I think it’s wonderful news that people will soon have the ability to legally purchase in-home HIV test kits in the United States later this year following the recent US Food and Drug Administration (FDA) approval, but I was surprised to find that these home testing kits cannot legally be sold in Australia and that it’s actually against the law in Australia to do home testing of infectious diseases according to the the chief executive of the Australasian Society for HIV Management.

The OraQuick In-Home HIV Test is expected to be available from 30,000 American retail outlets and over the internet from October, allowing people to obtain a result within 20 to 40 minutes from an oral swab specimen. I have always been a supporter of people being able to take control of their sexual health by having access to the tools needed to test for HIV in the comfort of their own home. HIV home test kits have been on the market for a number of years, but this is the first rapid test that has received FDA approval to test for HIV without the need for a laboratory to test the sample.

According to clinical studies, the OraQuick home HIV test has an expected performance of 92% for test sensitivity, the percentage of results that will be positive when HIV is present, which means a false negative result can be expected in one out of every twelve tests in HIV-infected individuals the FDA said. The FDA also said that similar testing indicates that one false positive would be expected out of every five thousand test results in uninfected individuals. OraSure Technologies said that a price of the over-the-counter test kit has not yet been decided, but would likely be higher than the US$17 charged for a similar unit the company already sells to hospitals, clinics and physicians.

I am actually surprised that it is illegal for Australian’s to test for infectious diseases in their own home using approved medical devices. I can see reasons why laws may be in place to deter testing for infectious diseases that are not approved testing locations, but I am surprised that even approved devices to test for infection diseases are illegal. Perhaps this will soon change now that the United States has recently approved this particular home testing kit.

According to the article I read at ABC News (Australia), the Therapeutic Goods Administration (TGA), which is Australia’s equivalent to the United States Food and Drug Administration (FDA) says that by law it is not allowed to evaluate applications to supply HIV home testing kits. Apparently the Australasian Society for HIV Management is looking at having point-of-care testing evaluated for use in Australia, but there are concerns about accuracy due to the window period giving people false-negative results and because people may not be taking the tests under the ideal circumstances.

It is good news that Australia will be looking at evaluating HIV home testing kits, because providing they are used correctly and as long as the necessary instructions, warnings and support mechanisms are in place, this could be an effective way for those who are afraid of visiting HIV testing locations to get tested for the virus and hopefully reduce the spread of HIV. According to the ABC News (Australia) report, Australia will be looking at point-of-care tests that use finger-prick blood rather than an oral sample, because the society believes the oral samples test isn’t up to the same standard.

According to the Australian Federation of AIDS Orgnisations (AFAO), in the year to December 2010, there were 1,043 diagnoses of HIV infection throughout Australia, up to December 31, 2010, the cumulative number of HIV infections in Australia was estimated at 30,486, an estimated 21,391 people were living with HIV/AIDS in Australia in 2010 and that transmission of HIV in Australia occurs primarily through sexual contact between men, with between 2006 and 2010 86% of newly acquired HIV infections were in men who have sex with men.

These statistics confirm that men who have sex with men are the highest risk group for HIV transmission in Australia. Quite often, men who have sex with men are uncomfortable visiting a clinic to get tested for HIV and may avoid getting themselves tested, which could result in further transmission cases. If in-home testing was made legal and if suitable test kits were made available, the number of infection cases may reduce because men will be equipped with the knowledge of knowing their HIV status and be able to more accurately disclose their HIV status when undertaking HIV discussions with potential sexual partners.

I acknowledge that there are concerns about the effectiveness of in-home testing kits, such as the accuracy of the results, the inability to record new infection cases for statistical reporting, the lack of support following a positive diagnosis and the possibility that the medical devices are not used correctly, but I still feel that this kind of testing would provide better results than men who have sex with men not getting tested at all.

I would like to support what I am saying about the treatment of gay and bisexual men when it comes to medical professionals. In 2010 I visited my doctor to check for testicular cancer, when I felt a lump during a self-test. It was established that the lump I felt was perfectly normal (where the vas deferens and epididymis connects to the testes), but my doctor still asked whether I was heterosexual and when I said no, he immediately referred me to the laboratory for a chlamydia and gonorrhea test and he seemed surprised when the results came back clear. I felt that I was judged because of my sexuality and I’m sure others feel the same way and may be afraid to get tested. This is why approved in-home testing kits should be made available to everyone throughout the world.

References:

  1. Home HIV tests unlikely to hit Aussie shelves – Australian Broadcasting Corporation
    http://www.abc.net.au/news/2012-07-04/australian-unlikely-to-seem-home-hiv-test-kits-soon/4110118
  2. Over-the-counter HIV test approved – news.com.au
    http://www.news.com.au/breaking-news/world/over-the-counter-hiv-test-gets-ok/story-e6frfkui-1226416298072
  3. HIV statistics in Australia – Australian Federation of AIDS Organisations
    http://www.afao.org.au/about-hiv/the-hiv-epidemic/hiv-statistics-australia/hiv-statistics-men-in-australia
2 Comments
Seaguy July 11, 2012 at 12:37 pm Reply

I am glad they approved this home test here in the USA. But people taking it need to be aware that if they test poz they should followup with a visit to their doctor for a more accurate test to be sure.

To me any test that will encourage those untested to get tested which this home test will do is better than nothing.

Knowledge is power!

Brad Berrigan July 12, 2012 at 2:35 am Reply

Hey Seaguy, I agree with you completely about anyone taking the in-home test needing to be aware that if they test positive they should follow this up with their healthcare professional for further testing to ensure they receive an accurate result. The in-home HIV test kits are one part of the process and followup testing is important. Knowledge is definitely power and hopefully these test kits will be useful to anyone wanting to monitor their HIV status.

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