Germany’s Siemens Healthineers has developed a laboratory-based total antibody test to identify individuals with past Covid-19 infections.
The test will help to identify the antibodies of SARS-CoV-2, the virus strain that causes the disease, in the individuals who have developed an immune response to the virus.
Currently, Siemens Healthineers is working to receive emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).
The company aims to make the Covid-19 test available by late next month, while its manufacturing facility in Walpole, Massachusetts, US, is expected to deliver more than 25 million tests per month from June.
Siemens Healthineers Laboratory Diagnostics president Deepak Nath said: “Siemens Healthineers is working diligently to address the need for high-quality tests in the fight against Covid-19.
“This test is being designed with the precision and controls, sensitivity and specificity that laboratories have come to expect from our immunoassay tests.”
The antibody test will be made available on the Atellica Solution immunoassay analyser. This equipment can run up to 440 tests per hour and will provide a result in approximately 14 minutes.
According to the company, the test is capable of identifying IgM and IgG antibodies and has demonstrated sensitivity and specificity of more than 99%.
Earlier, Abbott Laboratories and Switzerland’s Roche announced a plan to deliver antibody tests.
Abbott aims to deliver 20 million antibody tests per month by June.
Globally, Covid-19 virus has infected more than 2.7 million and nearly 191,000 people have lost their lives due to the pandemic.
Siemens Healthineers launched its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit earlier this month.