Beckman Coulter launches SARS-CoV-2 IgM Antibody Test, will begin shipping to U.S. labs

Aug. 25, 2020

Beckman Coulter has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay, according to a press release on the company’s website. The new IgM antibody test demonstrated 99.9 percent specificity against 1,400 negative samples and 98.3 percent sensitivity at 15-30 days post-symptom onset, according to a company press release.

Beckman Coulter’s SARS-CoV-2 IgM assay 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.

The new IgM assay is part of a suite of testing solutions the company is offering to guide clinical and public health decision making during the COVID-19 pandemic. The company 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 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 the U.S, Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its interleukin 6 (IL-6) assay. Additionally, Beckman 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. Earlier this year, the company announced that it 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.

The Access SARS-CoV-2 IgM test can be run on the Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, this test seamlessly integrates into laboratory workflows making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing

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