OraQuick is a home based test kit to detect AIDS. It is waiting for the FDA to give it an approval to be sold in the market. The Nasdaq-listed company already sells the kit to hospitals and public health clinics. OraSure's chief executive, Doug Michels, thinks that this product would become an important weapon to fight against HIV. It is almost 25 years since the first AIDS diagnosis was made. Statistics show that more than one million Americans are living with HIV/AIDS and about 40,000 new HIV cases prop up each year. OraSure's kit is similar to a home pregnancy test but is simpler and quicker and doesn't involve blood. Users have to swipe their gums with a swab, saturating it with saliva. They then insert the swab into a small tube-shaped bottle of fluid and wait 20 minutes.
The result appears in a transparent window: one horizontal red bar for negative, two bars if the user is HIV positive. But the problem was that on December, when clinics in 35 cities were testing the kit, about 1 % turned out to be false positive. But the FDA dismissed the issue to be the errors of the nurses' failure to follow directions. The agency also wants to give the best kind of written directions for the guidance especially for less educated users. OraSure also provides for counseling and referrals, for those who test positive. Orasure gives people options for knowing their status.
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