NEW YORK ─ Siemens Healthineers said on Monday that the US Food and Drug Administration has authorized its total antibody laboratory test to detect the presence of SARS-CoV-2 antibodies, including IgM and IgG in blood, for emergency use.
Erlangen, Germany-based Siemens Healthineers said that testing can begin immediately and that it has already shipped more than 1 million of the tests to health systems and laboratories.
The FDA on Friday granted two EUAs for the laboratory-based chemiluminescent immunoassay ─ one for its use on the Siemens Healthineers Advia Centaur XP and Advia Centaur XPT systems and the second for use on its Atellica next generation system.
The total antibody test can identify patients who have developed an adaptive immune response to the novel coronavirus, which indicates recent infection or prior exposure. The assay detects antibodies believed to neutralize the SARS-CoV-2 virus that attach to the spike protein on the surface of the virus, the company said.
It is unknown for how long antibodies persist following infection and whether the presence of antibodies confers protective immunity, the FDA said.
Test data for the total antibody assay showed 100 percent sensitivity and 99.8 percent specificity in patient samples 14 days or more after a PCR test, Siemens said.
The company last week announced that it had received the CE mark for its total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood and had begun shipping the test worldwide.
Siemens has an installed base of more than 20,000 instruments for all systems that could run its antibody serology test, with 6,000 in North America.
The company said it has production capacity for more than 50 million tests per month, and its high-throughput analyzers can deliver up to 440 tests per hour and report results in 10 minutes.
It is also developing an antibody-based serology assay for its Dimension Vista line of analyzers.