The assay has been designed for use with a variety of Beckman Coulter analyzers


Beckman Coulter gets FDA EUA status for SARS-CoV-2 IgM antibody test. (Credit: PRNewswire / Beckman Coulter Diagnostics)

Beckman Coulter has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay.

The assay has been designed to identify antibodies, which recognise the receptor binding domain (RBD) of the spike protein that helps the SARS-CoV-2 virus to enter the human host cells.

It is a qualitative immunoassay that uses an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein – enzyme conjugate to identify anti-SARS-CoV-2 IgM.

Access SARS-CoV-2 IgM assay from Beckman Coulter  is designed for use in random access mode

The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which enables to run the antibody tests along with other immunoassay tests.

The assay can be conducted on various analysers such as DxI 800 designed for large labs, DxI 600 for mid-sized labs and the DxC 600i and Access 2 analysers for smaller labs and healthcare clinics.

Beckman Coulter president Julie Sawyer Montgomery said: “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.”

Recently, the company also secured FDA EUA status for its interleukin 6 (IL-6) assay, which is suitable to detect a severe inflammatory response in patients with confirmed Covid-19 illness.

The assay helps in determining the risk of intubation with mechanical ventilation along with clinical findings and the results of another laboratory testing.

At present, Beckman Coulter is involved in the development of a SARS CoV-2 antigen assay and a quantitative IgG assay, which are expected to be launched by the end of this year.

The firm’s assays are conducted in automated or high-throughput immunoassay formats, as well as using Access 2 analyser that can be used in small hospitals and clinics.

In July this year, Beckman Coulter Diagnostics secured 510(k) clearance from the FDA for its PK7400 automated microplate system and its reagents.