HIV Test Inaccurate - Doctors
Warned - Thousands At Risk
By Mary Vallis
The National Post

The Canadian Medical Association Journal has issued a special alert to doctors warning that patients who tested negative for HIV may in fact be infected with the virus.

Authorities advised Health Canada of the risk in April, after problems with the sensitivity of two popular rapid screening kits for the human immunodeficiency virus were identified at British Columbia's Centre for Disease Control (BCCDC).

The tests involve a finger prick for a drop of blood and typically yield results within 20 minutes.

The manufacturer, BioChem ImmunoSystems Inc., agreed to stop selling the products and Health Canada sent a letter to health care professionals who perform HIV testing advising them to track down affected patients for further examination. At least one man who originally received a negative result has since tested positive for the AIDS virus.

But not all of the patients who may have received false negative results have surfaced. At Toronto's Hassle Free Clinic, Canada's busiest anonymous HIV testing site, only 21% of the 1,900 patients potentially at risk have been retested.

Health Canada and the manufacturer could have done much more to publicize the risk of false negative results, said Jane Greer, the clinic's director.

"Health Canada and BioChem really didn't do much of an advertising campaign," she said. "I felt it was left to us."

The clinic issued its own news advisory and bought $7,000 worth of newspaper advertising to alert its transient clientele of the risk.

The lack of patients willing to be retested is doubly worrying because new research probing the kits' accuracy has revealed they were less reliable than the BCCDC had feared.

For one part of their evaluation, staff at the agency used the kits on 63 HIV-positive patients at St. Paul's Hospital in Vancouver. The kits missed the virus at least seven times.

"The HIV tests we use routinely in labs now have nearly 100% sensitivity -- in other words, they might miss one person in many thousands," said Darrel Cook, laboratory manager at the BCCDC.

"We don't think anything less than 99.9% sensitive is acceptable."

The research and the advisory will appear in the Canadian Medical Association Journal later this month.

The alert is already posted on the journal's Web site as a precaution.

Health Canada should have sent its warning letter to all physicians, not just a select group, said Dr. John Hoey, the journal's editor-in-chief.

"Health Canada couldn't tell us how many of these test kits had been distributed nor where they had gone," he said.

"So we phoned the company. The company also had no way of tracking who had these kits.... We thought it was important for us as the medical journal that most physicians get to at least put it in our pages and let them know quickly that there really is a problem."

More than 14,000 of the Fast-Check HIV test kits have been sold in Canada since they were licensed in March, 2000.
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