WASHINGTON, Nov 8 (AFP) - A new diagnostic device allowing to detect the AIDS virus in as little as 20 minutes has received government approval in the United States in what officials described as a major step toward curbing the deadly epidemic.
"It's going to be a wonderful tool for our counselors and people to help us in our fight against HIV/AIDS in the country and in the world," said Health and Human Services Secretary Tommy Thompson as he announced Thursday the US Food and Drug Administration's decision.
The OraQuick rapid diagnostic test kit that was developed by OraSure Technologies, a Bethlehem, Pennsylvania-based medical research company, uses less than a drop of blood from a finger and has an accuracy rate of 99.6 percent, according to health officials.
After collection, the blood is transferred to a vial where it is mixed with a developing solution.
The test device is then inserted into the vial where, if HIV-1 antibodies are present, it displays two reddish-purple lines in a small window.
Unlike other antibody tests for HIV, the new device can be stored at room temperature and may be considered for use outside of traditional laboratory or clinical settings.
FDA Deputy Commissioner Lester Crawford said OraQuick will help, for example, identify pregnant HIV-positive women going into labor, who had not been tested during pregnancy.
It will allow doctors to take precautionary steps to block their newborn babies from being infected with the AIDS virus, Crawford said.
"It will also be a critical resource in helping identify HIV infection in health-care and emergency workers who are accidentally exposed to HIV-infected blood while doing their job," the deputy commissioner pointed out.
US health officials expressed hope the new test will also allow them, and their colleagues around the world, to draw a much clearer picture of how many people have been infected with the AIDS virus and raise public awareness of the danger.
As many as one-fourth of the 950,000 HIV-positive people in the United States remain unaware of their condition and may continue unwittingly to pass the virus on to others, according to estimates by the Centers for Disease Control and Prevention.
And the standard HIV test, which takes up to two weeks to evaluate, offers little help in solving the problem, officials complained.
Each year 8,000 HIV-infected people who take that test never return to get their results, the officials said.
For the moment, however, the OraQuick test has been approved to be conducted only in laboratory conditions by certified medical personnel.
But Thompson indicated this ruling could be reassessed if OraSure applied for a waiver.
The manufacturer is expecting to begin commercial distribution of the test kit in 30 to 60 days.
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