New COVID-19 antibody test will detect the IgG antibody which is found in the blood of patients in the later phase of the infection and remains elevated even after recovery
Ortho Clinical Diagnostics has launched a new COVID-19 antibody test VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test, following the US Food and Drug Administration (FDA) Emergency Use Authorization.
The company said that new Anti-SARS-CoV-2 IgG Test is its second FDA authorized COVID-19 total antibody test, and both of its COVID-19 tests have 100% specificity.
Ortho Clinical Diagnostics chief innovation officer Chockalingam Palaniappan said: “Both tests run on the widely used Ortho VITROS platform and the results will paint a vivid picture of a patient’s immune response status.
“Clinicians will now have invaluable information that will allow them to make decisions about the propriety of a patient returning to work. This is critical information for first responders, health care professionals and other essential personnel working with affected populations.”
Ortho’s new COVID-19 IgG antibody test can be run on its automated analyzers
Ortho said that its total antibody test will detect all COVID-19 related antibodies, including IgM, which appears in the early, acute stage of infection.\
The new test also helps determine the onset of a patient’s immune response by monitoring all antibodies generated through disease progression.
In addition, the test will only detect the IgG antibody which is found in the blood of patients in the later phase of the infection and remains elevated even after recovery.
Both the company’s COVID-29 tests are said to help health care professionals to know whether a patient has been exposed to and has developed antibodies to the COVID-19 virus.
The test has been designed to run on the company’s VITROS XT 7600 Integrated System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System and will be available soon on VITROS ECi/ECiQ Immunodiagnostic Systems.
VITROS Systems are already installed in more than 1,000 hospitals and reference labs in the US, and are self-contained.
The systems do not need an external water source to run, offering labs placement flexibility.
Ortho Clinical Diagnostics chief executive officer Chris Smith said: “Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity. During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”