Home saliva test for HIV unlikely to be approved

Despite approval by FDA panel this week, Health Ministry unlikely to approve home test for AIDS virus anytime soon.

By
May 17, 2012 18:49
1 minute read.
Aids ribbon

Aids ribbon 311. (photo credit: Thinkstock)

Although an expert panel of the US Food and Drug Administration (FDA) this week recommended the first over-the-counter home test for HIV/AIDS, the Health Ministry is unlikely to approve it for use in Israel anytime soon.

Over the years, the Health Ministry has insisted that in health fund clinics and public hospitals’ AIDS centers, the individual must identify himself before undergoing a test for HIV/AIDS. It has allowed some voluntary organizations, especially those involving homosexuals and foreign workers, to undergo HIV tests anonymously, but it has not encouraged it.

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One of the ministry’s main fears is that, if an individual learns that he is an HIV carrier or has full-blown AIDS, he could react badly and even commit suicide.

Another concern is that without the authorities knowing who the carrier is, it would be nearly impossible to prevent him, as health professionals generally do by providing information and condoms, from spreading the disease to others.

Therefore, so far, the ministry has not approved home tests. Instead, people who worry about the disease are advised to “undergo speedy tests” in recognized institutions.

The Washington Post reported this week that the FDA panel voted unanimously to recommend approval and sale of a kit that can be used in the privacy of people’s homes.

Such a test does not require a blood sample but only a swab of saliva in the mouth to determine whether antibodies to the AIDS virus are present. The result is ready in less than half an hour.



The US health authorities said the new home test could be very effective in helping to prevent new HIV infections.

The Washington Post quoted Richard Forshee, associate director for research in the FDA’s office of biostatistics and epidemiology, as saying that the test could potentially identify 45,000 new individuals who are infected and avert more than 4,000 HIV transmissions annually in the US. However, Forshee said that since the test is only about 93 percent accurate, it would also miss approximately 3,800 HIV-positive people per year.

The home test kit is virtually the same as that used in medical institutions, but when in the hands of trained professionals, it is said to produce more accurate results. In any cases, all HIV tests require another, more complicated test to confirm the diagnosis.


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