HPRA publishes new consumer advice on using HIV Self-Test kits

News Category: Regulatory news

Date: 02/08/2018

The Health Products Regulatory Authority (HPRA) today advised consumers and patients who may be considering using products to self-test for Human Immunodeficiency Virus (HIV) to be aware that whilst such tests have a role in assisting people to identify a potential virus, they should not be relied upon in isolation. As these products are becoming more widely available on the Irish market, and the incidence of HIV is also increasing in the population, the HPRA is today publishing a new information notice advice to assist those patients and members of the public who are thinking about buying HIV self-tests. This information highlights some key considerations on sourcing and using these products as well as providing practical advice on what to consider when purchasing them.

HIV self-tests (also called point of care or near patient tests) are a type of medical device that can be used by individuals at home. The number of people diagnosed with HIV in Ireland reached a record high at 508 cases in 2016 with provisional figures showing a similar rate for 2017. With the rate of new infections significantly higher during the past three years, self-testing for the virus is also growing in prevalence. However, while the HPRA recognises that self-tests have a role to play, it is important that if a person has concerns about a HIV self-test result or their health they should contact their doctor for advice.

Dr Niall MacAleenan, head of the medical devices department at the HPRA, states no HIV self-test can detect HIV immediately after infection. If a person thinks they have been exposed to the virus in the previous 72 hours, they should attend their nearest STI/genitourinary medicine (GUM) clinic for advice on testing and on post-exposure prophylaxis (PEP) a treatment which can reduce the chances of becoming HIV positive.

“Early, appropriate, treatment of HIV is critical; so if you get a positive result from a Self-Test for HIV, or if you get a negative result and you are still concerned about a potential exposure to HIV or other STIs you should urgently seek assistance from your GP or a Sexual Health Clinic.

It can take up to 90 days for HIV antibodies to develop in the body in sufficient quantity to be detectable by a self-test kit. We would also advise that no self-test is 100% reliable and it is very important that those considering self-testing are aware of the limitations of these products and that they don’t rely solely on the results provided. Other testing methods available at STI/GUM clinics may provide accurate results before the 90 day mark. We would always advise anybody with any concerns about their health to consult with their healthcare professional.”

The HPRA advises in particular that before purchasing a HIV self-test kit consumers should check the following:  

  • Self-test products should always display a CE mark along with a four digit number. This indicates that the test meets the basic requirements for safety and effectiveness under EU law. 
  • Check there is a European address on the packaging.
  • Only purchase products from a reliable source. In particular, always be careful when purchasing medical devices on the internet. Further advice is available in two of the HPRA’s consumer leaflets, which provide guidance on self-tests and on purchasing medical devices online.
  • Read the instructions and follow them carefully – pay particular notice to the length of time from exposure to the HIV virus to when the virus may be detectable.  It can take 90 days from potential exposure before a self-test can reliably detect the virus.
  • Check the packaging. Make sure that all seals are intact and do not use the test if it is out of date.
  • Prepare appropriately and make sure you have everything required to carry the test out including, for example, a timer. Make sure you know how to interpret the test results having read the instructions in advance.
  • HIV self-tests are not appropriate for people already diagnosed with HIV or for people taking PrEP as they are not a reliable way to monitor the effects of treatment and you may get an incorrect result if you use a HIV self-test while on treatment.



Siobhan Molloy/ Jo Twamley                              (01) 679 86 00

Weber Shandwick PR                                         086 817 5066/085 143 8320



The Health Products Regulatory Authority (HPRA) protects and enhances public health and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics.

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