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 of CRC. A number of quantitative point-of-care (POC) FIT systems marketed for professional use and intended for use in a clinical setting are available. Here we reviewed the POC FIT systems available; three (Eurolyser Cube, OC-Sensor iO and QuikRead go) were evaluated to assess their performance against manufacturers’ claims and suitability for use in a clinical setting.

Methods The analytical evaluation of the POC FIT systems was undertaken using Hb lysates, patient samples and an external quality assessment sample. The evaluation focused on linearity, recovery, imprecision, prozone effect, Hb variant detection and suitability for use in a clinical setting.

Results: All three POC FIT systems performed to their manufacturer’s claims and demonstrated good analytical performance with acceptable linearity, recovery, within- and between-run imprecision. The QuikRead go and OC-Sensor iO were able to accurately detect samples with results above their measuring range. However, because of a prozone effect the Eurolyser Cube gave falsely low results when using high concentrations of Hb. The QuikRead go performed best in the usability assessment due to portability and timeliness of result.

Conclusion: Each system performed according to their manufacturers’ claims. The QuikRead go and OC-Sensor iO are suitable for use. The Eurolyser Cube is not recommended because of the risk of falsely low results.

背景：粪便免疫化学测试（FIT）检测到粪便中是否存在血红蛋白（Hb）。它被用作结肠直肠癌（CRC）的筛查工具，并且越来越多地用于对出现CRC症状的患者进行分类。市场上有许多用于专业用途且打算在临床环境中使用的定量即时护理（POC）FIT系统。在这里，我们回顾了可用的POC FIT系统；对三个产品（Eurolyser Cube，OC-Sensor iO和QuikRead go）进行了评估，以评估其针对制造商的性能。声明及其在临床环境中的适用性。

方法使用Hb裂解物，患者样本和外部质量评估样本对POC FIT系统进行分析评估。评估集中在线性，恢复，不精确性，前区效应，Hb变异检测以及在临床环境中的适用性。

结果：三种POC FIT系统均按照制造商的要求进行操作，并显示出良好的分析性能，具有可接受的线性，回收率，批内和批间不精确度。QuikRead go和OC-Sensor iO能够准确检测样品，且结果超出其测量范围。但是，由于前区效应，使用高浓度的Hb时，Eurolyser Cube的结果错误地低。由于可移植性和结果的及时性，QuikRead go在可用性评估中表现最佳。

结论：每个系统都根据其制造商执行？索赔。适合使用QuikRead go和OC-Sensor iO。不建议使用Eurolyser Cube，因为这样可能会导致错误的结果。