2.
Primary and triage screening performance of physician- and self-collected careHPV at ≥1.0 RLU/CO for CIN3+ detection among 2,337 women, compared to VIA and cytology primary screening, and physician-HC2 triage strategies
| Primary Screening | Triage strategy | CIN3+ (N=23) | % (95% CI) | Colposcopy per CIN3+ (N) | ||||
| Sensitivity | Specificity | PPV | NPV | Youden’s index | ||||
| HPV, human papillomavirus; RLU/CO, relative light units/cutoff; CIN3+, cervical intraepithelial neoplasia grade 3 or worse; VIA, visual inspection with acetic acid; HC2, Hybrid Capture 2; ASC-H+, atypical squamous cells- cannot exclude high-grade squamous intraepithelial lesions or worse; 95% CI, 95% confidence interval; PPV, positive predictive value; NPV, negative predictive value; ASC-US+, atypical squamous cells of undetermined significance or worse. | ||||||||
| Physician- careHPV ≥1.0 RLU/CO | None | 20 | 87.0
(67.9–95.5) |
86.7
(85.2–88.0) |
6.1
(4.0–9.2) |
99.9
(99.6–99.9) |
73.6
(71.8–75.4) |
16.4 |
| ASC-US+ | 19 | 82.6
(62.9–93.0) |
93.5
(92.4–94.5) |
11.2
(7.3–16.9) |
99.8
(99.5–99.9) |
76.1
(74.4–77.8) |
8.9 | |
| VIA | 12 | 52.2
(33.0–70.8) |
98.8
(98.3–99.2) |
30.0
(18.1–45.4) |
99.5
(99.1–99.7) |
51.0
(49.0–53.0) |
3.3 | |
| Self-careHPV ≥1.0 RLU/CO | None | 18 | 78.3
(58.1–90.3) |
87.1
(85.7–88.4) |
5.7
(3.6–8.8) |
99.8
(99.4–99.9) |
65.3
(63.4–67.2) |
17.6 |
| ASC-US+ | 16 | 69.6
(49.1–84.4) |
95.2
(94.3–96.0) |
12.6
(7.9–19.5) |
99.7
(99.3–99.8) |
64.8
(62.9–66.7) |
7.9 | |
| VIA | 10 | 43.5
(25.6–63.2) |
98.9
(98.4–99.2) |
27.8
(15.8–44.0) |
99.4
(99.0–99.7) |
42.4
(40.4–44.4) |
3.6 | |
| Physician- HC2 ≥1.0 RLU/CO | None | 22 | 95.7
(79.0–99.2) |
84.4
(82.8–85.8) |
5.7
(3.8–8.5) |
99.9
(99.7–100) |
80.0
(78.4–81.6) |
17.5 |
| ASC-US+ | 21 | 91.3
(73.2–97.6) |
92.7
(91.5–93.6) |
11.0
(7.3–16.2) |
99.9
(99.7–100) |
84.0
(82.5–85.5) |
9.1 | |
| VIA | 13 | 56.5
(36.8–74.4) |
98.5
(97.9–98.9) |
27.1
(16.6–41.0) |
99.6
(99.2–99.8) |
55.0
(53.0–57.0) |
3.7 | |
| Cytology (ASC-H+) | None | 20 | 87.0
(67.9–95.5) |
95.4
(94.4–96.2) |
15.7
(10.4–23.1) |
99.9
(99.6–100) |
82.4
(80.9–83.9) |
6.4 |
| VIA | None | 13 | 56.5
(36.8–74.4) |
94.5
(93.5–95.4) |
9.3
(5.5–15.2) |
99.5
(99.2–99.8) |
51.0
(49.0–53.0) |
10.8 |