CERVICALCHECK HAS WRITTEN to 4,300 women to offer them a free repeat smear because their HPV tests were not carried out within the recommended 30-day window.

In November CervicalCheck was informed that HPV testing by Quest Diagnostics was being carried out beyond the manufacturer’s recommended timeframe of 30 days. 

It was originally estimated that as many as 6,000 women would have to go back for another test. The HSE has now told TheJournal.ie that this number has been reduced to approximately 4,300 women following a “detailed validation process” that CervicalCheck has undertaken.

It has written to all of these women, as well as a smaller number of women whose delayed tests were positive for HPV and who were subsequently referred for colposcopies. 

This group of women have been told they do not need to take further action as the HSE is confident the HPV test result was accurate and the advice to attend for a colposcopy was still correct, despite the fact that it was done outside the recommended timeframe. 

In a statement to TheJournal.ie the HSE said CervicalCheck’s clinical team is assured that these HPV tests are likely to remain effective outside the recommended 30-day timeframe and that the risk of incorrect results is low. 

“However in order to provide complete reassurance, we have asked some women who tested HPV negative to attend for a repeat smear test with their GP or smeartaker.”

For the women who tested positive and who were sent for a colposcopy, it said no further action is required as they have been, and in some cases continue to be, treated in colposcopy clinics. 

A wide net

Cancer researcher and scientist David Robert Grimes explained that the HPV test was introduced in 2015 as an additional test if abnormal cells were detected in a smear. He said examining smear slides is “entirely clinical judgement” which is why it usually involves two or more people looking at the slide.

The additional HPV test helps labs make a judgement on whether further action, such as a colposcopy referral, should be taken.

The idea of screening is that it’s casting a wide net. It does let things through – it’s not supposed to be perfect and it never could be. It’s not designed for individuals, it’s designed for populations. So if you screen hundreds you miss loads, but you will catch a few and you will save lives.

The delayed testing arose from an error in one of the labs. Instead of the ‘Day 0′ point being noted as the date the test was taken, it was marked as the date the lab received the sample.

This error existed before the CervicalCheck scandal emerged and in most cases in the past would not have resulted in late testing, Grimes explained to TheJournal.ie, as the lab would have got to those tests before the 30-day deadline anyway.

However the backlog created by the scandal resulted in a delay and the labs were in some cases testing these samples on what they thought was ‘Day 30′. This may in fact have been Day 33, for example. 

‘Worried’

One woman who received a letter this week told TheJournal.ie that she was confused by the wording in the letter as it did not explain how the HSE could stand over her test results. 

She had her smear test in May last year after the CervicalCheck scandal broke and she was informed that her HPV test was positive and was advised to go for a colposcopy.  

When she went for her colposcopy in September she was told everyone was normal. Then earlier this week she received the letter. 

It states that one of the labs told CervicalCheck that her HPV test was one of a number of samples that was tested after the recommended 30 days. 

It then goes on to say:

We are confident that the test result is accurate. The recommendation you were given to attend colposcopy was correct and we are satisfied that the advice and care you were given at the time is correct. You do not need to take any further action. 

The letter also apologises that the woman may have initially become aware of the issue in the media. 

We would like to offer you our sincere apologies for what has happened and for any concern this may cause you. We assure you that we are working with the lab in question to ensure this does not happen again.

The woman said initially the letter “really worried” her as she could not make sense of what it meant.

“I had gotten re-tested specifically when the scandal came out so to know that they had made a mistake with this precautionary smear but yet were still standing over the results didn’t make sense to me. I just don’t trust that my results were accurate – how could they be if it was tested out of the medically recommended window?

Thankfully I had had a further follow up and knew a little more in the meantime, but if I hadn’t it would have caused me a lot of anxiety and I’m still not 100% certain of where I stand with it. I’d be tempted to get another test just to make sure but it would be the third test that I’ve had in a year after two that I wasn’t satisfied were accurate – the first because of the scandal and the second because the smear wasn’t tested in the right window.

“It’s very frustrating and scary to think that even if you’re taking the time to get regular smears, you can’t guarantee that your samples are handled correctly,” she said.  

Explaining how the system works, Grimes said: “It’s a bit like buying food that is past the best before date, it’s not guaranteed that it’s gone off.”

But he believes the HSE was right to offer repeat tests for women who tested negative for HPV as a just-in-case measure.

“They err on the side of caution to put people’s mind at ease.”

In the case of the women who spoke to TheJournal.ie, he said the fact that she went for a colposcopy means she would not need a repeat smear now anyway, but he can understand how the letter caused confusion. 

He said it was “perhaps a mistake” by CervicalCheck not to include an explanation in its letter to the woman of why it was confident about the results of the HPV test.

“What they actually told you [in response to a press query] is far more useful in the hands of someone who just got that letter.”

CervicalCheck has this week begun to communicate to women affected and their GP or colposcopy clinic.

Approximately 4,300 women have been written to and invited to have a repeat smear test; these women’s GPs or smear takers have also been communicated with.

• A smaller group of approximately 300 women who had their HPV test in a colposcopy clinic will be contacted this week to advise them whether they need to take any action.
• Approximately 850 smear test samples are available to the laboratory and, the HSE said it believes at this stage, these can be retested without the need for women to attend for a repeat smear test. It will be writing to these women this week to inform them of this.

The HSE said it is “sorry for any concern that this issue regarding HPV test expiration may cause”.

The HSE has published information for women affected by this issue and if their questions are not addressed here, they are advised to speak to their GP or their colposcopy clinic.