The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Ortho Clinical Diagnostics’ total antibody assay, the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators to detect coronavirus (Covid-19).
This total antibody test helps to identify the currently infected or previously exposed individuals who may have developed an immunity.
When combined with information from a molecular test, it monitors disease progression by measuring when antibodies appear in the blood.
It can also help screen plasma donations for convalescent plasma therapy, which assists critically ill patients in fighting the virus.
Furthermore, the test will enable medical professionals and epidemiologists to better understand the spread of the disease. It is considered to be an important tool for aiding vaccine development efforts to monitor immune responsiveness.
Ortho Clinical Diagnostics CEO Chris Smith said: “Ortho is proud to be working toward large-scale solutions that will help people return to work, reducing the strain on both employees and the economy as a whole.
“Our focus on improving patients’ lives through diagnostics led us to rapidly develop this test, providing one of the key resources needed for diagnosing and treating Covid-19.”
The test can be run on Ortho’s laboratory analyser, the VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. It will soon be available on VITROS ECi/ECiQ Immunodiagnostic Systems.
These VITROS Systems are already installed in more than 1,000 hospitals and reference labs in the US.
The company intends to produce several million SARS-CoV-2 antibody tests over the next month and to ramp up the production thereafter.