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BC firm to manufacture instant HIV test kits

Provincial health authorities monitor quality control

The Ontario government has chosen the Insti HIV-1/HIV-2 Rapid Antibody Test produced by Richmond, BC-based Biolytical Laboratories for use in Ontario’s newly expanded network of anonymous testing facilities.

The decision to use Insti follows an announcement in June by Ontario health minister George Smitherman to expand the number of anonymous HIV testing sites in Ontario from 24 to 50 and to offer almost instant HIV test results.

Carl Roy, Biolytical’s chief executive officer, describes the deal as “huge for us financially and for its precedent-setting value for the rest of the country.”

Ontario is expected to pay about $350,000 per year for the testing. For perspective, one study estimates the lifetime cost of healthcare for one person living with HIV at $620,000.

“Ontario has set the bar as high as it could,” says Roy. “It’s the first jurisdiction in North America to take this approach to public HIV testing.”

Roy says healthcare officials in Quebec, BC and Alberta are investigating using the test kit in their provinces, too. Insti is the only rapid HIV point-of-care test licensed by Health Canada for use in this country. It was approved in October 2005 and has been piloted at Toronto’s Hassle Free Clinic since May 2006.

But instant HIV tests have not had an altogether successful history so far. A similar test, called Fast Check and produced by Montreal-based BioChem Immunosystems, was licensed for use in Canada back in 2000 but it was pulled from the market in 2002 after the British Columbia Centre for Disease Control (BCCDC) confirmed that the accuracy of the test had been compromised after the manufacturer outsourced the production of the test kits to save money.

“There were situations in which that test yielded a negative result but the person was actually infected,” Micheal Rekart, director of sexually transmitted disease and HIV/AIDS control at BCCDC told Xtra in January.

Rekart said then that after Insti was approved by Health Canada, Biolytical alone was responsible for quality control in the manufacture of the test kits.

“The only group that’s making sure that it’s accurate, batch after batch, is the company that makes it,” he said. “That’s a conflict. We have had problems with that kind of nonindependent quality control in the past.”

Despite the bumpy history of instant HIV testing Roy says he has full confidence in Insti.

“We have third-party quality assurance validation being done through the virology lab at Providence Health Care [in Vancouver],” he says. “They will issue a certificate to all users of the test on each batch. We’re really happy to be able to add that feature.

“It’s easy for people to say, ‘Oh, we had a failure before.’ [Insti is a] totally different product, unrelated, different technology and certainly [we have] a different approach to quality, proven now over significant numbers of people tested in the field by people not associated with the company.”

“As we roll out the program we’re putting in place very rigorous quality control and quality assurance measures so that we’re able to monitor the tests,” says Frank McGee, coordinator for the AIDS Bureau of the Ontario Ministry of Health and Long-Term Care.

Another concern previously raised about point-of-care tests is how it will impact the reporting and tracking of data used by researchers to study patterns and trends in the rates of testing and infection. For example if routine negative test results aren’t recorded by point-of-care healthcare providers researchers won’t have the necessary data to accurately calculate the ratio of positive results to negative results.

McGee says that using the Insti test will not impact any of the current ongoing data collection or reporting in Ontario.

“All that data will be inputted into the same database,” he says. “A part of the agreement that the ministry will have with sites that use the point-of-care test is that they will ensure that the data is collected as it would be for standard testing. We’re absolutely capturing that data.”

“We’re very supportive of the whole rollout of rapid point-of-care testing,” says John Maxwell, director of special projects at the AIDS Committee of Toronto. “There are many gay men that may not get tested on a regular basis even though they may be engaging in high-risk activities. They may have been tested once every couple of years for example. A lot of it has to do with the anxiety of going for the blood test and having to wait for up to two weeks to get your results back. Rapid testing gives the option of a smaller amount of blood being drawn and being able to get the results in the same time [which] relieves a lot of that anxiety.”