Thermo Fisher Scientific, Waltham, Mass, has launched a new portfolio of SARS-CoV-2 antibody tests featuring the Thermo Scientific OmniPath Covid-19 Total Antibody ELISA test and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test.
The OmniPath Covid-19 Total Antibody ELISA test has been granted FDA emergency use authorization (EUA) for qualitative detection of total antibodies (including IgM, IgA and IgG) to SARS-CoV-2 in human serum when run manually or when run using the Dynex Agility automated ELISA workstation.
Following its own thorough validation, and in accordance with the FDA’s “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised),” Thermo Fisher has made the EliA SARS-CoV-2-Sp1 IgG test commercially available while the FDA reviews its EUA submission. The EliA SARS-CoV-2-Sp1 IgG test is available on the Thermo Scientific Phadia250 instrument, designed for automated processing of up to 60 results per hour.
Additionally, the OmniPATH COVID-19 Total Antibody ELISA test and the EliA SARS-CoV-2-Sp1 IgG test are now available in Europe and countries accepting CE Mark. Further expansion of this portfolio is planned, with individual immunoglobulin M (IgM) and immunoglobulin A (IgA) EliA tests available now for research use only
“Thermo Fisher Scientific is committed to supporting the global healthcare community’s response to COVID-19 with innovative solutions, including this new portfolio of assays,” says Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. “The addition of these ELISA and EliA antibody tests to our larger testing portfolio, which includes widely used PCR tests, enables us to support testing on multiple fronts across the pandemic response.”
The new antibody test portfolio is designed to meet the need for open ELISA and automated workflows. This flexibility enables laboratories to run the tests at customizable speed and throughput while using automated instruments already in place, minimizing initial costs and reducing the time needed to begin testing.
For more information, visit Thermo Fisher Scientific.