The independent platform for news, articles and advice for professionals in laboratory medicine

Coronavirus antibody test: emergency authorisation

Roche has announced that the US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for its new Elecsys Anti-SARS-CoV-2 antibody test, which is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2.

Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as in the USA.

Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity (14-days post-polymerase chain reaction [PCR] confirmation), can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus.

Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world. These fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for one single test, with a test throughput of up to 300 tests/hour, depending on the analyser.

 “Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to manage the COVID-19 health crisis,” said Severin Schwan (CEO Roche Group). ”I am pleased about the high specificity and sensitivity of our test, which is crucial to support healthcare systems around the world.”

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” said Thomas Schinecker (CEO, Roche Diagnostics). “Roche is committed to helping laboratories deliver fast, accurate and reliable results to healthcare professionals and their patients.”

www.roche.com

Upcoming Events

USCAP 113th Annual Meeting

Baltimore Convention Center, Baltimore, Maryland, USA
23-28 March, 2024

Pathology Horizons 2024

MacDonald Bath Spa Hotel, Bath
18-20 April, 2024

Diagnostics North East Conference 2024

The Catalyst, Newcastle upon Tyne
19 April, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

Upcoming Events

USCAP 113th Annual Meeting

Baltimore Convention Center, Baltimore, Maryland, USA
23-28 March, 2024

Pathology Horizons 2024

MacDonald Bath Spa Hotel, Bath
18-20 April, 2024

Diagnostics North East Conference 2024

The Catalyst, Newcastle upon Tyne
19 April, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

Step Communications Ltd, Step House, North Farm Road, Tunbridge Wells, Kent TN2 3DR
Tel: 01892 779999
www.step-communications.com
© 2024 Step Communications Ltd. Registered in England. Registration Number 3893025