REACH Nexus, whose research paved the way for Canada’s first HIV self-test to be approved in Canada in Nov. 3, 2020, is now running a study of the OraQuick ADVANCE® Rapid HIV‑1/2 Antibody Test. REACH’s goal with this research is to secure approval for a second HIV self-test in Canada.
This clinical trial will evaluate the simplicity and accuracy of the OraQuick ADVANCE® when used by healthcare providers. Its results will contribute to data for licensure in Canada of OraQuick ADVANCE as a point-of-care HIV test.
REACH’s goal is to follow this clinical trial with another study focused on use of the OraQuick® HIV Self-Test by lay users. The OraQuick HIV Self-Test is based on the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test and utilizes an identical device, but contains labeling appropriate for self-testing by lay users rather than point-of-care use by trained healthcare providers. The combination of these two studies could provide the necessary data to get the OraQuick HIV Self-Test approved as another HIV self-test available in Canada. HIV self-tests are an effective and acceptable, low-barrier method to increase access to HIV testing and are critical to ending Canada’s HIV epidemic.
Having a second licensed HIV point-of-care test would increase options for access to HIV testing in Canada. Additionally, the availability of this test, which can be used with oral fluid as well as fingerstick or venous whole blood and plasma, could reduce barriers associated with the use of blood-based HIV tests, particularly for people who are less comfortable with having their blood taken.
This study is in partnership with Unity Health, Women’s Health in Women’s Hands, Medi Drugs Millcreek and Clinique médicale l’Actuel.
Read more on our OraQuick ADVANCE HIV-1/2 Rapid Antibody Test initiative page.