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22nd January 2021  Product update: rapidmicrobiology staff writer

New CE-Marked Quantitative SARS-CoV-2 IgG Antibody Test

Beckman Coulter has launched its Access SARS-CoV-2 IgG II assay in countries accepting the CE Mark. The new Access SARS-CoV-2 IgG II assay quantitatively measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection.

The ability to establish a quantitative baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus allows clinicians to assess relative changes of an individual’s immune response to the virus over time-based on a numerical value. 

The Access SARS-CoV-2 IgG II quantitative assay is the latest addition to Beckman Coulter’s full suite of testing solutions designed to provide valuable information to clinicians in their fight against COVID-19.

Results of the new Access SARS-CoV-2 IgG II test are delivered quickly on Beckman Coulter’s award-winning immunoassay analysers, including the DxI 800 high-throughput analyser, which is capable of processing up to 200 samples per hour. 

Access SARS-CoV-2 IgG II assay
The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus in response to a previous infection. The assay then provides a numerical result ranging from 2.00-450 AU/mL* and a qualitative result for SARS-CoV-2 IgG antibodies.

The test has a confirmed 99.9% specificity and 98.9% sensitivity 15-60 days post symptom onset. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing.

The assay can also be used with a variety of Beckman Coulter analysers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxCi and Access 2 analysers for smaller labs and healthcare clinics. 

Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the US under Policy C of the FDA’s emergency use authorization (EUA) program. Beckman Coulter can deliver up to 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.

*The result will be displayed as non-reactive (<10 AU/mL) and reactive (>/=10 AU/mL).

For more details, please use the 'Request Information' button provided below.

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Date Published: 22nd January 2021

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.

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