Table 4.
Accuracy of FIT, tier 2 reference standard (Mixed reference tests and registry follow up), comparing individual and combined assays, symptom clusters and study setting: Summary estimates (95% CI).
| Presenting symptoms | Analyser | Threshold (µg/g) | Setting | Number of studies (references) | n patients in analysis | Sensitivity (%) | Specificity (%) |
|---|---|---|---|---|---|---|---|
| Symptom groups | |||||||
| All (High-risk, low-risk or unstratified) | Pooled analysers | LoD (>4 OC-Sensor >2 HM-JACKarc) |
Any | 2 (29, 35)b | 18,423 | 96.7 (94.1, 98.3)e | 63.7 (63.0, 64.4)e |
| Primary care | 2 (29, 35) | 18,423 | 96.7 (94.1, 98.3)e | 63.7 (63.0, 64.4)e | |||
| Secondary care | 0 | ||||||
| >10 | Any | 10 (28, 29, 30, 31, 32, 34, 35, 36, 37, 38) | 43,191 | 88.2 (84.3, 91.2)d | 85.7 (81.0, 89.3)d | ||
| Primary care | 7 (29, 30, 31, 35, 36, 37, 38) | 41,532 | 88.8 (84.6, 92.0)d | 85.7 (82.3, 88.5)d | |||
| Secondary care | 3 (28, 32, 34) | 1659 | 86.4 (75.7, 93.6)e | 80.3 (78.2, 82.2)e | |||
| OC-Sensor | >4a | Any | 1 (29)b,c | 13,042 | 96.5 (93.2, 98.5) | 69.5 (68.7, 70.3) | |
| Primary care | 1 (29)c | 13,042 | 96.5 (93.2, 98.5) | 69.5 (68.7, 70.3) | |||
| Secondary care | 0 | ||||||
| >10 | Any | 4 (28, 29, 31, 38) | 22,305 | 86.6 (73.9, 93.6)d | 87.5 (80.0, 92.4)d | ||
| Primary care | 3 (29, 31, 38) | 22,127 | 89.8 (86.2, 92.7)e | 82.9 (82.4, 83.4)e | |||
| Secondary care | 1 (28)c | 178 | 71.4 (29.0, 96.3) | 95.9 (91.7, 98.3) | |||
| HM-JACKarc | >2a | Any | 1 (35)b | 5381 | 97.1 (91.9, 99.4) | 49.5 (48.1, 50.8) | |
| Primary care | 1 (35) | 5381 | 97.1 (91.9, 99.4) | 49.5 (48.1, 50.8) | |||
| Secondary care | 0 | ||||||
| >7 | Any | 4 (35, 36, 37, 40) | 15,945 | 90.0 (85.0, 93.5)d | 88.0 (81.0, 92.6)d | ||
| Primary care | 3 (35, 36, 37) | 15,515 | 89.9 (85.1, 93.5)e | 85.0 (84.4, 85.5)e | |||
| Secondary care | 1 (40) | 430 | 88.0 (68.8, 97.5) | 93.1 (90.2, 95.4) | |||
| >10 | Any | 5 (30, 32, 35, 36, 37) | 20,333 | 87.8 (83.3, 91.2)d | 86.4 (81.9, 89.9)d | ||
| Primary care | 4 (30, 35, 36, 37) | 19,405 | 88.1 (83.1, 91.7)d | 87.1 (81.8, 91.0)d | |||
| Secondary care | 1 (32)c | 928 | 86.7 (73.2, 94.9) | 83.5 (80.8, 85.9) | |||
| QuikRead go | >10 | Any | 1 (34)f,g | 553 | 92.9 (66.1. 99.8) | 70.1 (66.1, 74.0) | |
| Primary care | 0 | ||||||
| Secondary care | 1 (34)g | 553 | 92.9 (66.1. 99.8) | 70.1 (66.1, 74.0) | |||
| High-risk | Pooled analysers | >10 | Any | 3 (28, 29, 32) | 14,148 | 90.7 (86.6, 93.8)c | 82.0 (81.3, 82.6)c |
