Approval sought in the U.S. for 20 minute home HIV test

Oct 17 2005

Authorities in the U.S. are considering the approval of the first rapid home testing kit for HIV.

In a style very much like over-the-counter pregnancy tests, a single control line indicates a negative result, meaning signs of infection with the virus have not been detected.

Two lines means infection has been found and the person is positive for HIV.

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 counselling provided on a face to face basis.

In the UK home HIV testing kits are banned for such reasons, but unapproved kits are available over the internet, and experts advise caution in this respect.

The U.S. Food and Drugs Administration 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 analysed.

A free telephone number is then called, and a confidential and anonymous personal identification number is used to get the result and receive post-test counselling.

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 testing on their own may misinterpret a result or may not cope well with finding out that they are positive, without having access to live counselling.

It is proposed that a leaflet containing written information about counselling is included with the test.

The other concern is that a small number of results may be false, 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.

The importance for anyone who has a positive test result to see their doctor afterwards to confirm the finding and find out what care and support they need, some fear may not in fact happen.

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.

Many believe the UK should re-consider its stance on home HIV testing kits.

Lisa Power, head of policy at Terrence Higgins Trust, an Aids trust, says the charity is watching events with interest and supports a change in UK law to allow and regulate home testing for HIV, but there is a need for a test which combines sensitivity and simplicity.

According to a spokeswoman from Avert, if FDA approval is granted and it increases the number of people being tested, then that is a good thing, but they advise caution and are concerned about the risk of suicide if people find out on their own without enough support.

They encourage people to see their doctor after to get a confirmatory test and also to get advice on how to proceed and what care they need throughout their illness.