Table 3 Accuracy of the HM-JACKarc FIT assay
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) |