Ellume has received FDA-authorization for its rapid lateral-flow home-test that detects SARS-CoV-2 antigens. The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above.
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Roche's monthly output for its new CE-marked Elecsys SARS-CoV-2 rapid antigen test will be a double-digit million number by 2021. The test returns a result in 18 minutes and runs on the automated cobas e analyzer that can run 300 tests per hour. 
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EKF Diagnostics has announced FDA-EUA and CE-IVD marking for its Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit that determines both the presence and specific quantities of human IgG antibodies to the SARS-CoV-2 virus. 
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Moderna will use the Roche Elecsys^® Anti-SARS-CoV-2 S antibody test for its mRNA-1273 vaccine research trials. The test measures quantitative levels of anti-RBD SARS-CoV-2 antibodies and has been authorized by the US FDA.
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A SARS-CoV-2 self-test that uses either stool or sputum specimens is now CE-marked and is currently under evaluation in EC countries. The patent-pending test is a rapid lateral-flow antigen test that utilizes ACE-2 receptors to capture the S-protein of the virus. 
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Bacteria-based diseases present similar symptoms to COVID-19. ImmuView® P&L is the only urinary Antigen Test capable of identifying both Streptococcus pneumoniae and Legionella pneumophila at the same time – with just one test.
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AccessBio's rapid lateral-flow antigen test for SARS-CoV-2 is now available in the US after receiving FDA authorization. Results are shown clearly on the test due to the NanoAct™ colored cellulose nanobeads embedded in the test strip. 
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