Introduction The primary endpoint of this study aimed to investigate the correlation between self-collected vaginal specimens versus clinician-collected cervical specimens in detecting high-risk HPV infection. Furthermore, the secondary endpoint was the satisfaction of self-collection for HPV testing.
Methods From October 2021 to September 2022, 104 women with HPV16 or HPV18-positive or other 12 high-risk HPV-positive with cytology ≥ ASCUS were enrolled. The primary endpoint of the study was the assessment of the level of agreement and correlation between human papillomavirus (HPV) testing results obtained from self-collected vaginal specimens and those obtained from clinician-collected cervical specimens in detecting high-risk HPV infections, which was accomplished using Cohen’s Kappa coefficient (k). The secondary endpoint was the satisfaction of women with the vaginal self-collected method. Data analysis was using STATA (StataCorp LLC, College Station, TX), with results considered statistically significant at a P-value of less than 0.05.
Results Paired self-collected and clinician-collected specimens were obtained from 104 women with previous HPV-positive results. The agreement in detecting HPV infection was ‘substantial’ with a kappa coefficient of 0.75. More than 90% of participants rated self-collection as a very good to excellent method because of convenience and safety. For methods of further follow-up, 51% of participants chose self-sampling, the remaining preferred collection by clinicians. There were no complications with the intervention observed.
Conclusion/Implications Self-collected HPV testing is substantially correlated with clinician-collected specimens in detecting cervical high - risk HPV infection. This cell collection method appears to be highly satisfactory and may provide better compliance in the detection of cervical HPV infection.
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