Beckman Coulter today received FDA emergency use authorization for its Access SARS-CoV-2 IgG II antibody test.
The semi-quantitative assay measures the level of antibodies in response to a previous SARS-CoV-2 infection and can provide qualitative and numerical results of antibodies in arbitrary units.
Lenco Diagnostic Laboratories in New York City is one of the first labs to offer the test in its city and the trial-state metropolitan area, according to Beckman Coulter.
“To help in the fight against COVID-19, it is important that we partner with a company that has the reputation, quality, and testing accuracy like Beckman Coulter in meeting the needs of the people of New York,” Robert Boorstein, medical director at Lenco Diagnostics Laboratories, said in a news release. “This next step in COVID-19 antibody testing creates a pathway in helping us establish a quantitative baseline of different antibody levels and determine how a patient’s immune response to COVID-19 is affected over time. We expect that clinicians will find this assay useful for monitoring the progress of a patient’s COVID-19 recovery and assessing the immune response over time.”
The test measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus. It has a confirmed 99.9% negative percent agreement and a 98.9% positive percent agreement at 15-60 days post symptom onset. The assay can be used in Random Access Mode and seamlessly integrates into existing workflows without batch processing.
“Effective and high-quality diagnostic solutions are essential in the fight against COVID-19,” chief medical officer Shamiram Feinglass said. “Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual’s immune response to the SARS-CoV-2 virus over time. This information is essential because it helps continually inform therapeutics and vaccine development.”
Beckman Coulter’s assay is available in the U.S. and countries accepting CE mark.