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5th May 2020  Content supplied by: Roche Diagnostics

Roche COVID-19 CE-Marked Serology Test is Granted EUA by US FDA


Roche has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new Elecsys® Anti-SARS-CoV-2 antibody test. The test 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 the U.S.

Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity (14 Days post-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.

With extensive global manufacturing capabilities, Roche will be able to deliver high double-digit millions of tests per month. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world.

For countries with specific regulatory requirements, local approval timelines apply. In addition, there may be other country-specific regulations, such as import requirements, which will determine when the test becomes available locally. Roche will work closely with the respective regional representatives to ensure we appropriately support local registration efforts.

About Elecsys Anti-SARS-CoV-2 serology test
Elecsys Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma.

Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus.

Based on the measurement of a total of 5272 samples, the Elecsys Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing the common cold.

This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual but are specific for coronaviruses other than SARS-CoV-2. Elecsys Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.

The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population.

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.

Main Points: 

  • 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 Authorization, further ramping up capacities thereafter.
  • The test is available on Roche’s cobas e analysers which are widely available around the world.
  • As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.

    

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Date Published: 5th May 2020

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