Legal barrier to self-testing for HIV in UK to be lifted

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The Department of Health announced an important change to HIV testing policy for the United Kingdom this week. From April 2014, HIV self-testing kits approved by the Medicines and Healthcare Regulatory Authority will be available for sale to the public.

Any device designed for home testing will be required to carry the CE mark, which indicates that it conforms to minimum European standards regarding sensitivity and specificity (see here for further details of these standards).

The opportunity for self-testing has been welcomed by HIV organisations, although concerns are frequently expressed regarding the potential for failed linkage to care after a positive test.

Glossary

self-testing

In HIV testing, when the person testing collects their own sample and performs the whole test themselves, including reading and interpreting the result. 

linkage to care

Refers to an individual’s entry into specialist HIV care after being diagnosed with HIV. 

home testing

The term may be used to describe either self-testing or self-sampling. 

confirmatory test

A second test, to show that the result of a previous test was correct. Because the diagnosis of HIV infection is so important, a second (confirmatory) test, is done. The confirmatory test should be of a different type than the first test.

false positive

When a person does not have a medical condition but is diagnosed as having it.

A recently published systematic review of studies on self-testing found it to be acceptable across a wide variety of populations, but identified few data on linkage to care after testing positive.

The Department of Health said in its press statement: “If a test indicates a positive result people are advised to get a follow-up confirmatory test at an NHS clinic. Clear information about how to interpret the result and what to do afterwards will be included with the kit.”

Dr Richard Ma, sexual health lead for the Royal College of General Practitioners, said that GP practices should also prepare for patients seeking a confirmatory test after receiving a positive result on a home test.

At present, the only device specifically designed for home testing and approved by a stringent regulatory authority is the Orasure OraQuick HIV antibody test, licensed in the United States in April 2013. This test samples fluid from the gums on a swab. The swab is then placed in a tube of solution and will give a visual result 20 minutes later. (A video showing how the testing process works can be viewed here).

In practice, this test can already be ordered online for purchase from US vendors for around £25. How much this test will cost and when it will be marketed in the United Kingdom are still unknown.

Contrary to reports in The Independent newspaper, there is no commitment at present to make self-testing kits available free through the NHS, the Department of Health told NAM.

Home-sampling kits supplied by Terrence Higgins Trust and Public Health England have been available since January 2013 for gay men and African people living in England. Approximately 9000 people have requested the kits to date

Dr David Asboe, Chair of the British HIV Association said: "We welcome the availability of regulated HIV self-testing kits, while noting two important caveats.

"First, home tests can record negative results when a person first catches HIV at a time when they are usually highly infectious. False reassurance at this time could increase the risk of HIV transmission.

"Second, home tests also have significant rates of false positive results. It is therefore vital that home tests are not used as a substitute for the expanded testing currently available in healthcare and other settings, and that the transfer into high quality, specialist care of someone who tests positive is monitored. Psychological support and medical care are critically important. Furthermore, it is crucial that we evaluate the effectiveness of this policy in reducing undiagnosed infections without unwanted effects on behaviour, psychological wellbeing, and uptake of broader sexual health services."

Healthcare workers with HIV and medical procedures

The Department of Health also announced that healthcare workers with HIV will no longer be barred from carrying out some surgical and dental procedures – provided that they are on treatment, have undetectable viral load and receive regular medical monitoring.