- Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein
- The spike protein is the target of many COVID-19 vaccines in development
- This test may help identify recovering patients
who could potentially be serum and plasma donors for developing treatments for COVID-19
The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell.1,2 Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time. The test provides a numerical result describing the concentration of antibodies from 0.40-250 U/mL as well as a qualitative result.
“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” said Thomas Schinecker, CEO of
In addition to its role in helping to measure a patient’s immune response, the test may help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus. Convalescent plasma therapy is an investigational procedure that separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor to give the ill patient antibodies to help fight the virus.
The laboratory-based Elecsys Anti-SARS-CoV-2 S test runs on Roche’s widely available cobas e analyzers and is the latest addition to Roche’s growing diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions that help healthcare professionals diagnose COVID-19 and provide optimal patient care during the initial stages of infection and the recovery phase, as well as following the resolution of infection.
About SARS-CoV-2
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.3
About the Elecsys® Anti-SARS-CoV-2 S test
The Elecsys® Anti-SARS-CoV-2 S test is an immunoassay for the in vitro determination of antibodies to SARS-CoV-2. Through a blood sample, the test can measure antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected. The test has both a high negative percent agreement (NPA) of 99.98% (N=5991) and positive percent agreement (PPA) of 96.6% (N=233), 15 days or later after diagnosis with a PCR test. With this test,
Clinical laboratories can run these tests on Roche’s cobas e analyzers which are widely available around the world. These fully automated systems can provide antibody test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.4
About Roche’s response to the COVID-19 pandemic
To address the global COVID-19 healthcare crisis,
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic.
The
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorization (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring antibody response to the spike protein, to help assess a patient’s immune response and support the development of convalescent plasma therapy
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
About
Founded in 1896,
The
All trademarks used or mentioned in this release are protected by law.
References
[1] Masters PS (2006). The molecular biology of coronaviruses. Advances in
[2] Hoffmann,
[3] https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
[4] Full specifications of the
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
Dr. Phone: +41 61 687 05 17 | Phone: +41 61 688 44 86 |
Dr. Phone: +41 61 688 31 10 | Phone: +41 61 682 28 31 |
Nina Mählitz Phone: +41 79 327 54 74 | Phone: +41 61 687 43 05 |
Dr. Phone: +41 61 687 89 67 |
Roche Investor Relations | |
Dr. Phone: +41 61 68-78503 e-mail: karl.mahler@roche.com | Phone: +41 61 68-83894 e-mail: jon_kaspar.bayard@roche.com |
Dr. Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com | Dr. Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com |
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com | Dr. Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com |
Investor Relations | |
Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com | Dr. Phone: +1 650 467 8737 e-mail: tuomi.lisa@gene.com |
Attachment
- 02122020_MR_FDA EUA Elecsys Anti-SARS-CoV-2 S test_en
© OMX, source