Table 2 Accuracy of the OC-Sensor FIT assay
Study | Prevalence of condition specified below (%) | f-Hb cut-off (μg Hb/g faeces) | True positive | False negative | False positive | True negative | Total | Negative predictive value % (95% CI) | Sensitivity % (95% CI) | Specificity % (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|
Target condition CRC | ||||||||||
 10 μg Hb/g faeces or equivalent | ||||||||||
  McDonald 2013 [32] | 2.1 | ≥10a | 6 | 0 | 17 | 257 | 280 | 100 (98.5, 100) | 100 (54.1, 100) | 93.8 (90.3, 96.3) |
  Mowat 2015 [28] | 3.7 | ≥10 | 25 | 3 | 151 | 571 | 750 | 99.5 (98.5, 99.8) | 89.3 (71.8, 97.7) | 79.1 (75.9, 82.0) |
  RodrÃguez-Alonso 2015 [29] | 3.0 | ≥10 | 29 | 1 | 196 | 777 | 1003 | 99.9 (99.3, 100) | 96.7 (82.8, 99.9) | 79.9 (77.2, 82.3) |
  Terhaar sive Droste 2011 [35] | 5.4 | ≥10a | 102 | 10 | 253 | 1693 | 2058 | 99.4 (98.9, 99.7) | 91.1 (84.2, 95.6) | 87.0 (85.4, 88.5) |
  Summary estimate | 92.1 (86.9, 95.3) | 85.8 (78.3, 91.0) | ||||||||
 15 μg Hb/g faeces or equivalent | ||||||||||
  RodrÃguez-Alonso 2015 [29] | 3.0 | ≥15 | 29 | 1 | 164 | 809 | 1003 | 99.9 (99.3, 100) | 96.7 (82.8, 99.9) | 83.1 (80.6, 85.4) |
  Terhaar sive Droste 2011 [35] | 5.4 | ≥15a | 102 | 10 | 219 | 1727 | 2058 | 99.4 (98.9, 99.7) | 91.1 (84.2, 95.6) | 88.7 (87.3, 90.1) |
  Summary estimate | 92.3 (86.6, 96.1) | 86.9 (85.6, 88.1) | ||||||||
 20 μg Hb/g faeces or equivalent | ||||||||||
  Cubiella 2014 [31] | 12.3 | ≥20a | 85 | 12 | 156 | 534 | 787 | 97.8 (96.2, 98.7) | 87.6 (79.0, 93.2) | 77.4 (74.0, 80.4) |
  RodrÃguez-Alonso 2015 [29] | 3.0 | ≥20 | 28 | 2 | 135 | 838 | 1003 | 99.8 (99.1, 99.9) | 93.3 (77.9, 99.2) | 86.1 (83.8, 88.2) |
  Terhaar sive Droste 2011 [35] | 5.4 | ≥20a | 101 | 11 | 193 | 1753 | 2058 | 99.4 (98.9, 99.7) | 90.2 (83.1, 95.0) | 90.1 (88.7, 91.4) |
  Summary estimate | 89.5 (84.9, 93.1) | 86.6 (85.4, 87.7) | ||||||||
 Other f-Hb cut-offs | ||||||||||
  Terhaar sive Droste 2011 [35] | 5.4 | ≥30a | 95 | 17 | 158 | 1788 | 2058 | 99.1 (98.5, 99.4) | 84.8 (76.8, 90.9) | 91.9 (90.6, 93.1) |
  Terhaar sive Droste 2011 [35] | 5.4 | ≥40a | 94 | 18 | 142 | 1804 | 2058 | 99.0 (98.4, 99.4) | 83.9 (75.8, 90.2) | 92.7 (91.5, 93.8) |
Target condition advanced neoplasia (CRC or HRA) | ||||||||||
 10 μg Hb/g faeces or equivalent | ||||||||||
  McDonald 2013 [32] | 10.4 | ≥10a | 17 | 12 | 6 | 245 | 280 | 95.3 (92.0, 97.3) | 58.6 (38.9, 76.5) | 97.6 (94.9, 99.1) |
  Mowat 2015 [28] | 9.1 | ≥10 | 45 | 23 | 131 | 551 | 750 | 96.0 (94.1, 97.3) | 66.2 (53.7, 77.2) | 80.8 (77.6, 83.7) |
  RodrÃguez-Alonso 2015 [29] | 13.3 | ≥10 | 82 | 51 | 144 | 726 | 1003 | 93.4 (91.5, 95.0) | 61.7 (52.8, 69.9) | 83.4 (80.8, 85.9) |
  Summary estimate | 62.6 (56.0, 68.9) | 84.4 (82.7, 86.1) | ||||||||
 20 μg Hb/g faeces or equivalent | ||||||||||
  Cubiella 2014 [31] | 22.5 | ≥20a | 127 | 50 | 114 | 496 | 787 | 90.8 (88.1, 93.0) | 71.8 (64.4, 78.1) | 81.3 (77.9, 84.3) |
  RodrÃguez-Alonso 2015 [29] | 13.3 | ≥20 | 71 | 62 | 92 | 778 | 1003 | 92.6 (90.7, 94.2) | 53.4 (44.5, 62.1) | 89.4 (87.2, 91.4) |
  Summary estimate | 63.9 (58.2,69.2) | 86.1(84.2, 87.8) | ||||||||
 Other f-Hb cut-offs | ||||||||||
  RodrÃguez-Alonso 2015 [29] | 13.3 | ≥15 | 76 | 57 | 117 | 753 | 1003 | 93.0 (91.0, 94.5) | 57.1 (48.3, 65.7) | 86.6 (84.1, 88.7) |
Target condition all neoplasia (CRC, HRA or low risk adenoma) | ||||||||||
 McDonald 2013 [32] | 21.4 | ≥10a | 35 | 25 | 3 | 217 | 280 | 89.7 (85.2, 92.9) | 58.3 (44.9, 70.9) | 98.6 (96.1, 99.7) |
Target condition significant bowel disease (CRC, HRA or IBD) | ||||||||||
 Mowat 2015 [28] | 13.6 | ≥10 | 70 | 32 | 106 | 542 | 750 | 94.4 (92.2, 96.0) | 68.6 (58.7, 77.5) | 83.6 (80.6, 86.4) |
Target condition significant bowel disease (CRC, HRA, low risk adenoma or IBD) | ||||||||||
 McDonald 2013 [32] | 30.7 | ≥10a | 49 | 37 | 2 | 192 | 280 | 83.8 (78.5, 88.0) | 57.0 (45.8, 67.6) | 99.0 (96.3, 99.9) |