Table 3.

Relative accuracy of OncoPredict HPV SCR assay on vaginal and FVU self‐samples versus cervical specimens.

	Relative sensitivity [95% CI] for ≥ CIN2 detection	Relative sensitivity [95% CI] for ≥ CIN3 detection	Relative specificity [95% CI] for < CIN2 detection
Manufacturer cut‐offs a
Vaginal self‐sample	0.96 [0.90–1.02]	0.95 [0.87–1.04]	0.90 [0.84–0.96]
FVU	0.95 [0.88–1.02]	0.93 [0.85–1.03]	1.03 [0.96–1.12]
New cut‐offs b
Vaginal self‐sample	0.95 [0.90–1.00]	0.93 [0.86–1.01]	0.94 [0.88–1.01]

Abbreviations: CI, confidence interval; CIN, cervical intraepithelial neoplasia.

^a Manufacturer's positivity threshold for all hrHPV types in cervical samples and vaginal self‐samples: Ct ≤ 40; in FVU: Ct ≤ 44.

^b New a posteriori cut‐offs vaginal self‐sample: HPV16 Ct ≤ 39, HPV18 Ct ≤ 37, other hrHPV Ct ≤ 38.