Closing the gap
HPV vaginal self-collection as a transformative tool for cervical cancer screening
Screening for precancerous cytological changes has been a mainstay of the early detection of patients at risk of developing cervical cancer. Now, with the understanding that cervical cancer is caused by human papilloma-virus infection, screening has converted, largely, to primary detection of high-risk HPV strains 16 and 18. However, uptake of screening opportunities is still not as good as it could be, for a number of reasons. One barrier is the method of sample collection, which is something that has not changed over the years. CLI chatted to Dr Zhengchun Lu (Oregon Health & Science University, OR, USA) to discover more about work to reach under-served communities and how using sample self-collection methods can boost participation without reducing sample quality.
Can you give us some background about cervical cancer, please?
Cervical cancer is a disease that we know how to prevent, yet it remains a major global health challenge. In the USA, we expect about 13 000 new cases and 4000 deaths this year. However, the global picture reveals a heartbreaking gap in care: of the 350 000 women who died from this cancer in 2022, 94% lived in low- and middle-income countries. This reflects a massive inequality in access to basic healthcare.
The root cause is human papillomavirus (HPV), particularly the high-risk types. Although over 200 HPV types exist, 14 are recognized as high-risk, with types 16 and 18 responsible for the majority of cases. However, other high-risk types – such as 31, 33, 45, 52, and 58 – are also significant drivers of disease. While most people clear the virus naturally, persistent infection with these types can cause the cellular changes that lead to cancer. Because this progression typically takes many years, it provides a critical window for intervention – provided we can successfully reach the patients.
Early invasive squamous cell carcinoma, arising from cervical intraepithelial neoplasia grade 3 (magnification ×200)
Traditional Pap smears checked cells for signs of precancerous changes (Adobe Stock)
Why is it necessary to screen for cervical cancer?
The primary danger is that early-stage cervical cancer is almost entirely asymptomatic. By the time a patient develops symptoms – such as abnormal bleeding or pelvic pain – the disease is often advanced, and treatment options become much less effective. Screening allows us to detect precancerous changes [cervical intraepithelial neoplasia (CIN)] at an early, treatable stage when intervention is straightforward and highly successful.
Our clinical understanding has evolved significantly. We have shifted from simply looking at cells under a microscope (cytology) to testing for the virus itself. HPV testing is more sensitive and directly identifies those at true risk. This is a pillar of the WHO’s “90-70-90” strategy, which aims to eliminate cervical cancer by ensuring 90% of girls are vaccinated, 70% of women are screened with high-performance tests, and 90% of those identified receive treatment.
How is screening done?
For decades, screening required a Pap smear, named after Dr Papanicolaou whose work developed the technique of exfoliative cytology in the 1940s. The process of collecting cervical cells in a clinical setting and visually inspecting them on a slide for precancerous changes remained the same until the introduction of liquid-based cytology in the 2000s which also allows for high-risk HPV co-testing. Today, the “game-changer” is the shift toward primary HPV testing, which we do using the Cobas 8800 automated PCR-based HPV test (Roche). This test was designed to identify high-risk HPV DNA – specifically types 16 and 18, but also identifies 12 further high-risk HPV strains. However, the sample collection method remains the same and can be off-putting for women for many reasons and contributes to low uptake of screening opportunities. The most recent development, to help address this factor, the U.S. Food and Drug Administration (FDA) has approved the use of self-collected vaginal samples in May 2024. In 2025, we also saw the approval of the first at-home device, the Teal Wand (Teal Health; https://www.getteal.com/).
At Oregon Health & Science University (OHSU), we use a simple swab for self-collection that can be used in a clinic or at community outreach events. The process is straightforward: a patient rotates the swab in the vagina for 10 to 30 seconds. We then process it in our lab exactly like a clinician-collected cervical sample. While national guidelines now endorse this for average-risk individuals, it is not currently recommended for high-risk patients – such as those with a history of CIN2+ (CIN grade 2 or 3) or who are immunocompromised – as we are still gathering the necessary longitudinal data for those populations.
Stages of cervical intraepithelial neoplasia and cervical cancer development
(Adobe Stock)
What is the uptake of cervical screening and does it differ in different populations?
In the USA, about 75% of eligible individuals are up to date, but we have lost ground since the pandemic. We also see sharp disparities: screening rates are approximately 64% for Asian women and 69% for Hispanic women, compared to 80% for White women. Our 2026 study (“Effectiveness of human papillomavirus self-collection for cervical cancer screening in community outreach programs”) in Oregon highlighted these barriers. Among 156 participants at our community events, 80% spoke a primary language other than English, and more than half had no other access to screening. We found that 51% of this group were either overdue for a test or entirely unaware of their screening status. This confirms that the traditional clinic-only model is leaving a substantial portion of our population behind.
