Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance (French, HTML)

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Publisher-reported update

2020-05-11

The purpose of this document is to provide guidance to manufacturers of serological assays intended for the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19 disease. The guidance outlines recommendations regarding the minimum testing that should be performed for SARS-CoV-2 diagnostics.

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