Fujirebio Europe announces CE marking of the fully automated Lumipulse® G SARS-CoV-2 S-IgG assay

Product news

Gent, Belgium – August 18, 2021: Fujirebio Europe announces the CE marking of the Lumipulse G SARS-CoV-2 S-IgG assay, a quantitative antibody assay for a fully automated CLEIA (chemiluminescent enzyme immunoassay) system. The quantitative measurement of IgG antibodies to SARS-CoV-2 Spike (S) Receptor Binding Domain (RBD) can help in the assessment of immune response to the SARS-CoV-2 S protein.

Detection of the IgG-type antibodies to SARS-CoV-2 Spike protein provides important information about a diagnosis of SARS-CoV-2 and confirmation of antibody acquisition for vaccination.  With this new product, Fujirebio further positions itself as a leading global provider of COVID-19 testing solutions to the IVD industry and steps up its contribution to the worldwide battle against the pandemic. 

“With this new antibody test we provide a fully automated SARS-CoV-2 antigen and antibody testing solution, to be used on our LUMIPULSE® G series. We wish and expect that these innovations will have a positive impact on laboratory throughput of COVID-19 testing by consolidating immunoassay solutions,” says Christiaan De Wilde, CEO at Fujirebio Europe.

About the LUMIPULSE G series

The Lumipulse G SARS-CoV-2 S-IgG assay will be available for use on the LUMIPULSE G1200 and LUMIPULSE G600II instruments. The LUMIPULSE G series are robust, fully automated CLEIA instruments. The LUMIPULSE G1200 and G600II have a throughput of respectively 120 and 60 tests per hour and allow laboratory personnel to randomly load samples as needed. CLEIA technology and automated testing provides increased sensitivity, reproducibility, and throughput. 

About Fujirebio

Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.

Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.

Fujirebio is a wholly-owned subsidiary of H.U. Group Holdings Inc. (formerly known as Miraca Holdings Inc. and listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.