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 are calls for the law to be changed.

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 saliva or blood sample, and interprets their own results.

Instructions for follow-up and sources of support could be provided in the kits, online or by phone. A confirmatory test would be needed to confirm a reactive result.

Home testing is illegal in the UK³ and the USA. However, unregulated products may be 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.

However OraSure, manufacturers of rapid HIV tests using saliva samples, have been conducting studies in the USA on whether people are able to use their device without medical supervision and to evaluate the psychological risks for people testing HIV-positive this way. They will apply for FDA approval once those studies are complete.

In some parts of the world, including the Netherlands and Hong Kong, home testing kits are already available legally.¹

Moreover, the Terrence Higgins Trust and the National AIDS Trust have both called for the legalisation and regulation of home testing kits. It has been argued that the prohibition on self-testing is outdated, does not take account of new testing technologies, prevents the detection of undiagnosed infections, and denies patient autonomy.⁴