Summaries of health policy coverage from major news organizations
Canadian Health Agency Approves Country’s First Rapid HIV Test for Use in Point-of-Care Settings
Health Canada, the country's health regulatory agency, on Oct. 25 approved Canada's first rapid HIV test for use in point-of-care settings, such as clinics, doctors' offices and hospitals, the CP/London Free Press reports. The INSTI HIV test, manufactured by British Columbia-based bioLytical Laboratories, uses a drop of blood to determine within an average of 60 seconds whether a patient has developed antibodies to HIV, a sign of infection. According to Richard Galli, director of research and development at bioLytical, the test was 99.6% accurate in more than 16,000 trials involving 3,400 people, and the rate of false-positive results is similar to current laboratory HIV tests. He added that counseling patients who undergo HIV testing continues to play an important role, according to the CP/Free Press. BioLytical Chief Operating Officer Matthew Clayton said current HIV testing is conducted in provincial laboratories and results sometimes can take seven to 10 days to process. Although INSTI HIV is the country's first rapid test, it is not approved for home use, according to Health Canada spokesperson Nathalie Lalonde. BioLytical will sell the test for $7 to $10 per kit, and the company is planning to seek approval for the test in China, India, Eastern Europe and sub-Saharan Africa. The company also hopes to receive FDA approval to sell the product in the U.S. by late 2006 (Ubelacker, CP/London Free Press, 11/8).
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