Fujirebio Europe receives CE mark for automated Lumipulse G SARS-CoV-2 antigen assay and ESPLINE SARS-CoV-2 rapid antigen device

Fujirebio Europe receives CE mark for automated Lumipulse G SARS-CoV-2 antigen assay and ESPLINE SARS-CoV-2 rapid antigen device

Fujirebio Europe has received CE marking for their Lumipulse G SARS-CoV-2 Ag, a high-sensitivity antigen test for the fully automated CLEIA (chemiluminescent enzyme immunoassay) Lumipulse G system, and...

Supplied by Fujirebio Europe N.V.


Fujirebio Europe has received CE marking for their Lumipulse G SARS-CoV-2 Ag, a high-sensitivity antigen test for the fully automated CLEIA (chemiluminescent enzyme immunoassay) Lumipulse G system, and of the ESPLINE SARS-CoV-2 rapid antigen test. Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD) testing.

The Lumipulse G series are robust, fully automated CLEIA immunoassay 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.

The ESPLINE SARS-CoV-2 is an immunochromatographic rapid antigen test, and unlike other nucleic acid-based tests on the IVD market that also detect the SARS-CoV-2 gene with high sensitivity, the ESPLINE test does not require any special equipment. It is a cassette-style assay using a simple procedure, and it has a short reaction time of 30 min.

Both assays received Japanese regulatory approval in May and June 2020 for use with nasopharyngeal and saliva samples (Lumipulse only) as an aid in the diagnosis of SARS-CoV-2 infection.

“We are the first company to develop and provide a fully automated SARS-CoV-2 antigen testing solution, to be used on our Lumipulse G series, together with a rapid test device on the ESPLINE platform, and expect these innovations will have a positive impact on result turnaround times and laboratory throughput of COVID-19 testing,” said Christiaan De Wilde, CEO at Fujirebio Europe.


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