Canada approves HIV self-testing kit ahead of World AIDS Day 2020

Source: CMAJ and RI-MUHC

People with HIV can live long and healthy lives. A test, diagnosis, and connection to appropriate care and services are recognized as essential first steps.

Nitika Pant Pai, MD, PhD, a global expert on rapid diagnostics and HIV self-testing, has been a vocal advocate of HIV self-testing (HIVST) as a breakthrough in reducing barriers to HIV testing since 2008. A clinical epidemiologist and scientist in the Infectious Diseases and Immunity in Global Health Program at the Research Institute of the McGill University Health Centre (RI‑MUHC), Dr. Pant Pai recently published a commentary entitled “Time for HIV self-testing in Canada: a vision and an action plan” in the Canadian Medical Association Journal (CMAJ). She and her collaborator, Dr. Réjean Thomas of Clinique médicale l’Actuel in Montreal, argued that Canada should integrate self-testing for HIV into the health system to help reduce the burden of the disease and to reach elimination targets for HIV.

“In Canada, we need rapid approvals of many HIV self-tests, including oral, blood-based and urine, alongside deployment of diverse, culturally sensitive HIVST strategies and development of HIVST-specific provincial or federal guidelines,” Dr. Pant Pai told CMAJ. “Lack of funding, political will and widespread availability of conventional HIV testing through public health laboratories perhaps delayed introduction of HIV self-tests. It’s 2020, and the time to invest in HIVST is now.”

Shortly after this commentary was published, Health Canada announced the approval of the first HIV blood-based rapid HIV self-test in Canada. On November 3, 2020, bioLytical Laboratories announced that a medical device license had been granted for the INSTI HIV Self Test. The company states that the INSTI® HIV Self Test is made in Canada, provides results in one minute and is more than 99% accurate. They note that this test provides new opportunities to reach the undiagnosed, which can lead to better health outcomes and fewer new HIV transmissions.

In an interview with the Canadian Press about this first regulatory approval of a self-testing kit in Canada, Dr. Pant Pai said that “This is a historic first, but then we are looking forward to pushing more self-tests and rapid point-of-care tests so more people can get access.”

“Introduction of HIVST in Canada should lead to better detection of HIV in underdiagnosed populations who currently face barriers to testing and improve HIV management, bringing us closer to the UNAIDS 95-95-95 targets,” wrote Drs. Pant Pai and Thomas in their CMAJ commentary. “This would be a historic milestone in the long journey toward controlling and ending the HIV epidemic in Canada.”

Nov. 30, 2020

Further information

Read the commentary in CMAJ: Nitika Pant Pai and Réjean Thomas. Time for HIV self-testing in Canada: a vision and an action plan. CMAJ November 02, 2020 192 (44) E1367-E1368; DOI:

Learn about Dr. Pant Pai’s open access mobile app, HIVsmart!, designed to make HIV testing more accessible. Support this work by visiting the MUHC Foundation.

Learn more about HIV self-testing on Radio Canada’s program, Les années lumière, episode of Nov 29, 2020.

December 2 2020