Roche Receives FDA Emergency Use Authorization for Elecsys Anti-SARS-CoV-2 Serology Assay

On May 3 local time, Roche announced that the United StatesFDAEmergency Use Authorization (EUA) has been issued for the Elecsys® Anti-SARS-CoV-2 antibody test. This antibody test is designed to help determine whether patients have previously been infected with SARS-CoV-2 and whether they have developed antibodies against the virus. The serological assay demonstrates a specificity of greater than 99.8% and a sensitivity of 100% (at 14 days post-infection confirmed by nucleic acid testing). The high specificity of this test is critical for reliably determining whether an individual has been exposed to the virus and whether the patient has generated an antibody response.

Roche has begun shipping its new antibody test kits to laboratories worldwide and is ramping up production capacity to support tens of millions of tests per month, serving healthcare systems in CE-mark countries and the United States. In May, Roche will provide up to ten million tests to countries accepting the CE mark, and further increase capacity thereafter in the U.S. under Emergency Use Authorization (EUA). The test is available on Roche’s cobas analyzers, which are widely used around the world. Severin Schwan, CEO of the Roche Group, stated, “Thanks to the tremendous efforts of our dedicated colleagues, we are now able to supply large volumes of high-quality antibody tests, thereby providing an important tool for healthcare systems worldwide to better respond to the COVID-19 health crisis. I am particularly pleased that our test demonstrates high specificity and sensitivity, which is crucial for offering a reliable tool to support healthcare systems globally in their efforts to combat the COVID-19 health crisis.”

About Antibody Testing

Antibody tests, also known as serological tests, are used to determine whether an individual has acquired immunity to a pathogen. In the context of the COVID-19 pandemic, antibody tests must be capable of specifically detecting antibodies against SARS-CoV-2 without cross-reacting with other similar coronaviruses, which could lead to false-positive results and erroneously suggest potential immunity. Reducing false-positive results is particularly crucial when the prevalence of COVID-19 in a specific population is unknown. As of April 24, 2020, no studies had evaluated whether the presence of antibodies against SARS-CoV-2 confers immunity against subsequent infection with the virus.

About the Elecsys Anti-SARS-CoV-2 Serological Test

Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative in vitro detection of antibodies (including IgG) to the novel coronavirus in human serum and plasma. Testing of 5,272 samples demonstrated that the Elecsys Anti-SARS-CoV-2 assay has a specificity of 99.81% and shows no cross-reactivity with four common cold viruses. This means it can reduce the likelihood of false-positive results due to the presence of similar antibodies in individuals. In samples collected 14 days after infection was confirmed by nucleic acid testing, the sensitivity of the Elecsys Anti-SARS-CoV-2 assay reached 100%.

Hospitals and reference laboratories can perform tests using Roche’s cobas e analyzers, which are widely used around the world. These fully automated systems can deliver results for individual tests in approximately 18 minutes, with some analyzers capable of processing up to 300 tests per hour.BioValleyBioon.com）