July 5, 2012
Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.
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 relatively 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.
Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.