Roche receives FDA authorization for semi-quantitative test to measure the level of SARS-CoV-2 antibodies

Roche has announced that its Elecsys^® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The semi- quantitative serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus.

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 cell to bind to the host cell receptor, which is required for the virus to enter the host cell. The test also provides a numerical result from 0.40-250 U/mL as well as a qualitative result.

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.

"Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19", said Matt Sause, president and CEO of Roche Diagnostics Corporation. "Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response, and supporting the development of convalescent plasma therapy to help other patients fight the disease."

In addition to its role in helping to measure a patient’s immune response, semi-quantitative testing can 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 a 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.

Roche will begin shipping the Elecsys^® Anti-SARS-CoV-2 S test to U.S. laboratories in the next week. LabCorp, an early adopter of the test with broad geographic reach, will be the first lab to offer the testing option in the United States.

“As vaccines and other therapeutic treatments become available, it will become more important to have tests which are more specific about the levels of antibodies in patients,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “We’re pleased to expand our offerings in the fight against COVID-19 and be the first national lab to offer Roche’s semi-quantitative test to the market.”

To learn more about U.S. laboratories offering this test, please visit the Roche Diagnostics website.

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.

About Elecsys^® Anti-SARS-CoV-2 S and Elecsys^® Anti-SARS-CoV-2 serology tests

The Elecsys^® Anti-SARS-CoV-2 S test is an immunoassay for the semi-quantitative, in vitro determination of antibodies to SARS-CoV-2. Through a blood sample, the test can measure the quantity of 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, Roche also showed titer development over time for patient samples ranging >100 days following a reactive PCR result, with no samples showing a decline of titers below the reactive range. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity.

The Elecsys^® Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of antibodies to SARS-CoV-2 that target the nucleocapsid protein. The test can detect antibodies to the coronavirus, which could signal whether a person has been already infected. This test has been authorized only for the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.

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.

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