Home HIV testing kits now legal in UK

Behind the Headlines

Thursday April 10 2014

It is expected that testing kits will be available to purchase by 2015

US testing kits work by taking a sample of saliva

“Kits allowing people to test themselves for HIV at home can be bought over the counter in the UK for the first time,” BBC News recently reported.

The UK government has amended the law so “do it yourself” home testing kits for HIV are now legal to be sold over-the-counter.

 

Can go I out and buy a test?

No – at least not yet. No companies have applied for a license to sell self-testing kits within the European Union. Though this is understandable as self-testing kits were previously illegal.

The charity the National Aids Trust predicts that self-testing kits will become available by late 2014 or early 2015.

 

Why has the law been changed?

The government hopes that the change in law will encourage more people to get tested for HIV. It is thought that as many as one in five people with HIV do not realise they are infected.

Aside from the risk of spreading the virus to others, people whose diagnosis of HIV is delayed tend to have a worse outcome. If treatment begins soon after the infection occurs then there is a much better chance of preventing complications of HIV. With prompt treatment a person with HIV can expect to have a normal life expectancy.

 

How will the tests work?

It is likely that any commercially available test will be based on the same principle as the OraQuick In-Home HIV Test, which was approved by the US Food and Drug Administration (FDA).

This test works by checking for antibodies for HIV, an immune response that occurs if a person is infected. The test involves taking a swab of fluid from the upper and lower gums.

The swab is then placed into a supplied tube and then after 20-40 minutes either one or two lines should appear. One line means the test is negative, two means that the test may be positive. In the event of a positive test, follow up testing, from a sexual health clinic or similar is recommended.

 

How reliable are the tests?

At the moment there is only reliable data available on the OraQuick In-Home HIV Test.

Data collected by the FDA suggests that the OraQuick test will produce one false positive result out of about every 5,000; that is for every 5,000 people tested, one will be incorrectly diagnosed with HIV.

More worryingly, the FDA estimates that the same test has a false negative rate of 1 in 12; that is for every 12 people who are tested, one will wrongly be given the “all-clear”.

Due to this uncertainty, current advice is to consult a healthcare worker about testing.

 

Can I get a HIV test anywhere else?

There are various places to go for an HIV blood test, such as:

Home sampling kits are also available, which allow you to take a saliva sample or blood spot and send them off to a laboratory for testing.

These are available online and from some pharmacies, but you will generally have to pay for them.

 

How has the news been received?

Most of the reaction to the government’s change in policy has been positive. A spokesperson for the Royal Pharmaceutical Society, said “"HIV self-testing kits may help increase diagnosis by providing more choice for people who have been at risk but are reluctant to get a test in person from existing services.”

Certain sections of the media have raised concerns that home testing could lead to misdiagnosis in people who lack the proper training to interpret the results of the tests.

Similar concerns were raised when home pregnancy kits were introduced and they are now a commonly accepted form of testing.

 

What if I test positive for HIV using a self-test kit?

It is important is that any positive test result is confirmed by a health professional, not least because if you are HIV positive you will need advice on treatment options.

And if a test proved negative that should not be taken as licence to take sexual risks or inject illegal drugs.

The most effective way to reduce your risk of HIV is to always use a condom during sex and never share needles if you are an injecting drug user. Read more about HIV prevention.


Edited by
NHS Choices. Follow Behind the Headlines on Twitter. Join the Healthy Evidence forum.

Links to the headlines

UK law passes sales of HIV home tests before they exist. BBC News, April 6 2014

Sale of HIV home tests legalised in the UK: Change in the law means the kits could soon appear in shops. Mail Online, April 4 2014

Further reading

Public Health England. HIV Testing and Self Testing - Answers to frequently asked questions (PDF 217 KB). April 2014

Press release

Department of Health. Modernisation of HIV rules to better protect public. August 15 2013

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The 2 comments posted are personal views. Any information they give has not been checked and may not be accurate.

NHS News said on 16 April 2014

Dear carp_g_66 - thank you for your useful feedback. We were looking at older data provided to the FDA. Having looked at the latest data we agree with your analysis.

The article is now in the process of being updated.

We are grateful for your assistance in this issue.

Best Wishes,
The Behind the Headlines Team,

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carp_g_66 said on 12 April 2014

Your figures for the "accuracy" Oraquick Home HIV test are incorrect. Orasure's submission to the FDA for approval for OTC sales of their HIV test, concludes that 1 in 12 Orasure tests will generate a FALSE NEGATIVE. This means that 1 in 12 people who take the test who ARE HIV positive will generate a test result that is negative. This has serious consequences as new diagnoses of HIV infection are a vital part in the process of preventing onward transmission. Your article is misleading.

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Edited by NHS Choices

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