Where low grade changes are detected on a cervical smear test, a second, so-called ‘triage test’ – which looks for the HPV virus – is carried out by laboratories. If HPV is found, women are recommended to attend for further testing. If HPV is not found, women are recommended to attend for routine screening again in 3-5 years. In the test used by the laboratory concerned, the manufacturer’s recommendation is that the test for HPV should be carried out within 30 days of the sample having been given by a woman.
The current issue first came to light due to ongoing improvement work across the screening programme, including strengthening of the programme’s quality assurance processes as recommended in the Scally Report. The HSE was advised by Quest Diagnostics that there was a concern in relation to secondary HPV testing within the manufacturers recommended timeframe. This issue relates to some smear tests taken between 2015 when HPV testing was introduced, and 2018, when the issue was discovered.
The HSE advises that approximately 4,600 women will require a retest, and that letters to the vast majority of these women have now been issued.
The HSE has advised that clinical research shows that HPV tests remain effective even when they are performed outside the recommended timeframe and that there is little risk of inaccuracy due to the issue that Quest has identified. While the clinical advice is that the risk is very low, the HSE nevertheless is inviting the affected women to have a retest to provide assurance both to women and to the HSE. These tests will be processed by the laboratory as a priority.
In relation to the detail requested by the Deputy, I have asked the HSE to respond directly to him.