*2.4. Statistical Analysis*

The overall percentage agreement (OPA) between cervical and self-sample results was evaluated using Cohen's kappa value (κ) using the GraphPad QuickCalcs software (updated in 2014, available at http://graphpad.com/quickcalcs accessed on 30 October 2022). Agreement was interpreted as slight (κ < 0.200), fair (0.200 < κ < 0.401), moderate (0.400 < κ < 0.601), good (0.600 < κ < 0.801), very good (0.800 < κ < 1.000), or perfect (κ = 1.000). Sample results were evaluated using two different cut-offs: (i) clinical cut-off of 38.3 Ct (cycle threshold) for HPV 16 and 34.2 Ct for other HR genotypes, as indicated in the package insert and (ii) without the clinical cut-off (accepting positivity up to 40 Ct).
