Siemens receives FDA approval for SARS-CoV-2 antibody test

By Angela Betsaida B. Laguipo, BSNJun 3 2020

Siemens Healthineers has announced that the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization for its total antibody test to detect the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies, including Immunoglobulin M (IgM) and Immunoglobulin G (IgG) in the blood.

Called the SARS-CoV-2 Total (COV2T), the test can identify recent or prior SARS-CoV-2 infection, based on the patient’s adaptive immune response to the virus. The total antibody test demonstrated 100 percent sensitivity and 99.8 percent specificity in identifying antibodies against the novel coronavirus.

Antibodies attacking the SARS-CoV-2 virus. Image Credit: Kateryna Kon / Shutterstock

Detect antibodies to the spike protein

The spike protein on the surface of the virus enables it to penetrate and infect human cells, which are found in many organs and blood vessels in the body.

The total antibody test detects the antibodies believed to neutralize the SARS-CoV-2, specifically targeting the antibodies that attach to a spike protein on the viral surface. Many candidate vaccines being developed today target the spike protein, since it plays a pivotal role in the entry of the virus into cells.

“As a leader in laboratory diagnostics, Siemens Healthineers designed a high-quality, highly accurate antibody test with the capacity and reach necessary to help address a critical societal need. The test targets both IgM and IgG antibodies, which allows for early identification of individuals infected with the virus who have developed an immune response, even if they were asymptomatic or never diagnosed with the disease,” Dr. Deepak Nath, President, Laboratory Diagnostics, Siemens Healthineers, said.

Ramp up production

The company, based in Erlangen, Germany, said it could ramp up production immediately, and it has shipped more than 1 million test kits to health systems and laboratories. Currently, the firm is shipping worldwide, and the company is prepared to increase the production of its antibody test as the pandemic evolves.

The company has a capacity exceeding 50 million tests each month across its platforms starting in June. Plus, it plans to boost production in two facilities in Walpole and Glasgow.

“The company has production capacity for more than 50 million tests per month as the pandemic evolves to address the largest installed base in the U.S.,” the company said.

The total antibody test SARS-CoV-2 Total (COV2T) is available on the largest installed base of high-throughput analyzers in the U.S. The country has reported the highest number of infections, with about 1.83 million confirmed cases and more than 106,000 deaths. Globally, the confirmed cases exceed 6.37 million, with more than 380,000 deaths.

Further, there are about 20,000 Siemens Healthineers systems installed across the globe, including the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour and can provide results in just ten minutes.

“As one of the leading specialized laboratories, we recognized the critical need of our customers to have rapid and accurate testing to manage COVID-19 among their patients and staff. The Siemens Healthineers total antibody test enables us to confidently deliver fast, reliable results that will be extremely valuable in the surveillance of the disease,” Paul F. Beyer, CEO of Ascend Clinical, said.

Antibody testing

Also called a serological test, an antibody test detects antibodies produced in response to a virus. The test involves checking the blood for a past infection. Antibodies are proteins that help ward off infections, which are produced by the immune system when the body is exposed to antigens.

The antibody test will provide a more precise clinical picture as the disease progresses. It can help governments determine who vast the spread of the virus is and the proportion of the exposed people in the population.

Knowing who was exposed to the virus may help guide return-to-normal decisions, including reopening businesses and economies.

The U.S. Centers for Disease Control and Prevention (CDC) says that antibody test results should not be used to determine if someone can return to work and should not be used to group people, especially in jails, schools, and dormitories.