Information for people concerned about CervicalCheck
Last updated: 16:45 18 February 2019
Repeat screening tests recommended for some women
About 4,000 women have been invited for a repeat cervical screening test (smear test).
This is because one of our labs has told us that some HPV (human papillomavirus) tests were carried out beyond the manufacturer’s recommended time-frame of 30 days. HPV tests have been a routine part of cervical screening tests since 2015.
We have written to women affected by this issue. If you are affected by this issue, we will issue a letter to you by the end of this week (8th February 2019).
Not everyone who is affected by this issue will need to have a repeat test.
If you do need a repeat test, we will let you know. The repeat test will be free and will be processed as a priority.
Patients who are currently awaiting cervical screening test results are not affected by this issue. If you are affected, we will contact you.
We are sorry about this issue and any inconvenience or concern this may cause you.
We continue to update our website with information on this issue.
Here we have information which may answer some of your questions:
- What has happened to date
- Accuracy of your HPV test if done after the recommended date
- Women whose samples are affected
- If you are affected by this issue
- If you need a repeat cervical screening test
- Repeat cervical screening test results
- If you are told you do not need any follow-up
- If you are waiting for a result on a test you had in 2018
- If you are pregnant or have recently given birth
- Testing for HPV – how your cervical screening test is processed
- Labs affected by this issue
- Contacting CervicalCheck
What has happened to date
About 4,000 women have been invited for a repeat cervical screening test (smear test). This is because one of our labs has told us that some HPV (human papillomavirus) tests were carried out beyond the manufacturer’s recommended time-frame of 30 days.
These HPV tests were carried out on test samples where low-grade (minor) abnormalities or changes in the cells of the cervix were detected. When low-grade changes are found, the test samples are then also tested for HPV. This HPV testing has been a routine part of cervical screening since 2015.
There is no issue with the first findings of the cervical screening tests. This is the part of the test (known as cytology) where low-grade abnormalities were found.
The issue is only to do with secondary HPV tests that were done between 2015 and 2018. The lab that told us about the issue is run by Quest Diagnostics. It is 1 of 3 labs used by CervicalCheck.
Accuracy of your HPV test if done after the recommended date
HPV tests are still likely to be accurate even if carried out after the recommended date. But, in order to provide complete reassurance, we will ask some women to go for a repeat cervical screening test.
Women whose samples are affected
The women affected by this issue had their cervical screening tests processed by Quest Diagnostics between 2015 and 2018. This issue does not affect all women who had a cervical screening test during this time. It only affects women whose sample was tested for HPV. This is about 56 in 1,000 women screened.
If you are affected by this issue
If you are affected by this issue, we will write to you. We will also write to your GP.
We will tell you if any follow up is needed. Most women will not have to have any follow up or do anything. Some women will need to have a repeat cervical screening test. We will tell you if you need to have a repeat test.
If you are affected by this issue, you and your GP should receive a letter from us by 8th February 2019.
If you need a repeat cervical screening test
If we ask you to have a repeat cervical screening test, you can have it free-of-charge with any GP or smeartaker registered with CervicalCheck.
You will need to:
- make an appointment with a GP or smeartaker
- bring all the information we have sent you about this issue — the letter and the separate insert with the letter to your GP
The insert will be put with your sample. This is to let the lab know that your cervical screening test sample needs to be done as a priority. If you lose your insert or forget to bring it with you, don’t worry. Your GP will send your cervical screening test in the usual way. When your sample arrives in the lab, it will still be identified and processed as a matter of priority.
Some women had their cervical screening test in a colposcopy clinic. If you are one of those women, the clinic you attended will contact you to arrange an appointment for a retest. We will let you know in your letter if you should expect the clinic to contact you.
Repeat cervical screening test results
Repeat cervical screening tests will be processed within 4 to 6 weeks from the time the lab receives the sample from your smeartaker. Your GP will get a copy of your results letter. If you had your retest in a colposcopy clinic, the clinic will contact you when they receive your results.
Your HPV retest results are unlikely to be different from your original test result. Evidence shows that HPV tests are still effective outside the manufacturer’s recommended time-frame. But as a precaution, we are asking some women to have a repeat cervical screening test to confirm the original result.
