Wednesday 17 July 2019

6,000 women facing fresh smear tests amid fears abnormalities could be overlooked

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Eilish O’Regan and Kevin Doyle

Around 6,000 women who had a smear test carried out by CervicalCheck are to be called back for re-testing after problems arose in one of its laboratories which could lead to a risk of abnormalities being missed.

Quest Laboratories, which conducts screening of tests, developed an issue with its HPV screening.

HPV testing is an extra form of screening carried out in labs. It is used on smear samples where low-grade abnormalities have been detected by the lab, and are sent forward for HPV screening in the same lab within a specific timeframe.

If there is no low grade abnormality detected in the first instance, the woman is informed through her GP that her test was fine.

If a low-grade abnormality is detected, but the sample is not positive for HPV, the woman does not need a referral.

If the sample tests positive for HPV, the woman is given a referral.

Dr Peter McKenna, clinical director of Women and Infant’s Health Programme, said: “Our clinical review has assured us that this issue poses little risk to women’s health.

“Evidence shows that HPV tests of this kind are effective outside the manufacturer’s recommended timeframe, but as a precaution, we will likely be asking some women to attend their GP for a repeat smear test to confirm the result and to provide them with reassurance.”

A spokeswoman said last night it came to light in the “the context of ongoing improvement work across the screening programme, including strengthening of the programme’s quality assurance processes as recommended in the report of Dr Gabriel Scally”.

“Action is being taken to investigate the issue fully, review any clinical impact or risk, and communicate with women to inform them in the first place.”

Dr McKenna said that based on their current assessment of the information provided by Quest Laboratories, it’s expected up to 6,000 women will likely be called for a repeat smear test.

These tests will be processed by the lab as a “priority”.

Damien McCallion, interim national director of the National Screening Service, said: “The laboratory first informed us of this issue at the end of November 2018, and we established an expert clinical team to establish the facts with the laboratory and review the situation.”

He said they will be communicating with the women affected by the end of next week and says CervicalCheck are “committed to communicating openly with women”.

“We sincerely apologise for any concern that that may arise as a result of this,” Mr McCallion said.

It comes after Fianna Fáil leader Micheál Martin told the Dáil yesterday that the national screening programme was in jeopardy as it struggled to cope with a backlog of tests.

He described it as being in “crisis mode”.

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