It’s a Wednesday morning and a delivery of cardboard boxes has been sent to a towering, four-storey building located at the back of Dublin’s Coombe Hospital.
Standing in what used to be part of the hospital’s car park, the facility operates as the National Cervical Screening Laboratory (NCSL), a €20 million dedicated building that should allow the vast majority of samples provided by Irish women to CervicalCheck to be tested in the State.
Confidence in CervicalCheck was badly shaken when it emerged in 2018 that more than 200 women with cervical cancer were not informed that earlier, incorrect smear test results had been audited and changed.
In 2024, the Economic and Social Research Institute published research that found the CervicalCheck controversy “continues to have an impact on trust in cervical screening in Ireland”.
RM Block
During this time, most slides were tested abroad in US-based labs. The most recent figures show that in 2024, 83 per cent of samples were tested in private laboratories abroad.
Dr Gabriel Scally completed a report on the controversy, and though it endorsed standards at the US labs, he was critical of CervicalCheck’s oversight of the work being done across the Atlantic.
The intention of the dedicated laboratory at the Coombe is to reduce reliance on US labs.
The laboratory opens at 7am and samples are delivered in white boxes by courier or post. These are brought into the “specimen reception” area, where staff remove the clear, plastic cups contained within them to double-check the personal information of the individuals who provided the samples.
The lab receives an average of between 200 and 300 samples a day, but two weeks ago was particularly busy when there were 578 samples in a day.
Once the checks are completed and eligibility is confirmed, the information associated with the samples is digitised. The samples are then brought to a different floor for testing.
Dr Corrina Wright, clinical director of the NCSL, said the State is in a “very different space” compared with when the CervicalCheck controversy emerged.
“In 2020, the Irish screening programme switched to primary HPV testing. The WHO issued guidance around that time saying that primary HPV testing with high-performance technology is a more sensitive way of screening for cervical cancer,” she said.
“In addition, we are dealing with more vaccinated cohorts coming through. There is continuous investment in developing new technologies and innovations within cervical testing.”
This technology can be seen clearly on the testing floors. After the digitisation of information, samples are first tested for presence of the human papillomavirus (HPV), which causes about 90 per cent of cervical cancers.
HPV testing detects 18 out of 20 abnormalities in every 1,000 women screened; the older way of testing, which primarily examined cell changes, picked up 15 out of 20. The chance of a false negative test is also lower with HPV testing.
In the HPV testing area, the samples are put into batches of 92, which are then put into machines for analysing.
Aisling O’Connor, manager of the NCSL, said the process is completely automated, which reduces human error.
“They’re loading it on to these machines and that automation really brings great efficiencies. It reduces human error because you don’t have the risk of spillage,” she said.
“If you didn’t have the pre-analytical section [of the machine], you would physically have to open the vial, have it vortexed, use the pipette to take out the sample, then you might spill it, you might have picked up the wrong one. Then trying to re-lid it and load. So there’s a lot of risk there. This closed system guarantees safety and quality of the outputs.”
The machines currently run around five or six batches a day, but have capacity to do hundreds of thousands, she said, and they can run overnight. Results are then made available within four hours.
The technology and infrastructure would allow us to do a significantly higher volume than the current 75,000 samples that we have. A significant challenge that we have in the national screening laboratory is workforce investment
— Dr Corrina Wright
HPV was found in 11.9 per cent of samples in 2024; such samples are then screened for abnormal cells, a speciality known as cytology.
If an abnormality is detected – and this can happen in 40-50 per cent of HPV-detected samples – the woman is offered a colposcopy, or examination of the cervix, known as histology.
In cytology, a thin, single layer of cells is pressed on to a slide via machine, and the slide is then dyed to assist staff to identify any abnormalities. Each slide is then looked at by two different medical scientists under a microscope.
If abnormalities are identified by one of those scientists, it is then put forward for consultant review.
There is constant quality assurance throughout, O’Connor said, with every step of the process receiving multiple sets of eyes.
“We have real-time quality assurance so we can fix problems in real-time, as opposed to waiting 10 years. Nothing will get run until it’s QC [quality control] checked,” she added.
Having opened in 2023, the laboratory has scaled significantly – screening about 34,000 samples in 2024 and on track to process about 75,000 samples this year.
The CervicalCheck programme will always want to have another laboratory as a contingency in case of emergency, but scaling up samples in this facility is intended to reduce reliance on them on a regular basis.
Wright said staffing is the current obstacle to scaling further. The lab has 34 staff members, equating to a total of 30 whole-time posts, and has no vacancies. But the centre estimates it needs a further 20 positions funded across a number of specialities, which the clinical director said would enable it to carry out 200,000 samples a year.
“What we have is a workforce gap because the technology and infrastructure would allow us to do a significantly higher volume than the current 75,000 samples that we have. A significant challenge that we have in the national screening laboratory is workforce investment.
“We need to start securing the investment now, so we can meet the future needs. One of the areas that would be of particular challenge would be in the cytology [study of cells] team. There is a limited amount of cytology professionals in developed laboratories globally. All countries are competing for a very limited pool of expert cytology staff.”
Ireland has signed up to the World Health Organisation’s goal of eliminating cervical cancer by 2040, and the NCSL is viewed as an important tool in achieving this.
Wright is very positive about reaching that goal, particularly in light of recent UK research that found children who receive the HPV vaccine at age 12 to 13 have close to zero risk of dying from cervical cancer before the age of 30.
The study, published in The Lancet medical journal, found that between 2020 and 2024, there were no deaths from cervical cancer in women aged 20 to 24 in England for the first time.
“I really think it’s a reality. Now achieving it will require investment in vaccination, in screening, treatment and laboratory services,” she said.
“That investment needs to happen in order to maintain that trajectory on to achieving and maintaining cervical cancer elimination.”
Wright is very proud of what the lab has accomplished since its opening, but she is constantly looking to the future, at what else it can achieve.
Its scientists are examining the potential for self-sampling, as well as whether artificial intelligence or other technological advances can improve services.
The reason behind this, she said, is “so we can give women and people with a cervix a world-class screening service in Ireland”.
