Table 2

Diagnostic performance of human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA-125) in the subset of studies using binary data presentation

HE4CA-125
Study no. (ref)OC prevalenceThreshold (pmol/l)Sens % (95% CI)Spec % (95% CI)LR+ (95% CI)LR− (95% CI)PPV %NPV %Threshold (kU/l)Sens % (95% CI)Spec % (95% CI)LR+ (95% CI)LR− (95% CI)PPV %NPV %
1 (18)0.2033.290.9 (81 to 97)94.2 (91 to 97)15.2 (9.2 to 24.9)0.10 (0.04 to 0.21)80.097.638.372.7 (60 to 83)94.6 (91 to 97)13.0 (7.6 to 22.1)0.29 (0.19 to 0.43)77.493.1
2 (19)0.4070*–140†79.6 (71 to 87)97.0 (93 to 99)26.5 (11.1 to 63.2)0.21 (0.15 to 0.30)94.787.43593.8 (88 to 96)72.7 (65 to 79)3.4 (2.7 to 4.4)0.09 (0.04 to 0.18)70.294.5
3 (20)0.3014075.2 (67 to 83)98.6 (96 to 100)53.6 (20.1 to 142.5)0.25 (0.19 to 0.34)95.990.23580.0 (72 to 87)67.1 (61 to 73)2.4 (2.0 to 2.9)0.30 (0.21 to 0.43)51.388.6
4 (21)0.2815079.3 (71 to 86)98.9 (97 to 100)79.0 (25.5 to 244.5)0.21 (0.15 to 0.31)96.792.53582.9 (75 to 89)70.9 (65 to 76)2.9 (2.3 to 3.5)0.24 (0.16 to 0.36)52.691.4
5 (22)0.157064.7 (47 to 80)91.8 (87 to 95)8.1 (64.8 to 13.8)0.38 (0.24 to 0.61)57.993.73585.3 (69 to 95)59.5 (52 to 66)2.1 (1.7 to 2.6)0.25 (0.11 to 0.56)26.995.9
6 (23)0.2615073.1 (59 to 84)98.7 (95 to 100)73 (18.2 to 192.1)0.27 (0.17 to 0.43)95.091.43588.5 (77 to 96)58.0 (50 to 66)2.1 (1.7 to 2.6)0.21 (0.10 to 0.44)42.293.5
8 (25)0.297086.2 (68 to 96)85.9 (76 to 93)6.1 (3.4 to 11.1)0.16 (0.07 to 0.41)71.493.83569.0 (49 to 85)90.1 (81 to 96)6.9 (3.3 to 14.5)0.34 (0.20 to 0.60)74.187.7
9 (26)0.4170*–150†74.5 (67 to 81)83.3 (78 to 88)4.5 (3.3 to 6.1)0.31 (0.23 to 0.40)75.982.33579.5 (72 to 86)81.6 (76 to 86)4.3 (3.3 to 5.7)0.25 (0.18 to 0.34)75.384.9
10 (27)0.5374.276.4 (63 to 87)93.9 (83 to 99)10.9 (3.6 to 33.0)0.25 (0.16 to 0.41)93.378.03570.9 (57 to 82)77.6 (63 to 88)3.2 (1.8 to 5.5)0.38 (0.24 to 0.58)78.070.4
11 (28)0.3054.887.2 (81 to 92)89.4 (86 to 92)8.2 (6.0 to 11.2)0.15 (0.10 to 0.22)77.894.352.574.5 (67 to 81)93.7 (91 to 96)11.8 (7.8 to 17.9)0.27 (0.21 to 0.36)83.589.6
12 (29)‡0.4325100 (91 to 100)100 (93 to 100)1001003783.8 (68 to 94)100 (93 to 100)0.15 (0.07 to 0.31)10089.3
13 (30)0.637282.9 (68 to 93)87.5 (68 to 97)6.6 (2.3 to 19.3)0.20 (0.10 to 0.39)91.975.03573.2 (57 to 86)79.2 (58 to 93)3.5 (1.6 to 7.8)0.34 (0.20 to 0.58)85.763.3
14 (310.2715096.9 (84 to 100)100 (96 to 100)0.03 (0.00 to 0.21)10098.93587.5 (71 to 97)88.4 (80 to 94)7.5 (4.2 to 13.7)0.14 (0.06 to 0.35)73.395.0
15 (32)0.5973.7¶73.1 (67 to 79)85.4 (79 to 91)5.0 (3.4 to 7.4)0.31 (0.25 to 0.39)87.868.993.1574.9 (69 to 80)82.9 (76 to 88)4.4 (3.1 to 6.3)0.30 (0.24 to 038)86.369.7
  • *In pre-menopausal women.

  • †In post-menopausal women.

  • ‡Outlier for CA-125.

  • §Outlier for HE4.

  • ¶Original cut-off in pg/l, converted in pmol/l by using a multiplication factor of 0.04.

  • LR+, positive likelihood ratio; LR–, negative likelihood ratio; NPV, negative predictive value; OC, ovarian cancer; PPV, positive predictive value; Sens, sensitivity; Spec, specificity.