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As of yet, the oral HIV test is only available to doctors’ offices and health clinics. OraSure, however, is interested in marketing the test for over-the-counter use, and has applied for FDA approval to do so. If the application is successful, it would mark the first time that the FDA has approved an HIV test for private purchase and use, overcoming nearly nineteen years of dispute.
The controversy began in 1987, when a company applied for FDA approval to develop home-use HIV testing kits. At the time, public health officials and HIV/AIDS activists worried that such a test, while revolutionary, would cause self-diagnosed individuals to panic and consider suicide. Without the professionalism and supportive counseling offered by formal HIV testing sites, some argued, patients who tested positive could respond to their diagnosis in destructive ways.
Nineteen years later, as OraSure strives for FDA approval, interest in at-home HIV testing is mounting. Health officials hope that an over-the-counter OraQuick saliva test will encourage more widespread HIV testing. Meanwhile, recent advances in treating AIDS have assuaged the once-common fear that home HIV tests could lead to panic and suicide. As a result of new life-proloning medicines, many HIV/AIDS patients now view the condition as a chronic disease that they could comfortably live with for years.
Some social advocates are still critical of over-the-counter HIV testing, however, arguing that the rapidity and ease of administering the OraQuick saliva test could lead to its abuse. Mark Harrington of the Treatment Action Group, for instance, who lobbies for better HIV/AIDS therapies, wonders: “What if they started using it on every immigrant at every airport? I’d see that as a violation of human rights.” Harrington also worries that the OraQuick test could be used to by the police or by health authorities to screen prison inmates or intoxicated individuals leaving gay bars without their consent.
As the FDA considers the OraQuick saliva test for home use, OraSure must still conduct a clinical trial to determine whether ordinary people can administer the test as effectively as health professionals. OraQuick has already proven its test to be efficacious, rapid, and safe. Only the test of time, however, will demonstrate whether the OraQuick device can help stem the global HIV epidemic
Michaela Panter is a
Managing Editor of P.H. She is a
junior Biomedical Engineering
major at Yale University.
Continued
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Vol. 3 No. 2 Specials |
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Penile Politics and Religion in an HIV-wary India |
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AIDS Funerals in South Africa |
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Rick Warren’s Purpose-Driven Plan |
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An Interview from New Orleans
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Inside South Asia’s Fiercest Slum |
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The Struggle with Modernity |
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A Review of Jeffrey Sachs’
The End of Poverty |
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This virus is of a far different breed. |
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