Today, we’re speaking to Prof Emma Crosbie, Professor of Gynaecological Oncology based at the University of Manchester.

Title of paper: Urine human papillomavirus testing for cervical screening in a UK general screening population: a diagnostic test accuracy study

Available at: https://doi.org/10.3399/BJGP.2025.0105

The switch from primary cytology to primary human papillomavirus testing has enabled innovations in self-sampling for cervical screening. This study shows that urine self-collected with a first-void urine collection device has similar diagnostic test accuracy and acceptability to cervical sampling in a general screening population. Urine self-sampling has real-world potential as an alternative cervical screening option.

Transcript

This transcript was generated using AI and has not been reviewed for accuracy. Please be aware it may contain errors or omissions.

Speaker A

00:00:01.440 - 00:01:07.140

Hello and welcome to BJGP Interviews. I'm Nada Khan and I'm one of the Associate Editors of the bjgp. Thanks for listening to this podcast today.

In today's episode, we're speaking to Professor Emma Crosby, who is professor of Gynecological Oncology based at the University of Manchester. We're here to talk about her really exciting paper that's recently been published in the December 2025 issue of the BJGP.

The paper is titled Urine Human Papillovirus Testing for Cervical Screening in UK General Screening Population A Diagnostic Test Accuracy Study. So, hi Emma, it's lovely to meet you and to talk about this paper.

I really just wanted to start off talking a bit around cervical screening in the uk, and you mentioned this in the introduction to the paper as well, that cervical screening really does have variable uptake rates and we know that there are some, some barriers to access. But can you talk us through these and tell us a bit about why you decided to do this research?

Speaker B

00:01:07.940 - 00:03:41.440

So, as you've just really nicely summarised, cervical screening is really important weapon against cervical cancer.

So we know that it prevents cervical cancer and since the introduction of the NHS Cervical Screening program in the UK, we've seen deaths from cervical cancer drop by around 70%. So we know that it's very effective.

But in the uk, the number of people attending is declining year on year and currently, currently only around 68% of those people who are eligible for cervical screening actually attend. There are a whole range of different reasons for non attendance.

These include things to do with the speculum examination, so having to have an intimate examination to be examined. The anticipated embarrassment or fear of pain related to that procedure, I think are important barriers.

But there are also barriers associated with access to reaching screening appointments, taking time off work, having childcare and so on and so forth. So we thought that there was some really important barriers there that could potentially be addressed by self sampling.

Now, vaginal self sampling is actually been incorporated in many cervical screening programs around the world.

Some cervical screening programs are using it just for people who are non attenders or underscreened by traditional screening routes and other countries are using it as a choice for everybody.

Now, in the uk, we haven't yet taken up vaginal self sampling sampling, but it will be introduced this year in 2026, principally for under screened groups. And there is some work looking at whether or not it will be introduced as a choice for everyone in the future.

But we know from research that's been done in the UK that only around 12 to 13% of people who are offered vaginal self sampling who are under screened actually return a sample. And therefore it clearly doesn't address all the barriers to cervical screening. And we wondered whether a urine test would have more app.

It would have the same benefits of vaginal self sampling in that it can be collected at home and posted to the laboratory. So it removes that need for an intimate examination.

It removes the need for, you know, making an appointment at a healthcare facility to have your screen taken, but it perhaps, you know, removes some of the barriers towards putting a swab inside the vagina that might be culturally or religiously unacceptable to some groups. And so we thought that a urine self sample could be another option for people who currently aren't screened.

And so we wanted to see how accurate it was in this study.

Speaker A

00:03:42.320 - 00:04:03.760

And those issues around access are really important, especially in this population of women who are juggling lots of caring responsibilities with young children or caring for older relatives as well.

So sometimes it is just difficult to get to an appointment and, you know, juggling work hours and things which often then coincide with GP opening hours as well.

Speaker B

00:04:03.920 - 00:04:41.960

Yeah, absolutely.

And we, we have seen a drop in people, you know, in the youngest age group of people who are invited for screening, attending SCRE, their rates of attendance are even lower than the 68% that I quoted.

