Health Canada OKs First Rapid-Result HIV Test for Doctor's Office, Clinics
November 8, 2005
On Oct. 25, Health Canada approved for the first time a rapid HIV test for use in doctors' offices, clinics and hospital emergency rooms. Using a drop of blood, the Insti HIV antibody test produces results in 60 seconds on average, said Richard Galli, director of research and development for the test's maker, Biolytical Laboratories of British Columbia. It has proven 99.6 percent accurate in more than 16,000 trials on 3,400 people, he said. It is not intended for home use by consumers.
"The Insti test is designed to be very simple ... for a point-of-care situation with a patient and their health care provider," said Galli. "This test is designed as a screening test. It is not considered a diagnostic test for HIV," he said. "In other words, any positive on a screen has to go for confirmatory testing. The patient would be getting a presumptively positive result."
The test will cost $7-$10 Canadian ($6-$8 US), said Matthew Clayton, Biolytical's chief operating officer. The privately owned company is investigating regulatory approval for the test in China, India, Eastern Europe and sub-Saharan Africa. In late 2006, the firm intends to seek Food and Drug Administration approval for the U.S. market.
11.07.05; Sheryl Ubelacker
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.