Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clinic, C/Villarroel 170, 08036 Barcelona, Spain.
Gastroenterology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain; and IDIBAPS, CIBERehd, Barcelona, Spain.
Clin Chem Lab Med. 2018 Mar 28;56(4):625-633. doi: 10.1515/cclm-2017-0605.
An evaluation of SENTiFIT® 270 (Sentinel Diagnostics, Italy; Sysmex, Spain) analyser for the quantitation of faecal haemoglobin (f-Hb) was performed.
The analytical imprecision, linearity, carry over and f-Hb stability were determined. Evaluation of the diagnostic accuracy was performed on 487 patients.
Within-run and between-run imprecision ranged 1.7%-5.1% and 3.8%-6.2%, respectively. Linearity studies revealed a mean recovery of 101.1% (standard deviation, 6.7%) for all dilutions. No carry over was detected below 7650 μg Hb/g faeces. Decay of f-Hb in refrigerated samples ranged 0.2%-0.5% per day. f-Hb in patients with advanced colorectal neoplasia (ACRN) (colorectal cancer [CRC] plus advanced adenoma [AA]) were significantly higher than from those with a normal colonoscopy. Sensitivity for ACRN at f-Hb cutoffs from 10 to 60 μg Hb/g faeces ranged from 28.9% (95% confidence interval [CI], 21.7%-37.2%) to 46.5% (95% CI, 38.1%-55%), the specificity ranged from 85% (95% CI, 82.3%-87.3%) to 93.2% (95% CI, 91.2%-94.8%), positive predictive values for detecting CRC and AA ranged from 11.6% (95% CI, 7.6%-17.2%) to 20.6% (95% CI, 13.3%-30.3%) and from 34.7% (95% CI, 28.1%-42%) to 42.3% (95% CI, 32.4%-52.7%), respectively, and the negative predictive value for ACRN ranged from 90.2% (95% CI, 87.9%-92.2%) to 88.4% (95% CI, 86%-90.4%). Using two samples per patient sensitivity increased with a slight decrease in specificity.
The analytical and clinical performances of SENTiFIT assay demonstrate a specific and accurate test for detecting ACRN in symptomatic patients and those undergoing surveillance.
对 SENTiFIT® 270（Sentinel Diagnostics，意大利；Sysmex，西班牙）分析仪定量检测粪便血红蛋白（f-Hb）进行了评估。
测定分析精密度、线性、携带污染和 f-Hb 稳定性。对 487 例患者进行了诊断准确性评估。
批内和批间精密度分别为 1.7%-5.1%和 3.8%-6.2%。线性研究显示，所有稀释度的平均回收率为 101.1%（标准差为 6.7%）。低于 7650 μg Hb/g 粪便时未检测到携带污染。冷藏样本中 f-Hb 的衰减率为每天 0.2%-0.5%。患有晚期结直肠肿瘤（ACRN）（结直肠癌[CRC]加高级腺瘤[AA]）的患者的 f-Hb 明显高于结肠镜检查正常的患者。在 f-Hb 截断值为 10-60 μg Hb/g 粪便时，ACRN 的灵敏度范围为 28.9%（95%置信区间[CI]，21.7%-37.2%）至 46.5%（95%CI，38.1%-55%），特异性范围为 85%（95%CI，82.3%-87.3%）至 93.2%（95%CI，91.2%-94.8%），检测 CRC 和 AA 的阳性预测值分别为 11.6%（95%CI，7.6%-17.2%）至 20.6%（95%CI，13.3%-30.3%）和 34.7%（95%CI，28.1%-42%）至 42.3%（95%CI，32.4%-52.7%），ACRN 的阴性预测值范围为 90.2%（95%CI，87.9%-92.2%）至 88.4%（95%CI，86%-90.4%）。每位患者使用两个样本可提高灵敏度，同时特异性略有下降。
SENTiFIT 检测法的分析和临床性能证明，该检测法是一种针对有症状患者和接受监测的患者检测 ACRN 的特异性和准确性检测方法。
