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 since the fall of 2020.
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June 2, 2021 brings the next exciting step in development: Research program to distribute 50,000 free HIV self-testing kits across Canada: Program led by St. Michael’s Hospital will reach the undiagnosed with the goal of ending Canada’s HIV epidemic.
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.
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 approval 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. The clinical trial began in August 2019 and was completed in March 2020. This study offered a 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 main findings of the trial demonstrated the 1) INSTI HIV Self Test is highly accurate 2) it was easy to use and 3) participants were able to interpret results on their own. 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 Spring 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 recent approval and ongoing national distribution of the INSTI HIV Self Test, REACH Nexus will use this opportunity to conduct an evaluation about its reach, effectiveness, adoption, implementation, and maintenance across Canada.
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, in a November 2019 blog piece published by CATIE, it was highlighted 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.
As studies are conducted about this new testing technology, more information will be available to address these concerns. Stay tuned to updates from REACH Nexus on the results of these upcoming studies. They will also be updated on this page.
Other Testing Technologies
In addition to HIV self-testing, there are other types of tests for HIV, hepatitis C, and other STBBIs.
Dried Blood Spot testing (DBS)
Dried blood spot testing (DBS), is 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. This can be used as a confirmatory HIV test.
Multiplex point-of-care (POC) dual syphilis and HIV point-of-care tests
These medical devices can test for HIV and syphilis at the same time. The tests are used by taking a simple finger prick of blood which can determine results in under 5 minutes and treatment can be provided immediately.
Consult our blog post for more information on a current study by Dr. Ameeta Singh to screen at-risk Albertans for HIV and syphilis using dual syphilis and HIV point-of-care tests. The study is using two devices from Canadian companies, biolytical and MedMira. If these multiplex tests perform well, they will then need to be approved by Health Canada before widespread distribution and use.
Hepatitis C testing
There are a variety of tests for hepatitis C that work through different methods of sampling, result times, and approval status in Canada. For example, oral tests, POC and standard blood tests.
Please see the Hepatitis C Testing Technologies Visual Resource to view an illustrative overview of these different types of hepatitis technologies.
PAN STBBI Testing Work
STBBI testing technologies primer
We started by developing the New Testing Technologies for HIV, Hepatitis C, and Syphilis Testing Self-Testing & Beyond – The BC Context primer. This was developed to provide BC community-based organizations (CBOs) an overview of the up-and-coming STBBI testing technologies prior to conducting a BC testing needs assessment. Please read the blog post here and the primer (in PDF format) here.
BC testing needs assessment
PAN conducted a needs assessment in July/August 2020 with its members and allies 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 has been using 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:
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. (November 2020)
See the CATIE News Article: Health Canada licenses HIV self-testing
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.
Listen to Stacy Leblanc and Sean Rourke talk about HIV self-testing, now available in Canada, on Global News Radio. (December 2020)
Check out the WHO: HIV self-testing – Questions and Answers (November 2016)
Read our blog post about the Northern Alberta clinics testing a Canadian-made dual syphilis and HIV POC tests that has the potential to impact Alberta’s current syphilis outbreak. (December 2020)
CATIE blog by Nitika Pant Pai: HIV self-testing: An unnecessary disruption or a democratizing equalizer? (November 2020)
CATIE blog: More options for HIV testing in Canada (November 2020)
CMAJ’s article by Nitika Pant Pai and Réjean Thomas: Time for HIV self-testing in Canada: a vision and an action plan (November 2020)
CANFAR blog post: The HIV/AIDS epidemic in Canada is predicted to come to an end by 2025 with self-testing kits approval (November 2020)
To learn more about other new testing technologies for HIV and other STBBIs and CBOs, check out this PAN blog post. (July 2020)
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. (June 2020)
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) (February 2020)
Please see The Manitoba Community Event-Based STBBI Testing Toolkit (April 2021)
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.
REACH Nexus work
Stay tuned to the PAN site and newsletter for information about upcoming webinars by REACH Nexus.
Please see the materials from REACH Nexus: Key Messages on the INSTI HIV self-test approval (English | French) and the HIV Self-Test Clinical Trial Results Backgrounder (English | French) (October 2020)
REACH Nexus 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. (October 2020)
Members of REACH Nexus delivered a webinar on the new HIV self-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). (August 2020)
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). (July 2020)
If you want to learn more about PAN’s work on issues related to testing please contact Oralia, [email protected]
Page last updated April 22, 2021