And probably a lot of that is to do with having very busy lives, not seeing this as a priority, imagining that you're not at risk and seeing cervical cancer as something that affects older people, perhaps. So there are additional barriers related to certain age groups.

But I definitely think that making time for a screening appointment, juggling all the different millions of things that we have to do every day, is a really important barrier that something like a urine based test could help to overcome.

Speaker A

00:04:42.120 - 00:05:10.680

Yeah, fair enough. So this was quite a big prospective study of over 1500 women carried out across the northwest of England.

So women provided both regular speculum based cervical samples alongside urine sample too. And the main thing you were looking at here was the accuracy of the urine based HPV testing for cervical cancer.

But just in case people aren't completely aware of all this, can you talk us through first why we're now only looking at HPV in these samples?

Speaker B

00:05:11.060 - 00:06:30.230

Yeah. So, I mean, in 2019 in the UK, we changed from primary cytology based cervical screening to primary HPV based cervical screening.

So that means that the sample taken from your cervix is tested first for hpv and only if that is HPV positive is it then looked at under the microscope. To see if there are changes in the cells.

And this was based on a very large study done in the UK that showed that HPV testing is a much more sensitive test than cytology as the primary scre.

And by that what we mean is it's much more likely not to miss abnormal cells than cytology, which is very effective when there is a large lesion, if you will, that can be sampled with a cervical swab, but not so good at picking up smaller lesions. And so there is the chance that cytology might miss an abnormality. But HPV is really good at showing that somebody is at risk.

So we now do all primary screening by HPV testing. And of course this is what has opened up the opportunity for us to do different sample types.

So a vaginal swab tested for HPV or a urine sample tested for hpv, you know, could also be an effective way of screening people to see if they are at high risk of cervical pre cancers.

Speaker A

00:06:30.390 - 00:06:37.830

So talk us through the results. So how well did the urine based testing perform? So both in terms of how sensitive and specific the results were?

Speaker B

00:06:38.130 - 00:09:24.670

Well, first of all, it's really important to say that this piece of work followed on from another piece of work that looked at a high risk population. And in that other piece of work we were able to show that it's really important how the urine sample is collected.

So absolutely must be collected with a colipy device or a similar device that collects the first fraction of urine sampled. And that's important because the HPV isn't in the urine itself.

The urine is flushing cervical mucus that is accumulated around the urethra into the sample. And so if you don't collect that very first flush of urine, then you're likely to miss the hpv.

So on that background, using the COLIP device in this study and collecting that urine sample prior to the routine clinician obtained cervical sample, we were able to obtain two samples from each person that we were then able to test with the same HPV test. And we were able to compare absolutely how accurate the urine was compared to the matched cervical sample.

And because we were using a general population, so this is anybody that's due cervical screening rather than a high risk population, we knew that we weren't going to see very many people who had CIN2 plus, which is the cervical pre cancer that we want to identify and treat.

And actually what we were looking for here was to see, you know, what prevalence of HPV infections do we pick up using the two tests, you know, the urine test and the Cervical test and how well matched are they at terms of, you know, telling somebody that they're HPV negative and at low risk of cervical cancer and how well matched out they are picking up HPV positive people who also have cytological abnormalities that need to be referred to colposcopy.

So if we take all of that information on board, then the bottom line figure is that urine picked up around 16% of people as having an HPV infection, while a cervical sample picked up around 13.5%. So you can see that we picked up slightly more HPV infections with urine than we did with the matched cervical sample.

But when we look at, you know, how many of those had CIN2 plus, it was just a very small number. So only 25 of our 15, 17 people actually had a CIN2 plus lesion, and urine picked up 24 of those.

So when we look at the relative specificity, if you like, of urine versus cervical sampling for HPV detection in this population, it was really good. It was 97% relative sensitivity specificity.

And when we look at sensitivity, you know, we're a little bit underpowered because, like I said, we only had 25 CIN2 plus lesions, but urine picked up 24 of those 25. So it had really excellent sensitivity as well, even bearing in mind small numbers.

Speaker A

00:09:24.830 - 00:09:43.940

And I think one of the main things to look at here and to point out was what the participants felt about the different forms of testing.

