CATIE News

4 November 2020 

Health Canada licenses HIV self-testing

  • The INSTI HIV Self-Test is now the only HIV self-test licensed in Canada
  • The approval brings Canada in line with 77 countries that allow HIV self-testing
  • HIV self-testing helps to diagnose people who don’t routinely access traditional testing

The first HIV self-testing technology licensed in Canada is the INSTI HIV Self-Test, produced by the Canadian manufacturer bioLytical. Health Canada licensed the test for use and sale in Canada on November 2, 2020.

This approval, bolstered with evidence from a study conducted at three Canadian sites initiated in 2019, brings Canada in line with 77 other countries that allow HIV self-testing. In countries where HIV self-testing is already available, including the United States and the United Kingdom, self-testing has proven to increase the uptake and frequency of testing – particularly among populations that do not routinely seek out traditional HIV testing or who face obstacles to accessing healthcare.

With 14% of HIV-positive Canadians still undiagnosed, self-testing will offer an additional option for people who want to get tested. This will complement current efforts to diagnose and treat all Canadians living with HIV.

How does self-testing work?

HIV self-testing technologies vary in different countries, but the first and only technology approved in Canada entails a finger prick to produce a blood sample. A single drop of blood is needed for the test, with the result ready in one minute. Results are easy to interpret by non-professionals, with a single blue dot indicating a non-reactive result and two blue dots indicating a reactive result.

An HIV self-test is just a screening test. A reactive test result suggests that a person may be HIV positive, but requires a confirmatory test by a trained provider through a traditional blood draw. Although incorrect reactive results are extremely rare, they can happen. A confirmatory test is not required for a non-reactive result.

How accurate is self-testing?

Research studies have confirmed that self-testing is accurate and is able to produce the same results as point-of-care tests performed by trained healthcare providers. A large trial conducted in three Canadian cities to support this approval found that people can perform the self-test effectively and accurately interpret the results on their own. Self-testing has been shown to be safe, convenient, easy to use and empowering – with 95% of users in the Canadian study reporting they would use the self-test again and recommend it to family, friends and sexual partners.

The self-testing technology approved in Canada accurately identifies almost 100% of people who have HIV (sensitivity) and will incorrectly produce a reactive result in about 0.5% of HIV-negative people (specificity). Like with any HIV antibody test, this self-test detects antibodies produced in response to HIV, which can take time to develop after an exposure. In the case of the INSTI HIV self-test, the window period during which a new infection may not be detected can be up to three months prior to the test.

How can self-testing be used?

In other countries, HIV self-tests can be purchased online or in pharmacies to be used privately in people’s homes. Health and community organizations have found novel ways to use and distribute HIV self-tests, including assisted self-testing, free kits ordered online and distributed by mail, and peer distribution. It remains to be seen how self-testing will be implemented in Canada.

What are some possible challenges?

Traditional HIV testing approaches include counselling before and after a test to provide information about HIV transmission, prevention, and what a person needs to know if they receive a positive diagnosis. With self-testing, the information provided in pre- and post-test counselling will have to be delivered in more novel ways, such as print inserts within the self-test kit, telephone hotlines, websites or online videos. People who receive a reactive result may also require support or counselling.

Referral to confirmatory testing for reactive self-tests is another potential challenge. People who access self-testing need to know that a reactive result must be confirmed with a laboratory test, and need information about where they can access confirmatory testing. This linkage to care can also happen through print inserts, telephone hotlines and websites.

People have the right to be tested, and the right to not be tested. Although social harms resulting from HIV self-testing have not been observed in clinical trials, efforts must be taken to ensure that self-testing is always voluntary, without coercion from families, partners, employers or healthcare providers.

The self-test will shortly be available for purchase online from the manufacturer. To make self-testing accessible to the key populations affected by HIV in Canada, self-testing needs to be affordable and access programs will be necessary. The Canadian Institutes for Health Research (CIHR) Centre for REACH 3.0 is working with community organizations across Canada to launch a tele-health program in January that will distribute 60,000 self-tests and connect people who use the self-test with care.

Why is testing important?

A person living with HIV on effective treatment can expect to live a long and healthy life, and they can’t pass it on to a sexual partner. But in order to take advantage of the benefits of modern HIV treatment, a person must be diagnosed – the sooner, the better.

Testing is the first step towards engaging people living with HIV in treatment and care, which has benefits for the individual as well as their partners and the broader community. Epidemiologists project that we can end HIV as a public health threat if certain testing and treatment targets are met by 2030, including the diagnosis of 95% of people living with HIV. In Canada, we currently stand at 86% diagnosed.

What do service providers need to know?

Self-testing is now approved in Canada. Depending on when and how self-testing kits become available to Canadians, service providers will play a key role in informing their clients about this option and responding to inquiries from people who have used a self-test.

Service providers should:

  • make their service users aware of all the HIV testing options available to them, including self-testing
  • understand how the INSTI HIV Self-Test works, and be able to demonstrate its use to their service users
  • know how to offer or facilitate access to post-test counselling and care for a service user who has received a reactive self-test result
  • consider offering free HIV self-test kits to service users who would otherwise not be able to afford them

Resources on HIV testing