Journal of lower genital tract disease · 2025
Cross-Sectional Study on the Detection of HPV Infections for Cervical Cancer Screening Using a Self-Sampling Device.
СтатьяОценочное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Arnáez de la Cruz Marta, Martin Marti Anna, Álvarez Fernandez Stela, Gurrea Soteras Marta, Comes García Maria Dolores, Mauricio Aviñó Heidi, Haba Moya Julia, Domingo Del Pozo Santiago, Prieto Rodríguez Mireya
Аннотация
OBJECTIVES: This study evaluates a new vaginal self-sampling device for high-risk human papillomavirus (HR-HPV) detection compared to clinician-collected samples using real-time polymerase chain reaction (PCR).
METHODS: A total of 345 women aged between 23 and 72 were enrolled in this study. After receiving information about the study, women were provided with a vaginal collecting device to collect self-sample, and then a medical professional collected the cervical sample. All the clinician-collected samples were processed using the Cobas 4800 HPV assay, and the self-samples were processed with the automated MAIS extraction system. These results were used to compare the new device's performance to the clinician-collected cervical samples. All the clinician-collected samples were also analyzed with a new HPV screening assay to compare the performance of this assay on 2 different types of samples.
RESULTS: Overall agreement for detecting any HR-HPV between clinician-collected samples and self-samples was 93.7% with a Cohen κ coefficient of 0.842. As both assays allow to identify genotypes 16, 18 and to detect the same 12 HR-HPV genotypes in a pool, the authors analyzed the agreement between self- and clinician-collected samples by genotypes and it was shown to be also excellent for HPV16 and the pool of other HR-HPV.
CONCLUSIONS: This self-sampling device has demonstrated detection rates that are comparable to those of samples collected by clinicians.
METHODS: A total of 345 women aged between 23 and 72 were enrolled in this study. After receiving information about the study, women were provided with a vaginal collecting device to collect self-sample, and then a medical professional collected the cervical sample. All the clinician-collected samples were processed using the Cobas 4800 HPV assay, and the self-samples were processed with the automated MAIS extraction system. These results were used to compare the new device's performance to the clinician-collected cervical samples. All the clinician-collected samples were also analyzed with a new HPV screening assay to compare the performance of this assay on 2 different types of samples.
RESULTS: Overall agreement for detecting any HR-HPV between clinician-collected samples and self-samples was 93.7% with a Cohen κ coefficient of 0.842. As both assays allow to identify genotypes 16, 18 and to detect the same 12 HR-HPV genotypes in a pool, the authors analyzed the agreement between self- and clinician-collected samples by genotypes and it was shown to be also excellent for HPV16 and the pool of other HR-HPV.
CONCLUSIONS: This self-sampling device has demonstrated detection rates that are comparable to those of samples collected by clinicians.