Home testing to detect human immunodeficiency virus: boon or bane?

With the waiver of the Orasure Oraquick rapid human immunodeficiency virus (HIV) test in January 2003, testing for HIV infection in the United States moved from the laboratory to the clinic, the emergency room, and other outpatient settings. By now, millions of rapid HIV tests have been performed, largely by nonlaboratorians and largely outside of dedicated laboratory space. This experience has significantly transformed HIV testing nationally. The next logical step in broadening the settings in which HIV testing can be performed, approval of an HIV test for sale “over the counter” (OTC), involves clinical, technical, psychological, and public health issues along with a fair sprinkling of politics. Much of the rationale for both rapid, “waived” and homeuse HIV testing can be summarized by two simple statistics: (i) approximately 30% of HIV-infected persons in the United States are unaware of their serostatus, and (ii) in 2004, 39% of persons with AIDS (e.g., opportunistic infection or CD4 -Tcell count of 200) first tested positive for HIV within 1 year of their AIDS diagnosis (7). Current evaluative approaches are missing substantial numbers of infected persons and detect HIV infection at a later stage than is optimal. Expanding access to HIV testing is a logical approach to addressing these inadequacies. Newly proposed methods for HIV testing must be compared not with an ideal system but with the current state of HIV surveillance and testing. In the United States, kits for home diagnostic testing are available for a limited set of analytes (9). There are currently no OTC tests for infectious diseases; tests for group A streptococcal pharyngitis and for influenza were rejected for home use due to insufficient sensitivity. There are, however, home collection kits for hetatitis C virus and HIV infection that allow consumers to collect specimens and send them to laboratories for testing and direct reporting. The scientific literature on home testing has recently been reviewed and can best be described as “sparse” (12). There have been few studies of the accuracy of home testing methods beyond those performed for Food and Drug Administration (FDA) approval. Even for well-established practices such as home glucose monitoring, there are limited data with respect to outcomes: the recommendations of the American Diabetes Association and the World Health Organization are based primarily on cohort studies and expert opinion and not on controlled studies showing a clinically significant impact on outcomes. The randomized clinical trials that have been performed demonstrated mixed results; a few showed improvement in outcome measures such as hemoglobin A1c levels, but more trials showed no significant effects. Although tests are widely available, an estimation of the clinical or public health impact of any home testing method is nearly pure guesswork at this time.