HIV tests pulled

Health Canada has issued a recall on a rapid HIV test – a decision that affects as many as 2,000 people who’ve been tested at a downtown clinic. Some might think they’re negative when there is a chance they could be HIV-positive.

The Fast-Check HIV Test, which uses a pin-prick of blood to give patients results in 15 minutes rather than the usual two weeks, has been pulled from the market after the BC Centre For Disease Control discovered that it produced some false-negative results.

That means that about 1,900 people who have taken the test at Church St’s Hassle Free Clinic since November 2001 are being asked to come back for the standard test.

“We are encouraging people to come back if they tested negative with the rapid test,” says Robert Teixeira, an STD and HIV counsellor at the clinic. “We don’t want to alarm people unnecessarily. Based on available information, we’d be surprised if there were a lot of people testing positive after first being informed they were negative.”

A spokesman for the manufacturer, BioChem Immunosystems of Montreal, also says it’s unlikely people will be affected.

“I think the probability will be almost zero of finding someone who has a false negative,” says Paulo Bouca. However, he says that if even one person is found to have received the wrong result, the investigation that the company and Health Canada are conducting will have been worth it.

John Gaylord, a counsellor at the AIDS Committee Of Toronto, says that they haven’t received many calls from people who had the rapid test – but that could be a result of the message not yet reaching the community.

“The few who have called have had concerns about the accuracy of the tests, and they are wondering what else they can’t trust,” says Gaylord. He says some callers are concerned because they’ve made decisions around sexual activities after testing negative and are now wondering what they’re going to do if they end up testing positive.

The test was approved by Health Canada in March 2000 after clinical trials for accuracy, and it was found to be more than 99 percent accurate, the same as the standard lab test. Bouca says the company isn’t completely convinced there is a problem with the product.

“We’re not sure because of the conditions of the study,” says Bouca. He says that even in a high-risk population, the percentage of people who are HIV-positive is two to three per cent. The number of people who might have tested false-negative is a percentage of that percentage.

“In the case of British Columbia, they used a population of 100 percent positives,” he says. “This is an unfair way of doing it. It’s not the environment that this kit was created for. This kit was created for the normal population at risk.”

Meanwhile, the Hassle Free clinic is left holding a bag of questionable results. Because it tests anonymously, there is no way it can directly contact those who are affected.

“We’re not sure where the problem originated,” says Teixeira. “It could be just a batch problem, but we’re being cautious and making sure that rapid testing is stopped until they know what’s going on.”

Teixeira says there are no problems with the positive results. All people who had tested positive using the rapid test had blood drawn and sent to a lab.

Hassle Free was the only clinic in Toronto that offered the test. It was available for sale to doctors, but the cost wasn’t covered by OHIP.

“We were interested in the logistics of offering a rapid test to patients and we were giving patients the opportunity to give their input about how they felt about the rapid test,” says Teixeira. “We want to underline that the rapid test did go through accuracy trials and was found to be over 99 percent accurate.”

A press release from Hassle Free says that Health Canada licensed the test only at sites where appropriate HIV counselling is available.

Bouca says the investigation into whether there is a problem or not could take up to six months.

“We’re not coming back to the market until we’re sure about the quality of the product,” he says. Bouca also suggests altering the guidelines, so that blood samples would be sent to a lab for confirmation, whether the Fast Check test showed positive or negative results.

A spokesman for Health Canada would only confirm that there is an investigation.

“When the investigation is complete, if further action is required, and we don’t know if it will be or not, but if it is required, we’ll certainly take it. If further risks are identified, we’ll notify the public,” says Ryan Baker.

The British Columbia Centre For Disease Control estimates that 3,000 people had the rapid test in that province.