Beckman Coulter, a clinical diagnostics leader, 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.
Beckman Coulter’s antibody assays and its other planned SARS-CoV-2 offerings run on the organisation’s award-winning 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.”
Around the world, diagnostic labs are under immense pressure to be more efficient when it comes to meeting testing demands. Beckman Coulter’s assays can be performed in automated or high-throughput immunoassay formats.
The Access SARS-CoV-2 IgM test can also be run on Beckman Coulter’s Access 2 analyser, a compact, table-top analyser 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.
Able to deliver more than 15 million tests each month, the company can meet its customers’ global demands, including more than 16,000 immunoassay analysers worldwide.
For more information on Beckman Coulter’s suite of testing solutions or its commitment to the fight against COVID-19, visit the website.