A study looking at testing for HPV using a vaginal swab and a urine sample

Cancer type:

Cervical cancer

Status:

Results

Phase:

Other

This study looked at the reliability of testing for human papilloma virus (HPV) using a vaginal swab or a urine sample.

More about this trial

HPV is a common virus. There are many types and some can cause changes to cells in the cervix called cervical pre cancer. If they aren’t treated, these abnormal cells might develop into cervical cancer.

Women usually have a cervical smear test at the GP to check for abnormal cells. Testing for HPV is another and more sensitive way to see which women are at risk of developing cervical pre cancer or cancer.

When this study was done, testing for HPV was being looked at as the primary screening test for cervical cancer. Other research also showed it might be possible to screen women for HPV using a vaginal swab or a urine sample. These are tests that women can do at home by themselves. The researchers in this study wanted to see how well these tests worked in a large number of women.

The aim of the study was to confirm that HPV testing using vaginal swabs and urine samples was a reliable way of finding abnormal changes in the cervix.

Summary of results

The study team found that testing for HPV in vaginal samples collected by the women was as reliable at finding abnormal changes as the smear tests.

Women living in Dumfries and Galloway were invited to join the study when they were due to have their routine cervical smear.

5, 318 women aged between 20 and 60 years old took part. The average age was 43. None of them had been diagnosed with abnormal cells in the past. Just under 6 out of 10 (66%) of women under 23 had been vaccinated against certain types of HPV.

In this study, everyone had a smear test, which was also tested for HPV. They were also asked to:

provide a sample using a vaginal swab
give a urine sample

The researchers tested all the samples for HPV. They found HPV in:

just over 1 out of every 10 (14%) cervical samples
just under 2 out of every 10 (16%) vaginal samples
just over 1 out of every 10 (11%) urine samples

Women were referred to have a test called a colposcopy if they:

had moderate to severe changes to the cells in their cervix or
had borderline to mild changes that hadn’t resolved after a repeat smear test or
didn’t have abnormal cells but tested positive for 2 types of high risk HPV called HPV16 and HPV18

A total of 222 women had this test.

The researchers looked at the abnormal changes in the cervix (cervical pre cancer, which is also called cervical intraepithelial neoplasia Open a glossary item or CIN). They looked at the number of women who had CIN2 or more. They found 130 women had these changes.

Of the samples that tested positive for pre cancer (CIN2 or more), they found HPV in:

just under 10 out of every 10 (97%) cervical samples
just over 9 out of every 10 (95%) vaginal swabs
just over 6 out of every 10 (63%) urine samples

Other findings were:

that it was more likely to find HPV in the vaginal samples of women over 50 than in the cervical sample. This resulted in 1 in 4 women who were HPV positive in vaginal sample being HPV negative in the cervical sample.
testing for HPV in urine didn’t work as well as vaginal sampling - researchers hope to improve this test in the future

The study team concluded that HPV testing using vaginal samples works as well as cervical smear testing at finding abnormal changes in the cervix. So they say that vaginal sampling should be considered as a primary screening tool for cervical cancer.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.