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.
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.