And you looked and asked them what they thought about the cervical screening using a urine sample instead of the more traditional based speculum based testing. And what did they feel about that in terms of sort of acceptability?

Speaker B

00:09:44.740 - 00:10:51.420

Well, I mean, as we might expect, most of them were quite happy with attending for routine cervical screening appointments. This probably is not the population for whom a urine based test is intended.

It's probably, at least in the first instance, intended for people that are under screened. But it's perhaps not surprising that people who do go for routine cervical screening are more than happy to continue doing so.

So we found that around 42% would prefer to continue to for their screening appointment and to have a sample taken by a healthcare professional. Interestingly, around 30% would prefer to switch to a urine based cervical screening test.

And another sort of 30% or so had no particular preference over screening method.

And this is quite interesting because it suggests that we probably need to have a menu of choices for people that, you know, one option for everybody is not going to answer the problems of reduced uptake of cervical screening and that if we had a menu of choices whereby people could choose the way that they would be screened in the future, that this might have the best way of increasing the number of people who are screened.

Speaker A

00:10:51.500 - 00:10:55.180

Any other key findings from the paper that you want to touch on at all?

Speaker B

00:10:55.420 - 00:11:42.680

Well, I think the main thing is that we were really impressed with the performance of urine. This is kind of.

We didn't directly compare it to a vaginal swab result, which, as I'd already mentioned, is going to be introduced by the NHS Cervical Screening Program from 2026 for under screened women.

But if we compare how urine has performed in study, especially if we look at it in combination with the study that was done in a high risk population, and then compare it with the recently published HP Validate study that compared different vaginal swabs with HPV testing results, we can see that urine performs at least as well as vaginal self sampling, if not slightly better.

So we were, we were a little bit surprised that it performs better than vaginal swab, but extremely excited that this paves the way for further research in this area.

Speaker A

00:11:43.190 - 00:12:02.710

And based on this study, and you've talked a bit about the introduction of vaginal self sampling this year as well, what do you think is the future for cervical cancer screening in the uk?

You've mentioned about having a menu of options, but you've also touched on the fact that there might be some groups for whom this is actually the preferred method of screening.

Speaker B

00:12:03.510 - 00:13:54.680

Yes, I mean, I think initially the cervical screening program's decision to offer vaginal self sampling to under screen populations is a really good one because it can't do any harm. These people are not being screened by definition and so offering them another option to help them to be screened is fantastic.

From previous research, we might expect only around 8 to 13% of those people to actually take up the offer of vaginal self sampling. So it might be that we actually need to introduce another option for under screened people, such as urine based sampling.

So I definitely see it as having a role for people who couldn't be screened in other ways.

And there are plenty of people that have been, for example, victims of sexual violence, people for whom putting a swab in the vagina is culturally or religiously taboo, people who have pelvic pain conditions, vaginismus, painful vulval conditions and so on. I can definitely see that urine based sampling, if we can show it's as accurate as vaginal based sampling, has a place.

But in terms of whether or not we're going to offer different ways of self sampling, for everybody in the cervical screening program, I think that needs a little bit of a more careful consideration.

And the reason that I say that is that if, for example, vaginal self sampling and urine self sampling are even a tiny bit less accurate than cervical self sampling, and what we find is that by introducing these self sampling methods to the general screening population doesn't really increase the number of people being screened, but does substantially influence people to switch from regular screening to urine or vaginal based cell sampling. We might actually see a deterioration in the cervical screening program. We might actually see more cervical cancers and deaths from cervical cancers.

So we really need to do more research in this area before we just introduce it as other countries have done.

Speaker A

00:13:54.920 - 00:14:05.240

And I guess that's the next thing I want to touch on is what's the next steps for you and your team in this area? Are you planning any further research and looking at urine based HPV testing?

Speaker B

00:14:05.560 - 00:15:06.700

Yes. So we have done two other large studies. One is looking at under screened women.

So we have randomized women to receive either a vaginal self sampling kit sent to their home address, a urine based self sampling kit sent to the home address, or an offer of the choice between a vaginal or a urine self sampling kit, or an offer of vagina self sampling kit or an offer of a urine self sampling kit.

