Sep 04, 2005

A Canadian company is on the verge of becoming the first and only firm to be approved by Health Canada to sell instant HIV test kits which will be made available to doctors and clinics, the sun has learned. BC-based bioLytical is expected to hear as early as next week whether Health Canada has approved it to manufacture and market its INSTI kits for what is known as “point of care” use-or use by medical professionals and at clinics.

The kits would allow people to know within 60 seconds whether they have been infected. Currently, a patient has to wait at least a week before getting test results from a laboratory, and depending on the outcome, a second test is often recommended three months later.

“Rapid testing has been around for years. These tests were designed primarily for use… in the developing world in situations where laboratory testing is just not available,” said Rick Galli, bioLytical’s director of research.

“However, to a large extent they’ve been unregulated. There has been evaluations on these tests…and the quality is getting better but there has been some very poor performance of what they call rapid tests, and as a result a lot of that has muddied that whole world.”

Galli is referring to other instant HIV tests previously approved by Health Canada which were later pulled off the market because of unreliable results. Should Health Canada bioLytical’s test, it will have been through at least seven stages of testing and evaluation—a system Galli describes as “rigorous.”

‘POTENTIAL AND PROMISE’

“In this world of.. .therapy becoming more and more available, it really is impacting on the number of people coming forward for testing,” said Galli.

Dr. Isra Levy, the director of the Canadian Medical Association’s office of public health, said so-called instant HIV tests have “potential and promise” if used with due diligence.

“The question… always is: Can one have the same confidence that the result that will result from a point-of-care test will provide a test with as much reliability and accuracy as when you send it to a laboratory?” said Levy. “The two-edged sword is clearly there are some benefits to removing obstacles of access but the flipside is that there are also risks.”

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