INSTI now available for expanded point-of-care use in Canada

September 19, 2019


The world’s fastest HIV test is more accessible than ever before as Health Canada approves revised Intended Use statement.

RICHMOND, BC September 19 2019 /GLOBE NEWSWIRE/ – bioLytical Laboratories, a world leader in rapid diagnostic tests for infectious diseases, is pleased to announce that the INSTI HIV-1 / HIV-2 Antibody Test is being made more widely available in Canada. A recently approved amendment to INSTI’s Intended Use statement means the test can now be used by HIV testers and healthcare providers in a significantly expanded variety of settings.

Known globally for its outstanding performance, INSTI uses innovative technology to deliver instant, accurate HIV test results from a one-minute procedure. The test’s updated Intended Use statement makes it possible for an increased range of healthcare professionals to use INSTI, including HIV counsellors and peer testers. It also allows for INSTI to be performed in more point-of-care (POC) settings including outreach testing events. This is similar to the CLIA Waiver in the United States, which was granted to INSTI in 2012. The waiver certifies that INSTI is a “simple laboratory examination or procedure that has an insignificant risk of an erroneous result.” This means the test can be performed by a variety of users in POC settings across the country.

This is important news for Canada’s community-based organizations and HIV research community, who have been calling for better access to HIV POC test delivery for many years. “This is a watershed moment in Canada. With this increased delivery access of HIV POC testing, we will be able to significantly support the scaling up of community-based models to ‘bring the test to the people.’ It is only in this way that we will reach those who are undiagnosed with HIV and who need testing the most. Notably, their health, livelihood and survival depend on this increased access,” said Dr. Sean B. Rourke, FCAHS, MAP Scientist and Director of CIHR Centre for REACH 3.0, St. Michael’s Hospital.

INSTI was approved by Health Canada in 2005, making it the only POC HIV test of its kind in the country. At the time of its approval, the test was designated for use only in medical POC settings such as doctors’ offices, clinics and laboratories according to the Intended Use statement. This also meant that only trained healthcare professionals such as doctors, nurses and laboratory technicians were permitted to perform the test. INSTI is successfully used in traditional and non-traditional testing models worldwide due to its fast, flexible procedure, accuracy and ability to detect HIV as early as 21-22 days post-infection.

Convenient, accessible HIV testing is increasingly important in Canada amid reports that HIV is on the rise. An estimated 14% of people living with HIV in Canada are undiagnosed, which represents 9,090 individuals who are not aware of their status. Populations who may be most at-risk include people who live in remote communities, men who have sex with men, people of African and Caribbean background, Indigenous peoples (First Nations, Metis and Inuit), people who use intravenous drugs, and at-risk youth and women.

bioLytical commented, “Health Canada’s approval of this vital change to INSTI’s Intended Use is ground-breaking because it will allow rapid testing to become available more widely in Canada than ever before.  Studies have shown that at-risk individuals may be less likely to seek out HIV testing in traditional medical settings. Providing additional options for point-of-care testing gives us further opportunities for diagnosis and linkage to care. This can save and extend lives, giving us a new hope for ending the HIV epidemic in our country.”

About bioLytical Laboratories Inc.

bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in vitro medical diagnostics. Using its proprietary INSTI® technology platform, bioLytical’s product line features the INSTI HIV-1 / HIV-2 Antibody Test, INSTI Multiplex HIV / Syphilis Test and INSTI HIV Self Test, plus a pipeline that includes solutions for HCV and HBV. With worldwide regulatory approvals including US FDA approval, Health Canada approval, WHO Prequalification and CE mark, INSTI generates meaningful outcomes for patients, healthcare professionals, payers and public health organizations, as well as contributing to global health strategies. For more information, visit


previous article next article more articles
November 3, 2020

Canada’s First HIV Self Test Receives Licence

June 5, 2020

INSTI SARS-Cov-2 Antibody Test in the News

December 1, 2019

INSTI in the News: World AIDS Day