Medical regulators in the UK have issued a warning to the public not to use HIV self-testing kits bought over the internet. The Medicines and Healthcare products Regulatory Agency (MHRA) is cautioning that these tests are unregulated and that their quality and reliability cannot be guaranteed.
Free and confidential HIV tests are available at NHS sexual health clinics, community outreach settings, and through some GPs.
The MHRA warning applies to self-testing only. It does not extend to home sampling, which involves taking a sample of body fluid at home and sending it to a regulated lab for testing. The results of home sampling have to be given to an individual by a clinician.
Self-testing kits are not available for purchase over the counter in the UK. But they are offered for sale on the internet, often by websites that are registered outside the UK and which are not therefore subject to UK regulations.
Medical regulators are concerned that such tests may not meet European safety and quality standards. This means that the reliability of these testing kits cannot be guaranteed. There are also concerns that important decisions might be made on the basis of an unreliable self-test.
Key messages on this subject from the MHRA are:
- A recommendation not to buy self-testing kits over the internet.
- Self-testing kits bought over the internet have no checks on their reliability.
Individuals who have already purchased such kits are being asked by the MHRA to consider the following issues:
- Do you know how reliable the kit will be?
- Have you considered seeking proper medical advice?
- Have you thought about counselling to discuss the impact of any result?
- If a result is incorrect, there may be no legal recourse.