization. The assay detects antibodies that recognize the receptor binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells. The assay, which demonstrates 99.9% specificity and 98.3% sensitivity, is part of a suite of diagnostic solutions being developed by Beckman Coulter in response to the ongoing covid-19 pandemic to guide physicians and patients in their healthcare decision making.
“Since March, the Beckman Coulter team has worked around the clock to develop a suite of assays that play a critical role in the ongoing global fight against covid-19,” says Julie Sawyer Montgomery, president of Beckman Coulter. “As a science-driven company, we continue in our commitment to deliver rigorously validated diagnostics of the highest quality that provide meaningful information, so doctors and patients alike can trust the results for urgent, care decisions.”
Beckman Coulter’s suite of covid-19 testing solutions includes the Access SARS-CoV-2 IgM assay and the Access SARS CoV-2 IgG assay, which received EUA in June. The company also recently received EUA for its interleukin 6 (IL-6) assay, which can be used to assist in identifying severe inflammatory response in patients with confirmed covid-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Beckman Coulter is also currently developing a SARS CoV-2 antigen assay as well as a quantitative IgG assay anticipated to be launched later this year.
All of the Beckman Coulter assays to address covid-19 can be performed in automated or high-throughput immunoassay formats, as well as 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. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.
For more information, visit Beckman Coulter.
Featured image: Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles (yellow), isolated from a patient sample. The black area in the image is extracellular space between the cells. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: NIAID