New SARS-CoV-2 IgM assay introduced by Beckman Coulter in countries accepting the CE Mark

Overview

• Post By : Kumar Jeetendra


• Source: Beckman Coulter


• Date: 12 Nov,2020

Beckman Coulter, a medical diagnostics pioneer, today announced the launching of its accessibility SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The brand new IgM antibody test revealed 99.9% specificity with 1,400 negative trials and 100% sensitivity at >18 times post symptom onset and post positive PCR.

Beckman Coulter’s IgM assay is part of a full suite of testing solutions the company is growing to notify medical and public health decision making during the COVID-19 pandemic. Beckman Coulter is also developing a SARS-CoV-2 antigen test and quantitative IgG assay. Beckman Coulter’s antibody assays and its other planned SARS-CoV-2 offerings run on the organisation’s award-winning immunoassay analyzers, for example, DxI 800 high-throughput analyzer, which is capable of processing 200 samples per hour.

Our new SARS-CoV-2 IgM assay provides information about an individual’s immune status with a positive predictive value of 96.9% in a population with disease incidence as low as 3%. As COVID-19 outbreaks continue to grow in intensity in many of our communities, highly accurate tests such as this are critical for providing reliable information for both individual health decisions as well as population-based immunity monitoring.”

Julie Sawyer Montgomery, President of Beckman Coulter

Able to deliver more than 15 million tests each month, the company can meet its customers’ global demands, including more than 16,000 immunoassay analyzers worldwide. For more information on Beckman Coulter’s suite of testing solutions or its commitment to the fight against COVID-19, visit www.BeckmanCoulter.com/Coronavirus.