Exciting news! Health Canada has provided final approval of Canada’s first HIV self-test the blood-based test on November 3, 2020. Read the key messages from REACH Nexus related to this announcement.
Testing technologies for different sexually transmitted and blood-borne infections (STBBIs) have been changing rapidly, and new testing interventions are constantly being developed and introduced for wider use.
On this page you will find an overview of one of these new testing technologies and updates on what is changing in the Canadian context, including information on HIV self-testing, which has attracted national and international media attention, and has been approved for distribution in Canada.
HIV self-testing (HIVST)
What is it?
HIV self-testing (HIVST) is a process in which a person collects their own blood specimen, performs an HIV test, and interprets the result on their own. This testing is often performed in a private setting, either alone or with a trusted person. The self-test results act as an initial screening for HIV, and a confirmatory test is required for HIV diagnosis.
How does it work?
Two kinds of HIV self-testing have been developed to date:
- Blood-based test: This kind of self-test requires the collection of a blood sample obtained by prick from a person’s fingertip
- Oral swab test: This kind of self-test requires the collection of a saliva sample obtained with a swab from a person’s mouth
Both of these types of HIV self-testing are considered rapid diagnostics tests because the technologies behind them make it possible to obtain results in less than 20 minutes and the collected samples do not have to be sent to a laboratory for processing and testing.
How is HIV self-testing different from other testing methods?
Self-testing is different from self-sampling. HIV self-testing involves using a testing kit to both collect the sample and interpret test results. By contrast, self-sampling is when a person collects their own samples, but the test is carried out by a laboratory and the results are often provided by a healthcare provider.
What is the INSTI HIV Self Test?
Health Canada provided final approval of the blood-based test on November 3, 2020, for distribution across Canada. This builds off previous changes made in September 2019 to make HIV self-testing more accessible for use by non-healthcare providers. The HIV self-test to be approved was developed by the Canadian company bioLytical Laboratories Inc., and it will likely become better known for its commercial distribution name as the INSTI® HIV Self Test.
A ground-breaking Canadian study of the blood-based INSTI HIV Self Test was led by Dr. Sean B. Rourke and his team at the MAP Centre for Urban Health Solutions and the CIHR Centre for REACH at St. Michael’s Hospital. This study conducted the necessary real-world “intended user” trial required by Health Canada as part of the application to license the INSTI HIV Self Test for use in Canada. The clinical trial began in August 2019 and was completed in March 2020. You can read more about the findings here.
The mechanism behind the INSTI HIV Self Test uses blood samples to detect HIV antibodies. An HIV self-test can be taken with this new technology as early as 3 weeks after a potential exposure to the HIV virus, although in some people it may take up to 3 months to produce antibodies. Antibodies are the signs that the body is fighting off an infection, and it can take some time for HIV antibodies to reach a detectable level through the INSTI HIV Self Test technology. Once antibodies are present, the accuracy of a test performed with the INSTI HIV Self Test is estimated at 99% compared to a laboratory test.
REACH’s I’m Ready platform
REACH Nexus (a project that is part of the CIHR Centre for REACH in HIV/AIDS) is currently developing an online platform for the supported rollout of HIV self-testing across Canada set to launch in early 2021. The platform will consist of a website, mobile app, and online telehealth platform that will support testing and linkage to care with an option to connect with peer navigators. With the imminent approval and national distribution of the INSTI HIV Self Test, REACH Nexus will use the opportunity to conduct an implementation science evaluation about its reach, effectiveness, adoption, implementation, and maintenance.
What are the expected benefits and challenges of HIV self-testing?
The Ontario HIV Treatment Network (OHTN) has conducted a rapid review of the acceptability of HIV self-testing in high-income settings and found that this new testing technology may increase rates and frequency of testing.
The OHTN review also found that in higher-income countries:
- Gay and bisexual men a (GBM) appear to be willing to use self-testing due to the convenience and privacy it affords
- HIV self-testing may be best suited for first-time GBM testers, infrequent or sporadic GBM testers, and those who live in smaller communities.
Additionally, a November 2019 piece from CATIE highlights that HIV self-testing may help reach people who live with HIV and remain currently undiagnosed.
