Testing devices for COVID-19: Home testing devices

June 19, 2020

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Background

To expedite the review of medical devices that could be used to treat or diagnose COVID-19, the Minister of Health approved an interim order for importing and selling medical devices. This interim order (IO), signed on March 18, 2020, is one of the fastest mechanisms available to address large-scale public health emergencies.

About near patient in vitro diagnostic devices

A near patient in vitro diagnostic device (IVDD) is used for:

Typically, these rapid test devices are simple to use and provide visual results within a short time period.

A near patient IVDD used for COVID-19 could include:

To be useful in reducing the spread of COVID-19, near patient IVDDs must produce accurate and reliable results. It is also critical that the test results be made available to health authorities so they can connect patients to medical care, and provide guidance to prevent transmission of additional infections.

Point-of-care testing

Health care professionals use near patient IVDDs at the point of care so they can provide immediate results to their patients. Doing so can enable timely treatment, assist in disease surveillance, prevent transmission events, or facilitate containment of infectious disease outbreaks.

Under the IO, manufacturers may seek authorization for these devices. You must ensure that performance claims are supported by studies carried out:

To date, Health Canada has authorized the sale and importation of COVID-19 tests only for use by health care professionals or trained operators.

Home testing

Home use (self-testing) of near patient IVDDs would make it possible for a greater number of people to be tested. This is especially important in areas where health care professionals are not readily accessible. However, without the guidance of a health care professional, there is a significant risk that a patient could:

It may also be impossible for health care agencies to collect home test results. This information is key to important public health decisions involving disease control during a pandemic.

At this time, Health Canada does not consider that the benefits of using home test (self-testing) kits outweigh the risks. In accordance with section 5 of the IO, applications for authorization for these types of medical devices will be rejected without compelling new evidence to the contrary.

Recommendations by public health authorities on point-of-care testing

The Canadian Public Health Laboratory Network released a statement on point-of-care serology testing for COVID-19 in May 2020. It recommended that serology could be used to inform public health responses. However, near patient serological assays for SARS-CoV-2 should not be used for clinical testing in any capacity at this time.

The World Health Organization (WHO) recently provided advice on the use of point-of-care immunodiagnostic tests for COVID-19. The WHO recommended against using either antigen-detecting or antibody-detecting rapid diagnostic tests for clinical decision-making. It also suggested that new point-of-care immunodiagnostic tests should be used only in research settings. The WHO also noted the need to further validate these tests in appropriate populations and settings. It stated that the use of inadequate tests could hinder overall efforts to control the disease.

Manufacturers should be aware that these positions could limit the use of certain near patient IVDD devices for COVID-19, once authorized.

Contact us

Please direct any questions or comments about this notice to the following email address: hc.meddevices-instrumentsmed.sc@canada.ca.

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