| Primary care | 1 (29) | 13,042 | 92.1 (87.8, 94.9) | 81.7 (81.0, 82.4) | |||
| Secondary care | 2 (28, 32) | 1065 | 84.3 (71.4, 93.0)e | 85.0 (82.7, 87.2)e | |||
| OC-Sensor | >4a | Any | 1 (29)b | 13,042 | 96.5 (93.2, 98.5) | 69.5 (68.7, 70.3) | |
| Primary care | 1 (29) | 13,042 | 96.5 (93.2, 98.5) | 69.5 (68.7, 70.3) | |||
| Secondary care | 0 | ||||||
| >10 | Any | 2 (28, 29) | 13,220 | 91.4 (87.1, 94.7)e | 81.8 (81.2, 82.5)e | ||
| Primary care | 1 (29) | 13,042 | 92.1 (87.8, 95.2) | 81.7 (81.0, 82.4) | |||
| Secondary care | 1 (28) | 178 | 71.4 (29.0, 96.3) | 95.9 (91.7, 98.3) | |||
| HM-JACKarc | >7 | Any | 0 | ||||
| Primary care | 0 | ||||||
| Secondary care | 0 | ||||||
| >10 | Any | 1 (32) f | 928 | 86.7 (73.2, 94.9) | 83.5 (80.8, 85.9) | ||
| Primary care | 0 | ||||||
| Secondary care | 1 (32) | 928 | 86.7 (73.2, 94.9) | 83.5 (80.8, 85.9) | |||
| Low-risk | Pooled analysers | >10 | Any | 3 (30, 34, 36) | 4681 | 86.1 (75.9, 93.1)e | 83.6 (82.5, 84.6)e |
| HM-JACKarc | >7 | Any | 1 (36)b | 238 | 85.7 (48.7, 97.4) | 89.2 (84.5, 92.6) | |
| Primary care | 1 (36) | 238 | 85.7 (48.7, 97.4) | 89.2 (84.5, 92.6) | |||
| Secondary care | 0 | ||||||
| >10 | Any | 2 (30, 36)b | 4128 | 84.5 (72.6, 92.7)e | 85.3 (84.2, 86.4)e | ||
| Primary care | 2 (30, 36) | 4128 | 84.5 (72.6, 92.7)e | 85.3 (84.2, 86.4)e | |||
| Secondary care | 0 | ||||||
| QuikRead go | >10 | Any | 1 (34)f | 553 | 92.9 (66.1. 99.8) | 70.1 (66.1, 74.0) | |
| Primary care | 0 | ||||||
| Secondary care | 1 (34) | 553 | 92.9 (66.1. 99.8) | 70.1 (66.1, 74.0) | |||
| Individual symptoms | |||||||
| CIBH | OC-Sensor | >10 | Primary care | 1 (38) | 1144 | 93.3 (68.1, 99.8) | 82.2 (79.8, 84.4) |
| IDA | Secondary care | 1 (28) | 137 | 66.7 (22.3, 95.7) | 95.4 (90.3, 98.3) | ||
| HM-JACKarc | 1 (41) | 189 | 80.0 (56.3, 94.3) | 81.7 (75.0, 87.2) | |||
| Rectal bleeding | OC-Sensor | Primary care | 1 (43) | 462 | 96.2 (80.4, 99.9) | 38.3 (33.7, 43.0) | |
a
LoD for the assay.
b
All studies conducted in primary care settings.
c
All studies conducted in patients presenting with high-risk symptoms.
d
Bivariate Meta-analysis (STATA 13).
e
Random effects meta-analysis (Meta DiSc 1.4).
f
All studies conducted in secondary care settings.
g
All studies conducted in patients presenting with low-risk symptoms.
CIBH: change in bowel habit; CI: confidence interval; IDA: iron deficiency anaemia; LoD: limit of detection.