ALMOST 200 HPV-POSITIVE smear samples from May and April carried out by CervicalCheck will have to be re-tested after the samples expired before further examination could be carried out. 

The samples expired after an increase in the number of women coming forward to be screened as part of the CervicalCheck programme, particularly during the month of May.

Smear sample turnaround times have since “caught up” and are going through the labs “in good time”, the head of the National Screening Service has said.

The clinical director of CervicalCheck has said the women affected will be contacted “in the coming days” but that it is “very important” to state that the positive HPV tests are “very unlikely” to mean the women will develop cervical cancer.

CervicalCheck is sending out letters to inform GPs today, and the 180 women who are affected are to receive their letters from tomorrow. It is understood that informing GPs first is the usual protocol, in order to have the necessary supports in place for women.

The women’s repeat tests will be taken three months from now, so that cervical cells have a chance to grow back and yield the best smear samples.

It is understood that the 180 women who are affected will be prioritised for retesting, and are expected to wait around four to six weeks for their repeat cervical-smear test result.

There is currently an 8-10 week turnaround for smear test results at the moment, meaning some of the thousands of women who are waiting for their smear results may be concerned that they are among this group of 180 women.

How HPV testing works

CervicalCheck still screens for abnormal cells that can cause cervical cancer, but the way that they do it has changed.

Previously, a cytology smear test was carried out first to look for any cervical cell abnormalities, and then if that test found an abnormality, women were referred to a colposcopy clinic to test whether those abnormalities were low-grade or high-grade.

But studies have shown that the results are better if you test for HPV in cervical cells first, and if it is found, then refer the woman on for further examination (cytology).

HPV is very common virus with no noticeable symptoms. Over 90% are cleared by the body’s immune system after two years, but in some cases, HPV can develop into cancer in both men and women.

What caused the delay in testing

RTÉ News first reported this morning that in 180 samples tested positive for HPV, but they were not sent on for cytology examination within the required period of 42 days.

Speaking on RTÉ’s Morning Ireland programme, clinical director of CervicalCheck Dr Nóirín Russell said that the tests were not carried out in time because of the backlog in testing caused by the suspension of services last year due to the Covid-19 pandemic. 

There were actually 200,000 samples sent during the first half of this year and that was 50,000 more than we had been expecting. Our ability to screen that number of samples, whereas the vast majority did get processed and did get fully processed and fully screened, in approximately 200 samples we were able to test for HPV, the first part of the test, but we weren’t able to look at the cytology or look at the cells, the second part of the test because the samples expired.

The tests affected were mostly from May, with some from April and some also possibly from March. Patient advocate groups were told of the issue late last week. 

Dr Russel said that supports are currently in place to answer women’s questions:

“We have staff have ready on the info line ready to take calls to explain and to reassure, so all of those steps are in place and we’re expecting that the affected women will get their information in the next few days. That information will be in the form of a letter explaining that they’re HPV positive and that they need to have a repeat test,” she said. 

It’s really, really important that women who hear this, who hear HPV positive, know that it’s very unlikely to mean cancer but it’s really important they attend for that second test.”

CEO of the National Screening Service Fiona Murphy said on Today with Claire Byrne that 13% of smear tests come back positive for HPV, and are referred on for further examination, but this is just one “risk factor” for developing cervical cancer.

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She said that CervicalCheck had been expecting to receive 140,000 samples in the first six months of the year, and instead got almost 200,000 samples.

She said they came close to processing all these additional samples, but 200 samples expired.

I can only say sorry that we didn’t do that for those 200 women… Part of the trust and confidence [issue] is to tell people when we make a mistake. We won’t hide anything, when we make a mistake [we say] mea culpa and this is how we’re fixing it.

She said additional capacity has since been added to the system.

“Samples expire in labs across the whole country all the time. It’s normally very small numbers, the vial itself may have expired, or sometimes we have to ask for a retest because there’s not enough of a sample in the vial, or somewhere along the way from the GP to the Post to the sample collection centre it just takes too long.

We’re always aware of it, we’re always doing what we can to try to minimise that, but in this particular instance, because of the large volumes in mid-March and through early May, we weren’t able to process all of them.

The helpline for women who may have queries is now live and can be contacted on 1800 45 45 55.

Cervical screening with HPV testing prevents cervical cancer from developing in 90% of cases. An effective and free cervical cancer programme, coupled with high uptake rates of the HPV vaccine, could together eradicate cervical cancer.

From 2015 to 2017, there were 264 cases a year of cervical cancer in Ireland. Of that number, around 160 women a year are diagnosed via the CervicalCheck programme (around 60% of all diagnoses).

Each year in Ireland, 90 women die of cervical cancer. Without a national cervical smear programme, the numbers could double: 320 women could be diagnosed, and 180 women could die.

With reporting by Gráinne Ní Aodha.