Methods: We conducted a systematic review following published guidelines for systematic reviews of diagnostic tests. Twenty-one resources were searched to March 2016. Summary estimates were calculated using a bivariate model, or random effects logistic regression model.
Results: Nine studies are included in this review one additional study, included in our systematic review, was provided as 'academic in confidence' and cannot be described herein. When FIT was based on a single faecal sample and a cut-off of 10 µg Hb/g faeces, sensitivity estimates indicated that a negative result using either OC-Sensor or HMJACKarc may be adequate to rule out nearly all CRC; the summary estimate of sensitivity for OC-Sensor was 92.1% (95% CI: 86.9 to 95.3%), based on four studies (n = 4091 participants, 176 with CRC), and the only study of HM-JACKarc to assess the 10 µg Hb/g faeces cut-off (n = 507 participants, 11 with CRC) reported a sensitivity of 100% (95% CI: 71.5 to 100%). The corresponding specificity estimates were 85.8% (95% CI: 78.3 to 91.0%) and 76.6% (95% CI: 72.6 to 80.3%), respectively. When the diagnostic criterion was changed to include lower grades of neoplasia i.e., the target condition included higher-risk adenoma (HRA) as well as CRC, the rule-out performance of both FIT assays was reduced.
Conclusions: There is evidence to suggest that triage using FIT at a cut-off around 10 µg Hb/g faeces has the potential to correctly rule-out CRC and avoid colonoscopy in 75 to 80% of symptomatic patients.