Agreement Between High-Risk Human Papillomavirus Testing in Paired Self-Collected and Clinician-Collected Samples from Cervical Cancer Screening in Spain
Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Self-Sampling Device
2.2. HPV Test
2.3. Data Collection
2.4. Statistical Analyses
2.5. Ethics Approval
3. Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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N = 981 Women | ||
---|---|---|
N | (%) | |
Age (in years) | ||
<30 | 18 | (1.8) |
30–39 | 313 | (31.9) |
40–49 | 313 | (31.9) |
50–59 | 270 | (27.5) |
≥60 | 67 | (6.8) |
Area | ||
Canarias | 389 | (39.7) |
Catalunya | 592 | (60.3) |
Country of birth | ||
Spain | 845 | (86.1) |
Outside Spain | 136 | (13.9) |
Any previous screening test | ||
No | 11 | (1.1) |
Yes | 967 | (98.9) |
Missing | 3 | |
Last self-reported screening test among ever tested | ||
<3 years | 301 | (31.7) |
3–4 years | 629 | (66.2) |
>5 years | 20 | (2.1) |
Missing | 31 | - |
Number of self-reported screening tests in lifetime among ever tested | ||
1 | 30 | (3.2) |
2 to 4 | 304 | (32.4) |
5 to 7 | 241 | (25.7) |
8 to 10 | 169 | (18.0) |
>10 | 195 | (20.8) |
Missing | 42 | - |
Overall hrHPV Results | HPV16 | HPV18 | Other hrHPV Non-HPV16/18 | ||
---|---|---|---|---|---|
P1/P2 | 91 | 21 | 2 | 80 | |
N1/P2 | 43 | 9 | 5 | 38 | |
P1/N2 | 16 | 2 | 1 | 16 | |
N1/N2 | 826 | 944 | 968 | 842 | |
Positivity ratio | N | 1.3 | 1.3 | 2.3 | 1.2 |
95% CI | 1.1–1.5 | 0.9–1.9 | 0.9–4.8 | 1.0–1.5 | |
Positive agreement | % | 85.0 | 91.3 | 66.7 | 83.3 |
95% CI | 78.2–91.8 | 79.8–1.0 | 13.4–100.0 | 75.8–90.8 | |
Negative agreement | % | 95.1 | 99.1 | 99.5 | 95.7 |
95% CI | 93.7–96.5 | 98.5–99.7 | 99.1–99.9 | 94.4–97.0 | |
Positive concordance | % | 60.7 | 65.6 | 25.0 | 59.7 |
95% CI | 52.9–68.5 | 49.1–82.1 | 0.0–55.0 | 51.4- 68.0 | |
Negative concordance | % | 93.3 | 98.8 | 99.4 | 94.0 |
95% CI | 91.6–94.9 | 98.1–99.5 | 98.9–99.9 | 92.4–95.6 | |
Agreement | % | 93.9 | 98.8 | 99.4 | 94.5 |
95% CI | 92.5–95.4 | 98.2–99.5 | 98.9–99.9 | 93.0–95.9 | |
Kappa coefficient | N | 0.72 | 0.8 | 0.4 | 0.7 |
95% CI | 0.7–0.8 | 0.7–0.9 | 0.3- 0.5 | 0.7–0.8 | |
hrHPV prevalence in clinician samples | % | 11 | 2.4 | 0.3 | 9.8 |
95% CI | 9.1–13.1 | 1.5–3.5 | 0.1–0.9 | 8.0–11.9 | |
hrHPV prevalence in self-sampling | % | 13.6 | 3.1 | 0.7 | 12.1 |
95% CI | 11.5–15.9 | 2.1–4.4 | 0.3–1.5 | 10.1–14.3 |
Clinician-Collected Samples Result (Hierarchical) * | ||||||
---|---|---|---|---|---|---|
Cytology Result | HPV16 | HPV18 | Others hrHPV Non HPV16/18 | HPV Negative | Total | |
Negative cytology | ||||||
Self-sampling result (hierarchical) | ||||||
HPV16 | 11 | 0 | 1 | 6 | 18 | |
HPV18 | 0 | 0 | 0 | 4 | 4 | |
Other hrHPV non-HPV16/18 | 0 | 0 | 37 | 27 | 64 | |
HPV Negative | 2 | 1 | 9 | 764 | 776 | |
Total | 13 | 1 | 47 | 801 | 862 | |
ASC-US/LSILcytology | ||||||
Self-sampling result (hierarchical) | ||||||
HPV16 | 9 | 0 | 1 | 1 | 11 | |
HPV18 | 0 | 0 | 1 | 0 | 1 | |
Other hrHPV non-HPV16/18 | 0 | 0 | 22 | 5 | 27 | |
HPV Negative | 0 | 0 | 3 | 35 | 38 | |
Total | 9 | 0 | 27 | 41 | 77 | |
