Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Integrated Diagnostics and Therapeutics, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
Gastroenterology. 2014 Dec;147(6):1317-26. doi: 10.1053/j.gastro.2014.08.043. Epub 2014 Sep 6.
BACKGROUND & AIMS: We investigated whether 2 quantitative fecal immunochemical tests (FITs) with the same cutoff concentration of fecal hemoglobin perform equivalently in identifying patients with colorectal cancer (CRC).
A total of 956,005 Taiwanese subjects, 50 to 69 years old, participated in a nationwide CRC screening program to compare results from 2 FITs; 78% were tested using the OC-Sensor (n = 747,076; Eiken Chemical Co, Tokyo, Japan) and 22% were tested using the HM-Jack (n = 208,929; Kyowa Medex Co Ltd, Tokyo, Japan), from 2004 through 2009. The cutoff concentration for a positive finding was 20 μg hemoglobin/g feces, based on a standardized reporting unit system. The tests were compared using short-term and long-term indicators of performance.
The OC-Sensor test detected CRC in 0.21% of patients, with a positive predictive value of 6.8%. The HM-Jack test detected CRC in 0.17% of patients, with a positive predictive value of 5.2%. The rate of interval cancer rate was 30.7/100,000 person-years among subjects receiving the OC-Sensor test and 40.6/100,000 person-years among those receiving the HM-Jack test; there was significant difference in test sensitivity (80% vs 68%, P = .005) that was related to the detectability of proximal CRC. After adjusting for differences in city/county, age, sex, ambient temperature, and colonoscopy quality, significant differences were observed between the tests in the positive predictive value for cancer detection (adjusted relative risk = 1.29; 95% confidence interval, 1.14-1.46) and the rates of interval cancer (0.75; 95% confidence interval, 0.62-0.92). Although each test was estimated to reduce CRC mortality by approximately 10%, no significant difference in mortality was observed when the 2 groups were compared.
Different brands of quantitative FITs, even with the same cutoff hemoglobin concentration, perform differently in mass screening. Population-level data should be gathered to verify the credibility of quantitative laboratory findings.
我们旨在探究两种血红蛋白粪便免疫化学定量检测（FIT）在识别结直肠癌（CRC）患者方面是否具有相同的检测效能，这两种检测的粪便血红蛋白检测临界值浓度相同。
共有 956005 名年龄在 50 至 69 岁之间的台湾受试者参加了一项全国性 CRC 筛查计划，用以比较两种 FIT 检测的结果；其中 78%的受试者使用 OC-Sensor（n = 747076；Eiken Chemical Co，东京，日本）进行检测，22%的受试者使用 HM-Jack（n = 208929；Kyowa Medex Co Ltd，东京，日本）进行检测，检测时间为 2004 年至 2009 年。阳性发现的检测临界值设定为 20 μg 血红蛋白/g 粪便，基于标准化报告单位系统。使用短期和长期性能指标来比较这两种检测方法。
OC-Sensor 检测出 0.21%的患者患有 CRC，阳性预测值为 6.8%。HM-Jack 检测出 0.17%的患者患有 CRC，阳性预测值为 5.2%。接受 OC-Sensor 检测的受试者中间隔期癌症发生率为 30.7/100000 人年，接受 HM-Jack 检测的受试者中间隔期癌症发生率为 40.6/100000 人年；检测灵敏度存在显著差异（80%比 68%，P =.005），这与近端 CRC 的可检测性有关。调整城市/县、年龄、性别、环境温度和结肠镜检查质量的差异后，两种检测方法在癌症检出的阳性预测值（调整后的相对风险 = 1.29；95%置信区间，1.14-1.46）和间隔期癌症发生率（0.75；95%置信区间，0.62-0.92）方面存在显著差异。尽管两种检测方法均估计可使 CRC 死亡率降低约 10%，但比较两组时未观察到死亡率的显著差异。
不同品牌的定量 FIT 检测，即使临界值血红蛋白浓度相同，在大规模筛查中的表现也不同。应收集人群水平的数据来验证定量实验室检测结果的可信度。