In Europe, screening rates vary greatly by country. The highest participation rates among women aged 20–69 are in Northern and Western Europe: Sweden (77.7–78.8%), Czechia (74.1–74.7%), Slovenia (71.4–74.4%), Ireland (73.1–74.0%), and Finland (71.5–73.0%). The lowest are in Eastern Europe: Poland (10.9%) and Romania (4.5–6.2%). Participation rates in England are 68.8% for 2023–2024, which is down from previous years. Barriers to access are thought to include low income, limited education, rural residency and lack of organized, register-based screening programmes using primary HPV testing.
How can uptake be improved?
Self-collection is the most promising tool we have because it removes the “speculum barrier” and the need for a formal clinical appointment. While some providers worry about the validity of patient-collected samples, our study found a 100% valid sample rate, confirmed by the internal control of beta-globin. This proves that a self-collected vaginal swab is a reliable and easy-to-use format. Patients prefer it because it offers privacy, comfort, and significantly less anxiety than a traditional exam. By offering this as a standard option, we aren’t just making screening “convenient” – we are creating a necessary on-ramp to the healthcare system for those who have been historically marginalized.
What further developments are on the horizon?
Several shifts will define the next few years.
• Wider implementation
More laboratory systems in the USA are adopting self-collection and, as clinicians see the efficacy data, trust in the technology is growing.
• The genotype landscape
As vaccination rates rise, non-16/18 high-risk types are becoming more prominent. Our 2025 study in Diagnostics (“Retrospective analysis of human papillomavirus genotyping and cytology (Pap smears) in cervical cancer screening: an institutional experience in the State of Oregon, USA”) showed that nearly half of HPV-positive cases with lesions were associated with these other strains. We must maintain broad-spectrum testing to catch these cases.
• Integrated education
We need to combine screening with culturally tailored vaccine education. In our outreach, only 6.2% of participants were vaccinated – a major missed opportunity for prevention.
• Standardization
We need to harmonize clinical guidelines. Currently, the 2025 Consensus Guidelines recommend a three-year interval for a negative self-test, which is shorter than the five-year interval for clinician-collected cervical samples.
Primary high-risk HPV testing is now the preferred option for cervical screening
(Adobe Stock)
Why is it necessary to screen for cervical cancer?
The primary danger is that early-stage cervical cancer is almost entirely asymptomatic. By the time a patient develops symptoms – such as abnormal bleeding or pelvic pain – the disease is often advanced, and treatment options become much less effective. Screening allows us to detect precancerous changes [cervical intraepithelial neoplasia (CIN)] at an early, treatable stage when intervention is straightforward and highly successful.
Our clinical understanding has evolved significantly. We have shifted from simply looking at cells under a microscope (cytology) to testing for the virus itself. HPV testing is more sensitive and directly identifies those at true risk. This is a pillar of the WHO’s “90-70-90” strategy, which aims to eliminate cervical cancer by ensuring 90% of girls are vaccinated, 70% of women are screened with high-performance tests, and 90% of those identified receive treatment.
How is screening done?
For decades, screening required a Pap smear, named after Dr Papanicolaou whose work developed the technique of exfoliative cytology in the 1940s. The process of collecting cervical cells in a clinical setting and visually inspecting them on a slide for precancerous changes remained the same until the introduction of liquid-based cytology in the 2000s which also allows for high-risk HPV co-testing. Today, the “game-changer” is the shift toward primary HPV testing, which we do using the Cobas 8800 automated PCR-based HPV test (Roche). This test was designed to identify high-risk HPV DNA – specifically types 16 and 18, but also identifies 12 further high-risk HPV strains. However, the sample collection method remains the same and can be off-putting for women for many reasons and contributes to low uptake of screening opportunities. The most recent development, to help address this factor, the U.S. Food and Drug Administration (FDA) has approved the use of self-collected vaginal samples in May 2024. In 2025, we also saw the approval of the first at-home device, the Teal Wand (Teal Health; https://www.getteal.com/).
At Oregon Health & Science University (OHSU), we use a simple swab for self-collection that can be used in a clinic or at community outreach events. The process is straightforward: a patient rotates the swab in the vagina for 10 to 30 seconds. We then process it in our lab exactly like a clinician-collected cervical sample. While national guidelines now endorse this for average-risk individuals, it is not currently recommended for high-risk patients – such as those with a history of CIN2+ (CIN grade 2 or 3) or who are immunocompromised – as we are still gathering the necessary longitudinal data for those populations.
What is the uptake of cervical screening and does it differ in different populations?
