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10th December 2020  Content supplied by: various sources as indicated

Latest Updates on COVID-19 Testing - Kits, Products, Services, Instrumentation - 15 Dec 2020


FDA Authorizes Over-the-Counter COVID-19 Home Test

FDA Authorizes Over-the-Counter COVID-19 Home Test

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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Cobas e Rapid SARS-CoV-2 Antigen Test is CE-Marked

Cobas e Rapid SARS-CoV-2 Antigen Test is CE-Marked

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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SARS-CoV-2 Neutralizing Antibody Test is FDA-EUA and CE-Marked

SARS-CoV-2 Neutralizing Antibody Test is FDA-EUA and CE-Marked

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 Use Roche Antibody Test During Vaccine Trials

Moderna Use Roche Antibody Test During Vaccine Trials

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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SARS-CoV-2 Lateral-Flow Antigen Test Uses ACE-2 Receptor & Stool Specimen

SARS-CoV-2 Lateral-Flow Antigen Test Uses ACE-2 Receptor & Stool Specimen

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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Coronaphobia and Coinfections

Coronaphobia and Coinfections

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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Leading Rapid Malaria Test Kit Manufacturer Has SARS-CoV-2 Test FDA-Authorized

Leading Rapid Malaria Test Kit Manufacturer Has SARS-CoV-2 Test FDA-Authorized

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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Date Published: 10th December 2020


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