Thermo Fisher Scientific (NYSE: TMO) 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 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The EUA for the OmniPATH COVID-19 Total Antibody ELISA test authorizes 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.
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.1 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,” said 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.”
Developed in conjunction with Mayo Clinic and WuXi Diagnostics, the OmniPATH COVID-19 Total Antibody ELISA test detects three major antibodies – (IgM), (IgA) and immunoglobulin G (IgG) – to help clinicians determine exposure to SARS-CoV-2, the virus that causes COVID-19.
The EliA SARS-CoV-2-Sp1 IgG test is available on the Thermo Scientific Phadia 250 instrument, designed for automated processing of up to 60 results per hour. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the U.S.
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.
1The European Economic Area includes the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the following countries: UK, Norway, Iceland, Liechtenstein, Switzerland and Turkey.
For more information, please visit thermofisher.com.