Requirements for Serological Antibody Tests Submitted Under the COVID-19 Interim Order: Guidance

Source: Government of Canada. Published: 4/24/2020. This web page provides guidance to manufacturers of serological assays intended for the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19 disease. It outlines recommendations regarding the minimum testing that should be performed for SARS-CoV-2 diagnostics to support an application for an authorization under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. (Text)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - Category: International Medicine & Public Health Source Type: news