In the USA, the Food and Drug Administration (FDA)‘s advisory panel has this week voted unanimously to take forward plans to allow an oral (using a saliva sample) to be sold over the counter in the United States. This test, made by Oraquick, takes 20 minutes to run, and although not as accurate as a blood test (such as those offered by Better2Know in the UK).
The FDA believes that the benefits of having easy access HIV testing outweigh the risks of a less accurate result. A final decision is expected later this year.
In the UK, it is estimated that a quarter of the people in the UK who are HIV+ do not know their status. Increasing HIV testing is seen as key to preventing new transmission, and early detection is key to ensuring longevity for HIV+ people and prevents them from ever developing AIDS.
The trial conducted by Orasure shows that it only correctly identified HIV in 93% of people who were HIV+, and so some people would have a false negative result and perhaps continue their risky behaviour. However the FDA felt that the benefits of correctly identifying a number of people who were HIV+ outweighed this risk. The test is more accurate when conducted by a trained healthcare professional, rather than as in the trial, by the end consumer in their home.
“Over-the-counter testing has the potential to reach a far greater number of people who want to know their HIV status on their own terms” said Tom Donohue, the founder of an HIV awareness group.
Currently all tests which provide a result to an HIV status at home are illegal in the UK. It is legal to collect a blood or saliva sample at home and send this to a laboratory for analysis, and where the method of giving the results to the patient can be carefully controlled, and in case of a positive result the appropriate referrals are made.