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Beckman Coulter launches its SARS-CoV-2 IgM antibody test

Beckman Coulter has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark.

The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 100% sensitivity at >18 days post symptom onset and post positive PCR. Beckman Coulter’s IgM assay is part of a full suite of testing solutions the company is developing to inform clinical and public health decision making during the COVID-19 pandemic.

Beckman Coulter is also developing a SARS-CoV-2 antigen test and quantitative IgG assay. The company's antibody assays and its other planned SARS-CoV-2 offerings run on the organisation’s immunoassay analysers, including the DxI 800 high-throughput analyser, which is capable of processing 200 samples per hour. 

“Our new SARS-CoV-2 IgM assay provides information about an individual’s immune status with a positive predictive value of 96.9% in a population with disease incidence as low as 3%,” said Julie Sawyer Montgomery, President of Beckman Coulter. “As COVID-19 outbreaks continue to grow in intensity in many of our communities, highly accurate tests such as this are critical for providing reliable information for both individual health decisions as well as population-based immunity monitoring.” 

The full suite of testing solutions, including the IgM and IgG assays currently available and the antigen and quantitative IgG assay under development, provide valuable information in clinical decision making for patients suffering from COVID-19. The company developed separate SARS-CoV-2 IgM and SARS-CoV-2 IgG antibody assays to help clinicians determine a patient’s immune status in response to a recent or past infection.

The Beckman Coulter 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. Since each person’s seroconversion process is different, the two tests can be used together to provide the most accurate view of their immune response.

Rob Young, UK General Manager for Beckman Coulter, added: “This latest addition to our already extensive offering, which spans serological, antigen, and other diagnostic solutions, brings greater visibility to help monitor the progression of COVID-19 in patients. We continue to innovate and provide a multitude of high-quality tests in high volumes to help clinicians identify patients with the virus and support efforts in fighting the disease.”

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Upcoming Events

IPS 2021

ACC Liverpool
27th - 29th September

The Operating Theatres Show 2021

Hilton Metropole Hotel, London
7th October

Future Surgery 2021

ExCel London
9th - 10th November 2021

Medica 2021

Dusseldorf Germany
15th - 18th November

Arab Health 2022

Dubai World Trade Centre
24th - 27th January

Central Sterilising Club 60th Anniversary Annual Scientific Meeting

Crowne Plaza, Bridge Foot, Stratford-upon-Avon, CV37 6YR
4th - 5th April

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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