Evaluating the diagnostic accuracy of faecal immunochemical testing in the two-week wait referral pathway for colorectal cancer in the UK

Abstract

Objective: Colorectal cancer (CRC) is the second leading cause of cancer-related mortality in the UK. Early identification and timely intervention rely heavily on the faecal immunohistochemical test (FIT). However, FIT diagnostic accuracy varies, with a sensitivity ranging between 85% and 94% and a noteworthy negative predictive value (NPV) of 99%. The objective of this study was to evaluate the diagnostic accuracy of FIT in detecting CRC and advanced adenomas in patients referred through the 2-week wait (2WW) referral pathway following the National Institute for Health and Care Excellence (NICE) NG12 criteria. Method: A retrospective analysis was conducted on 1841 patients who were referred through the 2WW pathway. Data on clinical characteristics, FIT test positivity (faecal haemoglobin ≥ 10 µg/g), and subsequent investigations were obtained. The sensitivity, specificity, positive predictive value (PPV), and NPV were calculated based on the presence of adenomas (≥10 mm) or malignancies. Results: Positive FIT results were observed in 73.4%, negative FIT in 25.9%, and 0.65% of patients lacked FIT availability. The sensitivity, specificity, PPV, and NPV for CRC detection compared to the presence of advanced adenoma or CRC were 96.49% vs. 93.6%, 26.56% vs. 30.2%, 7.31% vs. 21.8%, and 99.18% vs. 95.8%, respectively. Conclusion: FIT showed the expected performance for CRC detection with an NPV of 99.18%, but a negative FIT result should not exclude investigation with colonoscopy due to a 4.2% likelihood of missing advanced adenomas. There is still a need for other types of testing for CRC screening.