NEW YORK ─ Siemens Healthineers said Tuesday that it has received the CE mark for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood and has begun shipping the test worldwide.
The company said it is targeting production of more than 50 million tests per month starting in June and plans to expand production at its facilities in Walpole, Massachusetts, and Glasgow, Delaware.
The antibody test can run on a global installed base of 20,000 Siemens Healthineers systems, including the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour and enables a result in 10 minutes. The test is further available on the Advia Centaur XP and XPT analyzers, which can test up to 240 samples per hour with a result in 18 minutes. Siemens said it is pursuing development of its antibody test for its Dimension Vista and Dimension EXL systems, and it intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves.
The CE-marked total antibody test can identify patients who have developed an adaptive immune response to the SARS-CoV-2 virus, which indicates recent infection or prior exposure. Erlangen, Germany-based Siemens Healthineers said data for the test has shown 99.8 percent specificity and 100 percent sensitivity 14 days after a positive PCR test.
The company said its total antibody test detects antibodies to a spike protein on the surface of the SARS-CoV-2 virus that binds to a human receptor found in lungs, the heart, multiple organs, and blood vessels. Studies indicate that certain neutralizing antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate, and infect human cells, Siemens said.
Earlier this month, the company received US Food and Drug Administration Emergency Use Authorization for its molecular PCR Fast Track Diagnostics SARS-CoV-2 Assay and test kit. Siemens said that to meet demand, it plans to ship more than 2.5 million molecular PCR tests per month worldwide as production capacity increases in May and June.