COVID-19: New And Updated EUA Templates Focus On Serology Tests
The US FDA issued a new template for serology test-makers that detect or correlate to neutralizing antibodies, and also updated an existing template to reflect concerns over viral mutations
You may also be interested in...
The US agency has updated its emergency use authorization template for developers making home-use coronavirus serology tests that use fingersticks to collect blood samples.
Tiger Tech’s COVID Plus Monitor is the first of its kind and could be crucial in identifying potential asymptomatic SARS-CoV-2 carriers in order to isolate them as the US economy starts reopening while the pandemic rages on.
The agency published a supplemental template for molecular and antigen COVID-19 EUA sponsors whose product can be used for serial testing, and a fact sheet that screening program organizers can use to pick the right test.