The company has partnered with LABCORP to make the test available at the laboratories.
Now, Roche plans to make the Covid-19 antibody test available in more than 200 sites over the next few weeks, a step that will help the laboratories to conduct approximately two million tests per week.
The US Food and Drug Administration (FDA) awarded Emergency Use Authorisation for Roche’s Elecsys Anti-SARS-CoV-2 antibody test earlier this month.
Roche Diagnostics North America president and CEO Matt Sause said: “Roche is proud to make this highly accurate serology test available in the US to determine if a person has developed antibodies to Covid-19.
“Reliable, high-quality antibody testing is essential to help us overcome this pandemic and will play an important role in getting people back to work.”
The antibody test is designed to detect mature (high-affinity) antibodies that developed late in the immune response. The process has a specificity of 99.8% based on the measurement of 5,272 samples and reduces false-positive results.
LabCorp president and chief medical officer Dr Brian Caveney said: “Our long-standing relationship and collaboration with Roche enables us to introduce many innovative, high-quality tests for clinicians and patients, which is more important now than ever before.
“Roche’s new antibody test allows LabCorp to provide more options and increase Covid-19 testing capacity as we support the country’s response to the health crisis.”
Coronavirus (Covid-19) has infected more than 1.5 million people in the US. The death toll in the country has reached 91,000.