“We anticipate that understanding the immune status of communities and convalescent plasma donation will play important roles in the fight against COVID-19 before a vaccine is widely available,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer Beckman Coulter. “While there is more to learn regarding how long an individual’s immune response to the SARS-CoV-2 virus lasts, this test may be crucial to determining the portion of the population that may already be immune.”
Sawyer Montgomery added, “Our assay can be utilized in a variety of healthcare settings, including central laboratories, as well as smaller clinics and hospitals in underserved communities with a range of Beckman Coulter immunoassay analyzers. This accessibility is vital to ensuring all communities, including minority, rural and urban have access to this testing and answers they can trust.”
While immunoglobulin M (IgM) antibodies play a prominent role in the body’s primary antibody response to infection, they decline within a short timeframe. IgG antibodies begin developing within the first 14 days, and may last for months or years depending upon the pathogen and the individual.
Dr. Feinglass added, “We developed the Access SARS-CoV-2 IgG test to help clinicians determine if a patient was infected with COVID-19 in the past and developed an immune response. In contrast, a total antibody test can’t help a clinician determine whether an individual is currently infected or whether they developed an immune response from an earlier infection. The clinician must therefore perform additional testing, requiring added time and cost.”
About the Access SARS-CoV-2 IgG Assay
The Access SARS-CoV-2 IgG Assay is a qualitative immunoassay that detects IgG antibodies directed to the receptor binding domain of the spike protein of the novel coronavirus that is driving the ongoing global pandemic. It is believed that these antibodies have the potential to be neutralizing antibodies and may play a role in lasting immunity. The test has a confirmed 100% Positive Percent Agreement (sensitivity) and 99.6% Negative Percent Agreement (specificity) and at 18 days post PCR confirmed positive test. The assay uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient blood or serum samples and reveals them using labeled anti-IgG antibodies. The Access SARS-CoV-2 IgG assay can be used with a variety of Beckman Coulter analyzers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxCi and Access 2 analyzers for smaller labs and healthcare clinics. The assay can be seamlessly integrated into existing workflows without batch processing.
Beckman Coulter will continue to focus on bringing innovative tests to market, and will be seeking EUA for IL-6 and Access SARS-CoV-2 IgM in the near future.
Access the latest information on the Access SARS-CoV-2 IgG assay, or discover more information about Beckman Coulter’s commitment to the fight against COVID-19.