Beckman Coulter, a clinical diagnostics leader, has announced research results that demonstrate its Access SARS-CoV-2 IgG assay shows excellent agreement to the Genscript SARS-CoV-2 Surrogate Virus Neutralization Test which detects antibodies that block the interaction between the Receptor Binding Domain (RBD) of the spike (S) protein and the ACE-2 host cell receptor that are necessary for infection. The findings come from the first in a series of research studies being conducted by Beckman Coulter, that show antibodies that target the RBD of the S protein are potentially neutralizing to the novel coronavirus. As a result, the study’s findings will be included in the intended use for Beckman Coulter’s CE Mark SARS-CoV-2 IgG assay.
In this first study, a total of 162 individual patient samples representing 62 SARS-CoV-2 PCR positive samples (≥ 20 days after onset of symptoms) and 100 blood donors samples collected before COVID-19 outbreak were used to evaluate agreement between the Access SARS-CoV-2 IgG assay and a SARS-CoV-2 surrogate viral neutralization test that can detect circulating neutralization antibodies (≥ 20% inhibition). The findings demonstrate that Beckman Coulter’s Access SARS-CoV-2 IgG serology assay may be useful as an aid in identifying patients with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection in conjunction with clinical presentation and other laboratory tests.
“This is the first in a series of antibody neutralization studies being conducted at Beckman Coulter to help us understand the neutralizing properties of antibodies detected by our SARS-CoV-2 serology assay,” said Shamiram Feinglass, M.D., MPH, chief medical officer for Beckman Coulter. “Detecting neutralizing antibodies is especially important because they can prevent the virus from interacting with host cells which they then seek to infect and destroy. It is through the work of these neutralizing antibodies that the body exhibits its immune response. While the length of a body’s immune response to the SARS-CoV-2 virus is still unknown, it is known that neutralizing antibodies are the ones that play a key role in creating a more sustained immune response.”
The Genscript assay utilized in the experiment uses purified RBD protein from the viral spike protein and the host cell receptor, ACE2, to mimic the virus-host interaction in an ELISA plate well. This highly specific interaction can then be blocked by specific neutralizing antibodies in patient sera in the same manner as in a conventional virus neutralization assay.
As part of its commitment in the fight against COVID-19, Beckman Coulter has several other research studies in progress to further show SARS-CoV-2 virus neutralization and will be submitting results for peer review publication. For more information on Beckman Coulter’s neutralizing antibody research, suite of testing solutions or its commitment to the fight against COVID-19, visit: www.BeckmanCoulter.com/Coronavirus.
About the Access SARS-CoV-2 IgM Assay
The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 98.3% positive percent agreement (sensitivity) at 15-30 days post symptom onset and 99.9% negative percent agreement (specificity). The assay utilizes an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also 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 DxC 600i and Access 2 analyzers for smaller labs and healthcare clinics.
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