Beckman Coulter announced the launch of Access SARS-CoV-2 IgG (1st IS), a fully quantitative lab-based Immunoglobulin G (IgG) serology test that measures the quantity of antibodies against the virus that causes COVID-19.
Beckman Coulter said the assay is traceable to the first World Health Organization (WHO) International Standard for anti-SARS-CoV-2, 20/136 and reports results directly aligned with BAU/mL (Binding Antibody Units) established by the WHO.
Access SARS-CoV-2 IgG (1st IS) measures the quantity of antibodies, so physicians can determine an individual’s COVID-19 antibody immune response and aids in the monitoring of patients who were previously diagnosed or suspected of having COVID-19.
The test has a PPA/sensitivity ≥15 days post-symptom onset of 100% and NPA/specificity of 99.8%.
The test is available in the United States and countries accepting the CE mark.