FDA approves 60-second HIV test
The Insti HIV Rapid Antibody Test, which detects antibodies to the virus in just a minute, may now be sold in the States; it is already available in more than 50 countries.
Canadian firm BioLytical received FDA approval this week for the sale of its Insti HIV Rapid Antibody Test in the United States.
The test, which, at 60 seconds, will be the fastest-working on the U.S. market (others tend to take between 10 minutes and 20 minutes) is already available in more than 50 countries. In Canada's Ontario province, the kits have been available since they were first commercialized in 2006, and in British Columbia, where BioLytical is based, health authorities plan to use them for the new $48 million pilot project called Seek and Treat for the prevention of HIV and AIDS.
The Insti kit requires pricking a finger to draw a blood sample, then mixing the sample with a reagent and color developer. One blue "control spot" reveals the absence of HIV antibodies (nonreactive results), two spots reveal the presence of such antibodies (reactive), and the absence of a spot indicates that the results are invalid.
Because this is a first-line test, all reactive (HIV-positive) results must be confirmed by a second testing system, the company advises, and all invalid tests should be conducted again with a new blood sample.
"Insti represents a significant improvement for point-of-care rapid HIV testing," Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors, said in a statement. "By eliminating the 15- to 30-minute wait for results, Insti streamlines the testing process. It allows for increased flexibility, as providers can conduct the test in whatever manner best suits their work flow."
Breaking into the U.S. market wasn't easy; Rick Galli, chief technical officer at BioLytical, told the Vancouver Sun that "we affectionately call [market approval in the U.S.] the holy grail for this particular product."
He added that the Insti device has been endorsed by the Centers for Disease Control and Prevention, and that the timing is ideal, as U.S. medical officials have recently been shifting from lab tests to rapid point-of-care tests.