[Value of self-sampling cervical exfoliated cells of HPV E6/E7 mRNA detection in cervical cancer screening: a multicenter clinical study].

Objective

To evaluate the clinical value of self-sampling cervical exfoliated cells of HPV E6/E7 mRNA detection in cervical cancer screening.

Methods

A total of 778 participants from Obstetrics and Gynecology Hospital of Fudan University, the Second Affiliated Hospital of Zhejiang University School of Medicine, Lianyungang Maternity and Child Health Hospital of Jiangsu Province, Yancheng Maternity and Child Health Hospital of Jiangsu Province and Yangzhou Maternity and Child Health Hospital of Jiangsu Province who were volunteered to engage in the study of self-sampling cervical exfoliated cells of HPV E6/E7 mRNA detection were included from March 2023 to April 2024. Both self-collected and clinician-collected samples underwent HPV E6/E7 mRNA detection. Statistical analysis was performed to compare the detection consistency between the two methods, and a questionnaire survey was used to assess participants' acceptance of self-sampling.

Results

Among 778 participants, the sensitivity between self-collected and clinician-collected samples was 90.8%, specificity was 97.8%, and the overall agreement rate was 96.5%. The Kappa value was 0.883 (P<0.001), indicating high consistency between the two methods. Stratified analysis revealed that Kappa value>0.8, overall agreement >95.0% in different age groups and geographical regions. The questionnaire showed that 95.9% of participants preferred self-sampling, citing ease of use (43.6%), convenience (40.6%), and privacy (30.5%) as primary reasons. Additionally, 64.3% participants favored hospitals as the preferred location for self-sampling.

Conclusion

Self-sampling demonstrates high consistency with clinician sampling for HPV E6/E7 mRNA testing and excellent acceptance, suggesting its potential as an effective tool to improve the coverage of cervical cancer screening.