So five different groups basically asking the question of whether we really need the option of vaginal versus urine self sampling or whether, you know, one type of option is going to be effective for everybody. And can urine based self sampling actually help people to to be able who are under screened to turn up for screening?

So that's the first study that we've done. And then another study that we have done is looking at the acceptability in a much larger population.

So several thousands of people who have tried urine based self sampling, what do they think about it? Compared to vaginal self sampling and compared to routine screening?

Speaker A

00:15:07.180 - 00:15:30.040

Brilliant.

That sounds like all really exciting work and as you say, it's tackling those challenges around the decrease in people taking up cervical cancer screening.

So I think this is really important work and it's been great to hear about it and look forward to hearing about the results from those other studies you're working on. But I just wanted to say that's I think a great place to wrap things up. So thanks very much for your time, Emma.

Speaker B

00:15:30.120 - 00:15:30.760

Thank you.

Speaker A

00:15:31.240 - 00:15:52.770

And thank you all very much for your time here and for listening to this BJ GP podcast.

Emma's original research article can be found on bjgp.org and the show notes and podcast audio are@bjgplife.com it's been great hearing about Emma's research in this area, and I hope you all enjoyed listening as well. Thanks again for your time and bye.

Hello and welcome to BJGP Interviews.

I'm Nada Khan and I'm one of the Associate Editors of the bjgp.

Thanks for listening to this podcast today.

In today's episode, we're speaking to Professor Emma Crosby, who is professor of Gynecological Oncology based at the University of Manchester.

The paper is titled Urine Human Papillovirus Testing for Cervical Screening in UK General Screening Population A Diagnostic Test Accuracy Study.

So, hi Emma, it's lovely to meet you and to talk about this paper.

I really just wanted to start off talking a bit around cervical screening in the uk, and you mentioned this in the introduction to the paper as well, that cervical screening really does have variable uptake rates and we know that there are some, some barriers to access.

But can you talk us through these and tell us a bit about why you decided to do this research?

So, as you've just really nicely summarised, cervical screening is really important weapon against cervical cancer.

So we know that it prevents cervical cancer and since the introduction of the NHS Cervical Screening program in the UK, we've seen deaths from cervical cancer drop by around 70%.

So we know that it's very effective.

But in the uk, the number of people attending is declining year on year and currently, currently only around 68% of those people who are eligible for cervical screening actually attend.

There are a whole range of different reasons for non attendance.

These include things to do with the speculum examination, so having to have an intimate examination to be examined.

The anticipated embarrassment or fear of pain related to that procedure, I think are important barriers.

But there are also barriers associated with access to reaching screening appointments, taking time off work, having childcare and so on and so forth.

So we thought that there was some really important barriers there that could potentially be addressed by self sampling.

Now, vaginal self sampling is actually been incorporated in many cervical screening programs around the world.

Some cervical screening programs are using it just for people who are non attenders or underscreened by traditional screening routes and other countries are using it as a choice for everybody.

And there is some work looking at whether or not it will be introduced as a choice for everyone in the future.

But we know from research that's been done in the UK that only around 12 to 13% of people who are offered vaginal self sampling who are under screened actually return a sample.

And therefore it clearly doesn't address all the barriers to cervical screening.

And we wondered whether a urine test would have more app.

It would have the same benefits of vaginal self sampling in that it can be collected at home and posted to the laboratory.

So it removes that need for an intimate examination.

It removes the need for, you know, making an appointment at a healthcare facility to have your screen taken, but it perhaps, you know, removes some of the barriers towards putting a swab inside the vagina that might be culturally or religiously unacceptable to some groups.

And so we thought that a urine self sample could be another option for people who currently aren't screened.

And so we wanted to see how accurate it was in this study.

And those issues around access are really important, especially in this population of women who are juggling lots of caring responsibilities with young children or caring for older relatives as well.

So sometimes it is just difficult to get to an appointment and, you know, juggling work hours and things which often then coincide with GP opening hours as well.

Yeah, absolutely.

And we, we have seen a drop in people, you know, in the youngest age group of people who are invited for screening, attending SCRE, their rates of attendance are even lower than the 68% that I quoted.

