Cross-Sectional Study on the Detection of HPV Infections for Cervical Cancer Screening Using a Self-Sampling Device

Autores de IIS La Fe

• Maria Amparo De La Cruz Perez

  Autor

• Anna Martín Martí

  Autor

• Marta Gurrea Soteras

  Autor

• Heidi Mauricio Aviñó

  Autor

• Santiago Domingo Del Pozo

  Autor

Participantes ajenos a IIS La Fe

• Fernandez S.A.
• García M.D.C.
• Moya J.H.
• Rodríguez M.P.

Grupos

• Grupo de Investigación en tumores ginecológicos, cáncer de mama y cáncer hereditario

• Medicina Fetal y Reproductiva

Abstract

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 ? 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. © 2025, ASCCP.

Keywords

• Adult; Aged; Cross-Sectional Studies; Early Detection of Cancer; Female; Humans; Middle Aged; Papillomaviridae; Papillomavirus Infections; Real-Time Polymerase Chain Reaction; Self Care; Specimen Handling; Uterine Cervical Neoplasms; Young Adult; Human papilloma virus vaccine; adult; aged; Article; atypical squamous cells of the cervix; cancer screening; cross-sectional study; epithelium lesion; follow up; genotype; health center; human; major clinical study; papillomavirus infection; real time polymerase chain reaction; smoking; uterine cervix cancer; Wart virus; comparative study; diagnosis; early cancer diagnosis; evaluation study; female; genetics; isolation and purification; middle aged; Papillomaviridae; procedures; self care; specimen handling; uterine cervix tumor; virology; young adult