Rapid HIV test approved for use

Artwork by Mark "Atomos" Pilon. Reprinted with permission.

Test kits that provide a preliminary HIV result in 15 minutes were approved for use in Canada in March 2000. The rapid test kits have been licensed by Health Canada's Medical Devices Bureau for use by health care professionals "at the point of care" (i.e. in a clinical setting where counselling, support and referrals are available).

The test kits are produced by Bio-Chem ImmunoSystems, a Montreal-based pharmaceutical company. The manufacturer has expressed no intention of seeking permission to make these test kits available for home testing via retail sale.

Vanguard participants were involved in a two-phase clinical trial to test the rapid test kits. In 1998/99, over 300 Vanguard participants helped test the accuracy of the rapid test kits through Vanguard nurse Mary Lou Miller. In this first phase of the trial, participants were not given the rapid HIV results, as the accuracy of the test kits was still undetermined.

The kits proved to be just as accurate as the standard ELISA test, which is the first of two lab tests used in conventional HIV testing. When someone tests negative on the ELISA, no further testing is done, and the same will be true when using the rapid test.

When someone tests positive on the ELISA, however, a more accurate lab test is conducted, called the Western Blot. People who test positive on a rapid test will therefore still require a blood sample to be drawn for a confirmatory Western Blot test.

In the second phase of the clinical trial, Mary Lou provided rapid HIV test results to 100 participants, in order to compile recommendations for amendments to pre- and post-test counselling guidelines used by health care providers.

In January 1999, Vanguard staff attended a Toronto conference exploring the practical and ethical implications of rapid testing. Hosted by the Canadian HIV/AIDS Legal Network, the conference discussed their report entitled "Rapid HIV Screening at the Point of Care: Legal and Ethical Questions," which is available on their web site.

These issues were also explored in a recent Georgia Straight article by Janet Smith entitled "New HIV Test Could End Tension of Two-Week Wait," which is available on the Vanguard web site.