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The IgG antibody test runs on the Architect i1000SR and i2000SR instruments and will expand to the company's Alinity i system.
Thermo Fisher will seek Emergency Use Authorization from the US FDA and international regulatory authorizations for the test over the next few weeks.
The firm withdrew its 2020 revenue guidance and missed Wall Street estimates for both revenues and earnings.
The high-specificity serology test is also available in countries accepting the CE mark, and the company has begun shipping the test globally.
Seroconversion for IgG and IgM occurred simultaneously or sequentially, and IgG and IgM titers plateaued within six days of seroconversion.
AMA's suggestions include increasing transparency about testing capacity and providing guidance on serology tests, among other things.
The test detects IgG antibodies in human serum and plasma and is intended to identify people with an adaptive immune response to SARS-CoV-2.
The tests for detecting IgG and IgM antibodies can be used manually or with any open automated ELISA analyzer, the company said.
On the company's earnings call on Wednesday Roche provided some details about its work on a serology test to determine immunity for patients who have had COVID-19.
The company is working to develop another lab-based serology test to detect IgM antibodies in people who have already had the virus.
