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At-home HIV test gets US FDA approval

More : AIDS Action Now, FDA, HIV criminalization, HIV prevention & services, HIV-Aids, OraQuick

by Jordan Arseneault on July 9, 2012

After seven years under consideration by the US Federal Drug Administration (FDA), at-home HIV saliva test, OraQuick, has been approved for distribution in over 30,000 US pharmacies. AIDS researchers and activists in Canada largely support Health Canada approving at-home tests here, but some remain wary…

While there is no known pending case of at-home HIV test approval by Health Canada, the US Federal Drug Administration (FDA) announced Friday (July 5) the OraQuick at-home HIV test could be distributed and sold to anyone 17 and over in the US. The test, which has undergone international clinical studies, is hailed as a useful tool for 100% confidential testing for the virus which continues to stigmatize and affect the health of an estimated 65,000 Canadians and over 1.2 million Americans. The OraQuick test has between a 92% and 100% accuracy rate for determining a positive HIV status through a swab of the upper and lower gums that is then inserted into a solution, much like an at-home pregnancy test.

Regulators have often been resistant to approve previous at-home tests, which have been technically available since 1987, because of the isolation and psychological impact of an individual testing positive at home, alone, without the pre and post-test counselling that would accompany an HIV test in most clinics. Particularly, opponents of the at-home test have raised the specter of the potential suicidal reaction to a positive result, which was seen as more common in the era before effective tritherapy.

Alex McClelland, a member of outspoken Toronto activist group AIDS ACTION NOW! raises another issue with the at-home test, which is whether the newly self-diagnosed HIV positive person would be inclined to find out what their legal obligations are to disclose their status.

“Post-test counselling is increasingly important, given the increasingly criminalized context [in Canada]; if people take the HIV test at home without receiving counselling, you could have a whole group of people who are not connected to services or support in any way,” McCelland told 2B. “And they may have no way of knowing the legal implications of what having a positive test result are, and what the increasing stigmatization of positive people could entail for them under this regime of the state criminalizing the behaviour of positive people.”

The fears of more stringent prosecution of HIV non-disclosure have been heightened by an unexpected shift in opinion on the part of Ontario’s Attorney General. Last week, provincial attorneys filed a 68-page document with the Ontario Court of Appeal recommending that HIV positive people continue to face criminal charges for not disclosing their status to their partners before sex, even when the risk factor is considered low, such as with oral sex and protected sex. Over the past two years, AIDS advocates with the Canadian HIV/AIDS Legal Network and prominent activists such as Tim McCaskell have worked with the province to limit how strictily HIV positive people are prosecuted for non-disclosure in cases of low-risk activity. Their efforts, however, seem to have come to naught.

This may not be the best time to approve a similar test in Canada, Alex McClelland alludes, “especially with this new move in Ontario from the Attorney General, changing the way they want to prosecute HIV non-disclosure cases, in terms of removing the significant risk test,” and given that the Supreme Court is still considering the Mabior case, which will decide on how significant a risk of infection must be to warrant holding HIV positive people criminally responsible for not disclosing their status.

Advocates of the oral test, such as Montréal researchers Mark Wainberg and Nitika Pant Pai, are part of a worldwide swelling of support for the at-home test, which many say will improve prevention and treatment of HIV.