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
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
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."