Siemens Healthineers announced today that it is now shipping its laboratory total antibody test1 to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood worldwide. The test received the CE mark and the data has shown a sensitivity of 100 percent2 and a specificity of 99.8 percent. The total antibody test can identify patients who have developed an adaptive immune response, indicating a recent infection or previous exposure.
The company is poised to increase production as the pandemic evolves with a capacity exceeding 50 million tests per month on all its platforms starting in June. Siemens Healthineers is poised to increase production at the company’s facilities in Walpole (Walpole, Massachusetts) and Glasgow (Newark, Delaware).
Antibody testing is now available in the largest installed base in the US and one of the largest in the world with 20,000 Siemens Healthineers systems installed worldwide. This includes the Atellica® Solution Immunoassay Analyzer, which can run up to 440 tests per hour4 and provides a result in just 10 minutes. By detecting IgM and IgG antibodies, the test provides a clearer clinical picture over a longer period of time as the disease progresses.
Importantly, the test detects antibodies against a key protein on the surface of the SARS-CoV-2 virus, a spike protein that binds the virus to cells with a distinct human receptor found in the lungs, heart, multiple organs, and blood vessels. Studies indicate that certain (neutralizing) antibodies against the spike protein can disarm SARS-CoV-2, presumably by interfering with the virus’s ability to bind, penetrate, and infect human cells. Several potential vaccines in development for SARS-CoV-2 include spike protein within their focus.
“Not all antibody tests are the same. A high-quality test that targets the correct protein and is highly scalable is essential for antibody testing to help ensure we are effectively managing the threat of COVID-19, ”said Deepak Nath, Ph.D., President of Diagnostics. Laboratory of Siemens Healthineers. “Siemens Healthineers sought to provide a high-precision antibody test that could reach millions of people to address the current need to identify the immune response and also to provide long-term value as we look toward immunity and vaccination.”
The total antibody test is also available from the company’s extensive installed base of ADVIA Centaur® XP and XPT analyzers, which can analyze up to 240 samples per hour, with a result in 18 minutes. Comparable tests are also being conducted for the Siemens Healthineers Dimension Vista® and Dimension® EXL systems, 5 with a view to achieving clinical scope. The company intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves.5
About the Siemens Healthineers SARS-CoV-2 Molecular Test
Siemens Healthineers also announced that the FDA issued a EUA on May 5 for its PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay6 molecular test kit, which can detect the virus that causes COVID-19. The FTD SARS-CoV-2 assay has also been CE marked for diagnostic use in the EU as of April 24. In method comparison studies, the real-time PCR test has shown a 100 percent positive concordance percentage and a negative 100 percent concordance percentage7. The molecular test, of which more than 500,000 have already been sold in Europe, is compatible with many laboratory platforms and evaluates two targets in a test tube, detecting two genes with less test preparation. The response time of the sample, including extraction and generation of the result, takes 2 to 3 hours, depending on the molecular system and laboratory resources used.
“I am proud of our team, who saw the societal need and moved very quickly to bring this high-quality diagnostic test to the US market,” said Deepak Nath. “Siemens Healthineers now offers the broadest portfolio of high-quality tests for SARS-CoV-2 to help address the global pandemic. Our tests provide healthcare professionals with the information they need to accurately detect SARS-CoV-2, assess disease severity and therapeutic response, and assist in managing the care of patients with comorbidities or complications, such as an escalating immune response or the sudden development of bleeding disorders. These tests will help clinicians with more interventions