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Is it Smart to Test for HIV at Home?

By on May 17, 2012
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Everything old is new again. This is especially true in the world of HIV testing, consider that in the late 1990’s Direct Access Diagnostics, a subsidiary of Johnson & Johnson, removed its Confide HIV home test kit from store shelves. It was reported that lack of consumer interest among other things.

Today, a 17-member FDA advisory committee voted unanimously to recommend the OraQuick In-Home HIV Test for approval as the first-ever over-the-counter, completely in-home HIV test. Apparently, concerns over confidentiality of test results, quality assurance, and the psychological health of the individual are less of a concern today. Can you imagine a teen or vulnerable adult self-administering a test for an incurable disease at home? Without the benefit of face-to-face counseling?

Advocates say the in-home test would provide a new and potentially powerful strategy for attacking an U.S. HIV epidemic that has infected nearly 1.2 million people and increases by 50,000 new cases each year. The company said it would expect the product to retail for less than $60, if approved and marketed over the next the several months. That is likely a price point many will find challenging, especially when HIV testing is accessible for free at most local clinics.

Panel members urged OraSure to undertake post-marketing studies to ensure that the test is available to under-served populations in a manner that would link those who use the kit to the healthcare services including confirmatory tests at professional settings. A home version of the professionally administered OraQuick Advance test, the new product is an oral swab rapid test that produces results within 20 minutes. The test should not be taken until 90 days after an individual last had an risky behavior.

FDA officials said the OraQuick In-Home test showed a high degree of effectiveness in detecting HIV infection. But some research data suggested the test lacked sufficient sensitivity to avoid false negative results. False negatives are of particular concern because they could lead HIV-positive individuals to take fewer precautions, raising the danger that they will engage in unprotected sex.

 

At present, only 62% of those with HIV are linked to the healthcare services and just 28% have access to drugs capable of suppressing the infection. Last week, another FDA panel recommended regulatory approval for Gilead Sciences Inc’s HIV drug, Truvada, as the first pill treatment for protecting uninfected individuals.

 

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