FIT diagnostic accuracy for CRC at a cut-off of 10 µg/g in patients with high-risk symptoms in the largest and most relevant studies
| Region | Design | Symptoms | n | Analyser | Reference standard | CRC sensitivity @ 10 µg/g | CRC specificity @ 10 µg/g | CRC PPV @ 10 µg/g | CRC NPV @ 10 µg/g | |
| NICE FIT 202128 | UK (England) | DTA | NG12 | 7194 | HM-JACKarc | Colonoscopy | 92.2% (88.2% to 95.2%) | 82.3% (81.2% to 83.2%) | 16.2% (14.3% to 18.2%) | 99.7% (99.5% to 99.8%) |
| Turvill et al 29 | UK (England) | DTA | All | 5040 | HM-JACKarc | Various | 87.4% (81.0% to 92.3%) | 80.9% (79.7% to 81.9%) | 12.4% (10.4% to 14.5%) | 99.5% (99.3% to 99.7%) |
| qFIT 202162 | UK (England) | DTA | NG12 | 3596 | OC-Sensor | Various | 83.3% (75.6% to 91.0%) | 80.1% (78.9% to 81.4%) | 9.7% (7.6% to 11.8%) | 99.5% (99.1% to 99.7%) |
| McSorley et al 31 | UK (Scotland) | SE | All | 4841 | HM-JACKarc | Colonoscopy | 94.7% (91% to 97%) | 47% (46% to 48%) | 9.4% (8.4% to 10.6%) | 99.4% (98.9% to 99.6%) |
| Mowat et al 18 | UK (Scotland) | SE | All | 5381 | HM-JACKarc | Various | 86.7% (78.6% to 92.5%) | 79.4% (78.3% to 80.5%) | 7.7% (7.1% to 8.4%) | 99.7% (99.5% to 99.8%) |
| Pin Vieito et al 21 | Spain | SE | All | 5623 | OC-Sensor | Various | 81.3% (71.3% to 88.3%) | 84.1% (83.1% to 85.1%) | 6.9% (5.4% to 8.7%) | 99.7% (99.5% to 99.8%) |
| Chapman et al 75 | UK (England) | DTA | NG12 | 732 | OC-Sensor | Colonoscopy | 89% (75% to 97%) | 74% (70% to 77%) | 16% (11% to 21%) | 99% (98% to 100%) |
| HM-JACKarc | 84% (69% to 94%) | 78% (75% to 81%) | 18% (12% to 24%) | 99% (98% to 100%) | ||||||
| Farrugia et al 73 | UK (England) | DTA | NG12 | 519 | HM-JACKarc | Colonoscopy / CTC | 84.9% (68.1% to 94.9%) | 81.3% (77.5% to 84.65%) | 23.6% (19.6% to 28%) | 98.8% (97.2% to 99.4%) |
| D’Souza 2020 | UK (England) | DTA | NG12 | 160 | HM-JACKarc | Colonoscopy | 87.5% (52.9% to 97.8%) | 84.2% (77.6% to 89.2%) | 22.6% (11.4% to 39.8%) | 99.2% (95.7% to 99.9%) |
| Khan et al 78 | UK (England) | DTA | NG12 | 928 | HM-JACKarc | Various | 85.1% (71% to 93.3%) | 83.5% (80.8% to 85.8%) | 22.6% (16% to 28.3%) | 99% (97.9% to 99.5%) |
| Nicholson et al 27 | UK (England) | SE | All | 9896 | HM-JACKarc | Record linkage | 90.5% (84.9% to 96.1%) | 91.3% (90.8% to 91.9%) | 10.1% (8.15% to 12.0%) | 99.9% (99.8% to 100.0%) |
| Herrero et al 36 | Spain | SE | All | 1572 | OC-Sensor | Colonoscopy | 93.5% (89.1% to 96.3%) | 63.4% (60.7% to 66.0%) | 28.9% (25.6% to 32.4%) | 98.4% (97.2% to 99.1%) |
| Widlak et al 82 | UK (England) | DTA | All | 562 | HM-JACKarc | Colonoscopy / CTC | 80.0% (66% to 93%) | 93% (91% to 95%) | 44.0% (32% to 56%) | 99.0% (98% to 100%) |
| Arraez et al 76 | Spain | DTA | IDA | 245 | OC-Sensor | Colonoscopy | 92.9% (76.5% to 99.1%) | 57.1% (50.3% to 63.8%) | 21.8% (15.4% to 30.1%) | 98.4% (96.2% to 100%) |
| Khasawneh et al 14 | UK (England) | DTA | CIBH | 5818 | OC-Sensor | CTC | 88.9% (79.6% to 94.3%) | 80.8% (79.7% to 81.8%) | 5.5% (4.3% to 6.9%) | 99.8% (99.7% to 99.9%) |
95% CIs given in brackets when reported.
CIBH, change in bowel habit; CRC, colorectal cancer; DTA, diagnostic test accuracy study; FIT, faecal immunochemical testing; IDA, iron deficiency anaemia; NPV, negative predictive value; PPV, positive predictive value; SE, service evaluation; SR, systematic review and meta-analysis.