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Is the UK prepared for HIV home testing kits?

IN a little over four weeks, it will be legal to pop into the supermarket, buy an HIV home testing kit and within 20 minutes of using it at home, get a result.

Surprised? So are many others, yet this legislative change has been made by the Department of Health, and supported by the Scottish Government.

Since 1992, legislation has protected the public by stipulating that marketing and sale of test kits is illegal and that the results of an HIV test must be given under clinical supervision.

There are approximately 4600 people diagnosed and living with HIV in Scotland, but around 1150 more are estimated to have the virus but not know about it.

Much has changed for the better for people living with HIV in the past 30 years, with more reason than ever to test early for HIV. Although there is no cure, we now know how to prevent and treat HIV so that those who test positive can expect to live a relatively normal life-span .

But many think the loss of the protection in the 1992 legislation is a retrograde step and will serve rogue traders plying unreliable test kits more than it will the consumer.

For HIV tests to benefit the individual, regulation requires that they be safe and accurate. A false result could be used as the basis of a number of potentially disastrous decisions, such as whether or not to use a condom.

OraSure Technologies' kit, approved by the FDA in the US, has been mooted for use in the UK with its reps presenting their product at health conferences, something unheard of and quite irregular for pharmaceutical products.

The company's own data indicate the test is not reliable at detecting HIV until at least three months after infection. The test also produces at least one in 12 false negative results in people who are in fact HIV positive.

The company warns not to use the results as a basis for any behaviour that might put you or anyone else at risk of HIV infection. Their OraQuick test with all its problems is probably one of the more reliable, but many thoroughly unsafe kits are on sale online, right now.

The decision announced last August by the Department of Health as part of its so-called Modernisation Programme was not well thought through.

The sole evidence base cited in support are the results of an online Terrence Higgins Trust (THT) survey of 657 people. THT and another campaigning organisation, the National Aids Trust, have advocated for a change in the law since 2008 on the basis unreliable kits were being sold online, and that some people found clinics unfriendly and were worried about confidentiality.

It is debatable whether any of these problems will be resolved by legalising sales of home self-testing kits, and ought to be tackled separately. It seems counter-intuitive to legalise the sale of a product that will be extremely difficult to monitor. Indeed, the Scottish Government has said there are no plans to measure even the uptake of kits as they will be sourced privately. The Government's own Expert Advisory Group on Aids (EAGA) has registered its concerns regarding clinical governance, quality and linkage to care .

Beside being a poorly-thought through change, there was inadequate consultation. We do know that the British HIV Association, the HIV profession's own representative body, was informed only after a press conference announcing the decision and expressed serious concerns about it. Furthermore, the views of the body responsible for regulation of diagnostic test kits, the Medicines and Healthcare Products Regulatory Agency (MHRA) were not sought.

Had proper consultation taken place, the UK's strong reputation for sound HIV policies might not now be questioned. As it is, Canada is unlikely to follow the example of its neighbour, the US, which has approved the OraQuick test. In Germany, AIDS Hilfe, a national HIV agency, assessed the issue, with particular reference to the UK, and turned its face against home self-test kits. Currently, the UK is subject to EU regulation, but at a messy meeting late last year, the EU decided under pressure from Britain to devolve decision-making on HIV testing kits to national governments.

Agencies on the ground are not ready for what is likely to be a market flooded by unscrupulous traders operating on Ebay or from under the counter to people wanting to find out if they have what remains an incurable and life-changing infection.

Clinics and community testing services will continue to offer world-class testing facilities and people will still be able to send legal postal home sampling kits off to an NHS lab for reliable testing. Now, there is good reason to test for HIV. But anyone contemplating a test should use the NHS service and avoid the risks of home self-testing kits.

Roy Kilpatrick is an independent HIV advocate and former chief executive of HIV Scotland.

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