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FDA Considers AIDS Virus Home Test

The Food and Drug Administration is considering whether to allow the sale of an over-the-counter test for the virus that causes AIDS. It means an individual will be able to tell within 20 minutes whether they have the infection or not, in the privacy of their own home. Although some HIV charities welcome wider use of home testing, many have expressed fears that people who find out in this way may kill themselves. They believe testing should be supervised and counseling provided on a face-to-face basis.

The FDA has already approved one other home HIV test, but this requires the individual to send off a dried blood spot on special paper, from a finger prick, to a lab to be analyzed. A toll-free telephone number is then called; a confidential and anonymous personal identification number is used to get the result and receive post-test counseling. The new OraQuick? test, which is now sold only to U.S. doctors and clinics, gives an instant result in the home after 20 minutes using a mouth swab.

Although the obvious benefits are that more people can easily find out their HIV status anonymously, which should lead to earlier diagnosis and earlier treatment. There is concern that people performing the test at home may misinterpret a result or may not cope well with finding out that they are positive without having access to live counseling. It is proposed that a leaflet containing written information about counseling is included with the test.

A small number of results may provide a false-positive - meaning some who think they are free of HIV following the test are not and others who think they have the virus actually do not causing concern. Patients testing positive need to consult a medical professional for treatment immediately for early treatment. The FDA is asking its advisory committee to consider such issues before it reaches a decision about whether OraSure's test should be sold in pharmacies over the counter.