And probably a lot of that is to do with having very busy lives, not seeing this as a priority, imagining that you're not at risk and seeing cervical cancer as something that affects older people, perhaps.

So there are additional barriers related to certain age groups.

But I definitely think that making time for a screening appointment, juggling all the different millions of things that we have to do every day, is a really important barrier that something like a urine based test could help to overcome.

Yeah, fair enough.

So women provided both regular speculum based cervical samples alongside urine sample too.

And the main thing you were looking at here was the accuracy of the urine based HPV testing for cervical cancer.

But just in case people aren't completely aware of all this, can you talk us through first why we're now only looking at HPV in these samples?

Yeah.

So that means that the sample taken from your cervix is tested first for hpv and only if that is HPV positive is it then looked at under the microscope.

To see if there are changes in the cells.

And this was based on a very large study done in the UK that showed that HPV testing is a much more sensitive test than cytology as the primary scre.

And by that what we mean is it's much more likely not to miss abnormal cells than cytology, which is very effective when there is a large lesion, if you will, that can be sampled with a cervical swab, but not so good at picking up smaller lesions.

And so there is the chance that cytology might miss an abnormality.

But HPV is really good at showing that somebody is at risk.

So we now do all primary screening by HPV testing.

And of course this is what has opened up the opportunity for us to do different sample types.

So a vaginal swab tested for HPV or a urine sample tested for hpv, you know, could also be an effective way of screening people to see if they are at high risk of cervical pre cancers.

So talk us through the results.

So how well did the urine based testing perform?

So both in terms of how sensitive and specific the results were?

Well, first of all, it's really important to say that this piece of work followed on from another piece of work that looked at a high risk population.

And in that other piece of work we were able to show that it's really important how the urine sample is collected.

So absolutely must be collected with a colipy device or a similar device that collects the first fraction of urine sampled.

And that's important because the HPV isn't in the urine itself.

The urine is flushing cervical mucus that is accumulated around the urethra into the sample.

And so if you don't collect that very first flush of urine, then you're likely to miss the hpv.

So on that background, using the COLIP device in this study and collecting that urine sample prior to the routine clinician obtained cervical sample, we were able to obtain two samples from each person that we were then able to test with the same HPV test.

And we were able to compare absolutely how accurate the urine was compared to the matched cervical sample.

And because we were using a general population, so this is anybody that's due cervical screening rather than a high risk population, we knew that we weren't going to see very many people who had CIN2 plus, which is the cervical pre cancer that we want to identify and treat.

And actually what we were looking for here was to see, you know, what prevalence of HPV infections do we pick up using the two tests, you know, the urine test and the Cervical test and how well matched are they at terms of, you know, telling somebody that they're HPV negative and at low risk of cervical cancer and how well matched out they are picking up HPV positive people who also have cytological abnormalities that need to be referred to colposcopy.

So if we take all of that information on board, then the bottom line figure is that urine picked up around 16% of people as having an HPV infection, while a cervical sample picked up around 13.5%.

So you can see that we picked up slightly more HPV infections with urine than we did with the matched cervical sample.

But when we look at, you know, how many of those had CIN2 plus, it was just a very small number.

So only 25 of our 15, 17 people actually had a CIN2 plus lesion, and urine picked up 24 of those.

So when we look at the relative specificity, if you like, of urine versus cervical sampling for HPV detection in this population, it was really good.

It was 97% relative sensitivity specificity.

And when we look at sensitivity, you know, we're a little bit underpowered because, like I said, we only had 25 CIN2 plus lesions, but urine picked up 24 of those 25.

So it had really excellent sensitivity as well, even bearing in mind small numbers.

And I think one of the main things to look at here and to point out was what the participants felt about the different forms of testing.

And you looked and asked them what they thought about the cervical screening using a urine sample instead of the more traditional based speculum based testing.

And what did they feel about that in terms of sort of acceptability?

Well, I mean, as we might expect, most of them were quite happy with attending for routine cervical screening appointments.

This probably is not the population for whom a urine based test is intended.

It's probably, at least in the first instance, intended for people that are under screened.

But it's perhaps not surprising that people who do go for routine cervical screening are more than happy to continue doing so.

