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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

From: Triaging HPV-positive, cytology-negative cervical cancer screening results with extended HPV genotyping and p16INK4a immunostaining in China

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
  1. Abbreviations: CI confidence interval, NPV negative predictive value, PPV positive predictive value
  2. aP-values for accuracy of the evaluated assay vs the ‘HPV16/18+’ strategy, * < 0.05, ** < 0.01, *** < 0.001
  3. bRelative sensitivity or specificity of evaluated triage strategies relative to the ‘HPV16/18+’ triage
  4. cP-values for accuracy of the evaluated assay vs the ‘HPV16/33+’ strategy, † > 0.05; †† < 0.01; ††† < 0.001