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Table 2 Accuracy of the OC-Sensor FIT assay

From: Faecal immunochemical tests (FIT) can help to rule out colorectal cancer in patients presenting in primary care with lower abdominal symptoms: a systematic review conducted to inform new NICE DG30 diagnostic guidance

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)
  Rodríguez-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
  Rodríguez-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)
  Rodríguez-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)
  Rodríguez-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)
  Rodríguez-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
  Rodríguez-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)
  1. aConverted from ng Hb/ml buffer using a multiplication factor of 0.2 [67, 68]
  2. CRC colorectal cancer, f-Hb faecal haemoglobin, HRA higher risk adenoma, IBD inflammatory bowel disease