An HIV test that requires only a small drop of blood, can be performed in a doctor’s office and which gives results in just 60 seconds was approved for use by Health Canada Oct 25.
“It reduces the anxiety of someone waiting for results,” says Debbie Collins, a spokesperson for BioLytical Laboratories, the manufacturer of the test kit. “As it stands now, you have to wait two or three weeks from the time you take the test to the time you get your results.”
BC Persons with Aids Society (BCPWA) Chair Paul Lewand says he’s all for a faster test as long as those who test positive get proper counselling. “The sooner people can have accurate information, the better,” he says.
The test could also reduce the cost of HIV antibody testing on an already over-burdened healthcare system. The kit itself costs only $7-10 and it doesn’t require the extra courier or lab fees the commonly used Western blot test does.
This is not the first instant HIV test approved for use in Canada. In 2000, approval for a test called Fast Check was withdrawn and the test pulled from the market because of a series of false negative results.
“I believe they took their manufacturing outside the country and the quality of the test kits went down,” says Collins. “We are ISO accredited and we have to continue testing every lot that goes out. We have continual research and development on the kit and it will always be manufactured in Canada.”
Dr Michael Rekart, director of STD/AIDS control at the BC Centre for Disease Control (BCCDC) who conducted part of the clinical trials on the test kit, says it’s a conflict of interest for the manufacturer to conduct quality control on its own product. That aside, he says he isn’t sure how valuable this new test will be.
“I think the main positive is that it might make testing more accessible to hard to reach populations,” says Rekart. “If it does that, then it is a good thing. There are some dangers, however.”
Rekart cautions that the test is instant only insofar as the results are instantly available; not that it can detect the virus in the bloodstream instantaneously after exposure. It generally takes about three months from the time a person is infected with the virus to the time HIV antibodies are detectable in his blood. During that period a person can test negative but still carry and transmit HIV.
“The other thing is that if a lot of people are using this test and most of them are negative,” says Rekart, “that’s data we won’t have.”
Rekart says negative results are a critical part of the puzzle of measuring the spread of HIV.
“For instance, when HIV was made reportable in May 2003,” he says, “much of the community were concerned that people would shy away from testing. We were able to show testing actually went up over those few years so that fear was not realized.” Without negative test data, BCCDC would not have been able to identify that trend.
“The other important issue is the percent positivity,” he continues. “If two or three percent of tests are positive year over year and then all of a sudden it’s 3.5 then four then five percent. Then something is going on that we have to figure out.” Again, without an accurate number of negative results, researchers can’t make that calculation.
“The other thing we get from negative test results is demographics,” says Rekart. “How many males are getting tested? How many females are getting tested from what age groups?”