First HIV home test approved for sale in UK

The BioSure HIV Self Test, designed to be used by untrained users at home was granted a CE mark yesterday, making it the first HIV home test which can be legally sold in the United Kingdom. The test is simple to perform and tests for the presence of HIV antibodies in a drop of blood.

The UK’s legal ban on HIV home testing was lifted a year ago, but until now no manufacturer has produced a test with a CE mark for self-testing, indicating that the test conforms to minimum European standards for accuracy and ease of use.

In the United States, the Food and Drug Administration (FDA) approved a different device, the OraQuick In-Home HIV Test, for home use in 2012. OraQuick’s manufacturer is hoping to gain a CE mark later this year.

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. 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

specificity

When using a diagnostic test, the probability that a person without a medical condition will receive the correct test result (i.e. negative).

sensitivity

When using a diagnostic test, the probability that a person who does have a medical condition will receive the correct test result (i.e. positive). 

home testing

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

Taking the BioSure self test involves using a safety lancet to produce a drop of blood from a finger, applying the blood to the tip of the test device, leaving the test to run for 15 minutes and then reading the result. Lines appear on a paper strip inside a plastic tube.

The test may not detect recent HIV infection as it can take up to three months for antibodies to become detectable.

For the moment, the test is only available to UK residents through BioSure’s website or from the Freedoms Shop, a service which also sells low-cost condoms and lubricant. Through either channel, the test costs £29.95.

BioSure’s test is based on a device that is already in widespread use by health professionals. The existing device, marketed either as the Chembio Sure Check HIV 1/2 Assay or as the Clearview Complete HIV 1/2 Assay, was licensed by the American FDA in 2006 and granted a European CE mark in 2013 – in both cases, for professional use only.

Several studies have shown that the device, when used by healthcare professionals, is highly accurate. The FDA judged the test’s sensitivity (proportion of HIV-positive samples accurately described as such) to be 99.7% and its specificity (proportion of HIV-negative samples accurately described as such) to be 99.9%.

BioSure believes that this is the most suitable device to be adapted for home testing – simple to operate, with an easy-to-read result, accurate, and hard to tamper with. They have paired it with an easy-to-use lancet and have developed specific packaging and clear instructions to guide people through the steps of taking a test.

This self-test version was tested in a study conducted by BioSure and University College London. A total of 403 people, including some recruited at a central London sexual health clinic where the prevalence of HIV is high, used the test. Results were checked against a second, established test performed by a health professional. In this trial, sensitivity and specificity in fact surpassed that observed in professional studies.

However, 3.2% of users had an invalid test – meaning that they were not able to complete the test and read a result. The product’s packaging clearly explains that a result will only be valid if a ‘control line’ as well as one or two ‘test lines’ can be seen on the device. As a result, all participants who had an invalid result knew that their test was invalid.

As a second part of the evaluation for self-testing, visuals of possible results on the device, including invalid tests and weak positives, were shown to participants. Sensitivity and specificity remained at 99.4% or above.

“The availability of the UK’s first home HIV testing kit is a really exciting development,” commented Dr Michael Brady of Kings College Hospital Trust and Terrence Higgins Trust. “The single biggest thing that we can do to have a major impact on the HIV epidemic is to dramatically increase HIV testing rates, especially in those most at risk. The availability of HIV self-testing will help us achieve that.”

French company gains CE mark for similar device

A French company has also adapted the same device (that was originally produced for professional use) for use in home testing. As the instructions and other details are different, a separate CE mark was issued. The AAZ company will market the test as 'auto test VIH' and make it available online and through retail pharmacies at the end of June.