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Diagnostic accuracy of point of care faecal immunochemical testing using a portable high‐speed quantitative analyser for diagnosis in 2‐week wait patients
Author(s) -
Maclean William,
Mackenzie Paul,
Limb Chris,
Zahoor Zahida,
Whyte Martin B.,
Rockall Timothy,
Benton Sally C.,
Jourdan Iain
Publication year - 2021
Publication title -
colorectal disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.029
H-Index - 89
eISSN - 1463-1318
pISSN - 1462-8910
DOI - 10.1111/codi.15780
Subject(s) - medicine , point of care testing , gold standard (test) , triage , point of care , referral , prospective cohort study , analyser , diagnostic accuracy , colorectal cancer screening , observational study , cohort , colorectal cancer , emergency medicine , colonoscopy , cancer , family medicine , pathology , chemistry , chromatography
Aim Laboratory‐based faecal immunochemical testing (FIT) is the gold standard for detecting the presence of blood in the stool. The aim was to perform a diagnostic accuracy study to confirm if a point of care (POC) analyser for FIT could be safely used as an adjunct in the triage and management of 2‐week wait (TWW) colorectal patients. Methods The Point of Care Faecal Immunochemical Testing (POC FIT) prospective observational cohort study was designed for TWW patients at a regional referral centre. Between July 2019 and March 2020, patients were invited to perform and bring a FIT sample to clinic. FIT was completed within the clinic appointment using a POC quantitative analyser that has a 2‐min processing time (QuikRead go®). Patients and clinicians were blinded to results within the clinic appointment. The results were compared with subsequent diagnostic outcomes. Faecal haemoglobin of <10 µg haemoglobin/g of faeces was considered a negative result. Sensitivities for colorectal cancer (CRC) and combined serious bowel disease (SBD) were calculated using this pre‐determined cut‐off. Results A total of 553 patients were included for analytical comparison with diagnostic outcomes. There were 14 (2.5%) patients with CRC and 52 (9.4%) with SBD. The sensitivities for CRC and SBD were 92.9% (95% CI 68.5%–98.7%) and 76.9% (95% CI 63.9%–86.3%) respectively. 379 (68.5%) patients had a negative FIT result (negative predictive value for CRC was 99.7%). Conclusions This POC FIT device is a useful adjunct to better manage TWW patients. The high observed sensitivity for CRC offers opportunities, within a single consultation, for improved triage and rationalization of investigation for those with bowel symptoms.