If you are told you do not need any follow-up
We are writing to all women affected by this issue. Not all women will need to take any action or have any follow up. Only some women need to have a retest. But we wanted to let you know what has happened. Your HPV test results are likely to be accurate even though the test was done after the manufacturer’s recommended time-frame.
You may not need any follow up because:
- you’ve had another HPV test since and that test was processed within the recommended time-frame
- you’ve attended a colposcopy clinic or are due to attend — HPV is one of the tests done in colposcopy so you’ll have been given advice on any treatment, if needed
- you had a cervical screening test in the last 6 months and the lab still has your sample. They will retest it with a different HPV test. Your GP will be sent the result.
If you are waiting for a result on a cervical screening test you had in 2018
If you are currently awaiting results for a cervical screening test you had last year, you shouldn’t be affected by this issue.
The screening test samples affected are ones that have already been processed and the results sent out. Any cervical screening test that has not been processed and where the results have not sent out is not affected by this issue.
But, you may still be contacted by us if a cervical screening test you had in the last few years is affected. If you are affected, we will let you know.
If you are pregnant or have recently given birth
A screening test isn't usually recommended while you're pregnant. Your GP will usually tell you to wait until 3 months after the birth before having another screening test.
The risk to your health and the health of your baby is very low if you decide to wait until 3 months after the birth.
The HPV test previously carried out on your smear test is still likely to be accurate even if it was carried out after the recommended date. The CervicalCheck Clinical Management team are confident of this.
We are offering some women a repeat smear test in order to provide complete reassurance. We also want to make sure we have an accurate record of their results on file.
Having a screening test while you are pregnant will not increase your risk of having a miscarriage. But, you may have slight bleeding afterwards.
If you are very concerned and wish to have a repeat test, talk to your GP.
Testing for HPV – how your cervical screening test is processed
When you have a cervical screening test your test sample is sent to 1 of 3 labs that we use. The lab then follows a standard process as they test the samples. All samples are examined for changes in the cells of the cervix. This stage is called cytology. Only some tests then need to be tested for HPV.
Step one – cytology
Cytology is where the lab examines your screening test sample under a microscope to look for any abnormalities (changes) in the cells of your cervix. These can range from low-grade (minor) changes to higher grade changes.
If no changes are detected, you are told to continue to go for routine screening tests when they are due. This is usually every 3 or 5 years depending on your age.
If high-grade changes are found, you are recommended to go for a colposcopy. A colposcopy is more detailed examination of the cervix.
Step two – HPV test
If low-grade changes are found, the lab also tests your sample for HPV. These HPV tests have been routine since 2015.
HPV is a very common virus. Most people will have had it at some time in their lives. It usually clears without treatment. But some types of HPV can cause changes in the cells of the cervix that can later develop into cervical cancer.
If the HPV test is negative, the low-grade changes are not a cause for concern. You are at a low risk of developing cervical cancer before your next screening test. You are recommended to go for your routine screening when invited. This is usually every 3 or 5 years depending on your age.
If the HPV test is positive, you will need to have an examination called a colposcopy. A colposcopy is a more detailed look at your cervix. It's free of charge. You will have it done in a hospital. You will be given advice on whether you need any treatment and when to have your next screening test.
Labs affected by this issue
The lab affected by this issue is run by Quest Diagnostics Inc, Teterboro, New Jersey, USA.
We are working with Quest Diagnostics to ensure this issue does not happen again.
We have also contacted the other 2 labs we use to ensure this issue does not occur with them.
We continue to update our website with information on this issue.
If your query is not answered here, you can call us on Freephone 1800 45 45 55 (+353 21 4217612 if calling from outside Ireland) and an advisor will take your details. This helpline is open from Monday to Sunday, 9 am to 6 pm.
Delays in screening test results
Almost 350,000 screening tests were carried out during 2018. There are usually about 250,000 cervical screening tests each year. This increase in 2018 was due to understandable concerns about cervical screening.
This increased workload has led to long and very regrettable delays in the reporting of results. Results are currently being reported on average of 93 days of the test being taken. In some cases this is taking up to 27 weeks. In the past, results would have been available in about 4 to 6 weeks.
Due to this delay, a very small proportion of the overall samples expired before they were transferred to slides for testing. Repeat testing was required in about 1,000 cases.
CervicalCheck has been in touch with women about this and with their GPs.
We are sorry about these delays. We are making every effort to improve the situation.