Assessment of the analytical performance of point-of-care faecal immunochemical tests for haemoglobin

Background The faecal immunochemical test (FIT) detects the presence of haemoglobin (Hb) in faeces. It is used as a screening tool for colorectal cancer (CRC) and increasingly to triage patients presenting with symptoms CRC. A number quantitative point-of-care (POC) FIT systems marketed professional use intended clinical setting are available. Here we reviewed POC available; three (Eurolyser Cube, OC-Sensor iO QuikRead go) were evaluated assess their performance against manufacturers’ claims suitability setting. Methods analytical evaluation was undertaken using Hb lysates, patient samples an external quality assessment sample. focused on linearity, recovery, imprecision, prozone effect, variant detection Results All performed manufacturer’s demonstrated good acceptable within- between-run imprecision. go able accurately detect results above measuring range. However, because effect Eurolyser Cube gave falsely low when high concentrations Hb. best usability due portability timeliness result. Conclusion Each system according claims. suitable use. not recommended risk results.