2 June 2020 - - The US Food and Drug Administration has issued an Emergency Use Authorization for German technology company Siemens' (OTC: SIEGY) Siemens Healthineers' laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood, the company said.

Test data demonstrated 100% sensitivity and 99.8% specificity.

The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.

Testing can begin immediately with more than one m tests already shipped to health systems and laboratories.

A spike protein on the surface of the SARS-CoV-2 virus enables the virus to penetrate and infect human cells found in multiple organs and blood vessels.

The Siemens Healthineers Total Antibody COV2T assay was thoughtfully designed to detect antibodies to the spike protein. These antibodies are believed to neutralize the SARS-CoV-2 virus and therefore prevent infection.

Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.

Tests with high level of specificity yield low false positive rates, which is highly desirable especially when prevalence of disease is low. For example, a test with 99.8% specificity, in populations with low disease prevalence (e.g., 5%), will yield a positive predictive value of 96.5%.

In other words, 96.5 people in 100 testing positive will truly have antibodies. This number only goes up as the disease prevalence increases; for example, in communities with 10% of disease prevalence, this test would yield a PPV of 98.3%, meaning that 98.3 people in 100 people with positive tests results have antibodies.

High-quality antibody testing is vital to accurately assess the prevalence of disease, which varies across the US

The total antibody test SARS-CoV-2 Total (COV2T) 3 is available on the largest installed base of high-throughput analyzers, including the Atellica IM immunoassay analyzers, which can run up to 440 tests per hour1 and enables a result in just 10 minutes.

The test also is available on the company's expansive installed base of ADVIA Centaur XP and XPT analyzers, which can test up to 240 samples per hour with a result in 18 minutes.

Comparable antibody tests4 for Siemens Healthineers Dimension Vista and Dimension EXL systems started shipping on May 29, further extending clinical reach across the company's 20,000 systems installed worldwide.

The tests were developed in the epicenter of the pandemic, are manufactured in Walpole, Mass. and Newark, Del., and are distributed from Plainfield, Indiana. The company is ramping up production, with capacity exceeding 50 m tests per month across its testing platforms.