Ortho Clinical Diagnostics, a company out of Raritan, New Jersey, has unveiled its SARS-CoV-2 (COVID-19) antibody test, a development that may allow the detection of those who have already fought off the virus, but never knew they had it. This will help with tracking the spread of COVID-19, identify clinical staff that can pretty safely inhabit the space of current COVID-19 patients, and significantly expand the study of the virus. Currently, the viral spread and level of public immunity to the virus is unknown, as the number of those who have fought off the virus is unknown.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, as the test is known, spots antibodies (including IgG and IgM) that are produced in response to COVID-19 and so can predict how the individual’s immune system will respond to exposure to the virus.
Testing is performed on one of Ortho’s systems, including the VITROS XT 7600 Integrated System (pictured), the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems. It should be possible to run 150 individual tests per hour using the new assay. There are over 1,000 hospitals and labs in the United States that use Ortho’s systems, so there’s substantial capability already present.
The company expects to make the COVID-19 antibody test kits available “in a few weeks,” according to the press release.
“Given the incredible demand for information to change the tide of this pandemic, Ortho felt it was necessary to market as quickly as possible with a notification to the FDA,” said Chris Smith, CEO. “We are working to make our antibody test kit available to the areas with the greatest need first and will be working in parallel to both increase our test kit production and follow additional regulatory pathways to secure further approvals.”