A test to detect HIV infection that provides results within minutes has been licensed for use in the US, but the manufacturer has yet to seek approval to sell it in Canada. Approval of the new test by the US Food and Drug Administration (FDA) came after the sale of 2 other rapid tests was halted in Canada.
The FDA says the OraQuick Rapid HIV-1 Antibody Test, which requires a finger-prick blood sample, detects antibodies to HIV within 20 minutes, with a sensitivity of 99.6%.
Tommy Thompson, the US secretary of Health and Human Services, says this type of point-of-care testing is vital. “Each year,” he says, “8000 HIV- infected people who come to public clinics [in the United States] for HIV testing do not return a week later to receive their test results.”
Approval of the new test in the US came 6 months after another manufacturer agreed to halt the sale in Canada of 2 rapid HIV tests after their accuracy was challenged (see CMAJ 2002;167 [2]:180).
Ryan Baker, a Health Canada spokesperson, would not say if the new test is being reviewed by Health Canada because that information is considered proprietary.
Bill Bruckner, a spokesperson for OraSure Technologies, said the company intends to market the device in Canada but is currently concentrating on rolling out the product for the US market.
He said the price is expected to be in the US$20 range. About 17 million HIV tests are conducted annually in the US, but this does not include those done for blood banks.
Jane Greer, director of Toronto's Hassle Free Clinic, says that facility would welcome the return of a rapid test. Staff at her clinic in the heart of Toronto's gay village saw 22 000 patients in 2001. The clinic is one of the busiest testing sites for sexually transmitted disease in Canada.
Greer says the earlier withdrawal of the rapid tests manufactured by Bio-Chem ImmunoSystems (now Adaltis Inc.) may have affected patient confidence, but the ability to offer immediate results remains attractive. “We'll be following this fairly closely,” she said. — Patrick Sullivan, CMAJ