Originally published October 27 2005
FDA to decide the future of home HIV test kits
by Mike Adams, the Health Ranger, NaturalNews Editor
The FDA will decide whether a new HIV home kit, manufactured by OraSure Technology of Bethlehem, Pa, will be sold over-the-counter.
Put that swab into a vial of test fluid, and 20 minutes later you'll learn whether you're infected with the virus that causes AIDS.
The OraQuick Advance test is already widely available in health clinics and doctors' offices.
Supporters of home kits say they will spur more people to get tested and get treatment sooner if infected.
If approved, the test would become the first FDA-approved test that a person can take without the presence of a health care worker, or the requirement of mailing a sample to a lab.
The test is accurate more than 99 percent of the time, Spair said.
To take the test, a person swabs the inside of his mouth, between his cheek and gum, picking up not saliva but cells lining the mouth.
Those antibodies become present in the body several weeks after a person acquires HIV; the test will not detect the virus if it was more recently acquired.
On Nov. 3, FDA's Blood Products Advisory Committee, will consider whether to recommend the product for over-the-counter sales.
FDA briefing documents posted on the Internet said these kits could lead to more people knowing whether they have HIV, which could mean earlier treatment of the infection.
People afraid or unwilling to take the test, particularly those without any symptoms, may more readily test themselves with a kit they can use privately.
"We want to provide that opportunity to the broadest number of people possible."
But the documents also note concerns about someone learning they probably have HIV when they are alone, with no health professional or counselor nearby.
Spair said the company would work with FDA to develop instructions with the kit for someone who receives a positive result.
One test, made by Home Access Health Corp., is approved for sale in the United States by the FDA.
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