*3.3. HPV Overall Positive Agreement between Cervical and Vaginal Self-Samples*

*3.3. HPV Overall Positive Agreement between Cervical and Vaginal Self-Samples*  Using clinical cut-offs of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes, compared to the cervical samples, the self-collected vaginal sample PPA (positive percentage agreement) was 36/43 = 83.7%; the NPA (negative percentage agreement) was 19/21 = *3.3. HPV Overall Positive Agreement between Cervical and Vaginal Self-Samples*  Using clinical cut-offs of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes, compared to the cervical samples, the self-collected vaginal sample PPA (positive percentage agreement) was 36/43 = 83.7%; the NPA (negative percentage agreement) was 19/21 = Using clinical cut-offs of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes, compared to the cervical samples, the self-collected vaginal sample PPA (positive percentage agreement) was 36/43 = 83.7%; the NPA (negative percentage agreement) was 19/21 = 90.5%. The OPA was 85.9% (55/64), and the Cohen's kappa was 0.699 (good agreement).

90.5%. The OPA was 85.9% (55/64), and the Cohen's kappa was 0.699 (good agreement). However, differences in collection procedures, preanalytical procedures, and the nature of the investigated samples may influence HPV detection rates on self-collected samples as compared to cervical specimens. Therefore, data analysis was performed without the clinical cut-off (accepting positivity up to Ct 40). Without the clinical cut-off, the PPA between self-collected vaginal samples and cervical samples was 45/47 = 95.7%; the NPA was 16/17 = 94.1%. The OPA was 95.3% (61/64), and the Cohen's kappa was 0.882 (almost 90.5%. The OPA was 85.9% (55/64), and the Cohen's kappa was 0.699 (good agreement). However, differences in collection procedures, preanalytical procedures, and the nature of the investigated samples may influence HPV detection rates on self-collected samples as compared to cervical specimens. Therefore, data analysis was performed without the clinical cut-off (accepting positivity up to Ct 40). Without the clinical cut-off, the PPA between self-collected vaginal samples and cervical samples was 45/47 = 95.7%; the NPA was 16/17 = 94.1%. The OPA was 95.3% (61/64), and the Cohen's kappa was 0.882 (almost However, differences in collection procedures, preanalytical procedures, and the nature of the investigated samples may influence HPV detection rates on self-collected samples as compared to cervical specimens. Therefore, data analysis was performed without the clinical cut-off (accepting positivity up to Ct 40). Without the clinical cut-off, the PPA between self-collected vaginal samples and cervical samples was 45/47 = 95.7%; the NPA was 16/17 = 94.1%. The OPA was 95.3% (61/64), and the Cohen's kappa was 0.882 (almost perfect agreement).

perfect agreement). Using the package insert cut-offs of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes for the cervical samples and a cut-off of 40 Ct for the vaginal samples, to account for the excessive dilution, the self-collected sample PPA was 43/43 = 100%; the NPA was perfect agreement). Using the package insert cut-offs of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes for the cervical samples and a cut-off of 40 Ct for the vaginal samples, to account for the excessive dilution, the self-collected sample PPA was 43/43 = 100%; the NPA was Using the package insert cut-offs of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes for the cervical samples and a cut-off of 40 Ct for the vaginal samples, to account for the excessive dilution, the self-collected sample PPA was 43/43 = 100%; the NPA was 18/21 = 85.7%. The OPA was 95.3%, and the Cohen's kappa was 0.890 (almost perfect agreement). All results are reported in Table 2.


**Table 2.** Agreement in HPV detection of cervical and self-collected samples using different cut-off values.
