Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance

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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Last Updated April 17, 2026, 18:12 (UTC)
Created April 17, 2026, 18:12 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2020-04-24 00:00:00
open_canada_keywords {"fr": ["Pandémie de COVID-19", "tests d'anticorps", "tests sérologiques"], "en": ["COVID-19 pandemic", "Antibody tests", "serological assays."]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice : Exigences relatives aux tests sérologiques d’anticorps soumis en vertu de l'arrêté d'urgence concernant la COVID-19
update_frequency as_needed