What is the INSTI test?
Health Canada has approved the expanded use of the INSTI HIV test, the only rapid point-of-care (POC) HIV test used in Canada. POC testing is convenient and a great tool to reach a broader array of people for HIV testing. INSTI is an HIV screening test that only detects HIV antibodies. It has a window period of up to three months (though in some people it can detect HIV as early as 22 days after infection). The INSTI test requires a few drops of blood from a finger prick to test for HIV. It produces accurate results in minutes. However, if the INSTI test is reactive (indicating the person is probably HIV positive), a vial of blood needs to be taken and sent to a laboratory for confirmatory testing.
How did the “intended use statement” change?
Changes to the INSTI “intended use statement” permit a wider variety of testers to administer the test, including peers and other laypeople, in a wider range of settings, such as in community-based organizations, during outreach or at community testing events. When the INSTI test was originally approved for use in Canada in 2005, only trained healthcare professionals (e.g., doctors) were allowed to perform the test, and only in medical settings such as doctors’ offices and clinics (however, in some settings trained non-health care providers have administered POC testing under a medical directive). This change was made because it is now recognized that the INSTI test is a simple procedure with a very low risk of getting a false result, regardless of the setting or tester.
What does this mean for access to POC testing in Canada?
Although the regulatory approval is an important first step, it will not be possible to expand the use of this test until provincial and territorial policies are put in place that allow for the use of POC testing by a wider variety of testers in different settings. Lack of funding within jurisdictions will also continue to hamper its use. Community-based organizations, HIV advocates and researchers have long called for increased access to POC testing. Advocacy will need to continue in order to make meaningful policy change that allows this intended use to be realized.