Skip to main content

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

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 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
  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; †† p < 0.01; ††† < 0.001