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Siemens Healthlineers has developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood.
Siemens Healthineers announced it is significantly expanding its infectious disease testing capabilities to aid in the COVID-19 pandemic. Recognizing the critical need for accurate diagnostic testing to manage COVID-19, the company has developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood.
This total antibody test will provide a clear view of patients’ disease progression by identifying individuals infected with the virus who have developed an immune response to the virus, even if they were asymptomatic or never diagnosed with the disease. The test, which detects both IgM and IgG antibodies, has demonstrated specificity and sensitivity of greater than 99 percent.
The company is pursuing Emergency Use Authorization (EUA) from the FDA as well as the CE Mark.