Research Fellow in General Surgery at Royal Surrey NHS Foundation Trust, Guildford, UK.
Research Assistant at the Bowel Cancer Screening Hub at Royal Surrey NHS Foundation Trust, Guildford, UK.
Clin Chem Lab Med. 2021 Oct 25;60(1):101-108. doi: 10.1515/cclm-2021-0655. Print 2022 Jan 26.
Faecal immunochemical testing for haemoglobin (FIT) is used to triage patients for colonic investigations. Point-of-care (POC) FIT devices on the market have limited data for their diagnostic accuracy for colorectal cancer (CRC). Here, a POC FIT device is compared with a laboratory-based FIT system using patient collected samples from the urgent referral pathway for suspected CRC.
A prospective, observational cohort study. Patients collected two samples from the same stool. These were measured by POC QuikRead go (Aidian Oy, Espoo, Finland) and laboratory-based FOB Gold Wide (Sentinel Diagnostics, Italy). Faecal haemoglobin <10 μg haemoglobin/g of faeces was considered as negative. At this threshold, comparisons between the two systems were made by calculating percentage agreement and Cohen's kappa coefficient. Proportion of negative results were compared with Chi squared testing. Sensitivities for CRC were calculated.
A total of 629 included patients provided paired samples for FIT to compare the QuikRead go and FOB Gold Wide. The agreement around the negative threshold was 83.0% and Cohen's kappa coefficient was 0.54. The QuikRead go reported 440/629 (70.0% of samples) as negative compared to 523/629 (83.1%) for the FOB Gold Wide, this difference was significant (p-value<0.001). Sensitivities for CRC detection by the QuikRead go and FOB Gold Wide were 92.9% (95% confidence interval (CI): 68.5-98.7%) and 100% (CI: 78.5-100%) respectively.
Both systems were accurate in their ability to detect CRC. Whilst good agreement around the negative threshold was identified, more patients would be triaged to further colonic investigation if using the QuikRead go.
粪便血红蛋白免疫化学检测（FIT）用于对结直肠检查进行患者分诊。市场上的即时检测（POC）FIT 设备在结直肠癌（CRC）的诊断准确性方面数据有限。在此，通过比较用于疑似 CRC 的紧急转介途径中患者采集的样本，将一种 POC FIT 设备与基于实验室的 FIT 系统进行比较。
一项前瞻性、观察性队列研究。患者从同一粪便中采集两份样本。使用即时检测 QuikRead go（Aidian Oy，埃斯波，芬兰）和基于实验室的 FOB Gold Wide（Sentinel Diagnostics，意大利）进行测量。粪便血红蛋白<10μg血红蛋白/g 粪便被认为是阴性。在此阈值下，通过计算百分比一致性和 Cohen's kappa 系数比较两种系统之间的一致性。使用卡方检验比较阴性结果的比例。计算 CRC 的灵敏度。
共纳入 629 例提供 FIT 配对样本的患者，以比较 QuikRead go 和 FOB Gold Wide。阴性阈值周围的一致性为 83.0%，Cohen's kappa 系数为 0.54。QuikRead go 报告 629 个样本中有 440 个（70.0%的样本）为阴性，而 FOB Gold Wide 报告有 523 个（83.1%）为阴性，差异有统计学意义（p 值<0.001）。QuikRead go 和 FOB Gold Wide 检测 CRC 的灵敏度分别为 92.9%（95%置信区间（CI）：68.5-98.7%）和 100%（CI：78.5-100%）。
两种系统在检测 CRC 的能力方面均准确。虽然在阴性阈值周围确定了良好的一致性，但如果使用 QuikRead go，将有更多的患者被分诊到进一步的结直肠检查。
