Home sampling and home testing

It is important to distinguish between home sampling and home testing.¹ Home sampling is available and legal in the UK. Home testing is illegal, although there is a possibility that the law will change soon.

Both home sampling and home testing may sometimes be referred to as over-the-counter (OTC) testing.

With home sampling tests, the individual purchases a kit from a chemist or online, and takes a saliva or blood sample in their own home. The sample is mailed to a laboratory, which will make the results available online or by phone. If the initial test is reactive (positive), the individual will be strongly advised to go to a clinic for a confirmatory test.

Home sampling is legal in the UK and in the USA.

In the UK, one private company (Dr Thom) makes kits available to order through the internet. Oral fluid samples are used and tested with a fourth-generation test (Adaltis Detect). The company acknowledges that the test may produce false positives, so rather than reporting ‘positive results’, it describes them as ‘reactive’ and stresses that they will need to be confirmed with a second test at a clinic.

In the USA, one home sampling kit is licensed by the FDA and has been available since 1996. The Home Access System kit requires a fingerprick blood sample which is collected on filter paper, and tests for HIV-1 antibodies only with an ELISA and confirmatory Western Blot. It can be purchased at pharmacies or online.

Pilot projects are underway to explore NHS provision of home sampling for men who have sex with men.²

A home testing kit is similar to a home pregnancy or diabetes monitoring test – the individual purchases a rapid test kit from a chemist or online, takes a sample, and interprets their own results.

For the United States, the FDA approved a home testing kit for the first time in July 2012. The OraQuick In-Home HIV Test requires a saliva sample and gives a result in twenty minutes.

In a few other territories, including the Netherlands and Hong Kong, home testing kits are already available.¹

However, home testing remains illegal in the UK.³ At the same time, unregulated products are available through the internet.

In 2008, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning to the public not to use HIV self-testing kits bought over the internet. They cautioned that these unregulated tests may not meet European safety and quality standards, and their reliability cannot be guaranteed.

In 2011 Terrence Higgins Trust staff purchased three kits online, from companies based in the UK, Malaysia and Taiwan. Two of the kits which were delivered were actually the EZ-Trust kit, which the manufacturer describes as being for professional use only. Accompanying information was basic or missing, especially in relation to safer sex and sources of support.⁴

Similarly, home testing kits for bacterial sexually transmitted infections have been found to be inaccurate. The websites selling them often have few reliable means for customers to make contact, for example to ask about testing procedures or to be referred on to treatment services.⁵

The Terrence Higgins Trust and the National AIDS Trust are among those who have called for the legalisation and regulation of home testing kits. It has been argued that the prohibition on self-testing is outdated, impossible to enforce, does not take account of new testing technologies, prevents the detection of undiagnosed infections, and denies patient autonomy.⁶

In 2011, a House of Lords select committee said that the ban on home testing is unsustainable and should be repealed: “A plan should be drawn up, in consultation with clinicians, patients, voluntary organisations and professional associations, to license kits for sale with appropriate quality control procedures in place. The licensing regime must make sure that the tests are accurate, and that the process gives comprehensive advice on how to access clinical and support services in order that those who test positive get the care that they need.”⁷

In response, the government said that it supports the committee’s recommendation. The Department of Health is reviewing the policy.⁸

The House of Lords made recommendations about quality control and licensing. In relation to this, it should be noted that there are concerns over the current system of CE-marking for medical devices in Europe.

The OraQuick In-Home HIV Test is a version of the OraQuickAdvance HIV 1/2, adapted for use by people who do not have medical training. It requires a sample taken by swabbing an absorbent pad around the outer gums, adjacent to the teeth. (Unlike the professional version, a fingerprick blood sample cannot be tested.) Results are given in twenty minutes, but a confirmatory test is needed to confirm a reactive result.

In order to be approved by the FDA, its manufacturer conducted studies in the USA on whether people are able to use the device without medical supervision and whether there were any psychological risks for people testing HIV positive this way.

In a trial of 5499 people who did not know their HIV status, participants had blood taken for a traditional antibody test conducted in a laboratory and then took away the OraQuick In-Home HIV Test for self-testing. They returned on another visit and reported the result the home test had given them – this was compared with the laboratory test result, which is the benchmark against which the home test was judged.

The test’s sensitivity was 93.0%, compared to 98.03% when the test is administered by a professional. In other words, 7% of people who really did have HIV received false-negative results.

On the other hand, the test’s specificity was 99.98%, which was extremely encouraging. This means that there were extremely few false positive results and that the test was very accurate when used with low-prevalence groups.

Around 1 in 100 users were unable to get a test result, usually because of mistakes in following the instructions or because of uncertainty in reading the results.

The FDA took the view that the benefits of the test outweigh its potential risks for consumers. While the test is not as accurate as professionally-administered tests, the panel felt it could provide an important way to make HIV testing available to more people.

Following the approval of the OraQuick home testing kit in the United States in 2012, a number of hopes and concerns about home testing were raised by advocates. Time will show which of these turn out to be valid.

• Will the improved availability of HIV testing reduce the numbers of people with undiagnosed infection?
• Is a test with less-than-perfect sensitivity and a considerable window period suitable for use in communities with high rates of HIV infection?
• Due to the limited support available to people testing, will people understand the test’s limitations and will they have missed an opportunity for an HIV prevention intervention?
• Will people who test HIV positive seek confirmatory testing and be linked to medical care?
• Can home testing help reach marginalised communities who are not effectively reached by current testing programmes? Will the product be appropriately priced, distributed and promoted so that this can happen?
• Will home testing increase autonomy by putting testing into the hands of the individual, rather than being controlled by healthcare professionals?
• Will some people coerce others – such as sexual partners, family members, employees and sex workers – into testing?