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15th September 2020  Product update: rapidmicrobiology staff writer

Firm's COVID-19 Rapid and Automated Antigen Tests Obtain CE-Marking


The Lumipulse G SARS-CoV-2 Ag and the ESPLINE SARS-CoV-2 rapid antigen tests from Fujirebio Europe are now CE-marked for use in the EEA.

In May 2020, Fujirebio Europe also received CE marking for the iAMP COVID-19 Detection kit, a molecular SARS-CoV-2 detection assay.

LUMIPULSE G series

The Lumipulse G SARS-CoV-2 Ag assay will be available for use on the LUMIPULSE G1200 and LUMIPULSE G600II instruments. The LUMIPULSE G series are robust, fully automated chemiluminescence enzyme immunoassay (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.

ESPLINE series

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 (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.

The initial submission of these tests to the FDA in the USA is expected to be made in September for nasopharyngeal swab in universal viral transport media. Submissions to expand sample types are expected to follow. 


    

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Date Published: 15th September 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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