Ortho Clinical Diagnostics, a US-based company involved in in-vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions, is introducing its SARS-CoV-2 (COVID-19/coronavirus) antibody test, the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, it was reported on Friday.
Testing kits are likely to be available in a few weeks.
The company followed the guidelines established by the US Food and Drug Administration's (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack detects antibodies (including IgG and IgM) to SARS-CoV-2 that can be utilised to detect immune response to the virus. The test is likely to be used in epidemiological research to help better understand the spread of the disease and may also be used to aid in the diagnosis of suspected COVID-19 patients in conjunction with molecular tests. The test will run on the company's flagship analyser, the VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems and can process around 150 tests in an hour. The systems are intended to remove barriers and are adaptable for non-traditional laboratory environments because they do not require an external water supply to run and are already installed in more than 1,000 hospital and reference labs throughout the US.
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