On May 13, 2020, Thermo Fisher Scientific announced it will expand its response to the COVID-19 pandemic by developing a total antibodies test in collaboration with WuXi Diagnostics and Mayo Clinic.  The new test is the result of ongoing collaboration between all three organizations, including clinical evaluation and support from Mayo Clinic. Thermo Fisher will seek U.S. FDA Emergency Use Authorization (EUA) and international regulatory authorizations for the test over the next few weeks.

Once approved for use, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine if a patient has been exposed to SARS-CoV-2. The test is designed to run on an open instrument platform, and the determination of antibody status will aid in the diagnosis of the disease during the acute and recovery stages of infection.

The global call to ramp up testing requires a combination of both PCR-based molecular tests and serological tests. Molecular tests, such as Thermo Fisher’s Applied Biosystems TaqPath Combo Kit, are considered the gold standard for determining if a patient has an active infection. Serological tests determine if a patient has antibodies to SARS-CoV-2 that indicate whether they have had – or still have – the virus and have built up an immune response. When used in combination, these tests provide greater clinical efficacy, support contact tracing and enhance epidemiological efforts to stop the spread of the virus. Thermo Fisher will begin manufacturing the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test at its sites in the U.S. and Europe in the next few weeks as it prepares to submit for EUA.