3.3 Clinical accuracy of OncoPredict HPV SCR assay

Clinical sensitivity for the detection of ≥CIN2 and ≥CIN3 and specificity for the detection of <CIN2 of OncoPredict HPV SCR assay on self-collected samples relative to cervical scrapes are reported in Table 3. Using manufacturer’s cut-offs, clinical sensitivity of OncoPredict HPV SCR assay for ≥CIN2 on FVU (ratio=0.95 [95%CI 0.88-1.02]) and vaginal (ratio=0.96 [95%CI 0.90-1.02]) samples was not different to that of cervical specimens. Specificity for <CIN2 on FVU was similar to cervical (ratio=1.03 [95%CI 0.96-1.12]), whereas specificity on vaginal samples was slightly lower (ratio=0.90 [95%CI 0.84-0.96]).

After cut-off adjustment, the specificity on vaginal samples improved (ratio=0.94 [0.88-1.01]). Supplementary Table 1 provides data in terms of clinical accuracy in women older or equal 30.

Table 3: Relative accuracy of OncoPredict HPV SCR assay on vaginal and FVU self-samples versus cervical specimens.