Table 1 Clinical performance of p16 immunostaining and extended genotyping, combined or alone, for detection of CIN2+ (n = 136) in HPV-positive, cytology-negative women
Triage strategies | Sensitivity, % (95% CI) a | Specificity, % (95% CI) a | PPV, % (95% CI) | NPV, % (95% CI) | Relative sensitivity b | Relative specificity b |
|---|---|---|---|---|---|---|
Single test | ||||||
 1.p16+ c | 83.1 (75.7–89.0) **††| 77.5 (75.8–79.1) ***††| 16.2 (13.6–19.2) | 98.9 (98.2–99.3) | 1.22 | 1.12 |
 2.HPV16+ | 62.5 (53.8–70.6) ** | 79.2 (77.6–80.8) *** | 13.6 (11.1–16.6) | 97.6 (96.8–98.2) | 0.91 | 1.14 |
 3.HPV16/33+ | 67.6 (59.1–75.4) | 74.4 (72.7–76.1) *** | 12.2 (10.0–14.8) | 97.8 (97.0–98.4) | 0.99 | 1.07 |
 4.HPV16/33/58+ | 77.9 (70.0–84.6) * | 61.9 (60.0–63.8) *** | 9.7 (8.0–11.6) | 98.2 (97.4–98.7) | 1.14 | 0.89 |
 5.HPV16/33/58/31+ | 81.6 (74.1–87.7) ** | 56.5 (54.6–58.4) *** | 9.0 (7.4–10.7) | 98.3 (97.5–98.9) | 1.19 | 0.81 |
 6.HPV16/33/58/31/35+ | 83.1 (75.7–89.0) ** | 54.2 (52.3–56.2) *** | 8.7 (7.2–10.4) | 98.4 (97.6–99.0) | 1.22 | 0.78 |
 7.HPV16/18+ (comparator) | 68.4 (59.9–76.1) | 69.4 (67.6–71.1) | 10.5 (8.6–12.7) | 97.7 (96.8–98.3) | 1.00 | 1.00 |
 8.HPV16/18/31/33/45/52/58+ | 91.9 (86.0–95.9) *** | 32.2 (30.4–34.0) *** | 6.6 (5.6–7.9) | 98.7 (97.6–99.3) | 1.34 | 0.46 |
HPV types + or p16+ | ||||||
 9.HPV16+ or p16+ | 93.4 (87.8–96.9) *** | 64.5 (62.6–66.3) *** | 12.1 (10.2–14.3) | 99.5 (98.9–99.7) | 1.37 | 0.93 |
 10.HPV16/33+ or p16+ | 94.1 (88.7–97.4) *** | 60.6 (58.7–62.5) *** | 11.1 (9.4–13.1) | 99.5 (99.0–99.8) | 1.38 | 0.87 |
 11.HPV16/33/58+ or p16+ | 97.1 (92.6–99.2) *** | 50.9 (49.0–52.8) *** | 9.4 (7.9–11.1) | 99.7 (99.2–99.9) | 1.42 | 0.73 |
 12.HPV16/33/58/31+ or p16+ | 97.1 (92.6–99.2) *** | 46.4 (44.5–48.4) *** | 8.7 (7.3–10.2) | 99.7 (99.1–99.9) | 1.42 | 0.67 |
 13.HPV16/33/58/31/35+ or p16+ | 97.1 (92.6–99.2) *** | 44.6 (42.7–46.5) *** | 8.4 (7.1–9.9) | 99.7 (99.1–99.9) | 1.42 | 0.64 |
 14.HPV16/18+ or p16+ | 94.9 (89.7–97.9) *** | 58.0 (56.1–59.9) *** | 10.6 (8.9–12.5) | 99.5 (99.0–99.8) | 1.39 | 0.84 |
 15.HPV16/18/31/33/45/52/58+ or p16+ | 97.8 (93.7–99.5) *** | 27.8 (26.1–29.6) *** | 6.6 (5.6–7.8) | 99.6 (98.7–99.9) | 1.43 | 0.40 |
HPV types + & p16+ | ||||||
 16.HPV16+ or HPV33/58/31/35 + &p16+ c | 79.4 (71.6–85.9) **†††| 74.1 (72.4–75.8) ***†| 13.8 (11.5–16.5) | 98.6 (97.9–99.0) | 1.16 | 1.07 |
 17.HPV16/33+ or HPV58/31/35 + &p16+ c | 80.1 (72.4–86.5) **†††| 70.3 (68.5–72.0) †††| 12.4 (10.3–14.8) | 98.5 (97.9–99.0) | 1.17 | 1.01 |
 18.HPV16/33/58/31/35 + &p16+ | 69.1 (60.6–76.8) | 87.1 (85.7–88.4) *** | 21.9 (18.1–26.2) | 98.2 (97.5–98.7) | 1.01 | 1.26 |
 19.HPV16/18/31/33/45/52/58 + &p16+ c | 77.2 (69.2–84.0) †| 81.8 (80.3–83.3) ***†††| 18.2 (15.2–21.7) | 98.6 (97.9–99.0) | 1.13 | 1.18 |