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March 24, 2021

FDA grants EUA to Beckman Coulter’s SARS-CoV-2 antibody test 

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Beckman Coulter’s semi-quantitative Access SARS-CoV-2 IgG II antibody assay. 

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Beckman Coulter’s semi-quantitative Access SARS-CoV-2 IgG II antibody assay.

In response to a previous SARS-CoV-2 infection, the assay assesses the antibody levels of a patient and offers their qualitative and numerical result in arbitrary units (AU).

With a confirmed 100% negative per cent agreement (specificity) and a 98.9% positive per cent agreement (sensitivity) at >/= 15 days after onset of symptom, the test measures IgG antibodies directed to the receptor-binding domain of the coronavirus’ spike protein.

It can be used in random access mode (RAM) and integrates effortlessly into current workflows without batch processing.

Beckman Coulter chief medical officer Shamiram Feinglass said: “Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual’s immune response to the SARS-CoV-2 virus over time.

“This information is essential because it helps continually inform therapeutics and vaccine development.”

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Currently, the Access SARS-CoV-2 IgG II antibody assay is available in the US and countries accepting the CE Mark.

The test results are delivered on the company’s immunoassay analysers, including the DxI 800 high-throughput analyser, which can potentially process up to 4,800 samples in a day.

In a separate development, ROSALIND has unveiled a web-based platform to monitor emergent SARS-CoV-2 variants and assess the effects on the performance of diagnostic tests.

Named ROSALIND Diagnostic Monitoring (DxM) system, the platform was developed with support from the Rapid Acceleration of Diagnostics (RADxSM) Tech programme of the US National Institutes of Health’s RADx initiative.

ROSALIND CEO Tim Wesselman said: “The DxM system has the potential to play a crucial role in identifying risks to diagnostic tests from this evolving virus, and aids test manufacturers and agencies with consistent analyses and recommendations.”

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