Fujirebio Europe Receives CE Marking for Fully Automated Lumipulse G SARS-CoV-2 S-IgG Assay

Fujirebio Europe (Gent, Belgium) has received the CE marking for its 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.

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.

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,” said Christiaan De Wilde, CEO at Fujirebio Europe.