BREA, CALIF., OCT. 6, 2020 —Beckman Coulter, a clinical diagnostics leader, today 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.