Table 2 Clinical performance of p16 immunostaining and extended genotyping, combined or alone, for detection of CIN3+ (n = 53) 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 | 79.2 (65.9–89.2) †| 75.5 (73.8–77.1) ***†| 6.0 (4.4–8.1) | 99.5 (99.0–99.7) | 0.86 | 1.10 |
 2.HPV16+ | 86.8 (74.7–94.5) | 78.4 (76.8–80.0) *** | 7.4 (5.5–9.8) | 99.7 (99.3–99.9) | 0.94 | 1.14 |
 3.HPV16/33+ | 90.6 (79.3–96.9) | 73.6 (71.8–75.2) *** | 6.3 (4.8–8.4) | 99.7 (99.4–99.9) | 0.98 | 1.07 |
 4.HPV16/33/58+ | 94.3 (84.3–98.8) | 61.0 (59.1–62.9) *** | 4.6 (3.4–6.0) | 99.8 (99.4–100.0) | 1.02 | 0.89 |
 5.HPV16/33/58/31+ | 94.3 (84.3–98.8) | 55.6 (53.7–57.5) *** | 4.0 (3.0–5.3) | 99.8 (99.4–99.9) | 1.02 | 0.81 |
 6.HPV16/33/58/31/35+ | 94.3 (84.3–98.8) | 53.3 (51.4–55.2) *** | 3.8 (2.9–5.1) | 99.8 (99.3–99.9) | 1.02 | 0.78 |
 7.HPV16/18+ (comparator) | 92.5 (81.8–97.9) | 68.7 (66.9–70.4) | 5.5 (4.1–7.3) | 99.8 (99.4–99.9) | 1.00 | 1.00 |
 8.HPV16/18/31/33/45/52/58+ | 98.1 (89.9–100.0) | 31.6 (29.8–33.4) *** | 2.8 (2.1–3.6) | 99.9 (99.2–100.0) | 1.06 | 0.46 |
HPV types + or p16+ | ||||||
 9.HPV16+ or p16+ | 98.1 (89.9–100.0) | 62.8 (60.9–64.6) *** | 5.0 (3.8–6.5) | 99.9 (99.6–100.0) | 1.06 | 0.91 |
 10.HPV16/33+ or p16+ | 98.1 (89.9–100.0) | 59.0 (57.1–60.9) *** | 4.5 (3.4–5.9) | 99.9 (99.6–100.0) | 1.06 | 0.86 |
 11.HPV16/33/58+ or p16+ | 100.0 (93.3–100.0) | 49.5 (47.6–51.4) *** | 3.8 (2.9–4.9) | 100.0 (99.6–100.0) | 1.08 | 0.72 |
 12.HPV16/33/58/31+ or p16+ | 100.0 (93.3–100.0) | 45.1 (43.2–47.1) *** | 3.5 (2.6–4.6) | 100.0 (99.6–100.0) | 1.08 | 0.66 |
 13.HPV16/33/58/31/35+ or p16+ | 100.0 (93.3–100.0) | 43.4 (41.5–45.3) *** | 3.4 (2.6–4.4) | 100.0 (99.6–100.0) | 1.08 | 0.63 |
 14.HPV16/18+ or p16+ | 100.0 (93.3–100.0) | 56.5 (54.6–58.3) *** | 4.3 (3.3–5.7) | 100.0 (99.7–100.0) | 1.08 | 0.82 |
 15.HPV16/18/31/33/45/52/58+ or p16+ | 100.0 (93.3–100.0) | 27.0 (25.4–28.8) *** | 2.6 (2.0–3.5) | 100.0 (99.3–100.0) | 1.08 | 0.39 |
HPV types + & p16+ | ||||||
 16.HPV16+ or HPV33/58/31/35 + &p16+ c | 92.5 (81.8–97.9) †| 72.7 (71.0–74.4) ***†| 6.3 (4.7–8.3) | 99.8 (99.4–99.9) | 1.00 | 1.06 |
 17.HPV16/33+ or HPV58/31/35 + &p16+ c | 92.5 (81.8–97.9) †| 68.9 (67.1–70.7) †††| 5.6 (4.2–7.3) | 99.8 (99.4–99.9) | 1.00 | 1.00 |
 18.HPV16/33/58/31/35 + &p16+ | 73.6 (59.7–84.7) * | 85.4 (84.0–86.8) *** | 9.1 (6.6–12.3) | 99.4 (99.0–99.7) | 0.80 | 1.24 |
 19.HPV16/18/31/33/45/52/58 + &p16+ c | 77.4 (63.8–87.7) †| 80.0 (78.5–81.5) ***†††| 7.1 (5.2–9.6) | 99.4 (99.0–99.7) | 0.84 | 1.17 |