Ortho Clinical Diagnostics, Raritan, NJ, has received FDA emergency use authorization for its second covid-19 antibody test, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG test.
The company previously received FDA emergency use authorization for its covid-19 total antibody test. Both tests have 100% specificity.
Chris Smith, Ortho Diagnostics.
“Ortho is proud that both of our covid-19 total and IgG tests are achieving 100% specificity,” says Chris Smith, CEO of Ortho Clinical Diagnostics. “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.”
The US launch of Ortho’s total antibody test was announced on April 3, 2020. The total antibody test detects all covid-19-related antibodies, including IgM antibodies, which appear in the early, acute stage of infection. The test helps determine the onset of a patient’s immune response by monitoring all antibodies generated through disease progression. Ortho’s second antibody test detects only IgG antibodies, which appear in a patient’s blood in the later phase of infection and remain elevated after recovery. Both of the tests help healthcare professionals to understand whether a patient has been exposed to and has developed antibodies to the covid-19 virus.
Chockalingam Palaniappan, PhD, Ortho Diagnostics.
“The results will paint a vivid picture of a patient’s immune response status,” says Chockalingam Palaniappan, PhD, chief innovation officer at Ortho Clinical Diagnostics. “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, healthcare professionals, and other essential personnel working with affected populations.”
The tests run on Ortho’s high-throughput, fully automated analyzers, including the company’s flagship Vitros XT 7600 integrated system, the Vitros 3600 immunodiagnostic system, and the Vitros 5600 integrated system. The tests will soon be available on Vitros ECi/ECiQ immunodiagnostic systems.
Vitros systems are already installed in more than 1,000 hospitals and reference labs in the United States. They are self-contained and do not require an external water source to run, offering labs placement flexibility.
Ortho plans to manufacture several million covid-19 IgG antibody tests each month.
Ortho’s covid -19 antibody tests are designed and intended to be performed solely by laboratory professionals. They are not for home use, and cannot be directly used by patients. Patients should consult with their healthcare providers to discuss antibody testing and back-to-work options.
For further information, visit Ortho Clinical Diagnostics.
