TPP—combined/mono-HPV DNA or RNA test
| Goal of test | To detect clinically relevant (=1.0 pg/mL) high-risk HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68), HPV DNA or RNA; correlated with CIN3+ |
| Intended use and target patient* | Screening: women aged 30–64 years or HIV-positive women at any age |
| Target use setting | To detect clinically relevant (=1.0 pg/mL) high-risk HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68), HPV DNA or RNA; correlated with CIN3+ |
| Results | Clear positive, negative or invalid result with minimal instructions for interpretation |
| Equipment | Single-use, biodegradable or recyclable disposable diagnostic test preferred, reader optional (small, portable, tabletop or handheld, no electricity/power supply required) |
| Target use(s) | |
| Reference technology | Laboratory-based NAAT |