Self-test HIV kits should 'not be relied upon in isolation' - warns watchdog
The Health Products Regulatory Authority (HPRA) has warned people to not rely solely on self-test HIV kits to check if they have the virus or not.
The warning comes as a new over-the-counter test went on sale in pharmacies across the country last week.
The HPRA have said that while these tests have a role in helping people detect a potential virus, they should not be relied upon in isolation.
The number of people diagnosed with HIV in Ireland reached a record high at 508 cases in 2016, with provisional figures indicating a similar rate for 2017. At the same time, the reliance on self-test kits has increased as well.
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,” he said.
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. The HPRA has said that no self-test is 100% reliable, and it is important that people consult with a doctor to get the confirmation.
The HPRA also warns that the self-tests are not suitable for people who are already diagnosed with HIV, or for people taking antiviral drugs to prevent HIV, as they are not a reliable way to monitor the effects of treatment and they may produce an incorrect result.
They have advised that people planning on using one of the tests 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.
- 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.
- 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 Make sure that all seals are intact and do not use the test if it is out of date.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.