Clinical diagnostics provider Beckman Coulter has introduced a fully-quantitative lab-based Immunoglobulin G (IgG) serology test called Access SARS-CoV-2 IgG (1st IS).
The new automated test has been developed to measure the quantity of antibodies against the virus, which causes Covid-19.
Designed to be used in random access mode (RAM), the Access SARS-CoV-2 IgG (1st IS) test enables integration into existing workflows without batch processing.
The test is suitable to run Beckman Coulter’s immunoassay analysers, including the DxI 800 high-throughput analyser that processes up to 200 Access SARS-CoV-2 IgG (1st IS) samples per hour.
The Access SARS-CoV-2 IgG (1st IS) test will allow physicians to determine an individual’s Covid-19 antibody immune response. It also enables to monitor patients who have been previously diagnosed, or suspected of having Covid-19.
Beckman Coulter Covid-19 task force global vice president Chris Hagen said: “The Access SARS-CoV-2 IgG (1st IS) assay may be used to inform clinicians about changes in antibody levels over time.
“This virus continues to evolve, which is why we are continually developing diagnostic solutions to help physicians save lives.”
According to the company, the assay is traceable to the first World Health Organisation (WHO) International Standard for anti-SARS-CoV-2, 20/136 and reports results directly aligned with BAU/mL (binding antibody units) established by the UN agency .
The Access SARS-CoV-2 IgG (1st IS) quantitative test demonstrated a clinical performance of 100% positive percent agreement/sensitivity in patients tested >/=15 days or more post-symptom onset, said Beckman.
Beckman Coulter is providing the test to all customers in countries accepting the CE mark, as well as customers across the US and Puerto Rico under FDA Policy D.
Last year, Beckman Coulter introduced its first Covid-19 IgG and IgM tests, which have been developed to qualitatively detect antibodies produced against the spike protein of the SARS-CoV-2 virus.
In March this year, the company introduced its $4 high-throughput antigen test to support the US government’s plan to invest over $12bn to expand Covid-19 testing.
