July 5th, 2012

Home HIV Test Big News — But Why? And What Impact Will It Have?

The recent FDA approval of a home HIV antibody test (OraQuick In-Home HIV Test) was covered just about everywhere. It’s an oral swab test, takes 20-40 minutes, and will be available over-the-counter.

How big a news story was it?

Note that the coverage of the approval has been overwhelmingly favorable.

I’m glad that the approval has raised the importance of HIV testing in the public’s eye, but confess I was a bit surprised by just what a huge news story this has become. Furthermore, relatively few have questioned how useful this test will be. After all, another home HIV test was approved for use in 1996, and its impact has been limited.

(Some believe that this is because it’s relatively costly and is not really a true home test — it requires a fingerstick at home, then mailing the specimen into a central lab.)

It’s significant that something similar to this recently approved true home test was initially under review way back in 2005.  Shortly thereafter, my inimitable colleagues Rochelle Walensky and David Paltiel published an opinion piece in the Annals of Internal Medicine entitled, “Rapid HIV Testing at Home: Does It Solve a Problem or Create One?”

The provocative title says it all:  They argued that home testing, while helping to increase the number of tests and decrease stigma, would have a negligible effect on identifying more people with undiagnosed HIV infection — all while creating additional problems due to the inaccuracy of the test:

Home HIV testing will attract a predominantly affluent clientele, composed disproportionately of HIV-uninfected, “worried well” persons and very recently infected persons with undetectable disease [due to the window period before seroconversion]. This will have the perverse effect of increasing the proportion of false-positive and false-negative results, while making little appreciable dent in the size of the undetected HIV pool.

So hooray for the normalizing of the HIV test.

But whether the home test will actually do much to identify those at greatest risk remains to be seen.


6 Responses to “Home HIV Test Big News — But Why? And What Impact Will It Have?”

  1. Cathy says:

    My thoughts about the home HIV test are similar to my thoughts about home tests for genetic mutations. We often need professionals to help us interpret the implications. Good job, Paul, of complicating the story.

    • Paul Sax says:

      Good job, Paul, of complicating the story

      Hi Cathy,
      It’s possible that you meant this as a nice thing to say (i.e., I’m adding nuance and detail to the story) or alternatively, that I’m just making a situation more complicated (worse). Let’s hope it’s the former!

  2. David Paltiel says:

    I too am struck by the unreserved enthusiasm that the FDA decision has prompted. Yes, of course, hooray for normalizing HIV testing. And yes, of course, let’s all hope that those at risk will use the test and respond to its signals appropriately. But let’s also hope that the manufacturer prices this test at a level that is affordable to more than just the affluent few. And let’s also bear in mind that the principal motivation to screen for HIV is to link infected persons to effective treatment, care, and prevention services – something which is most likely to occur when testing takes place in health care settings.

  3. Anonymous says:

    This is exciting news, everyone should be aware of their status, however I still feel this is opening a new can of worms. The recently infected may not carefully read the instructions and be convinced they are negative when, in fact, they are not. Had they approached a clinic, they would receive the counseling that is necessary to help them understand the window period and facts about transmission. Not to mention the announced sensitivity and specificity of this test seem to differ from what is currently being used in clinics. I would much rather take on and counsel another dozen or two dozen patients with “false reactive” tests than a dozen or two dozen new patients who were infected by partners convinced they were negative by an incorrectly interpreted home test.

  4. While the promise of early detection or reassurance seems ready to drive this test to drugstore shelves for wide use, I agree with the reservations. Although the privacy of home testing will appeal to many, it’s a missed chance for providers to explain the disease, offer assistance, and counsel safe practices.

  5. Dr Murugan Sankaranantham says:

    Hai Paul,
    While it seems simple and easier and many cases can be detected, at the same time there is every possibility that these individuals find positive HIV results would not have come out for being revealed their status and stigmatization because as they miss appropriate counselling.Thereby we may likely to miss considerable number of cases and they being further source of infection.

HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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