The HIV self-testing test has the potential to become a rapid and private testing modality that offers convenience and autonomy, may increase testing frequency, and provides new testing options to those hard to reach and those needing to test more often.
As HIV self-testing is rolled out in Canada, there remain a few concerns about this new testing approach, including:
- concerns about the accuracy of this new HIV testing technology
- whether people will go onto pursue confirmatory HIV testing once they’ve used self-test
- whether self-testing will be affordable for people, even if some projects and community-based organizations subsidize or offer INSTI HIV Self-Test kits to testers for free.
Other testing technologies for HIV and Hepatitis C
There are other types of facilitated and self-testing methods, such as dried blood spot testing, where a person on their own, or with the help of someone, collects blood samples on a testing strip and the dried blood samples are sent to a laboratory for testing. You can learn more about other testing technologies such as dried blood spot testing (DBS), hepatitis C self-test, pharmacy-based testing, here.
New Testing Technologies in BC
PAN conducted a needs assessment in July/August with its members and allied stakeholders on their thoughts about new testing technologies and how it may impact their organizations and clients/members. Please check out the report and summary document. PAN will use these findings to develop a work plan to support the work of CBOs during the rollout of HIV self-testing and to explore other testing work in the province. Other provinces will similarly be conducting needs assessments and supporting CBOs as HIV self-testing becomes available across the country.
The HIV testing landscape is certainly changing rapidly. So here we list a few more resources you can check out to learn more about HIV self-testing:
Read our blog post about the Northern Alberta clinics testing a Canadian-made dual syphilis and HIV point-of-care tests that has the potential to impact Alberta’s current syphilis outbreak.
Listen to Stacy Leblanc and Sean Rourke talk about HIV self-testing, now available in Canada, on Global News Radio.
Please see the CBC article: 1st HIV self-test approved in Canada and The Globe in Mail article: Canada approves first HIV self-test as it moves to increase access to screening on Health Canada’s November 2020 approval of HIV self-testing kit.
See the CATIE News Article: Health Canada licenses HIV self-testing and CANFAR blog post: The HIV/AIDS epidemic in Canada is predicted to come to an end by 2025 with self-testing kits approval
Check out the CityNews interview with Dr. Sean Rourke of REACH Nexus on the HIV Self-test approval
You can also check out, CMAJ’s article by Nitika Pant Pai and Réjean Thomas: Time for HIV self-testing in Canada: a vision and an action plan
CATIE blog by Nitika Pant Pai: HIV self-testing: An unnecessary disruption or a democratizing equalizer?
CATIE blog: More options for HIV testing in Canada
February – November 2020:
World Health Organization’s HIV self-testing resource page: It provides information and links to videos, recommended guidelines, scientific articles, and other promotional materials on this HIV rapid diagnostic technology. You can also check out their 4-minute Q&A video for a quick overview of this technology.
Please see the final report from the National Forum on STBBI Testing and Linkages to Care: Reaching the Undiagnosed meeting held on February 4-5, 2020 in Ottawa, Ontario. (English | French)
REACH Nexus has prepared a detailed FAQ on “Implementing HIV-Self-Testing in Canada” for healthcare and community providers. The document covers 1) how the test works 2) considerations for community-based organizations and 3) potential costs of the test. The FAQ can be accessed here (in English) and here (in French).
Members of REACH Nexus recently delivered a webinar on this new testing technology, stating that the accuracy of a test performed with the INSTI HIV Self-Test was 99% compared to a laboratory test. You can access the webinar slides here (in English) and here (in French).
Please see the opinion piece in the Globe and Mail by Dr. Sean Rourke – The end of the HIV crisis is within our grasp. We must apply the pandemic spirit to achieve it.
You can also check out and download CBRC’s two-page information sheet on new ways to get tested for HIV, hepatitis C and syphilis.
To learn more about other new testing technologies for HIV and other STBBIs and CBOs, check out this PAN blog post.
REACH Nexus has delivered a webinar titled, “HIV Self-Testing National Survey Results: Knowledge, Access, Usability, Supports, and Barriers.” You can access the webinar slides in English here and in French here.
Stay tuned to the PAN site and newsletter for information about upcoming webinars by REACH Nexus.
If you want to learn more about PAN’s work on issues related to testing please contact Oralia, [email protected]
Page last updated December 18, 2020