ASC-H+ cytology | ||||||
Self-sampling result (hierarchical) | ||||||
HPV16 | 1 | 0 | 0 | 0 | 1 | |
HPV18 | 0 | 1 | 0 | 0 | 1 | |
Other hrHPV non-HPV16/18 | 0 | 0 | 4 | 0 | 4 | |
HPV Negative | 0 | 0 | 1 | 1 | 2 | |
Total | 1 | 1 | 5 | 1 | 8 | |
Unsatisfactory cytology | ||||||
Self-sampling result (hierarchical) | ||||||
HPV16 | 0 | 0 | 0 | 0 | 0 | |
HPV18 | 0 | 0 | 0 | 0 | 0 | |
Other hrHPV non-HPV16/18 | 0 | 0 | 1 | 0 | 1 | |
HPV Negative | 0 | 0 | 0 | 9 | 9 | |
Total | 0 | 0 | 1 | 9 | 10 |
Self-Sampling Result | Clinician-Collected Samples Result | p-Value * | Univariate Lineal Regression # | |||||||
---|---|---|---|---|---|---|---|---|---|---|
HPV Negative | HPV Positive | HPV Negative | HPV Positive | Estimates | 95% CI | p-Value | ||||
N | N | Median CTs (IQR) | N | N | Median CTs (IQR) | |||||
Total | 843 | 133 | 32.9 (28.1–37.7) | 869 | 106 † | 30.6 (27.3–35.2) | 0.02 | |||
Age group (years) | ||||||||||
<50 | 544 | 96 | 32.8 (28.4–37.7) | 558 | 81 † | 30.0 (27.3–35.1) | 0.02 | Ref. | ||
≥50 | 299 | 37 | 34.8 (27.3–37.4) | 311 | 25 | 33.6 (27.7–36.4) | 0.57 | −1.63 | −3.4; 0.2 | 0.079 |
Cytology result | ||||||||||
Negative | 776 | 86 | 34.8 (28.8–38.1) | 801 | 61 | 33.1 (28.8–36.1) | 0.14 | Ref. | ||
Abnormal result | 41 | 44 | 30.5 (25.5–35.9) | 42 | 42 | 27.9 (25.5–30.3) | 0.07 | |||
ASC-US/LSIL | 38 | 39 | 30.5 (25.6–36.1) | 41 | 36 | 27.8 (25.5–30.5) | 0.09 | 1.89 | −0.5; 4.3 | 0.119 |
ASC-H+ | 3 | 5 | 30.6 (25.3–31.6) | 1 | 6 † | 28.4 (27.8–29.0) | 0.58 | 3.75 | −1.2; 8.7 | 0.139 |
Unsatisfactory sample | 9 | 1 | 26.1 | 9 | 1 | 25.8 | --- | 0.63 | −10.1; 11.4 | 0.908 |
Missing | 17 | 2 | --- | 17 | 2 | --- | --- | −0.62 | −8.3; 7.0 | 0.872 |
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Share and Cite
Ibáñez, R.; Roura, E.; Morey, F.; Andújar, M.; Pavón, M.Á.; Acera, A.; Bruni, L.; de Sanjosé, S. Agreement Between High-Risk Human Papillomavirus Testing in Paired Self-Collected and Clinician-Collected Samples from Cervical Cancer Screening in Spain. Cancers 2025, 17, 63. https://doi.org/10.3390/cancers17010063
Ibáñez R, Roura E, Morey F, Andújar M, Pavón MÁ, Acera A, Bruni L, de Sanjosé S. Agreement Between High-Risk Human Papillomavirus Testing in Paired Self-Collected and Clinician-Collected Samples from Cervical Cancer Screening in Spain. Cancers. 2025; 17(1):63. https://doi.org/10.3390/cancers17010063
Chicago/Turabian StyleIbáñez, Raquel, Esther Roura, Francisca Morey, Miguel Andújar, Miquel Ángel Pavón, Amelia Acera, Laia Bruni, and Silvia de Sanjosé. 2025. "Agreement Between High-Risk Human Papillomavirus Testing in Paired Self-Collected and Clinician-Collected Samples from Cervical Cancer Screening in Spain" Cancers 17, no. 1: 63. https://doi.org/10.3390/cancers17010063
APA StyleIbáñez, R., Roura, E., Morey, F., Andújar, M., Pavón, M. Á., Acera, A., Bruni, L., & de Sanjosé, S. (2025). Agreement Between High-Risk Human Papillomavirus Testing in Paired Self-Collected and Clinician-Collected Samples from Cervical Cancer Screening in Spain. Cancers, 17(1), 63. https://doi.org/10.3390/cancers17010063