In the USA, about 75% of eligible individuals are up to date, but we have lost ground since the pandemic. We also see sharp disparities: screening rates are approximately 64% for Asian women and 69% for Hispanic women, compared to 80% for White women. Our 2026 study (“Effectiveness of human papillomavirus self-collection for cervical cancer screening in community outreach programs”) in Oregon highlighted these barriers. Among 156 participants at our community events, 80% spoke a primary language other than English, and more than half had no other access to screening. We found that 51% of this group were either overdue for a test or entirely unaware of their screening status. This confirms that the traditional clinic-only model is leaving a substantial portion of our population behind.
In Europe, screening rates vary greatly by country. The highest participation rates among women aged 20–69 are in Northern and Western Europe: Sweden (77.7–78.8%), Czechia (74.1–74.7%), Slovenia (71.4–74.4%), Ireland (73.1–74.0%), and Finland (71.5–73.0%). The lowest are in Eastern Europe: Poland (10.9%) and Romania (4.5–6.2%). Participation rates in England are 68.8% for 2023–2024, which is down from previous years. Barriers to access are thought to include low income, limited education, rural residency and lack of organized, register-based screening programmes using primary HPV testing.
How can uptake be improved?
Self-collection is the most promising tool we have because it removes the “speculum barrier” and the need for a formal clinical appointment. While some providers worry about the validity of patient-collected samples, our study found a 100% valid sample rate, confirmed by the internal control of beta-globin. This proves that a self-collected vaginal swab is a reliable and easy-to-use format. Patients prefer it because it offers privacy, comfort, and significantly less anxiety than a traditional exam. By offering this as a standard option, we aren’t just making screening “convenient” – we are creating a necessary on-ramp to the healthcare system for those who have been historically marginalized.
What further developments are on the horizon?
Several shifts will define the next few years.
• Wider implementation
More laboratory systems in the USA are adopting self-collection and, as clinicians see the efficacy data, trust in the technology is growing.
• The genotype landscape
As vaccination rates rise, non-16/18 high-risk types are becoming more prominent. Our 2025 study in Diagnostics (“Retrospective analysis of human papillomavirus genotyping and cytology (Pap smears) in cervical cancer screening: an institutional experience in the State of Oregon, USA”) showed that nearly half of HPV-positive cases with lesions were associated with these other strains. We must maintain broad-spectrum testing to catch these cases.
• Integrated education
We need to combine screening with culturally tailored vaccine education. In our outreach, only 6.2% of participants were vaccinated – a major missed opportunity for prevention.
• Standardization
We need to harmonize clinical guidelines. Currently, the 2025 Consensus Guidelines recommend a three-year interval for a negative self-test, which is shorter than the five-year interval for clinician-collected cervical samples.
The interviewee
Dr Zhengchun Lu MD, PhD
Molecular Genetic Pathology Fellow,
Oregon Health & Science University; Incoming Medical Director, Molecular Microbiology Laboratory, Oregon Health & Science University (July 2026)
Oregon Health & Science University, Portland, OR, USA
Email: luzh@ohsu.edu
Bibliography
1. Lu Z, Ali R, Gall R et al. Effectiveness of human papillomavirus self-collection for cervical cancer screening in community outreach programs. Arch Pathol Lab Med. 2026;150:284–291 (https://doi.org/10.5858/arpa.2025-0325-oa).
2. Arbyn M, Verdoodt F, Snijders PJ et al. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014;15(2):172–183 (https://shorturl.at/UW0E0).
3. Wright TC, Stoler MH, Behrens CM et al. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015;136(2):189–197
(https://doi.org/10.1016/j.ygyno.2014.11.076).
4. Lu Z, Knapp M, Downs S et al. Retrospective analysis of human papillomavirus genotyping and cytology (Pap smears) in cervical cancer screening: an institutional experience in the State of Oregon, USA. Diagnostics (Basel). 2025;15(4):419 (https://doi.org/10.3390/diagnostics15040419).
5. Wentzensen N, Stewart Massad L, Clarke MA; Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. Recommendations for the use of self-collected vaginal samples for primary HPV screening. J Low Genit Tract Dis. 2025;29(2):144–152 (https://doi.org/10.1097/lgt.0000000000000885).
6. Cervical cancer screening coverage in Europe, 2022. Our World in Data, 2024 (https://shorturl.at/1V3KZ).
7. Cervical Screening Programme, England – 2023-2024. NHS Digital, 2024 (https://shorturl.at/ewIJ9).
8. Winterflood D, Romeo S, Sarıca Çevik H, Del Pino M. Closing the gaps: a new ECO report sheds light on the status of HPV screening programmes in Europe. European Cancer Organisation 2025 (https://www.europeancancer.org/closing-gaps-cervical-cancer.html).







