Thermo Fisher Launches Two New SARS-CoV-2 Antibody Tests to Further Broaden COVID-19 Test Portfolio

Thermo Fisher Scientific Inc. (Waltham, MA, USA) has launched two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test.

The new tests for detecting COVID-19 antibodies have expanded the company's SARS-CoV-2 test portfolio, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing.

The OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics, has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG). The EliA SARS-CoV-2-Sp1 IgG test is commercially available in accordance with the FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)". The EUA is currently under review by the FDA. The EliA test is designed for automated processing of up to 60 results per hour on the Thermo Scientific Phadia 250 instrument. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the US Individual IgM and IgA EliA tests are also available now for research use only.

Both the new antibody tests are 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. Additionally, these tests are now available in Europe and countries accepting the CE Mark.

"Thermo Fisher is committed to providing a range of innovative solutions, including new serology tests that complement our PCR-based tests," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "The addition of COVID-19 antibody tests to our broad portfolio further enables our support of the pandemic response on multiple fronts."