The U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization of a total antibody test to detect the presence of the coronavirus antibodies, including immunoglobulins IgM and IgG in the blood.
Headquartered in Germany, Siemens Healthineers, a medical technology company received the FDA approval for its total antibody test to detect the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies.
The antibody test is called the SARS-CoV-2 Total, or COV2T, which can identify recent or prior COVID-19 infection. The test demonstrated 100% sensitivity and 99.8% specificity in identifying antibodies against the new coronavirus.
SARS-CoV-2 Total detects the antibodies believed to neutralize the virus, specifically targeting those antibodies that are attach to a spike protein on the virus. Several companies are developing vaccine candidates that target the spike protein, as it plays a key role in entering the human cells.
Dr. Deepak Nath, President of Laboratory Diagnostics, Siemens Healthineers, said, “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,” he added.
Siemens said it has shipped over 1 million test kits to health systems and labs, and it could ramp up production immediately.
“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.,” Siemens said.
Also called a serological test, an antibody test will provide a clearer clinical picture of the disease progresses, which could help make important decisions. The U.S. Centers for Disease Control and Prevention (CDC) has said that antibody test findings should not be used to determine whether someone can return to work. The test result should not be used to group people, especially in schools, dormitories, and jails.
