Jurisdictional Guidelines and Resources

Global

World Health Organization (WHO) (updated 3/19/2020)

• Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans

• Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases (Interim Guidance)

• In areas with no known SARS-cov-2 infections:

  • To consider a case as laboratory-confirmed by nucleic acid amplifaction tests (NAAT) in area with no known COVID-19 virus circulation positive , one of the following conditions needs to be met: NAAT result for at least two different targets on the COVID-19 virus genome, of which at least one target is preferably specific for COVID-19 virus using a validated assay (as at present no other SARS-like coronaviruses are circulating in the human population it can be debated whether it must be COVID-19 or SARS-like coronavirus specific);

    • OR: One positive NAAT result for the presence of betacoronavirus, and COVID-19 virus further identified by sequencing partial or whole genome of the virus as long as the sequence target is larger or different from the amplicon probed in the NAAT assay used.

• In areas where COVID-19 virus is widely spread a simpler algorithm might be adopted in which, for example, screening by rRT-PCR of a single discriminatory target is considered sufficient.

Foundation for Innovative New Diagnostics (FIND)

• FIND Diagnostics Resource Centre

  • FIND is conducting independent evaluations of SARS-CoV-2 molecular tests and immunoassays, in partnership with the WHO - with performance data on sensitivity and specificity.

    • Independent Test Validation

    • SARS-CoV-2 Diagnostic Pipeline

    • SARS-CoV-2 Performance Data

    • SARS-CoV-2 Diagnostic Use Cases

    • Current Testing Situation Worldwide

    • Training on COVID-19 Diagnostics and Testing

USA

Center for Disease Control (CDC)

• Coronavirus Disease 2019 (COVID-19): Research Use Only Real-Time RT-PCR Identification Protocol

Food and Drug Administration (FDA)

• https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19-frequently-asked-questions

• Emergency Use Authorization (including In Vitro Diagnostics EUAs) from February 19, 2020, and updated March 16, 2020

  • This page lists current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.

Europe

European Centre for Disease Prevention and Control (ECDC) (updated 3/19/2020)

• Laboratory support for COVID-19 in the EU/EEA

• ECDC redirects to WHO-recommended tests. Also links to FIND for a list of commercial tests.

• Questions and answers regarding laboratory topics on SARS-CoV-2

Canada

• Federal: Public Health Agency of Canada

• Health Canada - List of Diagnostic devices for use against coronavirus (COVID-19) (Authorized and Listed Application filings)

• Ontario: Public Health Ontario (RT-PCR - refers to WHO guidelines)

  • Testing is being conducted at many laboratories across the province, in coordination with the Public Health Ontario Laboratory and the National Microbiology Laboratory in Winnipeg.

• Quebec: Ministère de la Santé et des Services sociaux, Optilab

Japan

• Detection of second case of 2019-nCoV infection in Japan

Other resources

Our World in Data

• https://ourworldindata.org/

• What can data on testing tell us about the pandemic? (April 13, 2020)

  • Data and charts on testing per country, per capita, testing vs. confirmed cases