HSE Press Release: Tuesday, 16 July 2019
The HSE learned last week that Quest Diagnostics had failed to send test results to the GPs of around 800 women. The tests were on samples which were retested because their original mRNA HPV test was carried out outside the manufacturer’s recommended timeframe.
These women had previously been found to have had low-grade cytological changes from their smear test. Since 2015 it has been the practice of CervicalCheck to test women with low grade abnormalities for the HPV virus. This allows the programme to decide the appropriate clinical pathway for each woman.
Quest retested these samples using a DNA HPV test, which has a longer expiration period. This avoided the woman having to get another smear test.Both of these tests are widely used in international screening programmes and are equally acceptable. The DNA HPV is a more sensitive test than the MRNA test, which has both advantages and disadvantages.
- As we would have expected, there are a small number of women whose HPV status changed as a result of the retest using the more sensitive test. A total of 52 who previously tested negative tested positive.
- The GPs of all of these 52 women, whose status had changed, received their test results in February of this year.
- CervicalCheck records show that over half of these women have been referred on for further investigation, and we are currently confirming directly with GPs that all the women’s results have been discussed in full with her in each case.
Dr Colm Henry, Chief Clinical officer of the HSE said;“In terms of clinical risk the women affected had shown low-grade cytological changes which is at a very low risk of progression.That said, we want to apologise again to any woman that has been affected by this issue and we are continuing to keep in contact with them in relation to what has happened and any action that they need to take. The delays in results being forwarded are not acceptable, and the HSE’s ongoing independent review into this incident will be investigating this in full detail.”
Issued by HSE Press Office
Phone: 01 921 3912
Last updated on: 17 / 07 / 2019