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Table 3 Accuracy of the HM-JACKarc 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 f-Hb cut-off (μg Hb/g faeces) Prevalence of condition specified below (%) True positive False negative False positive True negative Total Negative predictive value % (95% CI) Sensitivity % (95% CI) Specificity % (95% CI)
 CRC
 Godber 2016 [33] ≥10 2.2 11 0 116 380 507 100 (99.0, 100) 100 (71.5, 100) 76.6 (72.6, 80.3)
 Thomas 2016 [52] ≥7 5.1 21 2 89 338 450 99.4 (97.9, 99.8) 91.3 (72.0, 98.9) 79.2 (75.3, 83.0)
Target condition advanced neoplasia (CRC or HRA)
 10 μg Hb/g faeces
  Auge 2016 [34] ≥10 13.9 10 19 23 156 208 89.1 (83.7, 92.9) 34.5 (19.9, 52.7) 87.2 (81.6, 91.3)
  Godber 2016 [33] ≥10 5.9 21 9 106 371 507 97.6 (95.6, 98.7) 70.0 (50.6, 85.3) 77.8 (73.8, 81.4)
 Other f-Hb cut-offs
  Auge 2016 [34] ≥20 13.9 9 20 13 166 208 89.2 (84.0, 92.9) 31.0 (17.3, 49.2) 92.8 (88.0, 95.7)
  Auge 2016 [34] ≥30 13.9 9 20 12 167 208 89.3 (84.1, 93.0) 31.0 (17.3, 49.2) 93.3 (88.7, 96.1)
  Auge 2016 [34] ≥40 13.9 8 21 11 168 208 88.9 (83.6, 92.6) 27.6 (14.7, 45.7) 93.9 (89.4, 96.6)
Target condition significant bowel disease (CRC, HRA or IBD)
 Thomas 2016 [52] ≥7 NC NC NC NC NC 450 96.5 (94.5, 98.4) 72.1 (58.7, 85.5) 80.6 (76.7, 84.4)
Target condition significant bowel disease (CRC, HRA, IBD or colitis)
 Godber 2016 [33] ≥10 9.3 32 13 90 349 484 96.4 (94.0, 97.9) 68.9 (53.2, 81.4) 80.2 (76.1, 83.7)
 Godber 2016 [33] ≥15 9.3 31 14 77 362 484 84.6 (75.8, 90.6) 66.7 (50.9, 79.6) 83.1 (79.2, 86.5)
 Godber 2016 [33] ≥20 9.3 29 16 63 376 484 79.7 (69.6, 87.1) 64.4 (48.7, 77.7) 85.7 (81.9, 88.7)
 Godber 2016 [33] ≥25 9.3 29 16 55 384 484 77.5 (66.5, 85.6) 64.4 (48.7, 77.7) 87.5 (83.9, 90.3)
 Godber 2016 [33] ≥30 9.3 29 16 50 389 484 75.8 (64.2, 84.5) 64.4 (48.7, 77.7) 88.6 (85.2, 91.4)
 Godber 2016 [33] ≥35 9.3 29 16 47 392 484 74.6 (62.7, 83.7) 64.4 (48.7, 77.7) 89.2 (85.9, 92.0)
 Godber 2016 [33] ≥40 9.3 29 16 44 395 484 73.3 (61.0, 82.9) 64.4 (48.7, 77.7) 90.0 (86.7, 92.5)
  1. CRC colorectal cancer, f-Hb faecal haemoglobin, HRA higher risk adenoma, IBD inflammatory bowel disease, NC not calculable