Can a brush of the gums indicate if you have HIV? An oral self-test aims to do just that

A quick brush of the gums and you'll know your HIV status. No blood required. 

That's the kind of painless, fast and accurate HIV testing researchers at St. Michael's Hospital in Toronto are hoping will become the norm for Canadians as the researchers test OraQuick, a rapid oral self-test that will deliver results in 20 minutes. 

The federal government estimates about 62,000 people in Canada have the disease, based on surveillance data. But only about 87 per cent of those with HIV have been diagnosed, leaving about 13 per cent who may not know they are positive, it says.

While the test is new to Canada, OraQuick was approved by the U.S. Food and Drug Administration in 2012. 

St. Michael's is now testing OraQuick at two Toronto sexual health clinics, Hassle Free Clinic and Maple Leaf Medical Clinic, along with several others across Canada. Trials at the Toronto clinics started last week. 

The study will look at the test's accuracy and ease of use. OraSure Technologies, which created OraQuick, estimates the test has a 92 per cent accuracy rate. 

"The test is easier than the COVID test," said Sean Rourke, a clinical neuropsychologist and one of the leaders of the study. 

COVID-19 showed importance of easy at-home testing

Advances in HIV treatment mean that ideally, once diagnosed, a person can access medications that allow them to live a long life and not transmit the disease, even through unprotected intercourse or by giving birth, he said.

But first they need to know their status. And too many from vulnerable groups are unsure how to get tested or don't have contact with the health-care system. The groups that are primarily at risk are men who have sex with other men, those from Black and Indigenous communities, and those who engage in drug use, Rourke said.

Rourke and his colleagues need 900 participants to try OraQuick so that they can send the results to Health Canada — and get the test on the market. 

"We're raising all the money to do this," he said. "These are available technologies that everybody should get, regardless of where you live in Canada."

The importance of easy, at-home rapid testing to keep an illness from spreading was perhaps no better seen than during the COVID-19 pandemic, said Rourke. That, in part, is why governments need to keep the momentum going in making HIV self-tests available across the country, he said.

CBC News requested comment from Health Canada but has so far not received a response. 

Saliva test could be easier than using blood

The first HIV-self-test approved by Health Canada, called, INSTI, became available across the country in November 2020. 

INSTI, which uses a drop of blood to deliver results in one minute, costs $34.95 if ordered from the company's website. However, the test can also be accessed free through the I'm Ready to Know program created by St. Michael's Hospital that has distributed more than 10,000 tests in the last two years. 

There's also GetAKit, a program run by the University of Ottawa and partners, that offers free INSTI kits to those in specific regions through community partners, including Toronto. That program has distributed over 7,000 free kits across Ontario so far, said Patrick O'Bryne, a professor of nursing at the University of Ottawa leading the program.

Still, hospitals, community organizations and universities have been at the helm of campaigns to get rapid tests to populations who need them most, for free. 

Jane Greer, the director at the Hassle Free sexual health clinic, said people in Toronto who have clinics nearby are likely used to frequent testing.  But self-tests could be especially beneficial for those outside of urban cores, she said.

And not having to prick for blood could make this self-test easier to use too.

Early diagnosis key

Adam Awad, manager of communications at the Toronto-based Gay Men's Sexual Health Alliance, said he's excited about OraQuick as he's heard from some clients that a blood-based self-test is too uncomfortable.

But if OraQuick is approved by Health Canada, kits need to be available with as few barriers as possible, he said. Those who are at high risk but have never tested for HIV are unlikely to pay for a self test, he explained.

In August 2022, the Public Health Agency of Canada said the distribution of HIV self-tests are a priority and announced $8 million in funding for self-administered kits. 

But funding for these kinds of programs remains a patchwork and needs to be continually renewed to keep distributing tests, said Rourke.

Awad points to recent changes on HIV/AIDS care guidelines by the Ministry of Health in Ontario that aim to improve testing and treatment. He said he's encouraged to see that those guidelines call for health care providers to test patients more regularly and also reference the importance of self-tests.

About five to 12 per cent of all new HIV cases in Ontario are also found to have AIDS, the most advanced stage of the HIV disease when the body's immune system is badly damaged, he said.

That, says, Awad, is a "huge number" that he hopes will start to fall as easier-to-use self-tests become available. 

"These folks should have been tested far earlier," he said. "No one living in Ontario should be experiencing AIDS."