bioLytical developed INSTI HIV Self Test to provide more than 99% accurate results within one minute, using one drop of blood


BioLytical gets Health Canada approval for INSTI HIV Self Test. (Credit: PublicDomainPictures from Pixabay.)

Canada-based diagnostic testing firm bioLytical Laboratories has received Health Canada Licence to manufacture and market its INSTI HIV Self Test in Canada.

The company claimed that its INSTI HIV Self Test is the first at-home HIV self-test kit in Canada, and is capable of providing more than 99% accurate test results within one minute.

INSTI HIV Self Test is part of bioLytical’s portfolio of 1-minute rapid diagnostic tests for infectious diseases including HIV, Hepatitis C, Syphilis and recent Covid-19.

bioLytical chief executive officer Robert Mackie said: “Ending the HIV epidemic starts with testing. By providing innovative options like our 1-minute INSTI HIV Self Test, we can help people who are unaware of their HIV status to learn the facts and make informed health decisions much faster.

“In addition, bioLytical has received approval in Europe and is currently in FDA trials for our Covid-19 Antibody test, which uses the same 1-minute INSTI self-testing technology.”

According to the company, an estimated 14% of people living with HIV in Canada are not aware of their status, and the HIV self-testing option would lead to better health outcomes and reduced new HIV transmissions.

Similar to a home pregnancy test, the new HIV self-test will enable individuals to screen for HIV from their homes, following easy-to-understand, three-step instructions.

Only one drop of blood collected using a simple fingerstick method is adequate for receiving results that are more than 99% accurate in only one minute, said the company.

Health Canada approval for the test is supported by data from the company’s ground-breaking field study, which showed that individuals without medical training can perform the rapid self-test and understand their results correctly.

The study was jointly funded by The CIHR Centre for REACH 3.0 and the Canadian Foundation for AIDS Research (CANFAR), and was led by Sean B Rourke from St. Michael’s Hospital MAP Centre for Urban Health Solutions.

Rourke said: “We are excited to be bringing HIV self-testing to Canada to reach the undiagnosed, it’s long overdue, and without this option, we will not be able to end the HIV epidemic in Canada.

“Now approved, REACH is working closely with front-line community-based HIV organizations and other health agencies to develop, implement and scale-up a national (online) telehealth platform with peer navigators to support access to, and support with, HIV self-testing as well as linkage to care.”