So we found that around 42% would prefer to continue to for their screening appointment and to have a sample taken by a healthcare professional.

Interestingly, around 30% would prefer to switch to a urine based cervical screening test.

And another sort of 30% or so had no particular preference over screening method.

And this is quite interesting because it suggests that we probably need to have a menu of choices for people that, you know, one option for everybody is not going to answer the problems of reduced uptake of cervical screening and that if we had a menu of choices whereby people could choose the way that they would be screened in the future, that this might have the best way of increasing the number of people who are screened.

Any other key findings from the paper that you want to touch on at all?

Well, I think the main thing is that we were really impressed with the performance of urine.

This is kind of.

But if we compare how urine has performed in study, especially if we look at it in combination with the study that was done in a high risk population, and then compare it with the recently published HP Validate study that compared different vaginal swabs with HPV testing results, we can see that urine performs at least as well as vaginal self sampling, if not slightly better.

So we were, we were a little bit surprised that it performs better than vaginal swab, but extremely excited that this paves the way for further research in this area.

And based on this study, and you've talked a bit about the introduction of vaginal self sampling this year as well, what do you think is the future for cervical cancer screening in the uk?

You've mentioned about having a menu of options, but you've also touched on the fact that there might be some groups for whom this is actually the preferred method of screening.

Yes, I mean, I think initially the cervical screening program's decision to offer vaginal self sampling to under screen populations is a really good one because it can't do any harm.

These people are not being screened by definition and so offering them another option to help them to be screened is fantastic.

From previous research, we might expect only around 8 to 13% of those people to actually take up the offer of vaginal self sampling.

So it might be that we actually need to introduce another option for under screened people, such as urine based sampling.

So I definitely see it as having a role for people who couldn't be screened in other ways.

And there are plenty of people that have been, for example, victims of sexual violence, people for whom putting a swab in the vagina is culturally or religiously taboo, people who have pelvic pain conditions, vaginismus, painful vulval conditions and so on.

I can definitely see that urine based sampling, if we can show it's as accurate as vaginal based sampling, has a place.

But in terms of whether or not we're going to offer different ways of self sampling, for everybody in the cervical screening program, I think that needs a little bit of a more careful consideration.

And the reason that I say that is that if, for example, vaginal self sampling and urine self sampling are even a tiny bit less accurate than cervical self sampling, and what we find is that by introducing these self sampling methods to the general screening population doesn't really increase the number of people being screened, but does substantially influence people to switch from regular screening to urine or vaginal based cell sampling.

We might actually see a deterioration in the cervical screening program.

We might actually see more cervical cancers and deaths from cervical cancers.

So we really need to do more research in this area before we just introduce it as other countries have done.

And I guess that's the next thing I want to touch on is what's the next steps for you and your team in this area?

Are you planning any further research and looking at urine based HPV testing?

Yes.

So we have done two other large studies.

One is looking at under screened women.

So we have randomized women to receive either a vaginal self sampling kit sent to their home address, a urine based self sampling kit sent to the home address, or an offer of the choice between a vaginal or a urine self sampling kit, or an offer of vagina self sampling kit or an offer of a urine self sampling kit.

So five different groups basically asking the question of whether we really need the option of vaginal versus urine self sampling or whether, you know, one type of option is going to be effective for everybody.

And can urine based self sampling actually help people to to be able who are under screened to turn up for screening?

So that's the first study that we've done.

And then another study that we have done is looking at the acceptability in a much larger population.

So several thousands of people who have tried urine based self sampling, what do they think about it?

Compared to vaginal self sampling and compared to routine screening?

Brilliant.

That sounds like all really exciting work and as you say, it's tackling those challenges around the decrease in people taking up cervical cancer screening.

So I think this is really important work and it's been great to hear about it and look forward to hearing about the results from those other studies you're working on.

But I just wanted to say that's I think a great place to wrap things up.

So thanks very much for your time, Emma.

Thank you.

And thank you all very much for your time here and for listening to this BJ GP podcast.

Emma's original research article can be found on bjgp.org and the show notes and podcast audio are@bjgplife.com it's been great hearing about Emma's research in this area, and I hope you all enjoyed listening as well.

Thanks again for your time and bye.