1.
Primary and triage screening performance of physician- and self-collected careHPV at ≥1.0 RLU/CO for CIN2+ detection among 2,337 women, compared to VIA and cytology primary screening, and physician-HC2 triage strategies
| Primary Screening | Triage strategy | CIN2+ (N=68) | % (95% CI) | Colposcopy per CIN2+ (N) | ||||
| Sensitivity | Specificity | PPV | NPV | Youden’s index | ||||
| HPV, human papillomavirus; RLU/CO, relative light units/cutoff; CIN2+, cervical intraepithelial neoplasia grade 2 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 | 57 | 83.8
(73.3–90.7) |
88.1
(86.7–89.3) |
17.4
(13.7–21.9) |
99.5
(99.0–99.7) |
71.9
(70.1–73.7) |
5.8 |
| ASC-US+ | 55 | 80.9
(70.0–88.5) |
95.0
(94.0–95.8) |
32.5
(25.9–39.9) |
99.4
(99.0–99.6) |
75.9
(74.2–77.6) |
3.1 | |
| VIA | 21 | 30.9
(21.2–42.6) |
99.2
(98.7–99.5) |
52.5
(37.5–67.1) |
98.0
(97.3–98.5) |
30.0
(28.1–31.9) |
1.9 | |
| Self-careHPV ≥1.0 RLU/CO | None | 49 | 72.1
(60.4–81.3) |
88.2
(86.8–89.5) |
15.5
(11.9–19.8) |
99.1
(98.5–99.4) |
60.2
(58.2–62.2) |
6.5 |
| ASC-US+ | 45 | 66.2
(54.3–76.3) |
96.4
(95.5–97.1) |
35.4
(27.7–44.1) |
99.0
(98.4–99.3) |
62.6
(60.6–64.6) |
2.8 | |
| VIA | 18 | 26.5
(17.5–38.0) |
99.2
(98.7–99.5) |
50.0
(34.5–65.5) |
97.8
(97.1–98.3) |
25.7
(23.9–27.5) |
2.0 | |
| Physician-HC2 ≥1.0 RLU/CO | None | 66 | 97.1
(89.9–99.2) |
86.0
(84.5–87.4) |
17.2
(13.7–21.3) |
99.9
(99.6–100) |
83.0
(81.5–84.5) |
5.8 |
| ASC-US+ | 63 | 92.6
(83.9–96.8) |
94.4
(93.3–95.2) |
33.0
(26.7–39.9) |
99.8
(99.5–99.9) |
87.0
(85.6–88.4) |
3.0 | |
| VIA | 26 | 38.2
(27.6–50.1) |
99.0
(98.5–99.0) |
54.2
(40.3–67.4) |
98.2
(97.5–98.6) |
37.3
(35.3–39.3) |
1.8 | |
| Cytology (ASC-H+) | None | 58 | 85.3
(75.0–91.8) |
97.0
(96.2–97.6) |
45.7
(37.3–54.3) |
99.5
(99.2–99.8) |
82.3
(80.8–83.8) |
2.2 |
| VIA | None | 27 | 39.7
(28.9–51.6) |
95.0
(94.0–95.8) |
19.3
(13.6–26.6) |
98.1
(97.5–98.6) |
34.7
(32.8–36.6) |
5.2 |