On 3rd May, 2020 Roche’s COVID-19 antibody test received FDA Emergency Use Authorisation in the USA and is available in markets accepting the CE mark. The test already has approval from medical regulators in the EU
The blood test looks for antibodies to see if a person has already had the virus and might now have some immunity.
Public Health England (PHE) said scientific experts at its Porton Down facility had carried out an independent evaluation of the new blood test developed by Swiss pharmaceutical company, Roche.
On the 13th May, British health chiefs approved the Elecsys Anti-SARS-CoV-2 antibody test. Government Ministers are in talks with Roche to buy millions of the tests, which will be given to NHS and social care workers before being rolled out wider
Ministers are in talks with Swiss firm Roche to buy millions of the tests, which will be given to NHS and social care workers before being rolled out wider.
Prof John Newton, national coordinator of the UK coronavirus testing programme, said: “This is a very positive development because such a highly specific antibody test is a very reliable marker of past infection. link
Elecsys® Anti-SARS-CoV-2 antibody test. link
- The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation)
- The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies
- Roche will provide high double-digit millions of tests already in May for countries accepting the CE mark and in the U.S. under Emergency Use Authorisation, further ramping up capacities thereafter
- The test is available on Roche’s cobas e analysers which are widely available around the world
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 the US”, it said in a statement on 3 May. link